HTM 02 01 Part A
HTM 02 01 Part A
HTM 02 01 Part A
verification
Medical gases
Health Technical Memorandum
02-01: Medical gas pipeline
systems
Part A: Design, installation, validation
and verification
IS B N 0 -1 1 -3 2 2 7 4 2 -6
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Description This document covers piped medical gases, medical and surgical
air, and medical vacuum installations. It applies to all medical gas
pipeline systems installed in healthcares premises. Anaesthetic gas
scavenging and disposal system are included. Specifically, it deals
with issues in the design, installation, validation and verification
(testing and commissioning) of the MGPS.
ii
Preface
About Health Technical Memoranda main source of specific healthcare-related guidance for
estates and facilities professionals.
Engineering Health Technical Memoranda (HTMs) give
comprehensive advice and guidance on the design, The new core suite of nine subject areas provides access to
installation and operation of specialised building and guidance which:
engineering technology used in the delivery of healthcare. • is more streamlined and accessible;
The focus of HTM guidance remains on healthcare- • encapsulates the latest standards and best practice in
specific elements of standards, policies and up-to-date healthcare engineering;
established best practice. They are applicable to new and
existing sites, and are for use at various stages during the • provides a structured reference for healthcare
whole building lifecycle: engineering.
Figure 1 Healthcare building life-cycle
DISPOSAL CONCEPT
RE-USE
DESIGN & IDENTIFY
OPERATIONAL OPERATIONAL
MANAGEMENT REQUIREMENTS
Ongoing SPECIFICATIONS
MAINTENANCE TECHNICAL & OUTPUT
Review
PROCUREMENT
COMMISSIONING
CONSTRUCTION
INSTALLATION
Healthcare providers have a duty of care to ensure that Structure of the Health Technical
appropriate engineering governance arrangements are in
Memorandum suite
place and are managed effectively. The Engineering
Health Technical Memorandum series provides best The new series of engineering-specific guidance contains
practice engineering standards and policy to enable a suite of nine core subjects:
management of this duty of care. Health Technical Memorandum 00
It is not the intention within this suite of documents to Policies and principles (applicable to all Health
unnecessarily repeat international or European standards, Technical Memoranda in this series)
industry standards or UK Government legislation. Where Health Technical Memorandum 01
appropriate, these will be referenced. Disinfection and sterilization
Healthcare-specific technical engineering guidance is a Health Technical Memorandum 02
vital tool in the safe and efficient operation of healthcare Medical gases
facilities. Health Technical Memorandum guidance is the
iii
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
iv
Executive summary
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
vi
Acknowledgements
vii
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Contents
Preface
Executive summary
Acknowledgements
Chapter 1 Scope page 1
Guidance in this document
Other guidance
Chapter 2 General principles page 2
Introduction
Quality requirements for medical gases and air
Sources of supply
Sizing information for gas supply sources
Pipeline distribution system design
Safety
Installation/supply of equipment/maintenance
Modifications
Removal of pipework
Validation and verification
General fire precautions
Electricity supply to medical gas installations
Chapter 3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels
and LVAs page 10
General
Terminal units
Terminal units for helium/oxygen mixture
Nitrogen for surgical tools
AVSUs
Local alarm indicator panels
LVAs
Specific labelling requirements
Chapter 4 Gas flow page 22
General
Terminal unit flows
Pipeline flows
Oxygen
Hyperbaric oxygen chambers
Nitrous oxide
Nitrous oxide/oxygen mixture
Air
Vacuum
Helium/oxygen mixture
Anaesthetic gas scavenging systems
viii
Contents
ix
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Contents
xi
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
xii
1 Scope
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
2 General principles
Introduction Note
2.1 An MGPS is designed to provide a safe and
Portable suction devices should be used in infectious
effective method of delivering medical gases,
disease units.
medical air and surgical air from the source of
supply to the appropriate terminal unit by means of
a pipeline distribution system. Medical vacuum is
Quality requirements for medical gases
also provided by means of a pipeline system. and air
Anaesthetic gas scavenging disposal systems are 2.8 Medical gases supplied from cylinder or liquid
provided to control occupational exposure to waste sources comply with the appropriate sections of the
anaesthetic gases and agents. current edition of the European Pharmacopoeia
2.2 It is essential to ensure that there is no possibility of (Ph. Eur.). The Ph. Eur. also specifies the approved
a cross-connection between any system and that all testing methods to be adopted for gas identity.
parts of each system to which connections can be 2.9 The quality specification for medical, surgical and
made by users are gas-specific. synthetic air, and oxygen-enriched air produced
2.3 Dental compressed air and vacuum systems have from a pressure swing adsorber (PSA) system, is as
differing requirements, and these are covered given in Table 29. The medical air and synthetic air
in Health Technical Memorandum 2022 should also comply with the appropriate sections of
Supplement 1 – ‘Dental compressed air and the current edition of the current edition of the Ph.
vacuum systems’. Eur. (see Table 30).
2.4 During the installation stage, extensive tests are 2.10 The quality of piped medical compressed air, and
carried out to verify that there is no cross- the particulate content, dryness and concentration
connection. of impurities should comply with the requirements
for maximum concentrations given in Table 30.
2.5 Medical gas systems may be extended to those Information on testing procedures is given in
departments where respiratory equipment or Chapter 15 “Validation and verification”.
surgical tools are serviced, such as in electronic and
biomedical equipment (EBME) workshops and 2.11 Bacteria filters should be included in medical and
sterile services departments (SSDs). Specific surgical compressor systems to reduce the risk of
additional uses of air systems are covered in delivering spores or other infectious material to
Chapters 7 and 8. vulnerable patients.
2.6 MGPS should not be used to supply pathology 2.12 Micro-organisms can penetrate a bacteria filter if
departments, general workshops or mechanical the material is wet. Therefore it is essential that the
services. dryness of the medical air supplied to a bacteria
filter is checked regularly (at least every three
2.7 Separate installations should be provided for months) at the test point, using the test equipment
pathology and general laboratories and workshops, specified in Chapter 15.
although it is recommended that they be
constructed to the same specification as MGPS.
They should not be provided with medical gas
Sources of supply
terminal units. 2.13 Both BS EN 737-3:2000 and ISO 7396-1:2002
propose that all medical gas supplies should
comprise three sources of supply identified as
“primary”, “secondary” and “reserve”, although the
2 General principles
latter is more commonly referred to as a third 2.15 Regardless of these classification differences,
means of supply. The supply system should be the choice of central source will be defined by
designed to achieve continuity of supply to the the ability of the source not only to provide a
terminal units in normal condition and in a single continuous supply of gas over a range of possible
fault condition. A single fault condition is where a flow rates but also to offer security of supply by
single means for protection against a safety hazard virtue of adequate capacity.
in equipment is defective or a single external
2.16 For these reasons, types, capacities and locations of
abnormal condition is present. Loss of supply
primary, secondary and reserve sources of supply
due to maintenance of a supply source (or a
will be based on both system design parameters and
component within it) is not considered a single
the need for supply security, identified by a risk
fault condition.
assessment during the planning stage. Security of
2.14 Comparing this Health Technical Memorandum medical air supplies must be given a high priority.
with the above Standards will reveal a different Total electrical failure must not be allowed to
classification of, for example, individual banks of a jeopardise supplies, and all medical air systems
cylinder manifold. Whereas EN 737-3:2000 refers must be supported by an appropriate fully-
to the separate banks of an automatic manifold as automatic manifold. Tables 1–9 describe the
primary and secondary supplies, this Health various options for gas supply. For each, the
Technical Memorandum classifies such a manifold primary, secondary and reserve sources are
as a primary supply, that is, one single operating identified.
unit.
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
2 General principles
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
In these circumstances, care should be taken to ensure that appropriate backflow protection (or non-return valves) are used to
protect the system from failure of either manifold.
j. Manifolds supporting medical air, surgical air and PSA systems should be sited remotely from the compressor systems.
Appropriate backflow protection should be provided, as above.
k. Where practicable, a valved by-pass arrangement around compressor and VIE-plant non-return valves should be installed to
permit valve replacement without plant shutdown.
m. Fitting non-return valves one pipe size larger will reduce flow resistance, if this is shown to be a critical factor in system design.
n. All sources of supply should be fitted with a test point comprising weatherproof terminal unit and lockable isolating valve.
p. Where medical air is provided by multiple, locally-sited regulators fed from a combined surgical and medical air distribution
system, it will be impracticable to connect supporting manifolds at each regulating station. In this situation, extra care should
be taken to ensure that the third means of supply is able to support both systems simultaneously. Consideration should be given
to additional manifolds sited to support medical air supplies to critical care areas.
2 General principles
a. Automatic manifolds are generally expected to hold • the specification of a system that (with the
a minimum of two days’ supply on each bank. exception of liquid oxygen systems which may
include a secondary vessel) has duplicate
b. Sufficient cylinders for changing one complete components;
bank should be stored in the manifold room for
all gases except nitrous oxide/oxygen mixture, for • the provision of a third means of supply for all
which two complete changes should be stored in systems except vacuum;
the manifold room. • the provision of alarm systems; and
c. Sufficient additional cylinders should be held in the • connection to the emergency power supply
medical gas store to ensure continuous supply for system.
one week.
2.26 Surgical air systems are not considered to be
life-support systems and therefore duplicate
Pipeline distribution system design components are not normally required; an
2.19 The following general information is required to emergency/secondary supply is provided.
design an MGPS:
2.27 Quality of supply is achieved by the use of gases
a. schedule of provision of terminal units; purchased to the appropriate Ph. Eur. requirements
b. design flow rates and pressure requirements at or produced by plant performing to specific
each terminal unit; standards, by the maintenance of cleanliness
throughout the installation of the system, and by
c. diversified flows for each section of the pipeline the implementation of the various testing and
system; commissioning procedures.
d. total flow.
Installation/supply of equipment/
2.20 Guidance on deriving and calculating the above
parameters is given in Chapters 3 and 4 of this maintenance
Part. 2.28 The installation of an MGPS should be carried out
2.21 The definition of “departments”, which may
only by specialist firms registered to BS EN ISO
comprise several wards, treatment rooms etc, 9001:2000/BS EN ISO 13485:2003 with the scope
should be agreed at the project design stage to of registration appropriately defined.
avoid confusion.
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
2 General principles
Resilience of supply 2.45 Care should be taken when installing both electrical
systems and medical pipeline systems to avoid
2.39 Medical gas pipeline systems, associated equipment
occasional contact between pipework and electrical
and alarms are a critical service within a healthcare
cables, conduit or trunking. When physical
establishment. Due consideration should be given
separation is impractical or contact with extraneous
to ensure the continuity of service under mains
metalwork occurs (for example where the pipeline
power failure conditions.
is carried in metal partitions or where terminal
2.40 Medical gas equipment should be supplied from units are mounted on metal bed-head units),
a dedicated, final sub-circuit which is considered the pipeline should be effectively bonded to the
“essential” within the electrical distribution strategy. metalwork in accordance with BS 7671 wiring
Alternative means of supply should be considered regulations.
in the event that internal sub-distribution is
2.46 The final connection to any equipment (for
compromised.
example alarm panels or control panels) should be
2.41 In the event of power failure or interruption, all made using an unswitched fused connection unit;
systems should continue to function as they did a double-pole switch should be available to permit
before the interruption occurred. For example, work on the equipment.
except for automatic cycling compressors, dryers,
2.47 Where electrical systems and medical gas pipeline
pumps etc, the same compressor and dryer (or
systems are enclosed in a boom, rigid pendant or
vacuum pump) set should be on-line, and for
multi-purpose-type enclosure, care should be taken
manifold systems the same bank should be
to ensure that low voltage (LV), extra-low voltage
running.
(ELV) and communications and data systems are
2.42 All electrical systems, including plant control maintained together but separate from pipeline
systems, alarm interfaces etc, should be designed in systems. There should be no access to unprotected
accordance with electromagnetic compatibility live parts within the pendant except by the use of a
(EMC) directives. For further details, see the tool.
“EMC section” within Health Technical
Memorandum 06-01. Earthing
2.43 It is important that operational managers and 2.48 Medical gas pipelines should be bonded together
designers are fully aware of stand-by electrical and bonded to the local electrical distribution
supply arrangements and availability and that plans board in accordance with BS 7671 wiring
are available to deal with the total loss of electricity regulations. The pipelines should not in themselves
under adverse circumstances. be used for earthing electrical equipment.
2.49 Flexible pipeline connections, wherever used,
Electrical installation
should be bonded across the fixed points to ensure
2.44 Wiring systems for medical gas installations should earth continuity.
be selected in accordance with BS 7671 wiring
2.50 Where a medical gas outlet or pipeline system is
regulations with particular regard to the
present within a group 2 location as defined by IEE
environment and risk from mechanical damage.
Guidance Note 7 – ‘Medical locations’, care must
In this regard, PVC-insulated MICS (mineral-
be taken to ensure the resistance of the bonding
insulated copper-sheathed) cable for external/
connection is in accordance with the required
internal locations and heat-rated singles cable in
value.
galvanised conduit for plantrooms are considered
suitable. For large equipment, fire-rated SWA (steel
wire armoured) cable may be appropriate.
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
a. floor-mounted terminal units; 3.7 The terminal unit (AGS) is specified in ISO 7396.
AGSS are covered in Chapter 10.
10
3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels and LVAs
11
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
350 L/min – but this can be up to 100 kPa when b. the distance between the centre of the terminal
connected via a ceiling NIST (non-interchangeable unit and a potential obstruction on either side
screw thread) connector and 5 m of hose.) (for example when installed in a corner) should
be a minimum of 200 mm on either side;
3.16 Terminal units that are wall mounted should be
located as follows (see Figure 2): c. care should be taken to ensure that connected
medical gas equipment and hoses do not foul
a. distance between centres of adjacent horizontal
other nearby equipment and services during use.
terminal units:
Particular attention should be given to terminal
(i) 135 ± 2.5 mm for three or more terminal unit positioning with respect to worktops,
units; electrical sockets, cupboards, equipment rails,
(ii) 150 ± 2.5 mm for two terminal units only; ventilation flaps and door openings. A
minimum radial clearance of at least 200 mm
from these items is suggested, but this may have
Note
to be increased depending on the nature of
To promote a more “domestic” environment, some connected equipment.
in-patient accommodation is provided with terminal
units installed in recesses behind covers/decorative Terminal units for helium/oxygen
panels etc. To accommodate this it is necessary to allow
an additional 100 mm on each side of the outermost
mixture
terminal units and 200 mm from centre to top of 3.17 BS EN 737-1:1998 does not include a terminal
recess and 300 mm from centre to bottom of recess. unit for helium/oxygen mixture. They will be
The depth of the recess should be 150 mm. The included in a new edition of BS 5682:1998.
surface should be clearly marked with suitable legend
denoting medical equipment is installed within.
400 mm
TU separation
135 mm ± 2.5 mm
between centres,
Terminal unit mounting for 3 or more TUs
height range
900–1600 mm
above FFL
700 mm TU centreline
(Recommended range
900–1400 mm 200 mm (min)
above FFL) from side walls
TU separation
150 mm ± 2.5 mm
between centres,
for 2 TUs only
900 mm
12
3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels and LVAs
PANEL
800 mm
Mounting height
range for AVSUs Mounting height 1800 mm
1000–1800 mm range for local alarm
(1000 mm is the panel
optimum height: 1000–1800 mm
when multi-circuits
are installed, it may 1000 mm Recommended
be necessary to (800 mm) location –
reduce this to Nurse base
800 mm to avoid
too many columns)
13
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
14
Table 11 Provision of terminal units, AVSUs and local alarms
Department O2 N2O N2O/O2 MA4 SA7 VAC AGSS He/O2 AVSU Alarm
Accident and Emergency 1 set (1) 1 set hp/lp (9)
Resuscitation room, per trolley space 2 2 – 2 – 2 2 – 2 sets*
Note: One set either side of the trolley space, if installed in
fixed location, eg trunking; or both sets in an articulated supply
pendant that can be positioned either side of the bed space.
3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels and LVAs
Major treatment/plaster room per trolley space 1 1 1p 1 1p 1 1 – 1 set/8 TUs
Post-anaesthesia recovery per trolley space 2 – – 2 – 2 – – 2 sets*
Note: One set either side of the trolley space, if installed in
fixed location, eg trunking; or both sets in an articulated supply
pendant that can be positioned either side of the bed space.
Treatment room/cubicle 1 – – – – 1 – – 1 set/8 TUs
Operating department 1 set (1)
Anaesthetic rooms (all) 1 1 – 1 – 1 1 –
Operating room, orthopaedic:
For anaesthetist 2 1 – 2 – 2 1 – 1 set per suite 1 set per suite
(2)(3) hp/lp (10)
For surgeon – – – – 4 2 – – –
–
Note: Orthopaedic surgery is normally performed in operating
rooms provided with ultra-clean systems. Such systems are much
more effective in terms of airflow when provided with partial
walls. These walls may be effectively used to include terminal
units that can be supplied by rigid pipework. Such installations
do not suffer from excessive pressure loss when surgical air is
required at high flows.
Operating room, neurosurgery
Anaesthetist 2 1 – 2 – 2 1 – 1 set per suite 1 set per suite
(2)(3) hp/lp (10)
Surgeon – – – – 2 2 – –
Note: If multi-purpose pendants are used, there may be some
loss of performance of surgical tools because of bore restrictions
and convolution of the flexible connecting assemblies at the
articulated joints.
15
16
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Department O2 N2O N2O/O2 MA4 SA7 VAC AGSS He/O2 AVSU Alarm
Operating room, general surgery etc
Anaesthetist/surgeon (see (14) regarding CO2) 2 2 – 2 2p 2 2 – 1 set per suite 1 set per suite
(2)(3) hp/lp (10)
Note: Terminal units installed in separate pendants: p = project
team option where some orthopaedic overspill surgery may be
performed.
Post-anaesthesia recovery, per bed space 2 – – 2 – 2 – – 2 sets* (5) 1 alarm for both
sets of AVSUs (11)
Note: One set either side of the bed space, if installed in fixed
location, eg trunking; or both sets in an articulated supply
pendant that can be positioned either side of the bed space.
Equipment service room per work space 1 1 – 1 1 1 1 – 1 set 1 set hp/lp (12)
Maternity department 1 set (1) 1 set (9)
LDRP room (normal/abnormal) 1 set per 6–8
rooms (5)
Mother 1 – 1 – – 2 – –
Baby (per cot space) (allow for 2 cots only) 1 – – 1 – 1 – –
Operating suite:
Anaesthetist 1 1 – 1 – 1 1 – 1 set 1 set hp/lp (10)
Obstetrician – – – – – 2 – –
Paediatrician (per cot space) (allow for 2 cots only) 1 – – 1 – 1 – –
Post-anaesthesia recovery (per bed space) 1 – – 1 – 1 – – 1 set 1 set (11)
Equipment service room** per work space 1 1 1 1 – 1 1 – 1 set 1 set (12)
Neonatal unit, per cot space 2 – – 2 – 2 – – 2 sets* 1 for both sets of
AVSUs (11)
Note: One set either side of the bed space, if installed in fixed
location, eg trunking; or both sets in an articulated supply
pendant that can be positioned either side of the bed space.
Equipment service room** per work space 1 – – 1 – 1 – – 1 set 1 set (12)
In-patient accommodation:
Single bed room 1 – – – – 1 – – 1 set for ward 1 set (11)
unit
Multi-room, per bed space 1 – – – – 1 – –
Nursery, per cot space 1 – – – – 1 – –
Provision for 2 cots only irrespective of number of cot spaces
Department O2 N2O N2O/O2 MA4 SA7 VAC AGSS He/O2 AVSU Alarm
Diagnostics departments 1 set (1) 1 set (9)
3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels and LVAs
Urography 1 – – – – 1 – – 1 set
Tomography 1 – – – – 1 – – 1 set
Magnetic resonance imaging (MRI) suite 1 1 – 1 – 1 1 – 1 set 1 set (10)
CAT room 1 1 – 1 – 1 1 – 1 set 1 set (10)
Angiography 1 1 – 1 – 1 1 – 1 set 1 set (10)
Endoscopy 1 1 – 1 – 1 1 – 1 set 1 set (10)
Lineac bunkers 1 1 – 1 – 1 1 – 1 set 1 set (10)
General purpose rooms 1 – – – – 1 – –
In-patient accommodation 1 set for the
ward unit (1)
Single-bed room 1 – – 1 – 1 – – 1 set (11)
1 – – 1 – 1 – –
Multi-bed room, per bed space 1 – – 1 – 1 – –
Treatment room
(Appropriate for adult acute, children and the elderly) 1 – – 1 – 1 – –
Renal
Per dialysis station 1 – – 1 – 1 – –
Per bed space 1 – – 1 – 1 – –
Critical care area 1 set (1) 1 set (11)
Per bed space 4 2p 2p 4 4 2p 2p 2 sets* (4)
Note: One set either side of the bed space, if installed in fixed
location, eg trunking; or both sets in an articulated supply
pendant that can be positioned either side of the bed space.
Equipment service room, per work space 1 1p 1p 1 1 1p 1 set 1 set (12)
Coronary care unit (CCU)
Per bed space 4 4 4 2 sets* (4)(6)(7) 1 for both sets of
17
AVSUs (11)
18
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Department O2 N2O N2O/O2 MA4 SA7 VAC AGSS He/O2 AVSU Alarm
High dependency unit (HDU)
Per bed space 4 4 4 2 sets* (4)(6)(7) 1 for both sets of
AVSUs (11)
Burns unit 2 2p 2p 2 2 2p 2 sets* (4)(6)(7) 1 for both sets of
AVSUs (11)
Adult mental illness accommodation 1 set (1)
Electro-convulsive therapy (ECT) room 1 1 1 1 1 1 set (2) 1 set hp/lp (10)
Post-anaesthesia recovery, per bed space 1 1 1 1 set (1) 1 set (11)
Adult acute day care accommodation 1 set
Treatment room:
Anaesthetist 1 1p 1p 1 1p 1 set 1 set hp/lp
Surgeon 2 if (p) (10)
Post anaesthesia recovery, per bed space 1 1p 1 1 set 1 set (11)
Day patient accommodation 1 set (1)
3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels and LVAs
logical number.
** Where the delivery and neonatal units are in close proximity, the equipment service
(9) Installed in reception area.
room can be shared.
(10) Installed in the operating room in the “main panel” or within the room, or an
† Dental vacuum only.
ante-room, eg control room of an MRI device.
p = Project team option.
(11) Installed at the main staff base (nurses’ station).
hp/lp = high-pressure and low-pressure alarms for oxygen, medical air and nitrous oxide
(12) Installed in the room space with the AVSUs.
when installed together. All other local alarms, low pressure only.
(13) Separate AVSUs will be required if endoscopy room is included.
(1) Departmental AVSUs installed on the hospital street side of fire compartment
doors. (14) Carbon dioxide is used for insufflation during some surgical procedures. A
pipeline installation is a project team option and is covered in Chapter 11. Two
(2) Installed immediately outside the room.
NIST connector bodies units should be installed.
(3) Where air is used to control movable pendant fittings, it should be taken from the
General:
7 bar surgical air system.
Normally, departmental AVSUs would be installed at the hospital street side of the
(4) In addition to the dual circuits, additional AVSUs will be required to sub-divide the
entrance doors to a department and would reflect the method of horizontal evacuation
number of terminal units controlled. This subdivision should be based on the layout
in the event of an emergency. In some large departments, for example an operating
of the accommodation; for example, if the recovery area is divided into a number of
department, the clean-service corridor is likely to cross one or more fire compartment
separate room/areas, each would have a separate sub-set (see Figures 4 and 5).
walls. Additional AVSUs may therefore be required to reflect the evacuation route.
(5) This is intended to provide some flexibility and the exact number will depend on
If a department includes one or more floors, a set of AVSUs should be provided for
the total number of rooms within the department.
each floor, which will act as emergency overall fire valves.
(6) If a high-dependency unit is included within general in-patient accommodation,
AVSUs for zones within critical care areas should be located where they can be seen by
a separate set of AVSUs should be provided for the unit. In addition to the
staff – not necessarily at the staff base.
departmental valves or the ward as a whole, an additional set will be required to
control the single-bed, multi-bed and treatment rooms. Local alarms within critical care areas should be provided for the individual space; that
is, if a critical care area of, say, 18 beds is sub-divided into three separate six-bed wards,
(7) Department AVSUs may be required if the units are large and separate from, for
there should be one alarm only for each space (not one for each of the dual circuits).
example, the critical care area.
19
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Figure 4 Larger critical care area with isolation room and twin four-bed bays
Terminal
units
Bed 1 Bed 2 Bed 3 Bed 4
4 Bed Bay 1
AVSU
AVSU
Pressure
switch
AVSU AVSU
4 Bed Bay 2
Isolation Unit
20
3 Provision of terminal units, and the location of AVSUs, local alarm indicator panels and LVAs
Figure 5 Smaller critical care area with isolation room and five-bed bay
Terminal
units
Bed 1 Bed 2 Bed 3
Pressure
AVSU switch
location (b)
5 Bed Bay
Pressure
switch (a)
Isolation Unit
Note:
Pressure switch location is decided as follows:
21
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
4 Gas flow
22 22
4 Gas flow
Figure 6 T
ypical pressures in medical air/oxygen/nitrous oxide/nitrous oxide-oxygen mixture systems
under design flow conditions
Local alarm pressure switch
setting 360 kPa
23
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Figure 8 T
ypical pressures in a single pressure reduction surgical air system under design flow
conditions
Local alarm pressure switch
setting 650 kPa
Plant outlet pressure (dynamic) 850 kPa Maximum static pressure 950 kPa
Figure 9 T
ypical pressures in a double pressure reduction surgical air system under design flow
conditions
Local alarm pressure switch
setting 650 kPa
24
4 Gas flow
of the nominal pipeline pressure (see Figures 6–9, operating room and anaesthetic room should be
and Appendix G). able to pass 100 L/min. It is unlikely that an
oxygen flush will be administered simultaneously in
4.11 Pressure requirements for surgical air are based on
several operating rooms. The diversified flow Q is
the requirement that the minimum pressure should
based on 100 L/min for the first operating room
be 700 kPa at the terminal unit at a flow of 350 L/
and 10 L/min for the remainder. To obtain the
min.
flow to each operating suite, add together the flows
4.12 Details of pressure requirements for all systems are for the operating and anaesthetic room, that is,
described in paragraphs 4.43–4.50. 110 L/min.
4.19 For anaesthetic rooms, each terminal unit should
Oxygen be capable of passing 100 L/min (it may be
necessary to use oxygen “flush”), but the actual flow
In-patient accommodation
likely to be used is 6 L/min or less. As it is unlikely
4.13 Oxygen is used at a typical flow of 5–6 L/min. that a patient would be anaesthetised at the same
Each terminal unit should, however, be capable of time that a patient in the associated operating room
passing 10 L/min (at standard temperature and was continuing to be treated under an anaesthetic
pressure (STP)) at a supply pressure of 400 kPa (and because the duration of induction is short),
(nominal) as shown in Table 12, in case nebulisers no additional flow is included.
or other respiratory equipment are used. Table 13
4.20 In recovery, it is possible that all bed spaces may be
contains the formula for arriving at diversified
in use simultaneously; hence, no diversity is used.
flows.
4.14 For a 28-bed ward unit comprising single and four- Critical care, coronary care and high-dependency
bed rooms and a treatment room, the diversified units
flow is calculated on the assumption that one bed 4.21 The flow for these units assumes that, although all
space requires 10 L/min, and one in four of the bed spaces may be occupied, three-quarters of these
remainder require 6 L/min. For the purpose of pipe will require the use of oxygen. Each terminal unit
size selection, the diversified flow at entry to the should be capable of delivering 10 L/min. The
ward is taken as 50 L/min (strictly 50.5 L/min); it diversified flow is calculated assuming 10 L/min for
is assumed that a patient will use oxygen in a ward the first bed space and 6 L/min for three-quarters
or in the treatment room but not both. of the remainder.
4.15 When selecting the size of a sub-branch serving, for
4.22 Oxygen should not be used as the driving gas for
example, a four-bed ward, the flow would be taken gas-powered ventilators if they are capable of being
to be 28 L/min as all four in-patients could be powered by medical air. The minimum flow that
using oxygen; for larger wards no additional flow is has been shown to be adequate to drive current
added until the formula in Table 13 comes into types of ventilator is 80 L/min at 360 kPa. For test
play. purposes the minimum pressure is 370 kPa.
4.16 A department may comprise several ward units as 4.23 If oxygen has to be used to power ventilators and/
above. The diversified flow for each department Qd or ventilators are operating in CPAP mode, the
is based on Qw for the first ward unit, plus 50% of high flows that may be encountered should be
the flow for the remaining ward units. For the taken into account both when designing the
purposes of this calculation, the first ward unit is pipeline and when sizing the supply vessel. These
taken as the largest within the department. ventilators use exceptional amounts of oxygen,
4.17 If one ward unit is significantly larger than the particularly if adjusted incorrectly. If incorrectly
others, the flows from the ward units should be set, they can use in excess of 120 L/min, but their
averaged to obtain a more realistic value. therapeutic benefit will be effective at lower flows.
To allow for some flexibility, and additional
Operating departments capacity, a diversified flow of 75 L/min for 75% of
beds has been included. If significant numbers of
4.18 The diversified flow for operating departments
beds are required to treat patients using CPAP
is based on 100 L/min required for the oxygen
ventilation, consideration should be given to
flush. Therefore each oxygen terminal unit in the
running a separate pipeline from the source of
25
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
26
4 Gas flow
supply. Care should be taken when calculating air 4.25 In the event of multiple births, the additional gas
exchange rates in wards/rooms in which large usage will have negligible overall effect on the total
numbers of CPAP machines may be in use flow.
simultaneously and where failure of mechanical
4.26 Maternity department operating rooms are
ventilation could result in raised ambient oxygen
designed as a suite; that is, it is presumed that
concentrations. Consideration should be given to
oxygen will be provided either in the anaesthetic
installation of systems to warn of ventilation failure
room or in the operating room. In post-anaesthesia
and oxygen concentrations above 23%.
recovery, it is assumed that 75% of beds will
require oxygen to be delivered.
Maternity
4.24 For LDRP (labour, delivery, recovery, post-partum) Hyperbaric oxygen chambers
rooms, the diversified flow is based on 10 L/min
for the first terminal unit and 6 L/min for 25% of 4.27 Hyperbaric oxygen chambers should be supplied
the remainder. Two cot spaces may be provided, from a separate branch from the main riser/
each with a terminal unit. Only one will be distribution pipe: the pipeline system should be
considered to be in use. The diversified flow for cot from a liquid supply source. Typical flows for a
spaces is based on 10 L/min for the first and 50% single patient chamber are as shown in Table 14.
of the remainder at 3 L/min.
27
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
28
4 Gas flow
29
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Table 17 Typical pressure and flow requirements for ventilators and nebulisers
Ventilator type Pressure (kPa) Flow (L/min)
Anaesthesia, typically gas-driven, Nominally 400. Max 600(1) Pneumatically driven ventilators use up to 80 max.
electronically controlled 20 continuous
Critical care, electrically controlled, Nominally 400. Max 600(1) 180 peak(2)
gas-powered 80 continuous
Neonatal, gas-driven, electronically Nominally 400. Max 600(1) 80 peak(2)
controlled 40 continuous
Nebulisers 400 10
Notes:
1. It is strongly recommended that ventilators are not connected to the 700 kPa system since their blenders only work satisfactorily
with a tolerance of about 10%: with high differential pressures for air and oxygen an incorrect mixture could be obtained.
2. These flows can be achieved under certain clinical conditions. The peak flows are usually of very short duration.
30
4 Gas flow
Surgical air 700 kPa possibility of using nitrogen as the power source for
surgical tools.
4.48 The pressure requirements of surgical tools are
between 600 and 700 kPa and flows may vary 4.50 The pipeline systems should be designed to provide
between 200 and 350 L/min (STP; see Table 19). a flow of 350 L/min at 700 kPa at the outlet from
Most surgical tools are designed to operate within the terminal unit. Existing systems may not meet
this pressure range. Higher pressures are likely this requirement (but should be capable of
to cause damage to tools. Inadequate tool delivering 250 L/min at the terminal unit).
performance, however, is likely to result from the
lack of flow at the specified pressure. Note
4.49 The introduction of synthetic air (from on-site Some surgical tools require up to 500 L/min at up to
blending of oxygen and nitrogen) leads to the 1400 kPa. These will require a separate supply,
normally from cylinders.
31
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
32
4 Gas flow
to use portable cylinders, with a two-stage Medical supply units/bedhead trunking systems
regulator.
4.66 When designing vacuum (and medical gas
4.58 If a pipeline supply is to be provided, each terminal systems), it is expected that the greatest pipeline
unit should be capable of delivering 350 L/min. pressure losses will occur near to the terminal units.
Where several terminal units are provided, it is
4.67 Care must be taken when sizing vacuum pipework
unlikely that more than one terminal unit will be in
within medical supply units with two or more bed/
use at any time, and therefore the total design flow
treatment spaces, where availability of space will
for the equipment service workshop will be 350 L/
often limit the size of pipe. The largest size of pipe
min.
that can be accommodated (typically 22 mm)
should be used, as this will ensure that excessive
Vacuum pressure losses do not occur within the units. Such
losses could necessitate the installation of larger
General diameter pipework within the rest of the system in
4.59 In virtually all cases, vacuum is used via a suction order to ensure that the system pressure drops
control device and fluid is collected in suction jars. prescribed in this Health Technical Memorandum
On wards these are typically of approximately 1 L are not exceeded.
capacity. In operating rooms, two or four 2–3 L 4.68 In some instances it may be necessary to provide
capacity vessels are provided for the suction control more than one “feed” from the ceiling distributor
regulator. to the medical supply unit in order to keep pressure
4.60 Once full, suction jars have to be emptied; losses within acceptable limits.
therefore, vacuum cannot be applied continuously.
Operating departments
4.61 The greatest generation of fluid to be aspirated is
likely to arise in the operating room, particularly 4.69 Vacuum is provided for the surgical team and
during orthopaedic surgery, where jet lavage to anaesthetist in the operating room. It is also
irrigate and cleanse the wound may be in use. The provided in the anaesthetic and recovery rooms.
maximum rate of collection is about 4 L/min, but 4.70 Since it is possible for both the surgical team and
it is not continuous. anaesthetist to use vacuum simultaneously, each
4.62 During induction of anaesthesia, a patient may operating room will require 80 L/min and each
vomit. Therefore, it is essential that oral and nasal terminal unit should be capable of passing 40 L/
passages can be cleared as quickly as possible. The min (see Table 21).
highest likely amount of fluid to be aspirated in 4.71 As it is unlikely that a patient would be
this case will be no more than 0.5 L. anaesthetised at the same time that a patient in the
4.63 In order to aspirate fluid, a suction cannula is associated operating room was continuing to be
normally used, and this will aspirate air as well treated under an anaesthetic, the need to clear an
as the fluid to be removed. The flow required, airway is extremely unlikely and no additional flow
however, is higher than would be the case if fluid is included.
only were to be removed. The ratio of air/fluid
aspirated will depend upon the diameter of the Helium/oxygen mixture
cannula.
4.72 Helium/oxygen mixture is used by patients with
respiratory or airway obstruction and to relieve
In-patient accommodation
symptoms and signs associated with respiratory
4.64 For a 28-bed ward unit comprising single rooms, distress. It can be administered by means of face
four-bed rooms and a treatment room, the mask, a demand valve with face mask, a nebuliser,
diversified flow is based on 40 L/min. or a ventilator.
4.65 When selecting the size of a sub-branch serving, for 4.73 Pipeline supply will be primarily limited to critical
example, a four-bed ward, the flow would be taken care areas, where the gas mixture is used for driving
to be 160 L/min as all four terminal units could, in a ventilator. The design and diversified flows should
theory, be in use. be based on the figures given for medical air (see
Table 17).
33
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
34
4 Gas flow
Note:
1. For the purpose of sizing the AGS disposal system pump,
V is taken as either 130 L/min or 80 L/min (see paragraph
10.16).
35
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
5.1 A cylinder manifold installation comprises a 5.5 An automatic manifold changeover from duty to
primary and secondary supply system. stand-by should occur at a cylinder pressure that
will ensure the greatest possible utilisation of the
Primary supply system contents of the cylinders in the duty bank. If the
normal operation of the changeover control
5.2 The primary supply is provided by two banks of depends on an electricity supply, the design should
equal numbers of gas cylinders which are connected be such that failure of the electricity supply does
to the pipeline via a control panel. The changeover not disrupt the flow of gas to the distribution
from the “duty” to the “stand-by” bank of cylinders system.
should be automatic. All manifolds should be
capable of passing the full pipeline flow. The
Note
temperature of the gas may fall as low as –30°C as
the gas passes through the regulator at maximum Some systems are designed so that both banks (duty
capacity, and the equipment should be designed and stand-by) supply gas in the event of a power
accordingly. failure.
5.3 A schematic layout for a primary supply system
5.6 In the event of power failure, when the power is
is shown in Figure 10. Total storage is usually
restored, the original “running bank” should be on-
provided on the basis of a risk assessment. Each
line, that is, the same bank that was the “running
bank of the manifold should have sufficient
bank” prior to interruption of the supply.
cylinders for two days. Additional cylinders for one
complete bank change should be held in the
manifold room; for nitrous oxide/oxygen mixture, Note
sufficient cylinders to change two banks should be Some manifolds default to a specific bank following
held. a power failure, regardless of which bank was the
5.4 The nominal and usable capacity of the cylinders
running bank prior to interruption of the supply.
commonly used on manifolds are given in Table 22 NB: Some units may require manual resetting to the
(the figures are the equivalents at STP). original condition.
36
Figure 10 Typical automatic manifold control system and emergency reserve manifold
Terminal Ball
Lockable
unit valve
valve
Distribution
System
Non-return
Shut-off Shut-off Pressure valve
valve valve safety
Pressure
valve
switch
Pressure Ball Pressure
safety valve safety Pressure
Pressure
valve valve
safety regulator
valve
Isolation Isolation
valve valve
Non-return valve
Exhaust
(piped to safe position)
Tailpipe
Cylinder valve
5.7 Manifolds and control panels should be designed 5.11 Separate pressure regulating valves should be
and certificated for use with 230 bar cylinders. The provided for each cylinder bank. The control
manifold headers should incorporate a renewable system should be designed so that the cylinders of
non-return valve to prevent the discharge of a one bank can be changed, or the pressure regulator
complete bank of cylinders in the event of “tail- for one bank can be overhauled, without loss of
pipe” rupture. continuity of the gas supply.
5.8 The tail-pipe cylinder connector must be a pin- 5.12 Pressure safety valves should be of the self-closing
index yoke connector in accordance with BS EN type and be installed on each distribution pipeline
ISO 407:2004 for oxygen, nitrous oxide/oxygen downstream of the manifold line pressure regulator
mixture (50% v/v) and medical air. No non- and upstream of the main isolation valve. A
metallic flexible connectors should be used. The pressure safety valve should also be installed
connector for nitrous oxide should be a side outlet between the secondary source of supply
valve connector in accordance with BS 341-3:2002. (emergency/reserve manifold) and the pipeline
The manifold connectors should be in accordance distribution system. It should have a flow capacity
with the following: at least equal to that of the pressure regulator
immediately upstream of it. The discharge pipe
Thread Medical gas should be at least one size larger than the main
M24 x 2 Medical air pipeline and be separate for each safety valve.
M22 x 2 N2O/O2
5.13 This discharge pipeline should be vented to
M20 x 2 O2 atmosphere, outside the building, in an area where
M18 x 2 N2O the discharge of oxygen, nitrous oxide, or nitrous
Where it is necessary to use non-metallic materials, oxide/oxygen mixture will not present a fire hazard
consideration should be given to the use of non- or cause injury to personnel. Medical and surgical
halogenated polymers in high pressure systems air may be vented internally provided that this is
(>3000 kPa) delivering oxygen or gaseous mixtures done in a safe way. Warning signs should be posted
with oxygen concentrations greater than that in at the discharge positions; access for inspection
ambient air. Consideration should also be given to should be provided.
fitting sintered filters upstream of non-metallic 5.14 It should terminate at least 3 m clear of any door/
materials to minimise the risk of particle collisions window that can be opened or other ventilation/air
and impacts, which are a potential source of intake. The ends of the discharge pipelines should
ignition. In addition, there are tests that should be be turned downwards to prevent the ingress of dirt
conducted to ensure that the risk of ignition is and moisture, and be placed and protected so that
minimised. Attention is drawn to BS EN ISO frost cannot form or be collected upon them.
15001: 2004. Similar safety valve arrangements are required for
installations supplied from liquid oxygen cylinders.
Note
Studies have shown that inadvertent ignition of Note
halogenated polymers can lead to highly toxic High pressure cylinders with integral pressure
by-products being delivered to the gas stream. regulation can be used on manifold systems.
38
5 Cylinder manifold installations
5.16 All functions should be appropriately identified. c. for the pipeline distribution system, a red “low
Indicators should have a design life of at least five pressure” and a red “high pressure” indicator to
years. The system should be capable of automatic be illuminated when the respective conditions
reinstatement after restoration of the power supply. occur.
5.17 Manifold monitoring, indicating and alarm systems
Alarm signal status unit
should be on the essential electrical supply.
5.21 The following indication of manifold conditions
Manifold control unit should be provided:
5.18 The control unit should include a green “mains a. green “normal”: normal;
supply on” indicator.
b. yellow “duty bank empty, stand-by running”:
change cylinders;
Manifold monitoring
c. yellow “duty bank empty, stand-by low”: change
5.19 Each automatic manifold should be provided with
cylinders immediately;
monitoring to detect:
d. yellow “emergency reserve bank low”: reserve
a. duty bank operating;
low;
b. duty bank empty and stand-by bank operating;
e. red “pipeline pressure fault”: pressure fault.
c. stand-by bank below 10% capacity, when the
5.22 Conditions (b) to (e) should be transmitted to the
duty bank is empty;
central alarm system. Where relays are used, they
d. each secondary supply (emergency reserve) should be normally energised relays, which de-
manifold bank below nominal 14 bar (for energise under fault conditions, with contacts
nitrous oxide) and below 68/100 bar pressure having a minimum rating of 50 V dc and 50 mA.
for other gases; Volt-free, normally closed contacts rated at 50 V dc
e. pipeline pressure faults outside the normal and 50 mA should be provided for transmission of
range. conditions (b) to (e) to the alarm system.
5.23 The panel can be incorporated into the manifold
Manifold indicator unit control unit or be a separate unit within the
5.20 There should be indicators to show the following plantroom. If mounted separately, the cabling
conditions: should be monitored for open/short circuit. In the
event of such a cable fault, a red “system fault”
a. for each automatic manifold: lamp should be illuminated on the alarm signal
(i) a green “running” indicator for each bank. status unit, together with the appropriate alarm
This should display when the bank is condition.
supplying gas, irrespective of the pressure;
Manifold management
(ii) a yellow “empty” indicator for each bank
when the running bank is empty and 5.24 Connections should be provided that allow
changeover has occurred; monitoring of manifold alarm conditions (b) to (e)
and manifold running for each “bank”. These
(iii) a yellow “low pressure” indicator for each connections should be volt-free contacts normally
bank to be illuminated after changeover, closed for each condition having a minimum rating
when the pressure in the bank now of 50 V dc and 50 mA. The building management
running falls to the low pressure setting; system should not be used to control the manifold.
b. for each secondary supply (emergency reserve)
bank, a yellow indicator to be illuminated when Secondary supply system
the pressure in the bank falls below 14 bar for 5.25 An emergency reserve manifold system should be
nitrous oxide or below 68 bar for other gases provided to form a secondary source of supply, for
(this will require the use of separate pressure emergency use, or to permit servicing or repair.
sensors – one for each bank);
5.26 The supply should be designed to provide the
design flow of the primary system and have
39
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
sufficient connected capacity to supply the pipeline Figure 11 Typical emergency reserve manifold
for at least four hours. When such provision would From Automatic Distribution
result in more than ten cylinders on each bank, the Manifold System
additional cylinders should be held in the manifold
rooms. A non-return valve and isolating valve Ball
Exhaust valve
should be installed immediately upstream of the Terminal
(piped to safe position) Lockable
reserve manifold connection to the pipeline valve
unit
distribution system.
5.27 The requirements for the emergency reserve supply
Non-return
capacity should be set out in the operational policy valve
document; this should take into account the Pressure
safety
arrangements for the supply of cylinders and the valve
flow that the system is required to provide. The gas
supplier should be consulted.
Pressure
5.28 The specific requirements will depend on the regulator
method of primary supply. Where this results in an
unrealistic number of cylinders being kept on site, Pressure Sintered Pressure
the operational policy should be set out, giving switch filter switch
details of procedures to be followed in an
emergency to ensure continuity of supply.
Isolation Isolation
5.29 For large installations, it may be impractical to rely valve valve
on a cylinder manifold system; thus, consideration
should be given to either a bulk liquid or liquid
cylinder emergency/reserve supply.
5.30 The operational policy document should set out
the location of emergency manifolds, cylinders etc
and the action to be taken in the event of loss of
the primary source of supply.
40
6 Oxygen systems
41
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
6.12 There must be no modification to the design or Figure 13 Primary supply (liquid cylinder)
any part of the medical liquid oxygen system
without written authorisation from the gas supplier.
BS EN 737-3:2000 Full
of having three independent sources of supply for stock has fallen below
minimum
Risk assessed
stock
medical gas systems. This is covered in Chapter 2. Operating alarm signal
Pressure in primary
vessel has fallen below
Unusable stock
minimum
6.16 The reserve stock is the volume of product that is Figure 15 Secondary supply (liquid cylinder)
used to provide additional stock to take account of
fluctuations in demand or when the supplier fails
to make a scheduled delivery.
6.17 Both operational and reserve stock levels are Full
Full
Secondary supply
Operational
stock
Primary supply
42
6 Oxygen systems
Figure 16 Secondary supply cylinder manifold 6.21 The maximum potential daily demand should be
based on the peak flow conditions measured
between 8.00 am and 6.00 pm, with all operating
rooms in use and with maximum demand being
AUTOMATIC
MANIFOLD provided to pipeline outlets. It should not be based
on the theoretical pipeline design flow conditions.
Full
Where actual flow monitoring is impracticable,
daily cylinder or liquid consumption figures should
Lead bank Emergency
alarm signal
be used.
Operating Pressure from
Note
alarm signal Standby bank secondary supply
Changeover from has fallen below
lead bank to minimum and
standby bank emergency
Secondary supply supply may need
to be activated
Control panels should be capable of passing the
maximum design flow of the oxygen system’s pipeline
distribution system. This may necessitate installing two
Figure 17 Secondary supply liquid manifold control panels in parallel.
Choosing an oxygen supply system 6.23 For new hospitals, where no historic information is
available, the estimated demand should be based on
6.18 When designing or reviewing an installation to the proposed size and type of the hospital and the
supply medical oxygen to a hospital, the most usage figures of the facilities being replaced.
appropriate method of supplying the gas will be
determined by the potential size and variability of 6.24 It is essential to periodically review the average
the hospital’s medical oxygen demand. daily demand with the gas supplier and agree either
to revise delivery frequencies to maintain the
6.19 To determine the most suitable and cost-effective operational stock levels or increase the size of the
method of supplying medical oxygen and the storage system on site. Any planned increase in
appropriate size of the installation, comprehensive demand due to hospital site developments, pipeline
demand figures should be provided to the designer. extensions or changes in clinical practice should be
6.20 These demand figures (prepared as a part of the risk notified to the gas supplier to ensure that the
assessment) should be based on: changes do not jeopardise security of supply.
• the current average daily gas usage based on the 6.25 The medical liquid oxygen demand should be
past twelve months’ supplies; reviewed with the gas supplier at least annually (or
after a significant extension to the pipeline causing
• the maximum potential daily demand volumes increase in demand) to re-assess the size of the
based on peak flow conditions, as below; installation.
• any planned extensions to the hospital/pipeline 6.26 As the agreed stocks used for the supply of liquid
that may affect the demand; oxygen are all based on an average daily demand,
• the expected natural annual growth in the use of as the demand grows so the storage volume
medical oxygen. requirements will increase. With the increased
43
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
volume requirements for the reserve stock, the Its provision is determined by factors such as the
volume available for operational stock will reduce. size of the hospital, the availability of space for both
Having reviewed the average daily demand with the the installation and the delivery vehicle, the
gas supplier, it is necessary to agree either revised proximity of the gas supplier and the size of the
delivery frequencies to maintain the operational demand for medical oxygen.
stock levels or to increase the size of the storage
6.34 There are a number of operational benefits in using
system on site.
a medical liquid oxygen system over compressed gas
6.27 The review of the medical liquid oxygen cylinders, including:
installation should also include a review of the risk
• greater volume of medical oxygen stored on site;
assessment to ensure that no other conditions on
site have been changed that jeopardise the security • improved security of supply;
of the gas supply. • reduced storage area for the medical gas
6.28 For smaller hospitals, where the demand is typically cylinders;
below 3000 m3 per annum, the most cost-effective • reduced manual handling requirements for
method of supplying medical oxygen is from a cylinder handling.
compressed gas cylinder manifold.
6.35 When determining the cost-effectiveness of specific
6.29 As the demand increases, it becomes less practicable proposals from suppliers, the total supply costs
to use compressed gas cylinders and more cost- should be assessed, including costs for the site
effective to use medical liquid oxygen. A cylinder preparation and vessel installation, vessel rental and
manifold larger than 2 x 10 J cylinders is likely liquid supply over the total period of the contract.
to prove impracticable because of the manual
handling difficulties with the number of cylinders System configurations
involved. Liquid cylinders, which are ideally suited
to an annual consumption of between 3000 m3 6.36 In order to comply with the requirements of BS
and 40,000 m3, can be connected together by a EN 737-3:2000, it is necessary for all medical
manifold to provide adequate storage capacity and oxygen installations to have three independent
flow rate. supply sources capable of feeding medical oxygen
to the pipeline.
6.30 For hospitals with larger demands, a bulk medical
oxygen VIE will generally be used. There is a 6.37 These three sources are referred to as:
nominal overlap of annual consumption between • the primary supply – the main source of
27,500 m3 and 40,000 m3, where either a bulk medical oxygen on site, providing gas to the
VIE or a liquid cylinder installation could be pipeline;
considered, either to satisfy a particular
requirement, or to accommodate possible site • the secondary supply – the secondary source of
restrictions. medical oxygen on site, providing gas to the
pipeline and capable of providing the total
6.31 The main benefit of using gas cylinders is oxygen flow requirement in the event of a
that installation costs of manifold systems are primary supply failure;
significantly lower than those of a liquid oxygen
system. However, the cost of the medical oxygen in • the reserve supply – the final source of supply
compressed gas cylinders is higher than the cost of to specific sections of the pipeline, capable of
medical liquid oxygen (supplied either into liquid meeting the required demand in the event of
cylinders or into a VIE). As the demand grows, so failure of the primary and secondary supplies, or
the lower unit cost of the liquid oxygen offsets the failure of the upstream distribution pipework.
higher installation costs of the liquid oxygen 6.38 For smaller hospitals, the primary supply can be fed
systems. from compressed gas cylinders but as the demand
6.32 Cryogenic liquid systems are normally used where grows, the most practicable supply source will be
the demand is high enough to make bulk supplies either liquid cylinders or a VIE system.
cost-effective and where the demand makes 6.39 A fully automatic gas cylinder manifold will
cylinder supplies impracticable. normally be used as the secondary supply system
6.33 Liquid oxygen provides a flexible approach to for smaller VIEs and liquid cylinder systems.
both the size and the choice of installation design. Where it is impracticable to maintain supplies to
44
6 Oxygen systems
the hospital using a cylinder manifold, a secondary 6.47 The cryogenic storage vessel is normally
liquid oxygen system will be necessary. constructed from a stainless steel inner pressure
vessel that is supported in a mild steel outer shell.
6.40 Emergency supplies will not normally be fed from
The space between the vessels is filled with a high-
a liquid oxygen supply system, as it is not possible
performance insulating material, maintained under
to prevent the boil-off of the liquid oxygen over
a vacuum, to minimise heat transfer to the inner
extended periods when the emergency system is not
vessel, which reduces the rate of evaporation of the
in use.
liquid oxygen.
6.41 All attempts should be made to locate the primary
6.48 A pressure-raising regulator that permits the flow of
and secondary supply systems on separate sites.
liquid to the pressure-raising vaporiser, as required,
They should have independent control systems and
automatically controls the pressure in the liquid
supply routes into the hospital pipeline system and
oxygen system. The vaporised liquid is fed back to
be valved accordingly to ensure that the systems
the top of the vessel or liquid cylinder to maintain
remain independent.
the pressure in the system.
6.42 Where it is not feasible to utilise two sites, the risk
6.49 Under normal operating conditions for a VIE
assessment should evaluate the greater level of risk
system, the gas supply to the hospital will be
associated with using a single site and define the
maintained by feeding liquid oxygen to the main
appropriate actions that should be established to
vaporiser system where it is converted to a gas and
obviate the higher risks, such as using twin or ring-
warmed towards ambient temperature. There is
main pipeline systems, siting of the emergency
a tendency for the vaporiser system to “ice up”
supply manifold or installing suitable protection for
where hospital demands are high or continuous, or
the installation.
airflow to the vaporisers is restricted. Under these
6.43 The overall system should be designed so that the circumstances the options to be considered should
primary supply is used first, with the secondary include:
supply automatically switching in when the
• installation of additional vaporisers;
primary supply is either empty or fails to supply.
• an auto-changeover system between vaporisers;
Primary supply systems
Note
Cryogenic liquid systems (VIE)
In the event of power failure, control valves on all
6.44 These systems, commonly referred to as vacuum- vaporisers should fail “open”.
insulated evaporators (VIEs), are used to store the
medical gas as a liquid at cryogenic temperatures • hot water/electrically heated vaporisers;
and to vaporise it into a gas at ambient temperature
for distribution through the hospital pipeline. • increasing size of vaporiser;
Plant • repositioning.
6.45 The VIE system consists of: 6.50 Where hospital demands are low or very erratic,
the natural heat transfer into the vessel causes the
• a vacuum-insulated cryogenic storage vessel to liquid oxygen to boil and the vessel pressure to rise.
store the bulk liquid; When the vessel pressure rises to a set point, the
• one or more ambient-heated vaporisers to hospital pipeline is fed from the top gas to prevent
convert the cryogenic liquid into a gas for the vessel pressure rising above the safety-valve
supply to patients via a pipeline; setting. On safety-valve operation, oxygen must be
able to vent safely to atmosphere.
• control equipment to control the pressure and
flow of gas to the pipeline. 6.51 In all cases, the pipeline pressure is controlled
using a system of duplex pressure regulators and
6.46 The liquid oxygen is stored at cryogenic valves. It is essential that all materials used in the
temperatures (down to minus 183°C) and construction of the vessels, control equipment
converted to a gas at ambient temperature by and pipeline are compatible with oxygen at the
passing it through an air-heated vaporiser. operating temperatures that could be encountered
under normal operation with single fault condition.
45
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
The risk assessment will determine the exact 6.59 Only under extreme conditions should the safety
configuration. distances specified in BCGA CP19 be reduced.
Any relaxation of these safety distances needs
6.52 The control panel design should comply with the
to be agreed with the supply company’s safety
design requirements specified in BS EN 737-3 and
representative and the Authorised Person (MGPS).
be sized to provide the system design flow.
Both parties must ensure that an equivalent level of
Telemetry safety is achieved, and this should be approved and
documented.
6.53 The use of telemetry on the liquid storage system is
recommended because it permits both the hospital 6.60 The layout of the liquid oxygen installation should
and the gas supplier to monitor relevant supply provide adequate access to all of the relevant
conditions continuously, including storage vessel components of the system and permit adequate
levels and pressure. In addition, it can be used to airflow for the ambient vaporisers.
transmit other operational data from the storage
6.61 The plinth should be of concrete construction. The
vessel, pipeline and associated equipment for
area in front of the vessel(s) (tanker apron) should
monitoring purposes. It may be beneficial to make
be non-porous concrete. Under no circumstances
this information available to the relevant person(s)
should tarmac be used in the vicinity of the liquid
in the trust. By having continuous monitoring of
oxygen filling point, or areas where liquid oxygen
stock available through the telemetry system, an
spillage may occur.
existing vessel could be retained. This solution is
only acceptable provided that an appropriate risk 6.62 The location of the liquid oxygen compound
assessment, following the guidance given in this should permit the supplier to gain safe access with
chapter, supports the decision. the appropriately sized tanker. It is the supplier’s
responsibility to assess the space requirements for
Siting
vehicular access.
6.54 The Authorised Person (MGPS) will be responsible
6.63 The design of the liquid oxygen installation should
for agreeing the final location of the liquid oxygen
take into account the gas supplier’s requirements
compound(s), taking into consideration any issues
for discharging the liquid oxygen from the
raised in the initial risk assessment.
cryogenic tanker. The area directly in front of the
6.55 When considering the space requirements for vessel should be kept clear to provide access for
the liquid oxygen compound(s), there may be the delivery vehicle at any time. Under no
operational advantages in having two compounds circumstances should cars be permitted to park in
in different areas on the hospital site, rather than front of the compound.
one larger site utilising either a single large vessel or
6.64 The compound should not be used for the storage
multiple tanks. This arrangement may also have
of other equipment.
benefits with respect to both planning permission
and meeting the safety distances specified in the 6.65 Where the secondary or emergency supply system
British Compressed Gases Association’s (BCGA) is fed from a cylinder manifold, it should be in a
Code of Practice 19 (CP19): ‘Bulk liquid oxygen separate enclosure/manifold room and have
storage at users’ premises’ (henceforth known as adequate space to permit safe cylinder changeover.
BCGA CP19; see Table 23). Spare cylinders should not be held in the VIE
compound or liquid cylinder compound but stored
6.56 Each supply system should be located in a secure
in the nearest medical cylinder store.
fenced compound, which should be sized to allow
adequate access to all of the control equipment. 6.66 A pipework and installation diagram (P&ID) of
the plant should be displayed clearly to indicate the
6.57 The site should essentially be level but designed to
appropriate valves that are necessary to operate the
have adequate falls to prevent water accumulating
plant safely. The medical gases supplier should
beneath equipment.
make the Authorised Person (MGPS), and others
6.58 The location of drains in the vicinity of the site in the hospital that may operate the system, aware
should comply with the requirements specified in of its general operating principles. (Typical plant
BCGA CP19 (see Table 23). installations are shown in Figures 18–20.)
46
6 Oxygen systems
47
Figure 18 Primary supply VIE system with compressed gas cylinder manifold
48
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
PI PS PAL LAL
14A
V6
PSH PAL
PI
V4 V20
PSL PAH
V5 Alarm panel
V15
PI To hospital
33 PSV Pressure pipeline
21
V8
VIE raising
10.5 V9 vaporiser
Bar
LSL LIT
V13 V12
V19
14 14
PCV
28
Main vaporiser Pressure control panel
V10
V11 S36
PSV
22 Third
source of
supply
V7
Storage vessel
Auto-change
manifold
Reserve manifold
Figure 19 Primary and secondary VIE system on single plinth
V5 Alarm panel
V15
PI To hospital
VIE PSV pipeline
33
21
Pressure
10.5
V8
raising
Bar V9 vaporiser
LSL LIT
V13 V12
V19
14 14
PCV
28
V10
Main vaporiser
V11 S36
PSV Pressure control panel
22 Third
source of
supply
V7
V6
V4 V20
V5
V15 Economiser vaporiser
PI
33 VIE PSV Pressure
21 raising
10.5
vaporiser
Bar V9
LSL LIT
V19
V13 V12
14 14
PCV
28
V10
Back-up vaporiser
6 Oxygen systems
V11 S36
PSV
22
V7
49
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
PI PS PAL LAL
14A
V6
PSH PAL
PI
V4 V20
PSL PAH
V5 Alarm panel
V15
PI To hospital
33 VIE PSV
Pressure pipeline
21
V8
10.5 raising
Bar V9 vaporiser Pressure control panel
LSL LIT
V19
V13 V12
14 14
PCV
28
Main vaporiser
V10
V11 S36
PSV
22 Third
source of
supply
V7
V6
PSH PAL
V5 PI
V15 Economiser vaporiser
PI
33 VIE PSV
Pressure
PSL PAH
21
V8
10.5 raising
Bar V9 vaporiser
Alarm panel
LSL LIT To hospital
V19
V13 V12
14 14 pipeline
PCV Pressure control panel
28
Back-up vaporiser
V10
V11 S36
PSV
22
V7
Liquid cylinder systems cylinder relief-valve setting, thus ensuring that any
excess pressure is safely vented.
Plant
6.75 Where installed in buildings, generous ventilation
6.67 Liquid cylinder systems can also be used to store
should be provided by means of fully-louvred access
the medical gas as a liquid at cryogenic
doors to the outside. The appropriate calculation
temperatures and to vaporise it into a gas for
must be made to ensure adequate ventilation,
patient use. These systems are used where the
especially during the filling of the vessels, when
demand is too high for compressed gas cylinders
they may be venting freely to atmosphere inside the
to be a practicable option but where it is neither
manifold room.
economic nor possible to supply bulk medical
liquid oxygen in a VIE system. 6.76 A P&ID of the plant should be displayed clearly to
indicate the appropriate valves necessary to operate
6.68 Liquid cylinders are constructed in a similar way to
the plant safely. The Authorised Person (MGPS)
vacuum-insulated cryogenic storage units, that is,
and others in the hospital who may work with the
as double-walled vessels. However, unlike the VIE,
VIE system should be made aware of its general
the liquid cylinder has an internal vaporiser coil to
operating principles by the medical gas supplier.
convert the liquid into a gas.
(Figure 21 shows a typical liquid cylinder manifold
6.69 The size of the liquid cylinder can vary between installation with cylinder backup.)
200 L and 1000 L water capacity. To obtain
sufficient storage capacity and to meet the hospital’s Compressed gas cylinder manifolds
flow requirements, a number of liquid cylinders can
6.77 The simplest supply system to provide medical
be connected together via a manifold.
oxygen to a hospital pipeline system utilises
6.70 The liquid cylinder system consists of: compressed gas cylinders, connected together on
an auto-changeover manifold. As the demand
• a number of vacuum-insulated liquid cylinders;
increases, the number of cylinders fitted to the
• a system to manifold the liquid cylinders manifold can be increased to meet the hospital’s
together to store sufficient liquid on site to meet requirements. The secondary supply for this system
the hospital’s demand; will usually be a manual changeover compressed
• control equipment to regulate the pressure and gas cylinder manifold, which comes on line
flow of gas to the pipeline. automatically (via a non-return valve) in the event
of primary manifold failure.
6.71 Although liquid cylinders are suitable for
6.78 For a full description of manifold supply systems,
transportation when full, they are normally
installed as a fixed installation and remotely filled see Chapter 5.
whilst in situ.
Secondary supply systems
6.72 Liquid cylinders are designed and supplied with
6.79 Where the primary supply system is a VIE, the
gas-specific liquid-fill and gas-use connections
secondary supply system can be either:
(including the connection on the remote liquid-fill
connection where the liquid cylinders are filled in • another VIE; or
situ).
• a liquid cylinder manifold; or
6.73 The connections used are:
• a fully-automatic compressed gas cylinder
• liquid fill: CGA 440; manifold.
• gas use: ISO 5145. 6.80 Where the primary supply system is a liquid
cylinder system, the secondary supply system
Siting
should be a fully automatic changeover gas cylinder
6.74 Where there is no alternative, a liquid cylinder manifold that comes into operation automatically.
manifold may be installed in a building or confined
6.81 There should be a system of backflow prevention to
area, but only if the vent header (to which all liquid
protect either system venting through the other in
cylinder vents will be connected) is piped to a safe
the event of a single fault in either system.
area via a back-pressure control valve. This valve
should be set at a pressure below that of the liquid
51
Figure 21 Typical liquid cylinder manifold installation with cylinder backup
52
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
PI PS PAL LAL
14A
PSH PAL
PI
PSL PAH
Alarm panel
To hospital
pipeline
Level
monitor
Pressure control panel
Third
source of
Vent supply
Liquid
fill
Remote fill
PI PI
33 33
PCV PCV
28 28
V1
Reserve manifold
6.82 Where the secondary supply is fed from 6.90 Under most conditions, compressed gas cylinders
compressed gas cylinders, the size of the changeover are the appropriate method of providing an
manifold and the number of cylinders stored on emergency supply source.
site should be based on the gas supplier’s ability to
6.91 The size and design of the emergency supply
guarantee a delivery service within a defined period.
system should allow for cylinders to be changed
6.83 Where a liquid oxygen system is used for the whilst in operation.
secondary supply, the system design should allow
6.92 Consideration should also be given to the set point
any liquid oxygen that has boiled off to be fed to
of the regulator of any emergency supply system, to
the pipeline system to utilise product.
ensure that the pipeline pressure remains above the
6.84 Where the feed from the VIE compound to the minimum level of 3.8 bar.
hospital extends a long distance, or is exposed
to potential mechanical damage, particular Emergency inlet ports
importance should be given to siting the secondary 6.93 Emergency inlet ports are covered in Chapter 13.
supply system remotely from the main VIE In some instances, installation of a fixed manifold
compound with a separate supply to the hospital system will obviate the need for fitting an
pipeline system. emergency inlet port.
6.85 Where the secondary supply is sited remotely, 6.94 In smaller installations, fitting an emergency inlet
consideration should also be given to the set point port may be dispensed with if the risk analysis
of the secondary supply output regulator to ensure indicates that adequate supplies can be maintained
that the pipeline pressure is maintained at a via the NIST connectors of AVSUs supplying
minimum level of 4.1 bar. critical care areas.
6.86 When the vessels are located on separate sites, 6.95 When planning emergency provision for a
a backflow prevention device must be fitted on complete system, vulnerability of the primary
each leg feeding into the pipeline system. This will and secondary supplies will be a critical factor in
prevent loss of product, either from the other vessel determining both the type and the means of supply.
or from the hospital pipeline, in the event of failure
of or damage to a VIE unit or its feed into the Fixed automatic/manual manifold systems
hospital pipeline. The backflow protection should
be sited in a secure location where it is not liable to 6.96 Where two VIE units on the same plinth are in use,
mechanical damage and be as close to the hospital the emergency supply system should comprise a
curtilage as possible. fully automatic cylinder manifold permanently
connected to (one of ) the main oxygen riser(s) in
Emergency supply provision the hospital, or directly into a ring-main system. It
must be able to feed a riser automatically (without
6.87 In the event of total plant and/or main pipeline back-feeding to any damaged upstream section) on
failure, an emergency supply of oxygen should be failure of both primary and secondary plant, or the
available for patient use. MGPS upstream of the entry into the hospital.
6.88 The emergency supply system should be activated Such an arrangement is particularly suited to
automatically when the primary and secondary situations in which the main feed from the VIE
system is empty or fails to supply or when the installation to the hospital pipeline is vulnerable to
hospital pipeline pressure falls below 3.8 bar. It mechanical damage, for example when buried
must have the provision to automatically prevent under a roadway. The location and size of the
the backflow of medical oxygen into the remainder manifold should be determined by the risk
of the pipeline system should the pipeline fail assessment and according to the dependency of the
upstream of the connection. patients.
6.89 A variety of sources are available for the provision 6.97 When two separately sited VIE units are used to
of emergency oxygen, and these are detailed in provide the hospital supply, the need for emergency
paragraphs 6.96–6.105. manifold provision should be assessed against the
likelihood of failure of both VIE systems and their
respective feeds into the hospital pipeline.
53
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
6.98 Where it can be shown that one or both units are Discrete cylinder supplies
fed into the hospital pipeline in a manner such that
6.105 For non-critical care areas where there are no high-
the probability of disruption of one or both of the
dependency patients, it may be appropriate to use
feeds is negligible, the option to waive the fitting of
individual cylinders as the reserve source of supply.
further (manifold) supplies can be considered.
Cylinders fitted with integral valves and having a
product-specific terminal unit outlet are suitable
Local manifold provision (critical care areas)
for this purpose. The difficulties associated with
6.99 To offer additional protection against the storing, testing, maintaining, distributing and
possibility of a pipeline failure within the hospital, connecting large numbers of such equipment must
further (manual or automatic) manifolds can be not be underestimated. (Such protocols should be
permanently connected, via non-return valves, referenced in the MGPS operational policy.)
downstream of AVSUs controlling high-
dependency areas. Such units should come on line Alarm systems
automatically on failure of the main supply to an
6.106 Installations of the following type should be fitted
AVSU. A further non-return valve must also be
with alarm systems to provide visual and audible
added upstream of the AVSU to prevent back-
warnings for the following conditions. For:
feeding into a failed main supply system.
a. dual VIE vessels feeding into a single control
6.100 The positioning of these manifolds is very
panel; or
important to ensure that the critical supply/high-
dependency areas defined in the risk assessment b. a single VIE vessel supported by a liquid
process have adequate stocks of medical oxygen cylinder secondary supply; or
available in the event of a system failure. However, c. a single VIE vessel supported by a fully
the risk analysis for the complete system may automatic compressed gas cylinder manifold,
indicate that the probability of use of such a
manifold system is negligible, or that the the following displays should be presented at the
circumstances causing the system failure would in plant and in a 24-hour-staffed position.
any event require the evacuation of the area.
Status/fault condition Indication Legend
6.101 Availability of accommodation, staff and manual Normal operation
handling issues would also need to be considered Green Normal
System available for use
during the risk assessment process. Where space Primary supply system’s
limitations prevent the installation of such operational stock empty
manifolds, the implications of providing discrete Yellow Refill liquid
Primary supply system’s reserve
cylinder/regulator combinations must be stock in use
considered. Primary supply system’s reserve
Refill liquid
stock empty Yellow
Gas feed via an AVSU (or terminal unit) immediately
Secondary supply system in use
6.102 Oxygen supply to the downstream side of an Secondary supply system empty Emergency
Yellow
AVSU (with the valve closed) may be achieved Emergency system in use supply in use
using an “emergency supply kit” consisting of two Pipeline pressure high or low Red Pressure fault
cylinder regulators and associated supply hoses
6.107 For:
with gas-specific connectors.
a. two discrete VIE vessels feeding into separate
6.103 Such an arrangement may be used to support
parts of the pipeline system; or
high-dependency departments, albeit the unit will
usually be of limited capacity by comparison to a b. a single VIE vessel supported by a liquid
fixed automatic manifold system. cylinder secondary supply that feeds separate
parts of the pipeline system; or
6.104 Storage, maintenance, testing, security and
deployment arrangements for the emergency c. a single VIE vessel supported by a fully-
supply kits must be documented in the MGPS automatic compressed gas cylinder manifold
operational policy. secondary supply that feeds separate parts of
the pipeline system,
54
6 Oxygen systems
55
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
by the “pressure fault” alarm when the pressure record of the risk assessment will also act as a
rises above 4.9 bar. reference document when the system is reviewed.
6.118 Where the emergency supply is installed on 6.126 Additional local factors and requirements
individual zones of the pipeline system, the identified by the project team will also need to be
“emergency supply in use” alarm must be displayed considered when carrying out the risk assessment
within the pipeline zone area. A separate to take account of site-specific issues concerning
“emergency supply low” alarm should also be how the product is stored, distributed and used.
installed on each zone.
6.127 Any risk control procedures identified by the risk
6.119 Where more than one VIE is used and the assessment process which are designed to minimise
operational and reserve stock is distributed any identified risks must be recorded and
between multiple vessels, a lit “normal” display incorporated into the relevant hospital standard
indicates that the vessel is available for use. operating procedures (SOP) or work instructions
(WI).
6.120 In the event that the primary (or secondary) vessel
should become empty (or suffer from any other 6.128 When sizing the vessels and cylinder manifolds to
fault condition), the “normal” display should be provide adequate storage of medical oxygen on
extinguished, indicating that the vessel is not site, the stock should be distributed between the
available for use. three sources of supply as defined in BS EN 737-3:
2000; that is, the medical oxygen supply system
6.121 Alarm conditions should be transmitted to the
should normally consist of:
central alarm system.
• a primary supply;
6.122 Where relays are used, they should be energised
relays that de-energise under fault conditions, with • a secondary supply;
contacts having a minimum rating of 50 V dc and
• a emergency supply.
50 mA. Alternatively, volt-free, normally closed
contacts rated at 50 V dc and 50 mA should be 6.129 The capacity of the primary and secondary supply
provided for transmission of the conditions to the system will consist of:
alarm system. • operational stock;
6.123 Typical alarm trigger points are shown in • reserve stock.
Figures 12–17.
6.130 The operational stock is the volume of product
Determining system size through risk assessment that the gas supplier uses to manage deliveries to
the hospital, and its exhaustion signals the point at
Introduction which the vessel should be refilled under normal
conditions.
6.124 The 1997 edition of Health Technical
Memorandum 2022 defined a (fixed) VIE primary 6.131 The reserve stock is the volume of product that is
vessel capacity of 14 days’ oxygen supply but did used to provide additional stock, to take account
not define capacity of a liquid cylinder system. of fluctuations in demand, or when the supplier
This section addresses the risk factors associated fails to make a scheduled delivery.
with the supply of oxygen on a hospital site and,
6.132 The system should be designed so that the primary
with the aid of defined risk criteria, offers guidance
and secondary supply system stocks are kept
on the sizing of VIE, liquid cylinder and
separate from each other. Under no circumstances
compressed gas cylinder manifold installations for
can the primary supply system operational stock be
any specified location.
stored in the secondary supply system vessel.
6.125 The risk assessment should take into account all
6.133 However, where it is not possible to install a single
issues concerning the safety and continuity of
large VIE vessel for the primary supply (such as
the medical oxygen supply. It is suggested that
where planning permission restrictions prevent the
identified risk factors and criteria be evaluated
use of a single large vessel), it may be appropriate
using both qualitative and quantitative measures,
to hold all or some of the primary supply system
and that all results be recorded in a logical manner
reserve stock in the secondary supply vessel. Under
that will support the decisions being made. The
these circumstances the primary supply vessel
56
6 Oxygen systems
should retain a minimum level when changing 6.139 When determining the number and size of
over to the secondary supply system. The volume liquid cylinders required for either a primary or a
retained in the primary supply vessel should equate secondary supply to a VIE, an allowance has to be
to the secondary supply system reserve stock. This made for the unusable capacity of each cylinder
should provide adequate stock on site to enable the when connected to the manifold system.
gas supplier to resupply product to the primary Compressed gas cylinder manifold systems
vessel in the event of failure of the secondary
supply. This level should be determined by the risk 6.140 For auto-changeover cylinder manifolds, one
assessment process but should be at least one day’s bank of cylinders should be considered as the
usable stock. operational stock and the other bank as the reserve
stock. The size of each source of supply should be
Review of risk assessment determined by considering the operational and
reserve stock requirements for each source.
6.134 The documented risk assessment should be
reviewed after the installation is complete, prior to 6.141 The secondary supply will normally comprise a
commissioning, to assess whether any parameters manually operated manifold system, connected
or circumstances have changed since the initial such that it will come on line automatically (via a
assessment. The risk assessment must also be non-return valve) in the event of primary supply
reviewed at least annually (or when there is any failure.
significant change to the medical oxygen supply 6.142 For sizing compressed gas cylinder systems, the size
system or usage pattern) to ensure that the details of the manifold will normally be determined by
are current. At this review, all changes should be the ability of the hospital to provide adequately
considered that might have an effect on the safety trained staff to change over cylinders quickly
of the system or the security of supply. enough to meet the demand.
Sizing plant – general 6.143 The number of cylinders required to support
the manifold can be determined by dividing the
VIE installations
relevant stock figure by the usable volume of each
6.135 The operational and reserve stock for each supply cylinder (that is, the volume at full cylinder
system should normally be held in the same vessel. pressure less the volume at the pressure of the
Where planning restrictions prevent the use of a cylinder when the manifold changes over).
single large vessel on site, it may be appropriate to
utilise multiple vessels to provide adequate stocks The risk assessment process
on site. Risk assessment for management responsibilities
6.136 When sizing VIE systems for the primary or
6.144 The risk assessment criteria, when considering
secondary supply, the vessel size will be determined management responsibilities for the medical liquid
by adding the operational and reserve stock oxygen system, need to include the following:
together and allowing for the level of unusable
stock left in the vessel when the designed flow rate • the need to document and agree responsibilities
cannot be maintained. for the monitoring of the medical liquid
oxygen VIE, and the need to establish a back-
Liquid cylinder installations up procedure with the gas supplier to ensure
6.137 For liquid cylinder installations, the primary that adequate stocks will be maintained in the
system should be made up of a number of liquid event of a failure of the fitted telemetry system;
cylinders connected together by a manifold. The • the hospital should set up procedures to ensure
secondary system will comprise an automatic or that the VIE system is monitored at regular
manual compressed gas cylinder manifold system. intervals for any deviation from normal
6.138 Each liquid cylinder will have a maximum design operation (such as safety valves lifting, major
flow rate for continuous use. The number of liquid leaks, or failure of either the telemetry or alarm
cylinders required for an installation may be system);
governed by either the maximum storage capacity • the implications of any decisions to not fit
required on site or the flow rate required to meet telemetry or to utilise a vessel, or vessels,
the hospital’s maximum demand. that do not provide adequate operational and
57
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
reserve stocks. These decisions should be taken • the need to site the reserve sources of supply
at an appropriate level of management, should local to the point of use to protect against
be documented, and their implications should pipeline failure where high-dependency
be considered as part of the risk assessment; patients are located;
• consideration of the resources needed to • safety requirements for the storage of oxygen
maintain adequate supplies of medical oxygen on site, including compliance with the safety
either under normal, or emergency, conditions. distances specified in BCGA CP19;
When evaluating these requirements,
• the location and extent of the medical oxygen
consideration should be given to the risks that
pipeline system;
the trust would face in the event of supply
failure causing disruption of clinical services; • the vulnerability of the hospital pipeline to
mechanical damage and whether underground
• consideration of the operational management
sections of the pipeline system comply with
consequences of using different suppliers to
the requirements of this Health Technical
supply medical oxygen to different supply
Memorandum; and whether the pipeline is
systems supporting the same pipeline
capable of being inspected throughout its entire
installation. Any contracts involving different
length or pressure tested (whilst maintaining
suppliers should clearly state the obligations
the supply), or otherwise can be tested;
and limitations of liabilities.
• the space available for the liquid oxygen
6.145 Where manifolds are used as either the secondary
installation, or cylinder manifold, and the
or emergency supply, adequately trained staff
available access for the delivery vehicle;
should be available, whenever required, to ensure
continuity of supply. Consideration also needs to • the vulnerability of the site to external damage;
be given to the manual handling issues concerned • the possibility of interference with the supply
with changing cylinders on the manifold and system or other security issues.
arrangements to store adequate stocks to meet
demands. Risk assessment for sizing of operational stock
6.146 Consideration needs to be given to the type of 6.149 The risk assessment criteria for the sizing of the
clinical activities carried out in each area of the operational stock should include:
hospital and the ability to provide emergency • the average daily demand at the end of the
back-up to individual areas used for critical care, contract period. Any changes to the predicted
or within high-dependency units. growth of demand will need to be considered,
Initial risk assessment for siting of plant and changes made to the vessel size or delivery
frequency at the appropriate time within the
6.147 The initial risk assessment should consider the contract period. It may be beneficial to set a
requirements to ensure a continuous supply of daily demand rate at which changes to vessel
medical gas to the patient. size or delivery frequency will be considered;
6.148 The initial risk assessment criteria related to the • a review of vehicular access to the VIE, timing
complete installation should include: of the deliveries, any restrictions due to local
• the size and location of each source of supply planning requirements, and the effect of these
(for example the volume held as operational factors on the delivery frequency;
and reserve stock for each source of supply, • an environmental impact assessment.
located on one site or two independent sites);
Risk assessment for sizing of reserve stock
• the associated risks with siting tanks at either
the same or separate locations (for example 6.150 The risk assessment criteria for the sizing of the
physical space availability, accessibility for reserve stock should include:
delivery and maintenance requirements, • the average daily demand at the end of the
accessibility to the pipeline system [to tie-in contract period. Any changes to the predicted
points etc], alarm systems and cabling, pipeline growth of demand will need to be considered,
routing and protection); and changes made to the vessel size or delivery
frequency at the appropriate time within the
58
6 Oxygen systems
contract period. It may be beneficial to set a 6.153 The current average daily demand can be
daily demand rate at which changes to vessel calculated by dividing the current annual
size or delivery frequency will be considered; consumption by 365 days.
• the delivery frequency guaranteed by the gas 6.154 The operational stock should be based on an
supplier that can be provided at short notice average daily demand predicted for the end of the
should the primary supply system fail; contract period calculated by:
• the minimum response time from when Average daily demand = Current daily demand
the primary supply system fails to when the + Planned growth + Natural growth.
delivery vehicle could be on site to refill
6.155 The operational stock is calculated as:
the secondary supply VIE, or to provide
replacement compressed gas cylinders for the Operational stock = Average daily demand x
manifold. Agreed delivery period.
Risk assessment for the provision of emergency supply systems 6.156 If there is significant growth in average daily
demand within the contract period, either the
6.151 The risk assessment criteria concerning emergency
vessel should be resized or the agreed delivery
supply systems should include:
frequency should be reviewed to reduce the
• the need for installation of independent delivery period and maintain the operational stock
emergency supplies to zones on the medical gas level.
pipeline supplying critical care areas or wards or
6.157 The delivery period for the primary supply will
departments that are remote or vulnerable to
be based on the gas supplier’s normal delivery
interruption;
frequency.
• the positioning of the manifold to ensure ease
6.158 The delivery period for the secondary supply
of changeover of cylinders with respect to
will be based on emergency conditions when
access and manual handling issues;
the primary supply is not available. Under these
• the storage of cylinders associated with the circumstances, special delivery response times must
emergency manifold to ensure compliance with be agreed with the gas supplier.
the appropriate codes of practice and local
6.159 The supply agreement should commit the supplier
hospital requirements;
to manage the operational stock, based on an
• training requirements for both the relevant agreed delivery frequency and the minimum stock
clinical and operational staff to ensure correct level to be maintained in the vessel.
operation of the emergency supply system.
Calculation of primary reserve stock
Stock calculations 6.160 The table below provides a matrix for the
calculation of primary reserve stock based upon
Calculation of operational stock for primary and secondary
distance from gas supplier and fitting of telemetry.
supplies
6.152 The capacity of the operational stock of primary Kilometres from No telemetry Telemetry fitted
and secondary supply systems should be agreed gas supply depot (no of days’ stock) (no of days’ stock)
with the gas supplier and based on the following Up to 75 5 3
parameters: 75–150 6 4
• the current average medical oxygen daily 150–300 7 5
demand, plus any natural growth over the Over 300 8 6
contract period; Calculation of secondary reserve stock
• any additional planned growth (above any 6.161 The minimum level for reserve stock for the
natural growth) in the usage pattern within the secondary supply should allow for circumstances
contract period; in which the primary supply system is not available
• the agreed delivery frequency. for use.
59
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
6.162 This secondary supply system reserve stock level only be installed when an investment appraisal
will be dependent on: shows them to be economical.
• the proximity of the supplier’s distribution 6.167 When installed, a PSA system will deliver product
depot; gas via the “oxygen” pipeline system.
• the response time that the gas supplier needs to 6.168 Oxygen concentrators operate by adsorbing,
make a delivery under these conditions; under pressure, other gases in the atmosphere onto
materials which have specific physico-chemical
• the delivery frequency that can be sustained
properties, thus freeing the oxygen which is stored
under the conditions when the primary supply
and transmitting it for use. The adsorbents are
is unavailable for use.
known as artificial zeolites, more commonly
Calculation of capacity of emergency supply systems (cylinder referred to as molecular sieves. The sieve units
manifolds) are arranged in pairs, one adsorbing whilst the
6.163 The number of cylinders stored locally to the other regenerates. The waste product, essentially
emergency supply system manifold and the nitrogen, is discharged to atmosphere during
number of connections on the manifold(s) should regeneration of the adsorbents. In some systems,
be determined by risk assessment. the use of vacuum to remove the nitrogen increases
the efficiency of the regeneration/adsorption
6.164 When determining these requirements, the risk process. Regeneration requires the use of a small
assessment needs to consider: proportion of the product gas.
• the maximum demand from the high- 6.169 The PSA process has reached a high level
dependency patients who may be supplied of technical sophistication and is capable of
from the pipeline zone that the emergency producing oxygen with a concentration of about
supply system protects; 95%. (For the UK the minimum level, below
• the maximum duration for which the which the emergency/reserve manifold will
emergency state is likely to last; come into operation, is 94%.) The remainder is
mainly argon with some nitrogen. The highest
• the proximity of the supplier of the compressed concentration is not likely to exceed 97/98%,
cylinders to the hospital; except when the emergency/reserve manifold is in
• the ability of the hospital to connect cylinders use, when it will be 100% if these are from a gas
to the manifold. supplier.
6.165 Consideration needs to be given to the logistics 6.170 The major components of a PSA system and their
of storing and handling the number of cylinders layout are shown in Figure 22. The typical major
needed to provide adequate supplies until the components of the system are the compressors,
primary/secondary supply systems or the hospital receiver(s), dryers, molecular sieves, vacuum
pipeline can be re-established. pumps, filters and regulators. Other components
are identical to those used for medical air and
Oxygen concentrator installations (PSA vacuum plant, which are described fully in the
appropriate sections. A suitable operating and
plant) indicating system is also required, as specified
below. Package supply systems, which should be
General
specified to meet the requirements given in this
6.166 Oxygen concentrators or pressure swing adsorber memorandum, are available from manufacturers.
(PSA) systems may be an alternative to the more
traditional supply systems (the terms oxygen Siting
concentrator and PSA are interchangeable). 6.171 The plant should have all-round access for
Typical installations where PSA systems should maintenance purposes, and allowance should be
be considered are those sites having no access to made for changing major components.
reliable liquid supplies, such as remote or off-shore
locations, or where the safety criteria for a bulk 6.172 The siting of the plant should allow for adequate
liquid vessel cannot be met (for example, very flows of air for three different purposes:
restricted sites). Otherwise, PSA systems should a. air intake to the compressors;
60
Figure 22 Schematic diagram of a typical PSA installation
Primary supply air system PRV Primary supply molecular sieve device PRV Optional pipework
Non-return valve PRV PRV Pressure relief valve
After-cooler
(optional) PRV P Pressure gauge
P P
Flexible
Filter connector Booster Filter Reserve supply
Receiver Molecular Receiver
compressor filling system
(optional) sieve device (optional)
(optional) (if included)
Inlet
Drain
Oxygen
Compressor monitor
Shut-off valve
6 Oxygen systems
P PS PS P
Changeover
Press Press Safety relief device
Safety relief device
switch switch
Pipeline distribution system
Primary reserve Primary reserve
vessel(s) (Automatic) vessel(s)
61
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
b. cooling of the compressed air by the after- Compressor and vacuum pump noise
coolers;
6.178 The noise level produced by the compressors will
c. cooling of the compressors. increase with the capacity of the supply system.
The maximum free-field noise level for unsilenced
6.173 Each compressor may require ducting to ensure
compressed air plant, at 1 m from the plant, varies
an adequate flow of cool air. The manufacturer
with the type and power of the plant but should
should be consulted over the range of operating
not normally exceed the following values:
temperature for which the system is designed. In
extreme circumstances, refrigeration of the cooling Reciprocating Screw Vane Power
air may need to be provided. 85 dBA 76 dBA 76 dBA 7.5 kW
6.174 Air-inlet filters should be fitted either to the 89 dBA 78 dBA 76 dBA 7.6–15 kW
compressor inlet or at a suitable point in any 93 dBA 80 dBA 79 dBA 15.1–22 kW
ductwork. The filters should comply with BS ISO
97 dBA 92 dBA 90 dBA 22.1–60 kW
5011:2000 and be either dry medium filters or
grade CA paper element filters. 6.179 In noise-sensitive areas, an acoustic enclosure
should be included in the purchase specification
Plant configuration for all compressors. Such an enclosure should
produce a reduction of at least 10 dBA in the free-
6.175 The plant should comprise:
field noise level at 1 m.
a. a duplex compressor – if more than two
compressors are installed, the plant should Molecular sieves
provide the design flow with one compressor
6.180 Duplex molecular sieves should be provided in
out of service;
pairs to permit continuous generation of oxygen.
b. duplexed air treatment/molecular sieve One of the pairs of duplex sieves will be in the
devices, that is, two sets of filters and a pair adsorbing stage, whilst the other regenerates.
of molecular sieves (one adsorbing whilst the
other regenerates) and one vacuum pump (if Dryers
required by the manufacturer). 6.181 Air dryers of the desiccant type are usually
integrated within the molecular sieves and
Note therefore do not regenerate independently.
All duplexed components should be capable of Refrigerant dryers may also be included.
independent operation.
Oxygen monitoring system
Compressors and vacuum pumps 6.182 The plant should include a calibrated
paramagnetic oxygen monitoring system
6.176 The compressors for the PSA systems may be
comprising oxygen analyser, oxygen concentration
any of the type recommended for compressed air indicator, oxygen flow monitor and oxygen
systems. It is also possible to provide a combined concentration/flow recorder. Connections for
medical air PSA plant. Generally, the compressed calibration cylinders should also be provided. In
air requirement per litre of product gas is of the the event of the concentration falling below 94%,
order 4:1; as a result the compressor plant will be the monitoring system should isolate the PSA
on longer than that typically seen in hospitals. system from the pipeline distribution system so
6.177 A vacuum pump may be required as part of the that the emergency/reserve manifold operates.
system. The vacuum pump, if provided, is utilised Additionally, an independent monitoring system
during the adsorption/regeneration process. should be provided to isolate the plant when the
Vacuum pumps may be of any type as for the concentration falls below 94%. The second system
piped medical vacuum system. It will not generally need not be provided with a flow indicator or
be practicable to use water-sealed pumps or the recorder.
medical vacuum plant.
62
6 Oxygen systems
Operating and indicating system 6.189 A warning notice that complies with BS 5499-5:
2002 should be affixed which indicates the
6.183 The operating and indicating system should
presence of low voltage.
perform the following functions, as appropriate:
6.190 A further warning notice indicating that the plant
a. overall plant control and indication;
starts automatically should also be affixed near or
b. individual compressor starting; on the plant.
c. individual vacuum pump starting (where 6.191 Each compressor should have a selector switch
fitted); which, when turned to the “on” position, allows
d. control of dryers (where installed as separate the maximum and minimum pressure switches on
component); the receiver to control the “on” and “off ” loading
of that compressor. An alternative “auto” position
e. control of molecular sieves; of the selector switch may allow automatic
f. plant status monitoring and indication; selection of the compressors.
63
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
64
6 Oxygen systems
65
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
66
7 Medical compressed air systems
Figure 23 T
ypical duplex medical air 400 kPa plant and energy reserve manifold (reproduced by kind
permission of MEDÆS)
Pressure
safety
Inlet filter Pressure valve
Air Pressure gauge
Temperature
intake switch Fusible
switch
receiver 1
plug
Compressor 1 Non-return Ball
Aftercooler
Air
valve valves
Ball valve
Ball valve
Pressure Flexible
safety Ball connection Ball
valve valves valves
Automatic Automatic
drain drain
*1 *1
Inlet filter
Air Pressure
Pressure Temperature
intake switch safety
switch valve
Compressor 2 Non-return Pressure Fusible
Aftercooler
valve gauge plug
receiver 2
Ball valve
Pressure Flexible Ball
Air
safety Ball connection valves
valve valves Ball valve
Automatic
drain Ball
*1
valves
Automatic
Silencer drain
Notes: *1
1. Drains marked *1 should be fed to an oil/water separator
2. Filters marked *2 are activated carbon to remove hydrocarbon vapours Shut-off
valve Ball valve
3. Dryer control systems may incorporate shuttle valves as shown, or
may use other suitable arrangements of directional control valves Dryer 2 column 2
4. Symbols to BS 2971:1993/ISO 1219-1:1991
Bacteria Dust/Carbon Shut-off Oil Water
Pressure filter filter valve filter separator
safety *2
valve
Non-return *1 *1
Pressure valve
Pressure regulator
gauge Ball Ball valve
valve Ball Dryer 2 column 1
valve
Distribution Supply Ball Shut-off
valve Pressure valve Ball
System System switch valve
Silencer
Ball valve Pressure Flow
Flow Dewpoint transducer restrictor
Non-return restrictor transducer P
Lockable valve
valve D Silencer
Ball
Terminal Ball Shut-off valve
unit valve valve
Ball
Ball valve Dryer 1 column 2
valve
Pressure
gauge Bacteria Dust/Carbon Shut-off Oil Water
filter filter valve filter separator
*2
Pressure
safety
valve Non-return *1 *1
Pressure valve
regulator
Ball valve
Dryer 1 column 1
Shut-off
valve
Ball Terminal
Emergency Lockable unit
Supply valve valve Silencer
Shut-off Shut-off
valve valve
Pressure
switch
Pressure Ball Pressure
safety valve Pressure safety
valve safety valve
valve
Non-return valve
Exhaust
(piped to safe position)
Tailpipe
Cylinder valve
Cylinder
67
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Figure 24 Typical triplex medical air 400 kPa system (reproduced by kind permission of MEDÆS)
Inlet filter
Air Pressure
intake Temperature
switch switch Pressure
Non-return safety
Compressor 1 Aftercooler valve
valve Pressure
gauge
Ball valve Fusible
Pressure Flexible plug
receiver 1
safety Ball connection Ball
Air
valve valves valves
Ball valve
Automatic
drain
*1
Ball
Inlet filter valves
Air Pressure Automatic
intake Temperature
switch switch drain
*1
Compressor 2 Aftercooler Non-return
valve
Pressure
safety
Ball valve valve
Pressure Flexible
safety Ball connection Pressure
valve Fusible
valves gauge plug
Automatic
receiver 2
drain Ball
Air
*1 valves
Inlet filter Ball valve
Air Pressure
intake Temperature
switch switch
Ball
Compressor 3 Aftercooler Non-return valves
valve Automatic
drain
Ball valve *1
Pressure Flexible
safety Ball connection
valve valves
Silencer
Notes:
1. Drains marked *1 should be fed to an oil/water separator
Shut-off
2. Filters marked *2 are activated carbon to remove hydrocarbon vapours valve
3. Dryer control systems may incorporate shuttle valves as shown, or
may use other suitable arrangements of directional control valves
Dryer 2 column 2
4. Symbols to BS 2971:1993/ISO 1219-1:1991
Non-return Silencer
Ball valve valve Pressure Flow
transducer restrictor
Flow Dewpoint
restrictor transducer P
Lockable
valve D Silencer
Ball
Terminal Ball Shut-off valve
unit valve valve
Ball
Ball valve Dryer 1 column 2
valve
Pressure
gauge
Bacteria Dust/Carbon Shut-off Oil Water
filter filter valve filter separator
*2
Pressure
safety
valve Non-return *1 *1
Pressure valve
regulator
Fully Automatic
Emergency Reserve Ball valve
Dryer 1 column 1
Manifold
(see duplex schematic Shut-off
for detail) valve
Silencer
68
7 Medical compressed air systems
Figure 25 Typical quadruplex medical air 400 kPa plant (reproduced by kind permission of MEDÆS)
Inlet filter
Air Pressure
intake Temperature
switch switch
Compressor 1 Aftercooler Non-return
valve
Ball valve
Pressure Flexible
safety Ball connection
valve valves
Automatic
drain
*1
Inlet filter
Air Pressure
intake Temperature
switch switch Pressure
Non-return safety
Compressor 2 Aftercooler valve
valve Pressure
gauge
Ball valve Fusible
Pressure Flexible plug
receiver 1
safety Ball connection Ball
Air
valve valves valves
Ball valve
Automatic
drain
*1
Ball
Inlet filter valves
Air Pressure Automatic
intake Temperature
switch switch drain
*1
Compressor 3 Aftercooler Non-return
valve
Pressure
safety
Ball valve valve
Pressure Flexible
safety Ball connection Pressure
valve Fusible
valves gauge plug
Automatic
receiver 2
drain Ball
Air
*1 valves
Inlet filter Ball valve
Air Pressure
intake Temperature
switch switch
Ball
Compressor 4 Aftercooler Non-return valves
valve Automatic
drain
Ball valve *1
Pressure Flexible
safety Ball connection
valve valves
Silencer
Notes:
1. Drains marked *1 should be fed to an oil/water separator
Shut-off
2. Filters marked *2 are activated carbon to remove hydrocarbon vapours valve
3. Dryer control systems may incorporate shuttle valves as shown, or
may use other suitable arrangements of directional control valves
Dryer 2 column 2
4. Symbols to BS 2971:1993/ISO 1219-1:1991
Non-return Silencer
Ball valve valve Pressure Flow
transducer restrictor
Flow Dewpoint
restrictor transducer P
Lockable
valve D Silencer
Ball
Terminal Ball Shut-off valve
unit valve valve
Ball
Ball valve Dryer 1 column 2
valve
Pressure
gauge
Bacteria Dust/Carbon Shut-off Oil Water
filter filter valve filter separator
Pressure *2
safety
valve Non-return *1 *1
Pressure valve
regulator
Fully Automatic
Emergency Reserve Ball valve
Dryer 1 column 1
Manifold
(see duplex schematic Shut-off
for detail) valve
Silencer
69
Figure 26 Typical duplex combined medical and surgical plant with emergency reserve manifolds (reproduced by kind permission of MEDÆS)
70
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Notes:
1. Drains marked *1 should be fed to an oil/water separator
2. Filters marked *2 are activated carbon to remove hydrocarbon vapours
Pressure Silencer
3. Dryer control systems may incorporate shuttle valves as shown, or
safety
Inlet filter Pressure valve may use other suitable arrangements of directional control valves
Shut-off
Air Pressure gauge 4. Symbols to BS 2971:1993/ISO 1219-1:1991 valve
intake Temperature
switch switch Fusible
receiver 1
plug Dryer 2 column 2
Compressor 1 Aftercooler Non-return Ball
Air
valve valves
Ball valve Bacteria Dust/Carbon Shut-off Oil Water
Ball valve filter filter valve filter separator
Pressure Flexible Pressure *2
safety Ball connection Ball safety
valve valves valves valve Non-return *1 *1
Pressure valve
Automatic Automatic Pressure regulator
drain drain
*1 gauge Ball Ball valve
*1 Dryer 2 column 1
valve Ball
Inlet filter valve
Air Pressure Ball Shut-off
Pressure Temperature safety
intake switch valve Pressure valve Ball
switch valve switch valve
Compressor 2 Aftercooler Non-return Pressure Fusible Silencer
valve gauge plug Ball valve Pressure Flow
transducer restrictor
receiver 2
Ball valve Flow Dewpoint
Pressure Flexible Ball Non-return restrictor transducer P
Air
safety connection valves Non-return valve
Ball valve D Silencer
valve valves Ball valve
Ball
Automatic Ball Shut-off valve
Pressure
drain valve valve
*1 safety Ball Ball
valve valves Ball valve Dryer 1 column 2
Exhaust Pressure Automatic valve
regulator drain Pressure
*1 gauge Bacteria Dust/Carbon Shut-off Oil Water
Surgical Air filter filter valve filter separator
Ball valve Distribution System Pressure *2
Non-return Pressure Ball Ball safety
valve gauge valves valves valve Non-return *1 *1
Medical Air Pressure valve
Distribution System regulator
Ball valve
Exhaust Pressure Dryer 1 column 1
safety Shut-off
valve
valve
Emergency Ball Ball Terminal Emergency Ball Lockable Terminal
Medical Air Supply valve valve unit Surgical Air Supply valve valve unit
Silencer
Cylinder Cylinder
7 Medical compressed air systems
Reciprocating Screw Vane Power 7.12 Air-inlet filters should be fitted immediately
upstream of the compressor. In exceptional
85 dBA 76 dBA 76 dBA 0–7.5 kW
circumstances, additional screens, filters and
89 dBA 78 dBA 76 dBA 7.6–15 kW silencers may be required. The filters should
93 dBA 80 dBA 79 dBA 15.1–22 kW comply with BS ISO 5011:2000 and be either dry
97 dBA 92 dBA 90 dBA 22.1–60 kW medium filters or grade CA paper element filters.
7.9 In noise-sensitive areas, an acoustic enclosure
should be included in the purchase specification for Compressor types
all compressors. Such an enclosure should produce 7.13 There are many different types of compressor
a reduction of at least 10 dBA in the free-field noise currently available, the most common types being:
level at 1 m.
a. reciprocating piston compressors;
Air intake b. rotary vane compressors;
7.10 The position of an air intake can have a c. rotary screw compressors.
considerable effect on delivered air quality, 7.14 The compressors may be of any type, provided they
particularly with respect to levels of carbon are suitable for continuous running on load and
monoxide. The air intake for a compressor should for high frequency start/stop operation. When
be located to minimise contamination from selecting compressors, the opportunity should
internal combustion engine exhausts and the be taken to maximise energy efficiency. If
discharge from vacuum systems, AGSS and reciprocating compressors are used, they may be
ventilation systems or other sources of either of the single- or of the two-stage type,
contaminants. Air intakes should be ducted where although for a 400 kPa system a single-stage
necessary to avoid contamination; a minimum compressor is usually satisfactory.
height of 5 m above ground level should ensure a
reasonable quality of intake air. Where this cannot
be achieved, additional filtration and/or air
Compressor lubrication
treatment may be necessary. If the siting of the 7.15 Compressors may be oil-lubricated, provided that
compressor, regardless of the air intake location, is suitable arrangements are made to ensure that the
considered subject to a risk of aspirating toxic air quality specification given in Table 29 is
fumes and smoke as a result of a fire, an automatic fulfilled.
shutdown system, linked to local smoke detectors,
7.16 Rotary compressors are sealed and cooled by oil
can be installed. If such a system is planned, it is
or water. Oil control is therefore essential and is
essential that an automatic emergency supply
usually provided as an integral part of the
manifold system is sited well away from the fire-risk
compressor. Reciprocating compressors may be oil-
area and is arranged to come on-line automatically
lubricated, carbon ring, PTFE ring or diaphragm-
in the event of plant shutdown.
sealed type.
7.11 Care is needed when extending compressor air
7.17 Oil-free compressors may be beneficial in reducing
intakes. Manufacturers’ data should be consulted
filtration requirements.
to ensure that intake flow, and hence compressor
performance, are not adversely affected by excessive 7.18 Water should not be used as a sealant because of
lengths of intake ducting. Choice of intake material risk of microbial contamination and potential
is also important. Often, intakes are constructed problems with water treatment.
from solvent-welded PVC. In a fire, toxic materials 7.19 There is a danger that PTFE rings and lubricating
from the burning intake could be drawn into the oils could decompose at high temperatures to form
air compressor and distributed throughout the toxic products. This may be countered by fitting a
system. In addition, there is a risk that inadequate temperature sensor to the cylinder head or output
solvent drying time before use of the intake will of the compressor with suitable controls to cut off
result in toxic solvent fumes being drawn into the the power supply to the compressors if excessive
system. Corrosion-resistant ducting (for example temperatures are sensed. BS EN ISO 15001
stainless-steel flue liner) is a suitable material. specifies the requirements for selecting materials
used in medical supply equipment.
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Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
72
7 Medical compressed air systems
7.29 Although particles smaller than 40 µm are unlikely well-maintained oil-lubricated compressors, it is
to cause mechanical damage, a 5 µm intake filter unlikely to exceed 5 mg/m3 due to the high-
is preferred to avoid blockage of internal air/oil efficiency oil/air separator.
separators.
7.36 Oil-contaminated compressor condensate is
7.30 Filters are specified in terms of performance classified as a trade effluent by virtue of Chapter 14
tests – a sodium flame test, a DOP (dispersed oil of the Public Health (Drainage of Trade Premises)
particulate) test etc. Act 1937. An oil condensate separator should
therefore be installed.
Water
7.37 Under Chapter 85 of the Water Resources Act
7.31 Water is always a contaminant in a compressed air 1991, it is illegal to make a discharge of trade
system, regardless of the type and location of the effluent to “controlled waters” via a surface water
compressor plant, since the air drawn into the drain without the consent of the Environment
compressor intake is never completely free of water Agency.
vapour. The amount can vary from 2.5 g/m3 to
7.38 Similarly, under the Water Industry Act 1991, local
over 40 g/m3 depending on the climatic
water companies enforce the limit of oil condensate
conditions. The after-cooler and receiver remove
discharged into the public foul sewer. Prior consent
some of this, but about 20 g/m3 is likely to remain
to discharge is mandatory.
in the compressed air unless removed by dryers.
7.39 Condensate from oil-free compressors may be
7.32 A water content not exceeding 67 vpm (volume
discharged to drain.
parts per million – equivalent to dew-point –46°C
at atmospheric pressure) is specified for medical air 7.40 Any condensate produced from the compressor/
pipeline systems. Only desiccant dryers can usually dryer system must be regarded as trade effluent and
achieve this. A variety of desiccant types are is therefore not suitable for discharge to any surface
available. Activated alumina and silica gel are water system draining to any surface water sewer,
commonly employed. Molecular sieve desiccants water-course or soak away; this may not apply if a
employing zeolites can also be used, but on suitable separator is installed. Maximum oil content
occasions it has been found that this material has limits range from region to region, from 25 mg/L
produced air with an increased oxygen content, in up to 500 mg/L; the local water company should
the order of 24%. Refrigerant dryers can perform be consulted.
satisfactorily down to a pressure dew-point of +3°C
(atmospheric dew-point –20°C) and are therefore Dryer controls
not recommended as the sole form of drying. 7.41 The dryer control system should ensure that
regeneration is operated in proportion to the
Oil
compressed air usage. The effectiveness of the
7.33 With oil-lubricated compressors, it is inevitable control system will become apparent when the
that the compressed air will contain oil. Even with efficiency of the compressor system is tested at
oil-free compressors (non-lubricated), complete 10% and 0% of the system design flow. Evidence
freedom from oil and oil vapour cannot be of the reliability and performance of a dryer system
positively guaranteed, as hydrocarbon vapours may should be sought from manufacturers, since these
be drawn into the compressor. Oil levels in the air items are critical to the overall performance of the
supply must be controlled to 0.1 mg/m3 with compressor system. The dryer control system
means of monitoring on a routine basis. should include a dew-point hygrometer and display
with a minimum accuracy of ±3°C in a range from
7.34 Oil will exist in the system in three forms: bulk
–20°C to –60°C atmospheric dew-point, with a set
liquid, oil aerosol and oil vapour. Provided that the
point of –46°C. It should be arranged that in the
oil lubricant is appropriate and the after-cooler
event of open circuit, a “plant emergency” alarm be
properly designed, the amount of oil present as
initiated.
vapour should be small and is unlikely to exceed
0.5 mg/m3.
Dust filters
7.35 The amount of oil that is present as bulk liquid and
7.42 There should be a dust filter downstream of the
aerosol is more difficult to predict. With modern,
dryers to remove particles down to 1 µm, with a
73
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
DOP penetration of less than 0.03%, when tested 7.48 All safety valves should be of the closed-bonnet
in accordance with BS EN ISO 3549:2002. type and connected to suitably sized pipework to
allow safe discharge, not necessarily to the outside.
7.43 Each dryer and filter assembly should be rated for
continuous use at the system demand flow, with air
at 100% relative humidity at 35°C. Traps, valves and non-return valves
7.44 Duplex activated carbon filters should be installed 7.49 Electrically- or mechanically-operated automatic
upstream of the final bacteria filter for odour drainage traps should be provided on the after-
removal. coolers, receiver, separators and coalescing filters.
The discharge from these drainage traps should
Bacteria filters be piped to a suitable gully via an oil separator.
Co-ordination with building work is required for
7.45 Duplex bacteria filters should be fitted upstream this provision. Electrically-operated automatic
of the final pressure regulator with appropriate drains have been found to be more reliable.
isolating valves. The filters should provide particle
removal to 0.01 mg/m3 and a DOP penetration of 7.50 Drainage and tundishes are usually provided
less than 0.0001%. under the building contract. Separators should
be provided under the air compressor contract.
Pressure control Provision of interceptor tanks may be made under
either the building contract or the air compressor
7.46 The pressure control should maintain the nominal contract, as appropriate.
pipeline pressure within limits given in Chapter 4.
7.51 Non-return valves are required to prevent backflow
Duplex line pressure regulators should be provided
with suitable isolating valves. The regulators should of the air supply in certain situations. These valves
be of the non-relieving type. should be located as follows:
a. between the compressor and the receiver, but
Safety valves downstream of any flexible connector;
7.47 Safety valves should be provided in accordance with b. downstream of the dust filter on the dryer;
the requirements given in (a)–(c) below. All safety
valves should conform to BS EN ISO 4126- c. upstream of the emergency cylinder reserve
1:2004. A safety valve of the certified discharge connection in the pipeline connecting the plant
capacity stated should be fitted in each of the to the pipeline distribution system, to prevent
following positions: back-feeding this plant;
a. on the delivery pipe of each compressor and d. upstream of any inlet point that may be used to
upstream of any isolating valve, non-return feed the system in an emergency;
valve or after-cooler, capable of discharging the e. downstream of the emergency cylinder manifold
total throughput of the compressor; regulators.
b. on each air receiver and dryer tower, capable of
Isolating valves
discharging the sum of the throughput of all the
compressors. It is not necessary to provide safety 7.52 Isolating valves should be provided downstream of
valves on the dryer columns where the system non-return valves and upstream of, for example,
is already protected by a safety valve on the the connection of the emergency reserve manifold.
receiver and the downstream equipment, that is, Isolating valves should be provided in order to
if the dryer column is already sufficiently facilitate maintenance or replacement of plant
protected; items.
c. immediately downstream of each pressure 7.53 Manually-operated ball isolation valves should be
regulator, capable of discharging the system located in the positions shown in Figures 23–26 to
demand flow. allow isolation of components such as receivers,
dryers, automatic drains, pressure regulators and
filters. There should also be a valve on the
74
7 Medical compressed air systems
compressed air plant, downstream of the plant non- plant or on the plantroom wall. Control panels
return valve and the connection of the cylinder containing pneumatic components should have
manifold supply. vents to permit release of pressure in the event
of component failure. All indicators should be
Pressure indicators appropriately identified and should have a design
7.54 Pressure indicators should comply with BS EN life of at least five years.
837-1:1998 or have an equivalent performance 7.60 The operating system should be capable of
if electronic indicators are used. Calibration automatically restarting after reinstatement of the
should be in bar or kPa. All gauges should have a power supply.
minimum scale length of 90 mm, and the working
7.61 All components of the medical air supply system
range should not exceed 65% of the full-scale range
should be connected to the essential electrical
except on differential pressure gauges. Pressure
supply. The control system should ensure that
indicators should be connected by means of gauge
compressors restart in sequence to avoid
cocks.
overloading the power supply.
7.55 Pressure indicators should be located:
Plant control unit
a. on the plant control unit indicating receiver
pressure; 7.62 The plant control unit should have a separate
power supply for each compressor, controlled by a
b. on each receiver;
separate sub-circuit.
c. downstream of each pressure regulator;
7.63 The unit should allow either manual selection of
d. on each dryer tower; duty/stand-by for each of the compressors or have
e. on the plant pipework, upstream of the plant an automatic sequence selection with a means for
isolating valve. manual override. The unit should ensure that two
or more compressors do not start simultaneously
7.56 Differential pressure indicators should be located when power is applied.
on:
7.64 A warning notice that complies with BS 5499-5:
a. each coalescing filter; 2002 should be affixed which indicates the
b. each dust filter; presence of low voltage.
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Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
a. an isolator interlocked with the covers; (iv) the sub-assembly to remain in this mode
of operation until the fault has been
b. either HRC (high rupturing capacity) fuses to
rectified;
BS 88 or suitable circuit breakers to BS EN
60947-2:2003 and/or BS EN 60898-1:2003;
Note
c. an industrial grade ammeter to BS EN 60051-
1:1999, IEC 60051-1:1997 (digital ammeters of In the event of power supply failure, all drain and vent
similar accuracy to those compliant with BS EN valves should fail “closed”, and all inlet and outlet
60051-1:1999, IEC 60051-1:1997 may be valves should fail “open”.
used);
g. green function indicators for each dryer sub-
d. a “total hours” counter if not included in the assembly to indicate:
plant control unit;
(i) dryer 1 selected;
e. a green “mains supply on” indicator if mounted
separately from the plant control unit. (ii) dryer 2 selected;
(iii) selected dryer – “normal”;
Dryer control unit
(iv) selected dryer – “failed” (this fault
7.67 The dryer control unit may be mounted on the indicator should remain until manually
dryers or may be located with the plant control reset by means of a reset button);
unit. There should be separate power supplies for
the duty and stand-by dryer assemblies taken from h. a fail-safe system which on failure of the power
the same phase. supply causes the following:
7.68 The dryer control unit should contain the (i) closure of the exhaust and purge valves;
following: (ii) opening of the inlet and outlet valves.
a. a duty dryer selector switch;
Plant status monitoring
b. a service function – to enable selection of
7.69 A monitoring system should be provided to detect
continuous/normal running;
the following faults in the air compressor system:
c. individually fused, separate cycling systems for
a. plant faults (for each compressor):
each dryer;
(i) control circuit failed;
d. a system to control regeneration of the dryers in
relation to pipeline demand; (ii) motor tripped;
e. a hygrometer and display with a minimum (iii) after-cooler temperature high;
accuracy of ±3°C in a range from –20°C to
(iv) compressor temperature high;
–60°C (set to –46°C atmospheric dew-point)
and a pressure sensor; (v) compressor failed to go on load;
f. an automatic changeover to the stand-by dryer (vi) activation of other safety devices supplied
system in the event of failure of the duty unit by by the manufacturers;
either dryness or pressure. This requires: b. plant faults (for each dryer unit):
(i) electrical and pneumatic isolation of the (i) dryer failure;
duty sub-assembly so that it is taken off-
stream; (ii) pressure fault;
(ii) electrical and pneumatic energisation of c. plant emergency:
the stand-by sub-assembly so that it is (i) receiver pressure 0.5 bar below the stand-
brought on-stream; by cut-in pressure;
(iii) activation of the appropriate fault (ii) receiver pressure 0.5 bar above cut-out
indicator and associated volt-free contacts; pressure;
(iii) dryness above –46°C at atmospheric
pressure;
76
7 Medical compressed air systems
d. pressure fault (cylinder reserve): e. red “pipeline pressure fault” (pressure fault).
(i) pressure in duty bank below 50% (of 7.74 Conditions (b) to (e) should be transmitted to the
normal cylinder pressure); central alarm system. Where relays are used, they
should be normally energised relays that de-energise
e. pressure fault (pipeline):
under fault conditions, with contacts having a
(i) low pipeline pressure; minimum rating of 50 V dc and 50 mA.
(ii) high pipeline pressure. 7.75 Volt-free, normally closed contacts rated at 50 V dc
and 50 mA should be provided for transmission of
Plant status indicator unit conditions (b) to (e) to the alarm system.
7.70 In addition to the plant control indication, there 7.76 The panel can be incorporated into the plant
should be a plant status indicator panel that may indicator unit or be a separate unit within the
be mounted on the plantroom wall or adjacent to plantroom. If mounted separately, the cabling
either the compressor starter unit or the plant should be monitored for open/short circuit. In the
control unit. It should have a warning notice that event of such a cabling fault, a red “system fault”
complies with BS 5499-5:2002 to indicate the lamp should be illuminated on the alarm signal
presence of low voltage. status unit together with the appropriate alarm
7.71 There should be indicators for each compressor to condition.
show the following conditions: 7.77 The alarm signal status unit should be supplied
a. green “mains supply on”; from all individual plant control units or from a
separate common supply.
b. yellow “control circuit failed”;
c. yellow “overload tripped”; Plant management
d. yellow “after-cooler temperature high”; 7.78 Connections should be provided which allow
monitoring of plant alarm conditions (b) to (e)
e. yellow “compressor temperature high”; and pump running for each “compressor”. These
f. yellow for each individual safety device provided connections should be volt-free contacts normally
by the manufacturers; closed for each condition having a minimum rating
of 50 V dc and 50 mA. The building management
g. yellow “compressor failure”. system should not be used to control the plant.
7.72 There should be indicators for each dryer system to
show the following: Synthetic air
a. green “mains supply on”; 7.79 This section provides technical details of the
process and systems required to generate medical
b. yellow “dryness fault”;
air from mixing gaseous oxygen and nitrogen,
c. yellow “pressure fault”. derived from cryogenic supplies.
7.80 For the purposes of the Medicines Act 1968, it is
Alarm signal status unit
considered that the synthetic air is manufactured
7.73 An alarm signal status unit should be provided as on-site, for use on that site only, in exactly the same
part of the control system. It should display the way as for medical air derived from compressor
following conditions: plant. The production of synthetic air implies a
a. green “normal” (normal); manufacturing process, and as such, the process
should be subjected to the same safety requirements
b. yellow “plant fault” conditions ((b)–(g) in of any pharmaceutical process. This should include,
paragraph 7.71); for example, a HAZOP (HAZard and OPerability)
c. yellow “plant emergency” (low reservoir analysis and other safety analyses that may be
pressure/high moisture: that is, condition (b) in necessary.
paragraph 7.71); 7.81 Synthetic air is generated by mixing gaseous oxygen
d. yellow “reserve low” (emergency/reserve banks and nitrogen in a blender or mixing panel at pre-set
low (<50%)); pressures to ensure that the resultant mixture is
77
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
always correct. Continuous on-line monitoring 7.91 Since four VIEs will be required, the space
of oxygen concentration is provided to check the requirements will need special consideration when
mixture; the system shuts down automatically if the planning the installation of a synthetic air system.
oxygen concentration varies from the specified
7.92 The system comprises:
value.
a. storage vessels – one main vessel and one
7.82 If one mixing system shuts down, the pipeline is
secondary supply vessel for both oxygen and
supplied from the secondary mixing system to
nitrogen;
ensure continuity of supply.
b. vaporisers for both oxygen and nitrogen;
7.83 The feasibility study should provide more
information on the details of the monitoring and c. medical oxygen flow control – where used to
alarm systems required, as well as operational supply medical oxygen systems;
information. d. surgical nitrogen flow control – where required;
7.84 The VIE system supplying the medical oxygen e. a control panel for the nitrogen and oxygen
may be used to supply the synthetic air system, supplies to the mixing panels;
depending on the system demands.
f. duplicate air mixing panels;
7.85 Nitrogen supplied to the synthetic air system
may also be used to provide the power source for g. buffer vessels – each mixer has a buffer vessel to
surgical tools instead of surgical air at 700 kPa. smooth fluctuations in demand;
7.86 An electrical power supply is required in order, for h. a warning and alarm system;
example to operate solenoid valves and monitoring j. duplicate oxygen analysers on each mixer.
instrumentation. Therefore the system should be
connected to the essential power supply and via an 7.93 The system is shown in Figure 27.
uninterruptible power supply (UPS) with at least
four hours’ capacity; this should ensure continuity Storage vessels
of supply in the event of power failure.
Vessel summary
System description 7.94 The following vessels are required:
7.87 The gaseous oxygen and nitrogen are derived a. one main oxygen vessel;
from bulk liquid supplies contained in a VIE – as
described in the “Liquid oxygen systems” section of b. one secondary oxygen vessel with at least
Chapter 6. 24 hours’ capacity;
7.88 The oxygen for synthetic air may be taken from the
c. one main nitrogen vessel;
VIE supplying the medical oxygen system or it may d. one secondary nitrogen vessel with at least
be from a dedicated VIE. It would normally be 24 hours’ capacity.
more cost-effective for the oxygen to be taken from
the main VIE, although this would obviously Vessel operating pressure
depend on the existing VIE capacity, the demand,
7.95 The following operating pressures are required:
space constraints etc. The feasibility study should
provide more detailed information on whether it is a. main vessels: 12.5 bar;
likely to be more cost-effective to provide a totally b. back-up vessels: 12.5–14 bar.
separate VIE system or to use the existing medical
oxygen VIE. Main vessel capacity
7.89 For both the oxygen and nitrogen it is necessary 7.96 The main vessel should normally be sized on
to have a secondary supply system to ensure the basis of two weeks’ supply. This should be
continuity of supply; the system demands are calculated as 14 x the average daily usage. This
such that this should be derived from a second – should provide adequate storage and a cost-effective
normally smaller – VIE. vessel-filling regime. The gas supplier should,
7.90 This secondary oxygen supply can also serve the however, be consulted as there may be other factors,
hospital’s medical oxygen system. such as geographical location, space etc, which need
78
Figure 27 Synthetic air plant
PSH PAL
PI
PSL PAH
Alarm panel
Main storage vessel To hospital
O2 pipeline
Main vaporiser
VIE
O2
Economiser vaporiser Pressure control panel
Third
source of
supply
To surgical
N2 supply
VIE O2
N2
Main mixer
Main vaporiser
N2
VIE
N2
Back-up mixer
Gas control panel
Third
source of
supply
Back-up vaporiser
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
to be taken into account when sizing the main Medical oxygen flow control
vessels.
7.108 A control panel (similar in principle to a C11
Back-up vessel capacity panel) should be provided – the only difference is
that the secondary supply is taken from a low-
7.97 The stand-by vessel should have 24 hours’ capacity pressure liquid source.
at any time; that is, it should be sized on the basis
of twice the average daily usage. This will ensure
Surgical nitrogen flow control
that there is always 24 hours’ supply available.
7.109 A control panel to regulate the gaseous nitrogen to
7.98 In addition to the normal instrumentation as set
between 7.5 and 9.5 bar, depending on the system
out in the “Liquid oxygen systems” section of
design, should be provided.
Chapter 6, the vessels should be fitted with a
telemetry system to continuously monitor the 7.110 The pipeline distribution system should be
vessel contents. designed in exactly the same way as for surgical air
700 kPa systems, as described in Chapter 8.
7.99 This information should be transmitted direct to
the gas supplier and also the hospital. The exact
details of how much information, and where it Control panel for the nitrogen and
should be received, will depend on each hospital oxygen supplies to the mixing panels
site. 7.111 The control panel should be sized to provide
7.100 The main vessel low level alarm is activated at 25% pressure-regulated flows as appropriate for the
full; the back-up low level alarm is activated at mixing system; this would typically be up to
50% full. 200 Nm3/hr (normal cubic metres per hour).
7.101 The safety relief valves and bursting discs should 7.112 The stand-by supply regulation cuts in when the
be sized in accordance with BCGA CP19. main line pressure falls to 11 bar; there is no
regulation on the main supply line.
7.102 The liquid from the vessels should be supplied to
the process at a nominal pressure of 12.5 bar. 7.113 A non-return valve should be installed in both the
nitrogen and oxygen supply lines within the mixer
Vaporisation to prevent cross-contamination.
7.103 The main and stand-by vessels should have 7.114 A non-return valve should also be installed on
dedicated vaporisers designed for continuous both the main oxygen supply and the stand-by
capacity and 24-hour capacity respectively at 1.5 x oxygen supply to the mixer to prevent the medical
the required flows to ensure that the vaporisers are oxygen line becoming contaminated with
not overdrawn. nitrogen.
7.104 This may be achieved in each case by either a Air mixing panels
single set of vaporisers or by vaporisers operated on
timed or manual changeover. 7.115 A range of sizes of mixing panels is available
with, typically, nominal capacities of 50, 100 and
7.105 It is preferable for the vaporisers to operate on 200 Nm3/hr.
a timed changeover as this avoids the need for
hospital staff to manually operate the changeover 7.116 A regulated supply of nitrogen and oxygen is
valves. blended in a mixing valve. The differential pressure
at the inlet to the mixing panel is critical and
7.106 The timed changeover will require a 110 V or should not exceed 0.5 bar. A pressure-switch-
240 V supply; this should be on the emergency operated solenoid valve opens and shuts on a
supply and a UPS should also be provided, with at 0.5 bar differential.
least 4 hours’ capacity.
7.117 The main mixer solenoid valve opens when the
7.107 Each vaporiser or set of vaporisers must have a line pressure falls to 4.2 bar; the stand-by mixer
safety relief valve. solenoid valve will open if the line pressure
continues to fall to 4.0 bar.
80
7 Medical compressed air systems
7.118 Two independent paramagnetic oxygen analysers 7.124 Conditions (b) to (e) should be transmitted to the
are provided on each mixer to give continuous on- central alarm system. Where relays are used, they
line measurements. should be normally energised relays that de-
energise under fault conditions, with contacts
7.119 If the oxygen concentration falls outside 20–22%
having a minimum rating of 50 V dc and 50 mA.
as measured by either analyser, the mixer solenoid
valve is held closed and the mixer is shut down. In 7.125 Volt-free, normally closed contacts rated at 50 V
addition, a signal is relayed downstream to close dc and 50 mA should be provided for transmission
the solenoid valve on the buffer vessel associated of conditions (b) to (e) to the alarm system.
with that mixer.
7.126 The panel can be incorporated into the mixing
panel control unit or be a separate unit within the
Buffer vessels plantroom. If mounted separately, the cabling
7.120 Each mixer has associated with it a buffer vessel to should be monitored for open/short circuit. If such
smooth fluctuations in demand. a cabling fault occurs, a red “system fault” lamp
should be illuminated on the alarm signal status
7.121 In the event that the oxygen concentration differs unit together with the appropriate alarm
from the specification (that is, 20–22%), the condition.
solenoid valve downstream of the buffer vessel will
also close, preventing air from the buffer vessel
from entering the distribution system.
Emergency supply provision
7.127 A risk assessment should be carried out to establish
7.122 The buffer vessel, together with appropriate means
the vulnerability of the main supply system of both
of safety relief, should be sized to match each
oxygen and nitrogen. Further information is given
mixing panel to provide stable operation.
in Chapter 2 on sources of supply and in
Chapter 6.
Alarm signal status unit
7.123 The same alarm conditions for liquid oxygen Additional use of medical air systems
should also be transmitted and displayed for the
7.128 It is possible to use medical/surgical air as a power
liquid nitrogen system. The following conditions
source for pendant control and braking systems.
should be displayed for the mixing panels:
7.129 These additions must not compromise either
a. green “normal” (normal);
the medical air system or operation of connected
b. yellow “plant fault” (low gas pressure to any equipment. They must be connected via a non-
mixer); return valve and flow-limiting device, and be
c. yellow “plant emergency” (analysis out of capable of isolation by means of an AVSU labelled
specification on any mixer); to identify the equipment controlled.
d. yellow “reserve low” (operating on final mixing 7.130 Medical air systems must not be used to provide
panel/buffer vessel only); air for sterilizer chamber or door-seal use.
81
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
General Note
8.1 Surgical air at 700 kPa is only used as the power Systems designed to meet requirements of earlier
source for surgical tools. These tools typically editions of Health Technical Memorandum 2022 may
require high flows – up to 350 L/min – at 700 kPa not provide 350 L/min at 700 kPa. Information on
at the point of use. Where nitrogen is available on upgrading surgical air systems in given in Appendix J.
site, it may be used as an alternative source of
supply. 8.7 The maximum pressure at the terminal unit under
8.2 Supply systems for surgical compressed air may be “static flow” conditions should not exceed 900 kPa.
a cylinder manifold system, a dedicated 700 kPa 8.8 Cylinders of medical air or nitrogen stored locally
compressor system or a compressor system capable should always be available for use in an emergency.
of supplying both the 700 kPa and the 400 kPa
supplies. In practice, the decision about which 8.9 Vessels should be selected as follows:
compressor system to install needs careful
Design flow Vessel size Compressor
consideration because of the flow rates required and
(L/min) output (L/min)
total usage (see Chapter 7).
>500 1 × 200% design flow 0.33 × design flow
8.3 A compressor system will be required for large 500–2000 2 × 66.6% design flow 0.66 × design flow
operating department complexes specialising in
2000–3500 2 × 200% design flow 0.66 × design flow
orthopaedic and/or neurosurgery that require the
use of pneumatically-powered surgical tools. An 3500–7000 3 × 33.3% design flow 0.5 × design flow
automatic reserve manifold located in separate
accommodation should be provided. A typical Extension of surgical air systems into
system is shown in Figure 28. dental departments
8.4 It is possible to use nitrogen instead of air as the 8.10 Some surgical air systems have been extended
power source for surgical tools. This may be derived into dental departments; such an extension offers
from either a liquid source or cylinders. In either obvious economic and air quality advantages in
case, the terminal units must be different from the comparison with separate provision. When such
existing medical air 700 kPa terminal units. A extensions are made, a non-return valve or back-
NIST connector is already specified for nitrogen feed protection device, with upstream and
and should be used. downstream isolating valves, should be installed in
8.5 The pressure control equipment should comprise the supply line to the dental department. Before
duplex regulating valves with upstream and extending a surgical air system into a dental
downstream isolating valves, pressure gauges and department, the following must be taken into
pressure relief valves. account:
8.6 Whatever supply system is installed, the overall a. the extra demand on the existing system must
system should be designed to provide a minimum not compromise patient safety or operation of
of 700 kPa at the front of each terminal unit at a either the existing system or its extension. In
flow of 350 L/min. particular, the ability of an existing emergency
supply system to cope with potentially very high
demands must be carefully assessed;
b. the Authorised Person (MGPS) with
responsibility for the existing surgical air system
82
8 Surgical air systems
Figure 28 Typical simplex surgical air plant and automatic emergency reserve manifold
Pressure
safety
valve
Pressure
gauge
Fusible
plug
Ball
valve Air
receiver Ball valve
Ball valve
Inlet filter
Air Pressure
intake Temperature
switch switch
Compressor 1 Aftercooler Non-return Ball
valve valves
Silencer
Notes:
1. Drains marked *1 should be fed to an oil/water separator
Shut-off
2. Filters marked *2 are activated carbon to remove hydrocarbon vapours valve
3. Dryer control systems may incorporate shuttle valves as shown, or
may use other suitable arrangements of directional control valves
Dryer 2 column 2
4. Symbols to BS 2971:1993/ISO 1219-1:1991
Ball Shut-off P
Distribution Supply valve valve Pressure
Pressure
System System transducer
switch
Terminal Silencer
Ball valve unit
Flow Dewpoint
Non-return Lockable restrictor transducer
valve valve
D
Shut-off Shut-off
valve valve
Pressure
Pressure switch
Pressure
safety Ball safety
valve Pressure
valve valve
safety
valve
Non-return valve
Exhaust
(piped to safe position)
Tailpipe
Cylinder valve
Cylinder
83
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
will automatically assume responsibility for the source, the associated medical air system. If
whole of the dental compressed air and vacuum the system is further extended into a dental
system. Both the Authorised Person (MGPS) laboratory, surgical air could be used to support
and Quality Controller (MGPS) must the operation of such devices as natural gas/air
appreciate that extending a surgical air system burners. Cross-connection of these systems is
into a dental unit for dental instrument use unlikely, but the risk must be assessed;
will introduce “non-standard” pipework
c. if the surgical air is derived from a plant that
terminations, for example crimped or
supplies medical air, the medical air supply
compression-fitted connectors, in addition to
should have a separate manifold reserve supply
non-degreased components. Failure of these
when space and system design makes this
“non-standard” components could lead to a
practicable.
serious depressurisation of the existing surgical
air system and, if provided from the same
84
9 Medical vacuum systems
85
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Pressure
switch
To other
ward(s)
Terminal Terminal Terminal Terminal
unit unit unit unit
Riser
Pipework
Notes:
1. Non-return valves marked * are only required if exhausts from other
vacuum pumps share a common exhaust pipe
2. Symbols to BS 2971:1993/ISO 1219-1:1991
Pressure Pressure
gauge gauge
Ball
Ball valve
Ball Pressure
Ball Ball valve
valve valve valve transducer
P
Ball valve
Vacuum plant exhaust 9.14 Noise from the exhaust should be considered and a
silencer fitted if necessary.
9.13 The position of the termination point should be
carefully chosen to be clear of windows, ventilation 9.15 The construction should conform to the following
intakes and the intake of air compressors and other criteria:
equipment, since for oil-lubricated pumps the a. the exhaust should be sized to give a back
vacuum exhaust is likely to be polluted with oil pressure at system design flow which is matched
fumes. to the pump performance;
86
9 Medical vacuum systems
b. the termination point should be turned down equipment’ with the addition of Class F insulation
and provided with protection to reduce the and Class B temperature rise.
effect of wind pressure and prevent the ingress
9.23 A vacuum reservoir should be provided so that the
of rain, snow, insects or animals;
duty pump does not run continuously for low
c. weatherproof notices should be fixed at the loads. The reservoir should be manufactured in
discharge point(s) with the legend “medical accordance with BS EN 286-1:1998, with test
vacuum discharge point – do not obstruct”; certificates provided to the user. The minimum test
pressure should be 4 bar.
d. the exhaust pipe should be provided with a
drainage valve at its lowest point; 9.24 The water capacity of the reservoir should be equal
to the plant design flow at 450 mm Hg (60 kPa) in
e. a silencer should be fitted in the exhaust pipe
terms of free air aspirated in one minute with the
from each pump. This may be integral with the
pump operating at 475 mm Hg (60 kPa).
pump unit.
9.25 Provision should be made for draining the reservoir
Efficiency under vacuum conditions. By-pass facilities should
be provided so that the reservoir can be drained
9.16 The pump should be capable of producing a higher and inspected without interruption to the vacuum
vacuum than that required in the pipeline, so that supply. The reservoir should be fitted with suitable
the resistance of the bacteria filter and back lifting lugs and feet.
pressure in the exhaust system can be overcome.
9.26 If multiple reservoirs are provided, they should be
9.17 The capacity of the vacuum pump should be arranged in parallel.
specified in terms of the free air aspirated (FAA) in
L/min when the pump is operating at a vacuum of 9.27 The bacteria filters and drainage trap should
475 mm Hg (63 kPa) and at 450 mm Hg (60 kPa) comprise two identical sub-assemblies with
at the plant pipeline connection. manually-operated isolating valves, arranged to
allow either sub-assembly to be on stream. Each
Vacuum pumps sub-assembly should contain a bacteria filter rated
at the plant capacity.
9.18 Any type of pump apart from water-sealed pumps
can be used. 9.28 The bacteria filter should be marked with the
legend “bio-hazard”, together with a description of
9.19 Pumps should normally be oil-lubricated. Vapours a safe procedure for changing and disposing of the
from the lubricating oil are unlikely to be a filters and emptying the drainage trap.
significant component of the exhaust gases if
correctly maintained. “Dry running” rotary vane 9.29 The bacteria filters should have a filter efficiency,
pumps are available at increased capital cost and when tested by the sodium flame test in accordance
with lower efficiency than oil-lubricated pumps of with BS 3928:1969, of greater than 99.995% at
comparable performance. the system design flow.
9.20 At least three pumps should be provided. The 9.30 The pressure drop across a clean filter at the system
actual number is at the discretion of the plant design flow should not exceed 25 mm Hg (3 kPa)
manufacturer to ensure optimum cost benefit of at a vacuum of 475 mm Hg (63 kPa).
the system. All pumps should be designed for high 9.31 The drainage trap may be integral with the bacteria
frequency stop/start or continuous operation. The filter and should be fitted with a transparent bowl
opportunity to maximise energy conservation to collect liquid. The bowl should be suitable for
should be taken into consideration. steam sterilization at 134°C.
9.21 All systems should comprise pumps and motors 9.32 Although there is no firm evidence that has
of identical type that are suitable for continuous demonstrated the need for bacteria filters, it is
running and stop/start operation. recommended that such devices are included as
9.22 Pump motors should comply with the National precautionary measures.
Health Service Model Engineering Specification
C51 – ‘Electrical requirements for specified
87
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
9.33 The cut-in setting for the vacuum pumps should be a. the plant control unit indicating the vacuum in
adjusted to allow for the pressure drop across the the pipeline (that is, on the pipeline side of the
pipeline distribution system and the bacteria filters. bacteria filter);
The cut-in may be expected at about 500 mm Hg b. each reservoir.
(67 kPa).
9.42 A differential vacuum indicator (to indicate filter
9.34 The cut-out setting should be at an appropriate blockage rather than quantitative pressure drop)
point on the performance curve of the pump, should be located across the bacteria filter and have
which minimises stop/start operation but is at a a service isolation valve.
vacuum which is economically attained by the
pump. This cut-out setting may be expected at Electrical supply
about 650 mm Hg (87 kPa).
9.43 The electrical supply to the medical vacuum plant
Valves should be connected to the essential electrical
supply. A time-delay system should be provided to
9.35 Non-return valves should be fitted, when necessary, avoid overloading the power supply on changeover.
at the inlet and outlet of each pump to prevent
backflow when a common discharge pipe is used. Pump operating and indicating system
(Some vacuum pumps include integral non-return
valves.) General description
9.36 Manually operated valves should be arranged in the 9.44 The operating and indicating system should
positions shown in Figure 29 to allow isolation of perform the following functions:
components such as pumps, reservoirs, by-pass
pipework, drainage taps and bacteria filters. a. overall plant control and indication;
b. individual pump starting;
Pressure regulation of vacuum system c. plant status monitoring and indication;
9.37 A vacuum of 300 mm Hg is required at the
d. alarm signal status unit.
connection point of each terminal unit with a flow
of 40 L/min whilst the system is operating at 9.45 Provided that the individual pump starters are
system design flow. housed in a separate compartment, the operating
and indicating system may be housed in separate
9.38 This performance is tested by the procedures
units or may be installed in a common panel and
carried out in accordance with Chapter 15.
located on the plant or on the plantroom wall.
9.39 A pressure drop of 13 kPa (100 mm Hg) is allowed
9.46 Pneumatic components should have ventilation.
across the terminal unit at a flow of 40 L/min (BS
All functions should be appropriately identified.
5682:1998). The minimum pressure at the front
Indicators should have a design life of at least five
of the most distal terminal unit should be 40 kPa
years. The operating system should be capable of
(300 mm Hg) at a flow of 40 L/min. The
automatically restarting after reinstatement of the
minimum pressure (dynamic) at the plant should
power supply.
be 60 kPa (450 mm Hg).
9.47 The vacuum supply system should be connected to
Note the stand-by electrical supply. The control system
should ensure that pumps restart in sequence to
Precautions for changing filters are included in Part B.
avoid overloading the power supply.
Vacuum indicators
9.40 Vacuum indicators should comply with BS EN
837-1:1998 or have an equivalent performance if
electronic indicators are used. Calibration should
be 0–760 mm Hg (0–101 kPa). All gauges should
be a minimum scale length of 90 mm.
88
9 Medical vacuum systems
89
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
b. yellow “plant fault” conditions (b)–(d); see should be monitored for open/short circuit. In the
paragraph 9.56; event of such a cabling fault, a red “system fault”
lamp should be illuminated on the alarm system
c. yellow “plant emergency” condition (e); see
status unit together with the appropriate alarm
paragraph 9.56;
condition.
d. red “pipeline pressure fault” (pressure fault).
Plant management
9.58 Conditions (b) to (d) should be transmitted to the
central alarm system. Where relays are used, they 9.61 Connections should be provided which allow
should be normally energised relays, which de- monitoring (but not control) of plant alarm
energise under fault conditions, with contacts conditions (b) to (e) and pump running for each
having a minimum rating of 50 V dc and 50 mA. vacuum pump. These connections should be volt-
free contacts normally closed for each condition
9.59 Volt-free, normally closed contacts rated at 50 V dc
having a minimum rating of 50 V dc and 50 mA.
and 50 mA should be provided for transmission of
conditions (b) to (e) to the alarm system. 9.62 Plant should be operated in accordance with the
manufacturer’s instructions and be covered by a
9.60 The panel can be incorporated into the plant status
sound, effective planned preventative maintenance
indicator unit or be a separate unit within a
(PPM) policy.
plantroom. If mounted separately, the cabling
90
10 Anaesthetic gas scavenging disposal
systems
91
92
Figure 30 Schematic diagram of an AGS disposal system
Flexible hose
Apparatus
incorporating
integral transfer/
receiving system
Permanent
connection
Terminal unit
probe and socket
10.10 A typical system schematic is illustrated in
30 mm conical Receiving
connections Discharge
system Flexible
Means of boom or pendant
positive
pressure relief Permanent connection
Breathing
system Receiving
system
Transfer tubing
Probe/terminal
unit socket interface
Limits of Limits of
breathing transfer
system system Limits of receiving system Limits of disposal system
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
contamination. The materials should be reasonably below with the number of terminal units for which
resistant to corrosion and should withstand it has been designed for use.
cleaning, disinfection or sterilization as
appropriate. Disposal system standard
Pressure drop Flow rate
10.12 The fixed pipework may be of copper or other
BS 6834: ISO DIS BS 6834: ISO DIS
suitable material such as PVC. Where copper
1987 7396-2: 1987 7396-2:
pipework is installed at the same time as the 2005 2005
MGPS, it is desirable to use degreased pipework to
Maximum 1 kPa 1 kPa 130 L/min 80 L/min
the same specification as that used for the MGPS
(see Chapter 13) in order to avoid confusion. Minimum 4 kPa 2 kPa 80 L/min 50 L/min
Maximum 20 kPa 15 kPa
10.13 Where PVC pipes larger than 38 mm diameter
static (–ve) (–ve)
pass through a fire compartment, they should be pressure
protected with metal sleeves extending for 1 m
either side of the compartment in accordance Notes
with the Building Regulations 2000. The
recommendations of Firecode and Health Since the preparation of BS 6834:1987, developments
Technical Memorandum 81 should be followed. in anaesthesiology have resulted in reduced flows being
used. Depending on local circumstances, it may be
possible to commission systems for different flows in
Selecting the number of disposal accordance with ISO DIS 7396-2:2005. Details of the
system pumps test flows should be recorded in the commissioning
10.14 For operating departments, the number of disposal documentation.
system pumps should be selected in accordance The pump inlet should include a vacuum indicator for
with the number of air-handling units that are to commissioning purposes.
be installed for each operating suite. For example,
if a separate air-handling unit is supplied for each
suite, a separate AGS disposal system pump should Discharge outlet
be installed. Where an air-handling unit supplies
two or more operating suites, the AGS disposal 10.17 Careful consideration should be given to the
system should serve the same number and in siting of the discharge from the disposal system. It
this case be a duplex system with automatic should preferably be sited at roof level, well away
changeover. (Where a single pump is provided for from ventilation inlets, opening windows and
an individual operating suite, a spare pump for up other apertures, to prevent pollution re-entering
to six units should be provided for immediate the building.
connection into the system in the event of failure.)
Plant control indication
Flow and diversity 10.18 There should be indicators to show the following
10.15 Although more than one AGS terminal unit may conditions:
be installed in an operating room or anaesthetic a. green “mains on”;
room for convenience, it may be assumed that
b. green “air flow” normal;
only one terminal unit in each room will be in use
at any given time. The AGS terminal unit in the c. yellow “duty pump failed” (plant fault);
anaesthetic room and operating room, however,
d. red “system failed” (plant emergency).
may on rare occasions be in use simultaneously;
therefore, the plant is sized for two AGS terminal 10.19 Indicator panels should be installed in operating
units for each operating suite. rooms.
10.16 The performance criteria for the disposal system 10.20 The “air flow normal” indication should be
are specified in the relevant British, European and initiated by either a pressure switch or air flow
International Standards in terms of the extract detection device at the pump.
flows at specified resistance. The disposal system
should meet the requirements set out in the table
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94
11 Other medical gas pipeline installations
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Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
96
Figure 31 Typical warning and alarm system layout (reproduced by kind permission of Shire Controls)
CENTRAL ALARM PANEL
IN TELEPHONE ROOM REPEATER ALARM REPEATER ALARM
OR PORTERS LODGE IN PORTERS LODGE IN ENGINEERS OFFICE
TRANSMITTER
PLANT TO ALARM
INTERFACE
END OF LINE
COMPONENTS TRANSMITTER TRANSMITTER
END OF LINE
COMPONENTS END OF LINE
COMPONENTS
Figure 32 Typical area alarm panel (reproduced by kind permission of Shire Controls)
SUPPLY
PIPEWORK
PIPEWORK TO
DEPARTMENT
PRESSURE
SENSORS
END OF LINE
COMPONENTS
AVSU
INTER-
CONNECTING
WIRING
AREA ALARM
PANEL
98
12 Warning and alarm systems
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Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
12.28 The ELV power supply may be housed either in 12.35 A battery should be provided with sufficient
the alarm panels or in a separate metal enclosure. capacity to power the visual and audible “alarm
system fault” signal for a minimum period of
12.29 The power supply should be rated for the full load four hours. The battery should be sealed and
of the panel, with visual and auditory signals on all exchangeable, and should automatically recharge
normal and alarm conditions. within 72 hours.
100
12 Warning and alarm systems
g. helium/oxygen mixture. 12.50 The normal condition for all piped MGPS should
be displayed as a steady green visual signal. The
12.39 In addition to the gas service signal indicators, “normal” indicator should extinguish in warning
each panel must include: and alarm conditions.
a. a green “power on” indicator without an
audible signal; Warnings
b. a red “alarm system fault” indicator with an 12.51 Warning conditions appropriate to each MGPS
audible signal. should be displayed as a flashing yellow visual
signal that may be accompanied by a mutable
Labelling audible signal (see Table 24).
12.40 Panels should be labelled as follows: Emergency alarms
a. medical gas alarm; 12.52 Emergency alarms are generated by loss of pipeline
b. with the identification of the medical gas pressure or vacuum and are indicated by flashing
services indicated, and the areas and red visual signals accompanied by mutable audible
departments served. signals.
12.55 Operation of the continuous mute should inhibit 12.65 Operation of the mute should not inhibit the
the 15-minute reinstatement of the audible alarm. visual or audible indication of any subsequent
alarm conditions.
12.56 Operation of the mute should not inhibit the
visual or audible indication of any subsequent
alarm conditions. Integrated systems
12.66 The introduction of computer-based systems for
Panel legend and display a range of functions such as patient information,
12.57 Panel legend and display should be as shown in nurse call and other alarm conditions provides an
Table 24. opportunity to further include certain provisions
of medical gas pipeline warning and alarm
Repeater indicator panel requirements conditions. This concept is totally new and, at this
stage, the applications have not been thoroughly
Displays evaluated or analysed. One of the advantages of
the concept is that text prompts can be displayed
12.58 The repeater indicator panel should always display on the computer display when changes in the
“normal”, “emergency alarm” and “alarm system status of the pipeline occur, and these prompts can
fault” conditions as given above. The repeater advise staff of the need to take specific action.
panel should display some or all of the warning
conditions that are displayed on the central 12.67 The advantage of a computer-based system is that
indicator panel. The extent of the display of the advice given in the text message can be varied
warnings should be varied to suit local clinical to take account of specific circumstances, changes
requirements. in operating procedures and functional changes
within individual departments. Such systems
Mute functions are likely to be of most use in in-patient ward
accommodation; it may not be appropriate for
12.59 The temporary mute should cancel the audible central warning and alarm conditions or in
signal for about 15 minutes whilst the visual individual operating rooms and other
indicator continues to flash. Operation of the accommodation in which anaesthetic procedures
temporary mute (on the central panel) should are taking place.
change the visual indicator to continuous
illumination on the central and any repeater 12.68 It will be necessary to change the perception of
panels. users in that with this approach the “normal”
conditions of the pipeline systems that are
12.60 Operation of the continuous mute must inhibit continuously displayed on alarm indicator panels
the 15-minute reinstatement of the audible alarm. will not exist – audible emissions and displayed
12.61 Operation of the mute should not inhibit the messages generated by the computer-based system
visual or audible indication of any subsequent will be in response to changes from the “normal”
alarm conditions. situation. To ensure the long-term viability of the
system, any supplier or installer of such a system
Panel legend and display must supply sufficient information about the
system to allow modification, expansion or
12.62 The panel legend and display should be as shown
replacement of sections of the system by a third
in Table 24.
party. This must include source code for any
software, passwords and details of any other
Area warning and alarm panel security device, and details of any communication
protocols. This information must be handed to the
Panel displays and legend end-user before the system is accepted by the end-
12.63 Area panels should display the conditions listed in user.
Table 25.
Note
Mute functions
No further information can be given at this stage until
12.64 The temporary mute should cancel the audible further development and consultation takes place.
signal for about 15 minutes whilst the visual
indicator continues to flash.
102
12 Warning and alarm systems
Table 24 Signals and displays for central alarm panels and repeater panels
Supply system(1) Alarm conditions Legend Colour Audible Location(2)
system
Automatic manifolds 1. Duty bank empty: stand-by Change cylinders Yellow Yes AB
bank running
2. Stand-by bank below 10% Change cylinders Yellow Yes AB
capacity immediately
Compressed cylinders on automatic Changeover of manifold. Pressure Reserve low Yellow Yes AB
manifold serving a single vessel in each bank is not monitored.
cryogenic oxygen system or liquid
cylinder installation
Compressed cylinders on reserve Changeover of manifold. Pressure Reserve low Yellow Yes AB
manifold serving a compressor plant in each bank is not monitored.
Compressed cylinders on reserve Reserve pressure below 68 bar Reserve low Yellow Optional AB
manifold serving an automatic (<14 bar for N2O)
manifold
Medical air compressor and surgical 1. Plant fault Plant fault Yellow Yes AB
air compressor
2. Plant emergency Plant emergency Yellow Yes AB
Medical vacuum plant 1. Plant fault Plant fault Yellow Yes AB
2. Plant emergency Plant emergency Yellow Yes AB
Oxygen concentrator 1. Plant fault Plant fault Yellow Yes AB
2. Plant emergency Plant emergency Yellow Yes AB
Pressure fault (pipeline) high or low For each gas service to indicate Pressure fault Red Yes AB
and oxygen concentration fault for that the pressure in the
PSA plant distribution system has risen/
fallen from the “normal” working
pressure given in Chapter 4
and, for PSA plant, that O2
concentration <94%
Vacuum pressure (pipeline) To indicate that vacuum in the Pressure fault Red Yes AB
pipeline distribution system has
risen above the normal working
pressure given in Chapter 4
Notes:
1. For liquid supply systems, see Chapter 6.
2. A = Central indicator panel – telephone room and/or porters’ room, ie 24-hour occupancy.
B = Facilities management office reception.
103
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
13 Pipeline installation
13.1 Generally, MGPS should be kept away from areas damage (for example vehicular movement):
where they may be subject to any of the following: by means of galvanised, profile-section steel
of sufficient thickness to afford adequate
a. mechanical damage;
protection. The protection should cover the
b. chemical damage; entire space taken up by the pipeline(s), but
c. excessive heat; stand off the surface such that the pipes can be
inspected visually (The armour should be
d. splashing, dripping or permanent contact with readily detachable to permit more detailed
oil, grease or bituminous compounds, electrical inspection.);
sparks etc.
b. when crossing horizontal surfaces, roofs etc:
13.2 Service ducts or voids containing pipelines that similar protection to (a) above should be
include valves etc should have adequate ventilation provided to withstand “stepping” damage
to prevent gas build-up in the event of any leakage. using profiled section, as above.
Elsewhere, where pipelines are brazed throughout
13.6 Pipework should be protected from lightning
their entire length (and where they will have been
subjected to a pressure test), no ventilation is strikes by ensuring that they are run within a
required. 60‑degree cone beneath the lightning conductor,
for example when run along parapet walls, or when
13.3 Exposed pipelines should not be installed in lift penetrating parapet walls. When run across roof
shafts, kitchens, laundries, boilerhouses, generator surfaces, a copper lightning conductor should be
rooms, incinerator rooms, storage rooms designed run on the top surface of the pipework cover
to house combustible materials, or in any other providing physical protection, and should be
fire-risk areas. Where pipelines in hazardous areas bonded to it.
are unavoidable, they should be enclosed in non-
13.7 Internal pipelines should be suitably protected
combustible, non-corrosive materials that have no
electrolytic reaction with copper in order to prevent where there is a possibility of physical damage,
the possibility of the liberation of gases into the for example from the passage of trolleys, tugs etc.
room in the event of pipeline failure. Medical gas 13.8 Wherever practicable, a clearance of at least 25 mm
pipelines should be routed away from natural gas should be maintained between each service and
pipelines where there is a potential for a flammable 150 mm should be the separation distance between
gas mixture to accumulate in the case of a leak. the medical gas pipeline and heating pipes, hot
13.4 Where pipelines are run in enclosed ducts with water service and steam pipelines. Where pipelines
other services such as steam mains and water supply cross over other services and a clearance of 25 mm
systems, they should be inspected regularly as cannot be maintained, they should be electrically
corrosion can occur as a result of chloride deposits bonded and wrap-insulated, in accordance with
following leakage. They should not be run in IEE regulations. They should be bonded to main
enclosed ducts with other services where they earth at building entry and exit. Care is required
cannot be inspected. when selecting pipeline routes to prevent the pipes
coming into contact with electric cables and wiring,
13.5 External pipe runs should be avoided when and to minimise the risk of electric shock in the
possible. Where external runs, however, are event of a fault on adjacent cables (see Chapter 2).
necessary, they should be protected as follows:
13.9 Underground pipelines should be run in properly
a. on external vertical surfaces up to the drained ducts not less than 450 mm x 450 mm
maximum height of exposure to possible which have removable covers. Where it is not
104
13 Pipeline installation
possible to provide removable covers, two pipes Figure 34 Typical ring-main arrangement
should be run in separate trenches with valves
Primary
provided in a convenient location at either end. Primary
VIE
& Secondary
VIE
The valves should comprise LVAs with NIST
connectors for the purposes of pressure and other Non-return Non-return
tests. The separation distance between the two valve valve
Pipes in separate
ducts/trenches.
Minimum separation 2 m
Interior of building
LEGEND
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Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
107
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
108
13 Pipeline installation
system.
CO 2 CARBON DIOXIDE
109
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
110
13 Pipeline installation
at a later date in the event of the necessity to 13.65 LVAs should be provided as follows:
dismount and reconnect. a. at the connection of the pipeline to any source
of supply;
Note
b. at the emergency inlet port (that is, it forms the
After any such disconnection and reconnection, it will emergency inlet point);
be necessary to carry out the full range of anti-
confusion tests. c. at the pipeline entry to a building;
d. at the pipeline exit from a building;
LVAs and AVSUs e. at the connection of branches to the main
13.61 All valves should be of the lever-ball type, having pipeline run;
flanged O-ring seal connections which open and f. at the connection to risers;
close with a 90-degree rotation: the handle should
be in line with the pipeline when open. g. at branches from risers to serve a number of
similar departments;
LVAs h. upstream, downstream and in the branch
13.62 LVAs should be capable of being locked with the connection to a ring-main.
valve in the open or closed position. Means of
physically isolating and blanking the pipeline both Notes
upstream and downstream of the valve should be a. Where departments on a floor are functionally very
provided. The means of isolation should be in the different, for example wards and diagnostic areas,
form of a spade that can be readily deployed. It it is preferable to run separate branches from the
should blank both the pipeline and the valve port risers.
and be visible when deployed. Each valve should
be provided with a set of “through” and “blanking” b. LVAs should not be installed where a leakage of
spades; they should be coloured white and red gas could cause an accumulation that is likely to
respectively. The valve flange should include the result in a hazardous atmosphere developing.
thread, and the bolts should be of sufficient length The assembly should include clear labelling of the
to permit loosening to allow removal/replacement service.
of the spades without loss of structural integrity
of the connection. Union-type connections with AVSUs
O-rings are permissible, but the securing nut must
13.66 AVSUs are provided for user access in an
also have sufficient thread length to permit venting
emergency (or for maintenance purposes). They
while maintaining the structural integrity of the
should be in accordance with the requirements
connection. A single key for each service is
above for LVAs except that security is achieved by
considered to provide sufficient security.
installing them in an enclosure with a lockable
13.63 In the event of leakage of the through or door designed such that it can be closed with the
blanking spade, gas must be capable of venting to valve either in the “open” or “closed” position.
atmosphere and must not be able to enter either
the valve port or the pipeline section blanked. Note
13.64 The appropriate NIST connector bodies with self- The views of the building operator should be sought as
sealing check valves and lockable blanking nuts to the level of security that will be required and hence
should be provided upstream and downstream of the range of keys.
the flanges. Gas identity and flow direction arrows
should be provided for each valve. 13.67 In an emergency, the user must be able to gain
access in order to operate the isolating valves
Note quickly and simply without the need for a key.
A single NIST connector will suffice in ring-main There are several methods of providing such
branch connections between the three closely spaced emergency access, for example break-glass panels
valves. and plastic push/pull-out inserts. Whichever
method is used must be safe and secure and must
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Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
112
13 Pipeline installation
113
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
14 Accommodation
114
14 Accommodation
115
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
14.24 Free-field noise levels should be given to the where necessary to prevent the transmission of
architect to assist in acoustic design of the noise and vibration along the pipelines and
plantrooms. conduits. Electrical bonding will be required.
14.25 The discharge from some vacuum pumps may
Labelling/signage
require silencing.
14.28 Labelling for medical gas systems, equipment and
14.26 Compressors and pumps should be mounted on
accommodation should be in accordance with
properly-selected anti-vibration mounting, where
Appendix K.
necessary, to minimise transfer of noise and
vibration to the structure of the building.
14.27 All pipework and electrical conduits connected to
the plant should be fitted with flexible connectors
116
15 Validation and verification
15.1 This chapter covers the validation and verification coupling comprises two joints and a “T” comprises
and filling for use of MGPS. The requirements for three joints. On a minor modification, from which
AGS disposal systems are also covered in paragraphs existing terminal units would not be removed, the
15.169–15.178. carcass pressure test can also be omitted. All other
tests would be required, including a working
15.2 This chapter describes the tests required and the
pressure test.
test methods. The contractor should provide
instrumentation for the functional tests. The 15.6 The programme of tests is divided into three
Quality Control Pharmacist normally provides phases:
instrumentation for the quality tests. Calibration
a. tests and checks on the pipeline carcass;
certificates should be available for all
instrumentation. Tests are listed in Appendix A b. tests and commissioning of the complete
with the associated forms. pipeline system (with terminal units installed)
for safety, performance and particulate
15.3 The objective of testing and commissioning is to
contamination using test gas;
ensure that all the necessary safety and performance
requirements of the MGPS will be met. Testing and c. filling of the systems with specific gases for the
commissioning procedures will be required for new purposes of identity and quality tests of the
installations, additions to existing installations and specific gases prior to use for patient care.
modifications to existing installations. The scope of 15.7 The basic rationale for the tests is depicted as a
work will dictate the specific test programme decision tree in Figure 36.
required. This is described in more detail in
paragraphs 15.12–15.14.
Notes
15.4 For modifications and extensions (except for the
Systems that are not to be taken immediately into use
final connection), all work should be performed
should be filled with medical air and maintained at
with an inert gas shield; thus, it is essential that a
operating pressure. Systems other than medical,
physical break is employed between the pipeline
surgical or dental air supplied from compressors
being modified/extended and the system in use.
should be filled with medical air from cylinders.
(This will usually be by deploying “spades” in
AVSUs and LVAs, or by cutting and capping the Commissioning of liquid supply systems prior to
pipe.) Prohibition labels should be affixed to all handover should be avoided. (Under “no flow”
terminal units in the system affected in occupied conditions, liquid will evaporate and oxygen will blow
areas. off to atmosphere.)
15.5 For small extensions comprising fewer than 20
15.8 The personnel and test equipment needed for these
brazed joints per gas service, all the tests may be
tests are listed together with the test requirements
performed with the working gas – the carcass
in Table 27. The particulate contamination test for
pressure tests being replaced by a system leakage
all pipeline systems may be checked using medical
test of the complete extension. An extension
air to establish that the pipeline has been
comprising more connections would, however, be
constructed correctly and is not contaminated.
deemed to be a small installation, requiring all the
Successful completion of the commissioning tests
appropriate tests to be carried out, up to the final
normally indicates the end of the installation
connection; the final connection would be tested at
contract. The systems may then be left under
pipeline distribution pressure. For the purpose of
pressure, filled with medical air, for an indefinite
ascertaining the number of joints, a straight
period. Responsibility for the system during this
117
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Pre-Contract Works
Extension/ Test existing
Completely No modification to system for
new system? existing system performance
Yes
Prepare total
Install system system
to carcass/first performance
fix stage specification
No
Pass?
Yes
Yes
Remedial No Carry out Complete
work to remedial work installation to
carcass? 2nd fix stage
No
Pass?
No
Has
System Connect to System now to system been
to be taken No
medical air be taken into maintained
into use supply source use? under
now? pressure?
No
Pass?
Yes
Carry out
No No
performance Completely
Pass? tests of total new system?
system
Yes
Yes
Remove
Construction
labels
System
available for
use
118
15 Validation and verification
period needs to be clearly defined in the contract; MGPS after handover should be permitted access
the Authorised Person (MGPS) ultimately during contract work. This should be included in
responsible for the day-to-day management of the the contract agreement.
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15 Validation and verification
Tests before use test can be carried out by using the medical air
compressor system, provided that the quality tests
15.14 The following tests must be carried out after
have been satisfactorily carried out to demonstrate
purging and filling with the working gas:
that the criteria set out in Table 30 have been met
a. tests for particulate contamination (see and that the air supply plant is continuously
paragraphs 15.93 and 15.130–15.136); monitored for moisture during the test.
b. tests for gas identity; 15.19 Such a compressor system can also be used for the
c. tests for gas quality. single point performance tests etc and for initial
purging and particulate testing of these systems.
Once tests have been completed, the system
General requirements for testing should be maintained under pressure by means of
15.15 The tests described in this document are air supplied from medical gas cylinders until filled
generally carried out, in the order given, for new with the working gas, when full QC checks will be
installations. It may be necessary to amend the test carried out.
programme for modifications or extensions to
existing systems. Care must be taken, however, Note
to ensure that the basic principles are followed.
The use of portable, non-medical air compressors is
Paragraphs 15.32–15.44 give details of the tests
not appropriate. Not only should a Quality Controller
required for modifications/extensions to existing
(MGPS) check all compressors before use, but also
systems.
QC checks during use are important. Preferably, an
on-line dew-point meter should be fitted to the plant
Note or pipeline system.
When tests and/or purging are/is carried out on
systems fed by sources serving an operational hospital, 15.20 When employing compressors for this type of test,
it is essential to ensure that the flows generated during it is important that the system demand should not
any tests do not result in interruption of continuity or exceed the maximum flow capacity of the dryers,
impairment of adequacy of supply in the operational otherwise wet air will result. It is suggested that the
areas. total flow required by the system under test should
not be more than 75% of the flow capacity of the
15.16 Testing for leakage is normally carried out in two dryers.
stages: the first to the pipeline carcass, the second 15.21 It is also important not to introduce such a
to the completed distribution system, which will compressor after identity checks have taken place.
include terminal units and medical supply units as
appropriate. 15.22 Special care will be required when carrying out
QC checks, as some synthetic oils cannot be
15.17 Purging and testing must be carried out with detected using portable equipment.
clean, oil-free, dry air or nitrogen, except for those
tests where medical air or the specific working 15.23 Special connectors will be needed to introduce test
gas is prescribed. All test gases must meet the gas into different pipeline systems. These must
particulate contamination requirements set out in be of distinctive construction and permanently
paragraphs 15.130–15.136. The shield gas may be labelled with their function and the contractor’s
used for the tests on the pipeline carcass described name. The location of special connectors on the
in paragraphs 15.49–15.56. Cylinders of medical site must be recorded and should be subject to
air will normally be used as the source of test gas routine inspection under a planned preventative
for oxygen, nitrous oxide, nitrous oxide/oxygen maintenance (PPM) system. They should be
and helium/oxygen systems in order to prevent the removed from site when work is complete and the
possibility of contamination with oil. contractor should record their removal.
15.18 However, in the case of a large oxygen system, for 15.24 New terminal units are supplied with “Do not use”
example a new-build, the use of cylinders will be labels. These labels should remain in place until
impracticable for the total system performance the final identity and quality tests have been
test. As it may be undesirable to commission the completed. They are then removed by the
liquid supply system, the total system performance Authorised Person (MGPS).
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15.25 In the case of existing systems, “Do not use” labels calibration records. On-site pre- and post-testing
should be affixed to all terminal units within the calibration of equipment against an appropriate
section being modified. standard will be performed at the discretion of the
Quality Controller (MGPS).
15.26 The results of all tests must form part of the
permanent records of the hospital and should show 15.31 In a completely new installation, flow meters,
details of the services and areas tested. Examples of anaesthetic trolleys etc should not be moved into
the appropriate forms are given in Appendix A. All rooms until validation and verification tests have
signatories are entitled to copies of the test forms. been satisfactorily completed.
The procedure for filing and retaining these forms
should be included in the local MGPS operational Note
policy.
In existing installations, particular care must be taken
15.27 For total system pressure tests on oxygen, nitrous to ensure that medical gas equipment left in areas
oxide and nitrous oxide/oxygen mixture, the where work or testing is taking place is, and remains,
system under test must be physically isolated from disconnected from the system.
the source of supply (for example by the use of
Medical and nursing staff should be made aware of this
spades). In the case of compressed air and vacuum
situation by the posting of appropriate exclusion
systems, the pressure at the plant must be
notices and terminal unit “Do not use” labels.
respectively below and above pipeline distribution
pressure.
Modifications, extensions or repairs to
15.28 All errors found during testing must be rectified, existing systems
and the relevant systems must be retested as
appropriate before the records are signed. 15.32 Where modifications, extensions or repairs to
existing systems are carried out, the tests and the
15.29 The contractor (MGPS) must provide all sequence of tests summarised in paragraphs 15.12–
engineering forms, labour, materials, instruments 15.14 should be followed as far as possible.
and equipment required to carry out the tests
described in this chapter. In the case of engineering 15.33 The permit-to-work system should always be
tests, this must include all cylinders of test gas followed whenever any work is carried out on an
together with “open” bore NIST connector probes, existing system. The Authorised Person (MGPS)
pressure-measuring equipment and gas specificity/ should act on behalf of the management and
flow pressure testing device(s), metered leaks and therefore would not normally be a member of the
AGS disposal system test equipment. The Quality installation contractor’s staff.
Controller (MGPS) will be responsible for 15.34 Whenever modifications or extensions are carried
supplying all QC forms, unless otherwise out, it may be advisable but not always possible to
requested by the trust, calibrated test equipment, test both the existing system and the new system
connections etc. separately before the break-in is made. Existing
systems should, if possible, be tested to determine
Note their performance and to identify any potential
If there is to be a delay between completion of the limitations that may arise as a result of
MGPS and when it is taken into use, it will be modifications.
necessary to carry out the particulate and odour test 15.35 Where there is any doubt as to the cleanliness,
prior to purging and filling with specific gases. In such it is in the interest of both the contractor and
cases the contractor must also provide labour, materials management for particulate tests to be carried out
and equipment to carry out these tests. on the existing system prior to any break-in, and
it is the responsibility of the hospital authority to
15.30 The Quality Controller (MGPS) should provide ensure that these tests are carried out prior to the
the test equipment specified in Appendices D, E design phase of any modifications or extensions.
and F. The Quality Controller (MGPS) should
provide all equipment for gas quality and identity 15.36 It is the responsibility of the hospital’s
testing. It should be regularly serviced and management to ensure that any required remedial
calibrated to an appropriate standard and the work is carried out on an existing system before
Quality Controller (MGPS) should maintain extensions are added.
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15 Validation and verification
15.37 No system should be modified during the process 15.44 The break-in to the existing system should be
of testing. It is important that any modifications carried out with an inert gas shield where possible,
are documented and that any additional testing for example where AVSUs have been installed, and
required, as a consequence of those modifications, a downstream blanking plate has been deployed.
is performed. A leak test must be carried out using a suitable
leak detection fluid on this final joint at working
15.38 A permit-to-work (or another form of appropriate
pressure, and the joint purged with the working
document) must be issued if additional works
gas.
are to be carried out during the commissioning
process, even though a permit will not have been 15.45 Connection of the upstream side of the AVSU into
issued for the original commissioning. the existing system will usually be made without
use of the shield gas. This joint can be purged with
15.39 The tests for particulate contamination of any
the working gas (exiting via the AVSU upstream
extension or modification may be carried out with
NIST).
medical air, prior to connection and handover
to the Quality Controller (MGPS), although in
extensions comprising fewer than 20 joints, the Note
working gas will generally be used to perform all In some articulated pendant fittings, it is not always
tests. possible to achieve the specified pressure requirements
15.40 The Quality Controller (MGPS) will normally
for surgical air and vacuum. In the case of surgical
carry out all checks, including a repeat of the air, it is most likely to be a potential problem in
particulate matter test, using the working gas. orthopaedic operating rooms. As these normally
include an ultra-clean system into which can be
15.41 The exact tests to be carried out will depend incorporated surgical air (and other terminal units),
on the nature of the modification/extension. supplied by rigid pipework, there may not be a
A specification should be prepared for the problem in practice. If the static pressure exceeds the
performance of the completed system. This nominal pressure during flow by more than 25%,
specification should be as close as possible to that the possibility of installing hoses with a greater bore
given in Table 28. should be considered. In the case of vacuum, the flows
15.42 Some older compressed air systems will have been required during surgery are less than those used during
designed to provide 250 L/min at the terminal testing.
unit in accordance with Health Technical
Memorandum 22 (1978). It may not be possible Requirements for pipeline carcass tests
for such systems to provide 350 L/min, as specified 15.46 If sectional testing is performed, it is essential that
in Table 19, and there may be circumstances where as-fitted drawings are available so that the extent of
this would be acceptable. This should be clearly the system(s) under test can be identified. For the
stated in the specification for the performance of purpose of the leakage test, all pressure gas systems
the completed system. However, every effort may be interlinked, provided that the test can be
should be made to comply with the performance performed at the highest pressure required. (This
and quality specifications given here, although also has the advantage that the pipeline carcass
particular care must be taken to avoid degradation could be assigned to a different service.)
of air quality arising from dryer units working at
flow rates above their design specification.
Notes
15.43 It may be necessary to repeat some of the system
In the event of a leak, it will be necessary to test each
performance tests (such as flow and pressure drop)
system separately.
at selected terminal units on the completed system
to demonstrate satisfactory performance (see It is advantageous to perform the tests with nitrogen,
paragraph 15.77). To ensure a valid result from since – in the event of a leak or cross-connection –
such a test, it should be performed when flows in remedial action can be taken immediately.
the system are representative of typical maximum When connecting systems together, vacuum systems
demands. should not be included, as particulates from an
unpurged vacuum system may be drawn into any
part of any pressure gas system by venturi effects.
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15 Validation and verification
measuring equipment is in doubt and recourse is Leakage from total compressed medical
made to a 24-hour test, Appendix B contains
gas systems
information on the method of calculation. Systems
must be tested at a working pressure of 18.0 bar 15.59 This test must be carried out on the completed
for medical compressed air systems for surgical use, system with all terminal units, AVSUs, pressure
10.0 bar for all other compressed medical gas safety valves and pressure transducers fitted. Once
systems and 5.0 bar for vacuum systems the test pressure has been applied, the system
constructed in copper (1 bar for systems should be isolated from the plant. For the purpose
constructed in plastic). of this test, the supply system extends from the last
valve(s) nearest to the plant detailed on the
15.51 This test should be carried out with AVSUs, LVAs
appropriate schematic drawing. This point should
and other service valves open; any safety valves and
be identified on the contract drawings. The test is
pressure-sensing devices installed may be removed
performed at pipeline distribution pressure.
and the connections blanked off. The results of the
test may be recorded on Form B1. 15.60 During a test period of two hours, the maximum
pressure loss should be less than 0.2 kPa for
Cross-connection 400 kPa systems and vacuum, and 0.5 kPa for
700 kPa systems. The test results may be recorded
15.52 Before performing these tests, any links between on Form B3.
systems should be removed and all pipelines
should be at atmospheric pressure with all AVSUs
Leakage into total vacuum systems
etc open.
15.61 Prior to testing, the vacuum plant should be
15.53 A single pressure source should be applied to the
operated to allow any moisture in the system to
inlet of the system to be tested and at least one
evaporate. With the system at pipeline distribution
terminal unit base block on all other systems
pressure and with the source isolated, the pressure
should be fully open.
increase in the pipeline must not exceed 1 kPa
15.54 Each terminal unit base block on the pipeline after one hour. There is no additional allowance
under test should be opened in turn, checked for for temperature correction in this test.
flow and then re-blanked. (To permit refitting of
15.62 The test results may be recorded on Form B4.
blanking caps, it is necessary to partially open at
least one base unit – but it is still necessary to
achieve a detectable flow.) When the test on one Closure of area valve service units and
pipeline has been completed, the pressure source line valve assemblies
should be removed and the pipeline should be left 15.63 For pressurised systems, the system upstream of
open to atmospheric pressure by removing at least the closed AVSU under test must be maintained at
one base block blanking plate. pipeline distribution pressure and the downstream
15.55 The test is repeated for other systems, one at a line pressure should be reduced to about 100 kPa.
time. The downstream pressure must be recorded, and
there should be no change in pressure over a
15.56 The results may be recorded on Form B2. period of 15 minutes.
Requirements for pipeline system tests 15.64 For vacuum systems, the systems on the supply
plant side of the closed valve must be maintained
15.57 There must be no links between the pipeline at pipeline distribution pressure and the terminal
systems. Engineering (pressure) tests should be unit side should be at about 15 kPa. The upstream
carried out with electronic pressure-measuring (terminal unit side) pressure must be recorded, and
equipment with a minimum resolution of 0.2 kPa there should be no change in vacuum over a period
in 1000 kPa, and 0.5 kPa in 2000 kPa. of 15 minutes.
15.58 The scope of the system and scale of provision of 15.65 For LVAs, a similar test procedure is adopted.
terminal units, AVSUs, LVAs and warning and There is no change in the time for vacuum.
alarm system panel indicators should be checked
for compliance with Table 11 and any deficiencies
noted.
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Note Notes
The reduced residual pressure is intended to take into These tests can be performed at the same time as the
account any potential terminal unit leakage on the cross-connection/terminal unit pressure drop tests.
assumption that it is unlikely any such leakage would
Where pneumatically activated pendant fittings are
equate to that of the valve under test; there would be
installed, a check should be made to ensure that the
less certainty if the pressures were reduced to zero.
source of air has been taken from the correct AVSU
zone.
15.66 The test results may be recorded on Forms B5A
and B5B. 15.69 The test results may be recorded on Forms B5A
and B5B.
Zoning of AVSUs and terminal unit
identification Cross-connection
15.67 This test is performed to ensure that each AVSU 15.70 All systems must be checked to ensure that there is
in the pipeline controls only those terminal units no cross-connection between pipelines for different
intended by the design. Each terminal unit must gases and vacuum. The tests should not commence
be checked to ensure that it is for the correct until all installations are complete and plant
service and that it is in accordance with BS EN operational. (The tests can be performed using
737-1:1998; unambiguous cross-referenced “test” gas or “working” gas.)
labelling of AVSUs and terminal units controlled
by them is essential. It is particularly important Note
to establish correct identification where dual or
separate circuits have been installed; often it is not Oxygen and vacuum can be tested simultaneously,
obvious by the spatial relationship of AVSUs and followed by medical air and surgical air simultaneously,
terminal units which of the AVSUs controls which followed by the other gases, that is, nitrous oxide and
terminal unit arrays. nitrous oxide/oxygen mixture. (Helium/oxygen
mixture usage is increasing, and pipeline systems may
Notes be encountered. Also, carbon dioxide pipelines are
being installed.)
The contractor may wish to carry out this test as part
of the carcass tests before any section of the pipeline is 15.71 The sequence of the test is, first, to open all valves
“enclosed”. on all systems (for example AVSUs, LVAs and any
Terminal-unit first-fix back blocks inadvertently other valves). For oxygen and vacuum systems, the
fitted upside-down will result in inverted second-fix main plant isolation valves should be opened (the
components, unless gas-specific components are main plant isolation valves on other systems
deliberately removed. Therefore, a selection of terminal remain closed). A check must be made to ensure
unit second-fixes, for example one per ward area, that there is a flow at every oxygen terminal unit
should be removed and examined to ensure that no and suction at every vacuum terminal unit, and
gas-specific components have been removed. that the systems are at the correct operating
pressure; there must be no flow at any other
15.68 The test is performed by turning off an individual terminal unit for the other gases.
AVSU and venting the zone to atmospheric 15.72 For the next stage, the main isolation valves for
pressure. A check is then made to establish that medical air and surgical air, if present, are opened.
only those terminal units controlled by the AVSU (It is not necessary to return the oxygen and
are at atmospheric pressure. All other terminal vacuum systems to atmospheric pressure.) A check
units, including those for other gas services, should is made to ensure that there is a flow at every
be at the operating pressure. Once a zone has been medical air terminal unit and every surgical air
vented, it is not necessary to repressurise. The terminal unit and that the operating pressure is
other AVSUs are then tested successively. correct; there must be no flow from the nitrous
oxide and/or nitrous oxide/oxygen mixture
terminal units, if present, and helium/oxygen,
if present.
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15 Validation and verification
15.73 The process is then repeated for nitrous oxide – 15.78 It must be demonstrated for each terminal unit
again there is no necessity to return any of the that the appropriate gas-specific probe can be
previously tested systems to atmospheric pressure. inserted, captured and released, and it should be
A check is made to ensure that there is flow at visually confirmed that an anti-swivel pin is
every nitrous oxide terminal unit and that the present, or absent, in terminal units with a
operating pressure is correct; there must be no flow horizontal or vertical axis, respectively.
from the nitrous oxide/oxygen terminal units and
helium/oxygen terminal units (if present). Notes
15.74 The process is then repeated for nitrous oxide/ Terminal units to BS EN 737-1:1998 need not be
oxygen mixture, and finally helium/oxygen challenged with the full complement of BS 5682:1998
mixture. (If other medical gases are encountered, test probes.
for example carbon dioxide, the sequential testing
The terminal unit should be fitted complete with bezel
methodology will continue.) As before, there is
plates etc. The clearance hole should be reasonably
no necessity to return any of the previously tested
concentric with the terminal unit rim – it must not be
systems to atmospheric pressure. Checks are made
in contact.
to ensure that there is no flow from any system
that is still isolated at the plant.
15.79 The results of the tests may be recorded on
Form B7A.
Note
15.80 All NIST connectors must be checked to ensure
The tests can be carried out on a total system basis, that gas flow is achieved when the correct NIST
departmental basis or sub-departmental basis, having probe is inserted and mechanical connection
previously checked for cross-connection up to the made. The correct identification of gas flow
appropriate AVSUs. When carrying out the tests on a direction should be confirmed for AVSUs (that is,
sectional basis, it is essential that as-fitted drawings are which are the upstream and downstream NIST
available such that the extent of the system(s) can be connectors). NIST connectors can be checked
established. when performing other tests on AVSUs and LVAs.
15.75 This test must be repeated in full if any subsequent
modifications are made to the pipeline system. Note
15.76 The test results may be recorded on Form B6.
Whereas it should not be necessary to carry out
these tests on AVSUs bearing a CE Mark, in
certain circumstances factory-assembled units are
Flow and pressure drop at individual dismantled for installation purposes and can be
terminal units, mechanical function and subsequently incorrectly re-assembled. In the case of
correct installation LVAs (whether or not CE marked), disassembly and
subsequent incorrect re-assembly or, indeed, insertion
15.77 These tests can be carried out as part of the cross-
into an incorrect line, is also possible.
connection tests above using appropriate test
devices as described in Appendix C with the The primary purpose of the test is to ensure that
correct probes inserted for the pipeline(s) under whenever it is necessary to make a connection, the
test. The pressure must achieve the values given in appropriate connectors will be to hand; the test is
Table 28 at the specified flows. a further safety aid, although it is assumed that
personnel making connections to NIST fittings are
Note appropriately qualified and authorised to do so.
When performing these tests as part of the cross-
15.81 It must be demonstrated (except for vacuum) for
connection tests, there is the possibility that the
each NIST connector that the self-sealing device
400 kPa and vacuum test devices could be connected
substantially reduces the flow of gas when the
to the incorrect service, particularly a vacuum and
connector is removed without hazard to personnel
oxygen reversal. The instruments used, therefore,
or reduction in pipeline pressure.
should include appropriate directional check valves.
(There is a possibility of damaging the gauges.
Alternatively an open probe can be used to determine
pressure or vacuum.)
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Note Note
Personnel should take care not to stand in front of the In principle it is permissible, although unlikely to be
NIST connector when performing this test. practicable for large installations, to test all systems
simultaneously, particularly oxygen and vacuum,
15.82 The results may be recorded on Form B7B. where terminal units are installed in pairs and where
they require different metered leaks (this includes
Performance tests on the pipeline vacuum when testing oxygen will not significantly
increase the time needed).
system
15.83 The performance of individual pipeline systems is
measured by introducing a sufficient number of Functional tests of supply systems
calibrated metered leaks (with orifice sizes
15.85 All supply systems must be tested for normal
providing different flows that replicate the range of
and emergency operation, according to the
medical devices for which the pipeline is designed;
manufacturers’ manuals and contract
see Table 12) to represent the total “diversified”
specifications. For the purpose of the tests, the
system design flow, less the flow generated by the
systems must be connected to both the normal and
test device. Thereafter, a representative number
stand-by power supplies. The results of these tests
of terminal units (see note below) are tested for
should be recorded on Form B9.
pressure and flow: the diversified flows should be
derived from the data in Tables 13, 15, 16, 18, 20
and 21. Pressure safety valves
15.86 Pressure safety valves are not tested. They should
Notes be examined to ensure that they are correctly rated
for the pipeline system and are in accordance with
In a 28-bed ward module a representative number
the contract specification. Each should be provided
would be in the order of two terminal units furthest
with a test certificate confirming the certificated
from the AVSU, two near the entrance, and the
discharge pressure. Records of safety valve details
treatment room, if applicable for each gas and vacuum.
should be noted on Form B10.
In an operating department, a representative number
15.87 Check that the specified pressure safety valves, line
would be one terminal unit in each operating suite and
valves and non-return valves have been fitted.
20% of terminal units in recovery for each gas and
vacuum. For oxygen, one metered leak should be 15.88 Verify that the pressure safety valves are certified
100 L/min to represent oxygen “flush”. to operate in accordance with the contract
specification and conform to BS EN ISO 4126-1:
It is not necessary to insert metered leaks into the
2004.
actual number of terminal units used to calculate the
“diversified” design flow, provided the numbers used
are evenly distributed and orifice sizes are selected to Warning and alarm systems
achieve this flow. 15.89 The operation of warning and alarm systems
should be tested in all normal operating and
15.84 The metered leaks should be stamped or similarly emergency modes. Particular attention should be
be identified to show the flow (air equivalent) at, paid to the following:
for example, 10, 20, 100, and 275 L/min for
a. that all systems operate within the specified
400 kPa systems, and 350 L/min for 700 kPa
tolerance limits at all operating parameters and
systems; the results of the tests may be recorded on
fault conditions, and can be seen and heard as
Form B8.
specified in Tables 23 and 24;
b. that systems react correctly following return to
normal status;
c. that all indicator panels and switches are
correctly marked;
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15 Validation and verification
d. that all functions on all indicator panels operate drawings have been recorded and the results may
correctly; be recorded on Form B12.
e. that the system will operate from the essential
supply stand-by power source; Filling with medical air
f. that all indicator panels are labelled to show the 15.93 An indefinite time may elapse after completion
areas they serve, or as detailed in the contract of the MGPS before the system is taken into use.
specifications. The installation contract may be written in the
expectation that this will happen. In such
15.90 The following tests should also be carried out: circumstances the contract should require that
a. for central indicator panels, check that the the particulate contamination and odour tests
operation of the mute switch cancels the specified in paragraphs 15.130–15.136 are carried
audible alarm and converts the flashing signals out as an interim measure, using medical air as
to steady, for all systems and conditions; the test gas. Satisfactory completion of these
particulate contamination and odour tests may
b. for repeater indicator panels, check that the then signify the completion of the construction
mute switch cancels the audible alarm and that contract.
the flashing signals are converted to steady only
on the central alarm panel, for all systems and 15.94 It is the responsibility of the client to ensure that
conditions; proper provision is made in a specific contract for
the maintenance of the systems, their integrity, and
c. for area indicator panels, check that the any special connectors that may be required during
operation of the mute switch cancels the this interim period.
audible only, for all systems and conditions;
15.95 All MGPS should be left filled with medical air at
d check power failure operates red “system fault” pipeline distribution pressure until they are filled
indicator and the audible alarm; with the specific working gas shortly before use.
e. check that a contact line fault operates the The medical vacuum pipeline need not be
“system fault” indicator, the main alarm maintained under vacuum.
displays and the audible alarm; 15.96 Provision should be made for regular running and
f. check audible reinstatement for each alarm maintenance of all supply plant during such an
panel; interim period.
g. check that the audible signal can be 15.97 Details of the work carried out, as well as records
continuously muted via operation of the of the system pressures, should be recorded. This
internal push-button for gas service alarm information is required in order to demonstrate
conditions only; that the systems have been satisfactorily
maintained under pressure during this interim
h. check for correct identification of each gas period. Tests for particulate contamination should
service on alarm panels and “departmental” or be carried out after the systems are filled with the
plant specifying labels; specific gas. The extent of the tests is at the
j. check that each alarm panel emits the correct discretion of the Quality Controller (MGPS).
(two-tone) audible alarm. (Some manufacturers 15.98 The “Danger – do not use” label should remain
supply panels set for a single tone – in use, staff affixed to each terminal unit until all testing is
may confuse this sound with that emitted by completed.
some models of patient monitoring
equipment.) 15.99 When the construction contract has finished, the
contractor should record the removal of all special
15.91 The results of the tests are recorded on Form B11. connectors and cylinders from site.
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15 Validation and verification
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Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
15.120 Users must be aware of the limitations of all types Particulate matter
of detection equipment, including ambient
15.130 MGPS should be free from particulate
operating conditions and cross-sensitivities
contamination, as they have been constructed
specified for each type of detector tube.
using chemically cleaned, capped components
15.121 These tests must be carried out on a and joined in a controlled process using a filtered
representative sample of terminal units/NISTs in shield gas.
each system at the discretion of the Quality
15.131 However, on-site contamination can occur
Controller (MGPS).
from ingress of building materials, dust etc. The
15.122 If terminal units are being tested, the sample presence of such particles can adversely affect the
must include, as a minimum, the most distant quality of the delivered gases. Therefore, tests to
terminal unit on each branch. This may be the indicate their absence are important.
first terminal unit to be tested, but care must
15.132 New systems should be purged until the
be taken to ensure, for example, that a new
particulate filter is completely clear of visible
extension connected to old pipework is first well
particles when viewed in a good light.
purged via a terminal unit/NIST connector as
close as possible to the junction of the systems so 15.133 Older systems may exhibit particulates, even after
as to avoid the spread of any contamination into considerable purging, as they can be released or
the extension. carried along by the gas stream after disruption of
the system, reverse gas flow, pressure waves down
15.123 It will not normally be necessary to test the most
the pipe, or physical vibration.
distant terminal unit if distal NIST connectors
are provided.
Note
15.124 Depending on the results of this test, the Quality
When connecting new pipework to an older (possibly
Controller (MGPS) should decide the number
contaminated) system it may be advisable to perform
and location of additional terminal units/NISTs
the first purge via the inlet NIST of the first AVSU, or
to be tested.
the first terminal unit of the new system, in order to
reduce the possible spread of contamination into the
Note new system.
Provision of NISTs throughout an MGPS is to be
encouraged, as this will greatly facilitate testing, 15.134 Where it is evident that extended purging may
particularly QC testing. not completely clear the system of particulates,
a decision to accept the level of contamination
15.125 These tests are summarised in Table 28. present, agree a cleansing procedure or, in very
exceptional circumstances, condemn the system
15.126 All sources of supply should be tested for quality
will be made.
before the pipeline distribution system is filled
with the working gas. This test is not intended 15.135 The test for particulate matter should be carried
as a test of certificated gases but is to ensure out at every terminal unit on a new system. It
that supply source equipment (manifolds, can be carried out either after completion of
compressors, VIEs etc) does not compromise the the construction phase using medical air (see
quality of such gases when delivering them to the paragraph 15.93) or after the system has been
pipeline systems. filled with the specified gas. Once the system is
filled with working gas, it would not normally be
15.127 When extending existing systems, supply sources
necessary to repeat the test at every terminal unit.
will not normally be retested before being used to The actual number of terminal units sampled is
fill the extension with the working gases. at the discretion of the Quality Controller
15.128 For new installations, quality tests should be (MGPS). It would, however, be necessary to
carried out on the plant as well as on the pipeline repeat the test in full where there is insufficient
distribution system. evidence to show that the system has been
satisfactorily maintained under operating pressure
15.129 The results of the test may be recorded on
with medical air for the interim period.
Form B14.
132
15 Validation and verification
15.136 When tested with a membrane filter at a flow not 15.143 A representative sample of terminal units on both
less than 150 L/min for 30 s, the filter must be new and modified medical compressed air and
free from visible particles when viewed in good oxygen concentrator systems supplied by
light. A suitable test device is described in compressor plant may be checked at the
Appendix D. discretion of the Quality Controller (MGPS).
15.144 Care should be taken in siting the test point to
Notes ensure a representative sample.
When testing surgical air terminal units, a flow of
350 L/min for 30 s should be used. Water
When testing nitrous oxide/oxygen mixture terminal 15.145 This test is intended to identify contamination of
units, a flow of 275 L/min for 30 s should be used. the pipeline system by moisture. It should not be
confused with the test for compressor plant dryer
When testing helium/oxygen mixture systems, oxygen- performance, although it may indicate a failure in
free nitrogen is used at the manifold and this will the dryer system.
require special connectors.
When tests and/or purging is carried out with the Notes
sources of supply serving an operational hospital, it
When testing terminal units supplied via low pressure,
is essential to ensure that the test flows used are not
flexible connecting assemblies, it is often found that
detrimental to the continuity or adequacy of supply in
– on initial testing – moisture levels exceed the
operational areas. When a flow rate of 150 L/min or
0.05 mg/L limit; this is the result of desorption of
more may not be possible without compromising the
minute quantities of moisture into the gas stream. This
hospital system, a lower flow rate should be used at the
is particularly noticeable where the test flow is low, and
discretion of the Quality Controller (MGPS).
should not cause undue concern. The Quality
Controller (MGPS) should establish, however, that the
Oil elevated readings at such terminal units result from
this effect and not water contamination of the
15.137 This test should be carried out at the plant test
pipeline. (For example, the results should be compared
point of all newly installed medical/surgical
with the readings achieved at nearby terminal units
compressed air plant and for all medical/surgical
supplied by copper pipework.) New developments in
compressed air plant on a quarterly basis.
hose materials may lead to hoses with reduced water
15.138 When break-ins to a tested (and compliant) vapour permeability characteristics.
medical/surgical air system have been completed,
The effects of flow rate through dryer units and
repetition of this test will not normally be
sampling times on detection equipment indications
required.
should also be taken into account when measuring
15.139 Work involving strip-down of compressor plant water content.
and subsequent replacement of oil-sealing
components may require a follow-up oil test, 15.146 The plant test point and a representative sample
at the discretion of the Quality Controller of terminal units distributed throughout the
(MGPS). pipeline systems should be tested for total water
content. The water content must not exceed
15.140 Oil may be present as liquid, aerosol or vapour,
67 vpm (equivalent to an atmospheric pressure
and an appropriate test device is described in
dew-point of approximately –46°C). The typical
Appendix E.
water content of medical gas cylinders is normally
15.141 The total oil content should be in accordance below 5 vpm. Water vapour content may be
with Table 28. measured using the appropriate test device
15.142 It is desirable to carry out this test at a plant test described in Appendix E (see also paragraph
point before any pipeline system is supplied 15.117).
by that plant so as to prevent inadvertent
contamination of the distribution system.
133
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
Sulphur dioxide
Note
15.152 The most distant terminal units in medical/
Older compressor/dryer combinations may fail to
surgical air pipeline systems supplied from a
meet the Ph. Eur. requirement of 67 vpm. In these
compressor plant, and oxygen terminal units
circumstances, the Quality Controller (MGPS) will
supplied from a PSA plant, must be tested for
decide whether application of the older atmospheric
sulphur dioxide. (It will not normally be
dew-point limit of –40°C (127 vpm) is acceptable
necessary to test more than five terminal units in
(Health Technical Memorandum 2022: 1997).
a single system.) The concentration should not
exceed 1 ppm v/v.
Carbon monoxide
15.153 When break-ins to a tested (and compliant)
15.147 The most distant terminal units on each branch medical/surgical air system have been completed,
of a medical/surgical air pipeline system supplied repetition of this test (and those in paragraphs
from a compressor plant and PSA systems must 15.111–15.114) will not normally be required.
be tested for carbon monoxide, although it would
not normally be necessary to test more than five Oxides of nitrogen (NO and NO2)
terminal units. The concentration of carbon
15.154 The most distant terminal units in medical/
monoxide should not exceed 5 ppm v/v. This may
surgical air pipeline systems supplied from a
be measured at up to five terminal units in each
compressor plant, and oxygen terminal units
system using the appropriate test devices
supplied from a PSA plant, must be tested for
described in Appendix E.
oxides of nitrogen. (It will not normally be
15.148 When break-ins to a tested (and compliant) necessary to test more than five terminal units in
medical/surgical air system have been completed, a single system.) The concentration should not
repetition of this test will not normally be exceed 2 ppm v/v.
required.
15.155 When break-ins to a tested (and compliant)
medical/surgical air system have been completed,
Carbon dioxide
repetition of this test (and those in paragraphs
15.149 The most distant terminal unit on each branch 15.111–15.114) will not normally be required.
of a medical/surgical air pipeline system supplied
from a compressor or an oxygen concentrator Important:
plant must be tested for carbon dioxide. See Note (d) in Table 29 on disparity between Ph. Eur.
15.150 The concentration of carbon dioxide must not and EH40 with reference to acceptable levels of
exceed 500 ppm v/v in medical air or 300 ppm sulphur dioxide and oxides of nitrogen.
v/v in oxygen from an oxygen concentrator plant.
15.151 When break-ins to a tested (and compliant) Nitrogen
medical/surgical air system have been completed, 15.156 Oxygen-free nitrogen is used as the inert gas
repetition of this test will not normally be shield, and all terminal units of all gas systems
required. should be tested to ensure that the systems have
been adequately purged.
Notes
15.157 For oxygen systems and nitrous oxide/oxygen, an
Increasing or fluctuating carbon dioxide readings in air oxygen analyser must be used to ensure that the
or PSA-generated oxygen can be an early indication of oxygen concentration is not less than that given
dryer failure or poor compressor maintenance. in Table 30.
Carbon dioxide is no longer used as an inert shield gas 15.158 For nitrous oxide systems, an instrument based
during pipeline brazing. on thermal conductivity, or an infrared meter,
If carbon dioxide has been installed (see Chapter 11), must be used to check that the system has been
the test methodology should be at the discretion of the adequately purged at every terminal unit.
Quality Controller (MGPS). 15.159 If a thermal conductivity meter is used, it will be
necessary to prove absence of carbon dioxide
134
15 Validation and verification
Pipeline odour/taste
15.160 An odour test is performed because it
incorporates, qualitatively, many impurity checks,
as several contaminants are detectable by odour.
This test is normally carried out as the final test
with the working gases, except for nitrous oxide,
nitrous oxide/oxygen and carbon dioxide, which
should not be inhaled. The odour threshold of
particulate matter is approximately 0.3 mg/m3.
15.161 In certain circumstances (see paragraph 15.93),
it may be carried out as the first test after
completion of construction of the pipeline
installation using medical air as the test gas. In
such circumstances, a pipeline odour/taste test
can be carried out on nitrous oxide and nitrous
oxide/oxygen systems.
15.162 In addition to all new terminal units, a
representative sample of terminal units on
existing parts of the systems must be checked.
Notes
For some time it has been known that materials
used in the construction of low-pressure connecting
assemblies can present an odour. This was recognised
in the 1984 version of BS 5682:
“Plastics materials currently in use will release small
quantities of volatile organic matter into the gas stream
throughout the life of the plastics components of the
material. The quantities released appear to be below the
levels normally considered toxic but, as yet, insufficient
research has been carried out to be able to identify and
quantify these components, therefore no tests are
recommended.”
More recent work has shown that the quantities of
those agents that can be identified are significantly
below levels considered to be toxic. It is possible that
developments in hose material structure will result in
the reduction of odour (and moisture retention).
The Quality Controller (MGPS) should perform
additional oil and polytest analyses if indistinct odours
are detected where flexible hoses are not involved.
New developments in hose materials may lead to hoses
that are odour-free and do not leach chemicals into the
gas stream.
135
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
Table 29 Quality specifications for medical gas pipeline tests (working gases)
Gas and Particulates Oil Water CO CO2 NO SO2 Poly- Odour
source and test tube
NO2 (Optional)
Oxygen Free from visible ≤0.1 ≤67 vpm ≤5 mg/ ≤300 ≤2 ≤1 No None
from PSA particles in a 75 L mg/m3 (≤0.05 mg/L, m3; ppm ppm ppm discoloration
plant sample atmospheric dew- ≤5 ppm v/v v/v v/v
point of –46°C) v/v
Nitrous Free from visible – ≤67 vpm – – – – No SAFETY
oxide particles in a 75 L (≤0.05 mg/L, discoloration Not
sample atmospheric dew- performed
point of –46°C)
Nitrous Free from visible – ≤67 vpm – – – – No SAFETY
oxide/ particles in a 75 L (≤0.05 mg/L, discoloration Not
oxygen sample atmospheric dew- performed
mixture point of –46°C)
Medical Free from visible ≤0.1 ≤67 vpm ≤5 mg/ ≤900 ≤2 ≤1 No None
and surgical particles in a 75 L mg/m3 (≤0.05 mg/L, m3; mg/ ppm ppm discoloration
air sample (for medical atmospheric dew- ≤5 ppm m3; v/v v/v
air) and 175 L point of –46°C) v/v ≤500
sample (for surgical ppm
air) v/v
Dental Free from visible ≤0.1 ≤1020 vpm ≤5 mg/ ≤900 ≤2 ≤1 No None
compressed particles in a 75 L mg/m3 (≤0.78 mg/L, m3; mg/ ppm ppm discoloration
air sample atmospheric dew- ≤5 ppm m3; v/v v/v
point of –20°C) v/v ≤500
ppm
v/v
Synthetic Free from visible – ≤67 vpm – – – – No None
air particles in a 75 L (≤0.05 mg/L, discoloration
sample atmospheric dew-
point of –46°C)
Oxygen Free from visible – ≤67 vpm – – – – No None
from bulk particles in a 75 L (≤0.05 mg/L, discoloration
liquid or sample atmospheric dew-
cylinders point of –46°C)
Helium/ Free from visible – ≤67 vpm – – – – No None
oxygen particles in a 75 L (≤0.05 mg/L, discoloration
mixture sample atmospheric dew-
O2, <30% point of –46°C)
Notes:
a. The quality of the gases delivered at the terminal units should also comply with the specifications given in the current
edition of the Ph. Eur. (see Table 30). Additionally, contamination introduced by the MGPS, and not limited by the Ph. Eur.
specification, should not exceed levels that might pose a threat to patients. It should be borne in mind that the safe levels for
medical gases delivered to patients are likely to be significantly lower than those permitted for healthy individuals.
In addition to the monograph, the official standards section of the general notices should be read.
b. The tests for oil, carbon monoxide, carbon dioxide, sulphur dioxide and oxides of nitrogen are not normally carried out when
the source of supply is from cylinders or cryogenic systems, although it should be noted that rare instances of oil contamination
arising from the pipeline have occurred.
c. Synthetic air will be tested for identity as shown in Table 30. A GLC (gas-liquid chromatography) test for nitrogen is possible
but not without practical difficulties. Nitrogen content will, therefore, usually be inferred from oxygen analyser test results.
136
15 Validation and verification
d. The Health and Safety Executive has revised its guidance on exposure limits for sulphur dioxide, nitrogen monoxide and
nitrogen dioxide.
Occupational exposure standards (OESs) for nitric oxide, nitrogen dioxide and sulphur dioxide were removed from EH40 in
the Amendment of April 2003.
Time-weighted averages (TWAs) for nitrogen monoxide and nitrogen dioxide are now suggested as no greater than 1 ppm, and
limits for sulphur dioxide exposure as less than 1 ppm for both 8-hour TWA OES and 15-minute STEL (short-term exposure
limit).
Some breathing air standards seek to limit the levels of such contaminants to 10% of the 8-hour TWA, as medical gases
are intended for use by people who are not in the best of health. Therefore it is suggested, when testing for these specific
compounds, or any contaminants not listed in the Ph. Eur., that a limit of 10% of the OES should be confirmed.
e. See Note following paragraph 15.146.
Note
Particulate level tests and polytests are NOT included in the Ph. Eur.
137
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
138
15 Validation and verification
AGS disposal systems 15.174 The test should be carried out as described in
Appendix K of BS 6834:1987. The test device
General is inserted into each terminal unit in turn and
checked for pressure at flows of 80 L/min and
15.169 BS 6834:1987 specifies the tests to be carried out
130 L/min for BS systems, and 50 L/min and
on AGS disposal systems that comply with the 80 L/min for ISO systems. Adjustment is then
British Standard. The tests specified are designed made if necessary.
to ensure adequate performance and that the
safety provisions of receiving systems will be met. 15.175 The test device and a number of metered leaks
are then inserted into the system to replicate
15.170 The responsibility for the tests should be
the design flow. The measurements above are
clearly identified at the contract stage for new repeated. If the test results are satisfactory, the test
installations, in the same way as for the medical device is removed and substituted by a metered
gas pipeline system. In general, the contractor leak.
should carry out the tests, which should be
witnessed by the Authorised Person (MGPS).
Note
Performance tests The test device is designed to replicate either type of
receiving system for which the disposal system has
15.171 All equipment should be tested to ensure that
been designed (see paragraph 15.73).
it performs satisfactorily during continuous
operation under full load for one hour.
15.176 The other terminal units are then tested in turn
15.172 All electrically powered equipment should be by substituting the test device for each metered
tested as follows: leak including the test device.
• check for correct rotation;
Note
• check the current through the powered device
at full load. For the purposes of diversity, it may be assumed that in
any operating department only one receiving system
15.173 The disposal system should be tested to ensure for each operating room is in use at any time. (In a
that it meets the requirements set out in the table typical theatre suite with two terminal units in the
below, with the number of terminal units for operating room and one in the anaesthetic room, the
which it has been designed in use. total number of metered leaks used for testing is two;
Disposal system standard that is, one being placed in an operating room
terminal unit and the other in the anaesthetic room
Pressure drop Flow rate
terminal unit.)
BS 6834: ISO DIS BS 6834: ISO DIS
1987 7396-2: 1987 7396-2: 15.177 The operation of user-controlled switches, power-
2005 2005 on indicators and alarm systems should also be
Maximum 1 kPa 1 kPa 130 L/min 80 L/min checked.
Minimum 4 kPa 2 kPa 80 L/min 50 L/min
15.178 AGSS terminal units should be checked for
Maximum 20 kPa 15 kPa This check is made correct mechanical operation and that the check
static (–ve) (–ve) before performing the valve operates satisfactorily.
pressure flow tests
139
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
140
Appendix A – Testing, commissioning and
filling for use: forms to be
completed during testing and
commissioning of piped medical
gases systems
Form
Summary of tests B0
Carcass tests
Labelling and marking B1
Sleeving and supports B1
Leakage test B1
Cross-connection test B2
System tests
Leakage test B3
Vacuum leakage test B4
AVSUs – closure and zoning tests B5A
LVAs – closure and zoning tests B5B
Cross-connection test B6
Functional test of terminal units B7A
Functional tests of NIST connectors B7B
Design flow performance test B8
Functional test of supply system B9
Pressure safety valves B10
Warning systems B11
Verification of drawings B12
Purging and filling B13
Quality B14
Gas identification B15
Certificate of completion B16
141
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
142
Appendix A – Test forms
Section tested Test pressure Hours on test Pressure drop Pressure loss Pass/Fail
(kPa) (kPa) (kPa/h) <0.2/2h
(400 kPa systems)
<0.5/2h
(700 kPa systems)
143
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
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144
Appendix A – Test forms
Section tested Test pressure Hours on test Pressure drop Pressure loss Pass/Fail
(kPa) (kPa) (kPa/h) <0.2/2h
(400 kPa systems)
<0.5/2h
(700 kPa systems)
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
145
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
146
Appendix A – Test forms
Medical Gas Pipeline Total System Tests Form B5A (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Area Valve Service Units – closure and zoning tests
This is to certify that CLOSURE and ZONING of the AVSUs was tested in accordance with paragraphs 15.63–15.68 on the
pipeline system as follows:
AVSU number Test pressure Downstream/upstream Terminal units controlled Terminal unit labelling
(kPa) pressure change after (total no)
15 min (kPa)
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
147
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Medical Gas Pipeline Total System Tests Form B5B (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Line Valve Assemblies – closure and zoning tests
This is to certify that CLOSURE and ZONING of the LVAs was tested in accordance with paragraphs 15.63–15.65 on the
pipeline system as follows:
LVA number Test pressure Downstream/upstream Terminal units controlled Terminal unit labelling
(kPa) pressure change after (total no)
15 min (kPa)
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
148
Appendix A – Test forms
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Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
149
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Medical Gas Pipeline Total System Tests Form B7A (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Functional tests of terminal units
(in accordance with the contract specification and paragraphs 15.77–15.78)
System ....................................................................................................................
Specified flow .................................. L/min Specified pressure drop . ................................. kPa
Terminal unit Room number Specified flow Specified pressure Mechanical Gas specificity
number achieved drop achieved function
Yes/No Yes/No
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
150
Appendix A – Test forms
Medical Gas Pipeline Total System Tests Form B7B (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Functional tests NIST connectors
(in accordance with the contract specification and paragraphs 15.80–15.81)
System ....................................................................................................................
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
151
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
152
Appendix A – Test forms
Manifold
Manifold
Air compressor
Vacuum plant
Oxygen concentrator
153
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Medical Gas Pipeline Total System Tests Form B10 (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Pressure safety valves
The pressure safety valves fitted to the pipeline systems have been inspected together with their certification and are in accordance
with the contract specification and paragraphs 15.86–15.88.
154
Appendix A – Test forms
Medical Gas Pipeline Total System Tests Form B11 (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Warning systems
This is to certify that WARNING SYSTEMS on the following medical gas pipeline systems have been tested in accordance with
paragraphs 15.89–15.91 as follows:
Warning given
Return to normal
Marking
Stand-by power
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
155
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Medical Gas Pipeline Total System Tests Form B12 (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Verification of drawings
This is to certify that in accordance with paragraph 15.92, the as-fitted drawings of the following systems record all variations from
the contract drawings:
O2
N2O
N2O/O2
MA-4
Surgical air
VAC
AGS
Helium/oxygen mixture
Carbon dioxide
156
Appendix A – Test forms
Medical Gas Pipeline Total System Tests Form B13 (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Purging and filling
This is to certify that medical gas systems have been purged and filled with medical air/O2 free nitrogen/the working gases (delete
as appropriate) in accordance with paragraphs 15.93–15.99 and/or 15.100–15.101 as follows:
Special connectors/cylinders
removed from site
Filling
Venting
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
157
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
Medical Gas Pipeline Total System Tests Form B14 (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Quality specifications for medical gas piepline tests (working gases). This is to certify that medical gas systems have been tested in
accordance with paragraphs 15.109–15.162 as follows:
Gas and Particulates Oil Water CO CO2 NO SO2 Poly- Odour Tick when
source and test tube parameters
NO2 (Optional) are met
Oxygen Free from visible ≤0.1 ≤67 vpm ≤5 ≤300 ≤2 ≤1 No None
from PSA particles in a 75 L mg/m3 (≤0.05 mg/L, mg/ ppm ppm ppm discoloration
plant sample atmospheric dew- m3; v/v v/v v/v
point of –46°C) ≤5
ppm
v/v
Nitrous Free from visible – ≤67 vpm – – – – No SAFETY
oxide particles in a 75 L (≤0.05 mg/L, discoloration Not
sample atmospheric dew- performed
point of –46°C)
Nitrous Free from visible – ≤67 vpm – – – – No SAFETY
oxide/ particles in a 75 L (≤0.05 mg/L, discoloration Not
oxygen sample atmospheric dew- performed
mixture point of –46°C)
Medical Free from visible ≤0.1 ≤67 vpm ≤5 ≤900 ≤2 ≤1 No None
and particles in a 75 L mg/m3 (≤0.05 mg/L, mg/ mg/ ppm ppm discoloration
surgical air sample (for medical atmospheric dew- m3; m3; v/v v/v
air) and 175 L point of –46°C) ≤5 ≤500
sample (for surgical ppm ppm
air) v/v v/v
Dental Free from visible ≤0.1 ≤1020 vpm ≤5 ≤900 ≤2 ≤1 No None
compressed particles in a 75 L mg/m3 (≤0.78 mg/L, mg/ mg/ ppm ppm discoloration
air sample atmospheric dew- m3; m3; v/v v/v
point of –20°C) ≤5 ≤500
ppm ppm
v/v v/v
Synthetic Free from visible – ≤67 vpm – – – – No None
air particles in a 75 L (≤0.05 mg/L, discoloration
sample atmospheric dew-
point of –46°C)
Oxygen Free from visible – ≤67 vpm – – – – No None
from bulk particles in a 75 L (≤0.05 mg/L, discoloration
liquid or sample atmospheric dew-
cylinders point of –46°C)
Helium/ Free from visible – ≤67 vpm – – – – No None
oxygen particles in a 75 L (≤0.05 mg/L, discoloration
mixture sample atmospheric dew-
O2, <30% point of –46°C)
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Quality Controller
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
Appendix A – Test forms
Medical Gas Pipeline Total System Tests Form B15 (Sheet of Sheets)
Hospital ........................................................................................ Scheme .............................................................................
File Number . ................................................................................ Date ..................................................................................
Identification of medical gas pipeline working gases
This is to certify that medical gas systems have been tested in accordance with paragraphs 15.163–15.167 and the results are as
follows (insert values for gases – tick for vacuum):
Gas and source Paramagnetic oxygen Thermal conductivity/ Carbon dioxide Vacuum probe
analyser reading infra-red instrument detector tube indication
reading if TC meter used
Oxygen from liquid or
– – –
cylinders
Oxygen from
– – –
concentrator
Nitrous oxide –
Nitrous oxide/oxygen
– –
mixture
Synthetic air – – –
Vacuum – – –
Helium/oxygen mixture
Test 1 – –
Test 2
Contractor’s Representative
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Contract Supervising Officer
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Quality Controller
Status ............................................................................................. Signed ...............................................................................
Date ............................................................................................. Name ...............................................................................
Witnessed on behalf of .................................................................................................................................................................
By ............................................................................................. Status ...............................................................................
Signed ........................................................................................... Date ...............................................................................
159
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Signed .............................................................................................
Quality Controller (MGPS)
Signed .............................................................................................
Contractor’s Representative (MGPS)
Signed .............................................................................................
Authorised Person (MGPS) on behalf of Trust/other
Witnessed .......................................................................................
Trust/other Building operator/owner
Date ................................................................................................
accept responsibility for the systems above and undertake to carry out any future work in accordance with the recommendations of
Health Technical Memorandum 02-01 and the permit-to-work procedures.
Signed .............................................................................................
Date ................................................................................................
160
Appendix B – Gas pressure variation with
temperature
161
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
General Orifices
1. Special test devices are required to measure the 11. The orifices should be selected from the
pressure at specified flows at each terminal unit. information on the manufacturer’s data sheets or
from practical testing.
2. Suitable test devices are commercially available or
may be constructed in accordance with the outline 12. These devices should be checked against a
specification given below. flowmeter before use.
6. The test device is connected to the terminal unit Test pressure kPa Scale Scale interval
by the gas-specific probe and the pressure at the 400 0–7 bar 0.1 bar
specified flow is read on the gauge. 700 0–11 bar 0.5 bar
Vacuum 0–100 kPa 5 kPa (50 mm Hg)
Functional requirements (0–760 mm Hg)
7. The test device should consist of the following 1 bar = 100 kPa
components: approximately
162
Appendix D – Membrane filter test device
163
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
Notes
Non-agent-specific detector tubes are difficult to
interpret and are not recommended because of their
qualitative and non-quantitative response.
164
Appendix F – Equipment for gas identification
Notes
A paramagnetic meter is the specified instrument for
identity of oxygen.
165
Health Technical Memorandum 02-01: Medical gas pipeline systems – Part A
Solution
2. The pressure drop Δp across the pipe can be calculated from the formula:
Δp = Measured length of pipe
Nearest length of pipe from Table A1
× [ Design flow
Nearest flow from Table A1 ]2
× Pressure drop from Table A1
(2)
3. From Table A1, the nearest length to 12 m is 15 m and the nearest flow rate to the design flow of 800 L/min is
711 L/min in the 15 m column, at which there is a pressure drop of 21 kPa across a 15 mm diameter, 15 m
length of pipe.
4. Using these values, Equation (2) gives a pressure drop across the 12 m pipe of:
15 711 [ ]
12 × 800 2 × 21
= 21.3 kPa.
5. If this loss is unacceptable, use the next (higher) pipe size, that is 22 mm. The nearest flow rate to 800 L/min is
now 1135 L/min, representing a pressure loss of 7 kPa over 15 m.
6. In this instance:
Δp = 2.8 kPa.
166
Table A2 Pipeline pressure loss: 400 kPa (4 bar) pipelines
British Standard Size Tube
Distance from source (m) at 400 kPa for 7, 14, 21 kPa (1, 2, 3 psi) pressure loss
BS EN 1057: R250, Table X
Outside Pressure loss 8 15 30 61 91 122 152 183 213 244 274 305 335 366 396 427 457
Diameter (kPa)
(mm) Free air flow rate (L/min)
12 7 311 209 141 95 75 64 56 50 46 43 40 37 35 34 32 31 30
14 455 307 207 139 110 94 82 74 68 63 59 55 52 50 47 45 44
21 564 382 258 174 138 117 103 93 85 78 73 69 65 62 59 57 55
15 7 579 391 263 177 140 119 105 94 86 80 75 70 66 63 60 58 56
14 845 572 386 260 207 175 154 139 127 118 110 104 98 93 89 85 82
21 1038 711 481 325 258 219 192 173 159 147 137 129 122 117 111 107 102
22 7 1677 1135 768 518 411 349 307 277 254 235 220 207 196 186 178 170 164
14 2441 1656 1123 759 604 513 451 407 373 345 323 304 288 274 262 251 241
21 3023 2053 1395 945 751 638 562 507 465 431 403 379 359 342 326 313 301
28 7 3363 2283 1547 1047 832 706 622 560 514 476 445 419 397 378 361 346 332
14 4881 3320 2257 1530 1218 1035 912 823 754 699 653 615 583 555 530 508 488
21 6034 4109 2800 1901 1514 1287 1135 1024 938 870 814 767 726 691 660 633 609
35 7 6023 4096 2783 1886 1500 1275 1124 1013 928 861 805 758 718 683 653 626 602
14 8720 5943 4051 2752 2192 1865 1644 1483 1360 1261 1180 1111 1053 1002 957 918 883
21 10758 7344 5018 3415 2723 2317 2044 1845 1692 1569 1468 1383 1310 1248 1192 1143 1099
42 7 10103 6883 4685 3180 2533 2154 1899 1713 1570 1456 1362 1283 1215 1157 1105 1060 1019
14 14587 9963 6806 4633 3694 3145 2775 2504 2296 2130 1993 1878 1780 1694 1619 1553 1493
21 17963 12290 8421 5743 4584 3904 3446 3112 2855 2648 2478 2335 2213 2107 2014 1932 1858
54 7 14974 10588 7487 5294 4323 3743 3348 3056 2830 2647 2496 2368 2257 2161 2076 2001 1933
14 21176 14974 10588 7487 6113 5294 4735 4323 4002 3743 3529 3348 3192 3056 2937 2830 2734
3 140 m of 28 mm pipe would carry 800 L/min with a pressure loss of 9.92 kPa. ie: 140/152 x (800/912)2 x 14
Table A3 Pipeline pressure loss: 700 kPa (7 bar) pipelines
168
British Standard
Size Tube BS EN Distance from source (m) at 1100 kPa for 7, 14, 34 kPa (1, 2, 5 psi) pressure loss
1057: R250, Table X
Outside Pressure 8 15 30 61 91 122 152 183 213 244 274 305 335 366 396 427 457
Diameter loss (kPa)
(mm) Free air flow rate (L/min)
12 7 487 356 252 177 144 124 112 102 94 88 84 79 75 72 69 67 65
14 689 503 355 249 204 177 158 144 133 124 118 111 106 102 98 94 91
34 1084 791 560 392 321 277 249 227 210 197 185 176 167 161 154 148 143
15 7 867 634 448 314 257 222 199 181 168 157 148 141 134 128 124 119 115
14 1226 895 633 444 363 314 281 257 238 222 209 199 189 181 174 168 162
34 1929 1409 996 698 572 494 443 403 373 350 330 313 298 285 275 264 256
22 7 2332 1703 1205 845 692 598 535 487 452 423 399 378 360 345 332 319 309
14 3294 2405 1701 1193 977 844 755 689 638 597 562 534 509 487 468 451 436
34 5185 3787 2678 1878 1537 1328 1189 1084 1005 939 886 840 801 767 737 710 686
28 7 4469 3263 2308 1618 1325 1145 1025 935 866 809 764 724 691 660 636 612 591
14 6311 4608 3259 2286 1872 1616 1448 1320 1223 1143 1078 1022 976 933 897 864 835
34 9935 7255 5130 3598 2946 2544 2279 2077 1926 1799 1698 1609 1535 1469 1412 1359 1315
35 7 7718 5636 3985 2795 2289 1976 1771 1614 1495 1397 1319 1250 1192 1141 1097 1056 1021
14 10898 7959 5628 3947 3231 2791 2500 2279 2112 1973 1862 1765 1684 1611 1549 1492 1442
34 17157 12530 8860 6213 5087 4394 3936 3587 3325 3107 2932 2779 2651 2537 2439 2348 2271
42 7 12550 9166 6481 4545 3721 3214 2879 2624 2432 2272 2144 2033 1940 1855 1784 1718 1661
14 17724 12944 9152 6418 5255 4538 4066 3706 3435 3209 3029 2871 2739 2620 2519 2426 2345
34 27902 20377 14409 10104 8273 7145 6401 5834 5407 5052 4768 4519 4312 4125 3966 3819 3692
8. Another alternative is to derive graphs from the tables, although it may be necessary to draw several graphs,
at different scales, to obtain accurate results.
9. The graphs of flow vs pressure drop provide a pressure loss per metre of pipe, not a total pressure loss. This figure
must be multiplied by the length of the pipe in order to find the actual total pressure drop.
10. Because a pipe and the fittings in the system cause frictional resistance to the gas flow, a pressure loss occurs that
is greater than that which would occur if the gas were flowing through the same distance of straight pipe.
11. Each valve, fitting etc is allocated a “length” equivalent in frictional resistance to a straight piece of pipe of the
same diameter. This length is hence known as the equivalent length of the fitting.
12. To calculate design flows, the sum of the lengths of the straight runs of pipe plus the sums of the equivalent
lengths of all of the fittings etc in that run are added.
13. In practice many designers simply add 25–30% to the total measured length or use only 60–75% of the
allocated pressure drop when sizing.
14. Equivalent lengths of some fittings are given in Tables A6 and A7.
Table A7 Equivalent lengths for ABS (acrylonitrile butadiene styrene) vacuum fittings
40 mm 50 mm 70 mm 100 mm 125 mm
Tee (Thru’) 0.95 1.23 1.65 2.20 2.56
Tee (Branch) 2.76 3.38 4.57 6.12 7.68
90° elbow 1.25 1.71 2.44 3.08 3.84
171
Appendix H – Checklist for planning/installing/
upgrading a cryogenic liquid
supply system
1. Information given in this Appendix can be used to • Will other facilities be lost/reduced, for example
determine the need for a particular capacity or type car-parking space?
of supply system. Many of the factors described will
• It will be less economical in terms of delivery
also apply to planning an upgrade to an installation
charges and unit gas costs to deliver large loads
by way of increase in system size or a change of
(for example 20 tons) using rigid vehicles
system type.
(maximum 12 tons). Articulated vehicles will
2. Some factors that should be considered are outlined deliver the largest loads but may require
below. roadway/access modifications.
• Cranage access for vessels.
Delivery frequency
• When choosing liquid cylinder systems, will
• Does current frequency cause logistical problems adequate ventilation be available?
for the supplier/your site?
• Emergency supply location.
Calculating consumption • Pipeline protection and possible need for dual
• Consumption is rising at approximately 10% feeds.
per annum. It doubles in seven years. • Pipeline extension into other sites if applicable,
• Use pharmacy records for cylinder/liquid for example two hospitals supplied from the
consumption. Look for peaks in demand, for same VIE system. There are possible insurance
example winter influenza epidemics. issues with this arrangement.
• When average and peak flow rates are known, • Modifications to the alarm system may have to
calculate the required size of the emergency be made.
supply. • Alarm panel + telemetry in waterproof
enclosures.
Age of current system • Are alarms compatible with the existing system?
• The secondary supply of older VIE systems will • Alarm arrangement for dual (but separate) tank
be a compressed gas cylinder manifold, which installations.
may have very limited capacity. Consideration
should be given to either a single VIE plus fully • Cable ducts and trays: examine possible routes.
automatic manifold or, preferably, a dual VIE • Possible need to move gates/fences to install new
system. pipework.
• What planning restrictions apply (vessel size, • Sealing windows of adjacent buildings.
noise etc)? • Position of frame for valve tree (fix to fence for
• What are convenient locations for cylinder/ rigidity?).
liquid delivery? • Position of emergency gate.
• Advantages of separating primary and secondary • Position of fill couplings must allow driver to see
supplies, if space is available. tank gauges.
172
Appendix H – Checklist for planning/installing/upgrading a cryogenic liquid supply system
• Cabling and alarm runs for the emergency • What, if any, commitment is required by the gas
supply manifold (ESM). company?
• Availability and presentation of alarms for ESM. • How will gas prices vary during this period?
• Power and lighting during work. • Is there any agreement to provide, for example,
modified roadway facilities if rigid vehicular
• Drainage – catch pits, diversions, pad resizing.
deliveries are too frequent to be convenient to
supplier? Or if such roadway modifications take
Costs place within a defined timescale, new rates etc
• Make sure all costs are allowed for, for example: may need to be negotiated.
(i) Site inspection. • Check defects liability (usually 12 months).
(ii) Cost of continuing delivery using rigid
and non-articulated vehicles. Emergency provision
(iii) Gas charge/HCM (hundred cubic metres) • Examine the vulnerability of current system and
and any inflation likely. main feeds to hospital.
(vii) Road/compound loans will be seen as £x • Alarm/monitoring systems and power supplies
added to gas price over y years. for ESM and its accommodation.
173
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
174
Appendix H – Checklist for planning/installing/upgrading a cryogenic liquid supply system
• Access for cranage must be kept open (car • Proximity of flammables and vital services
parking control). during installation – vulnerability to mechanical
damage (cutting discs etc), welding and cutting
• Drainage (may have to move existing drains/
flames/sparks.
soakaways and create new pipe runs; remember
oxygen separation distances). • Power and lighting supplies during work.
• Road markings and signage. • Water supply (washing and concrete) during
work.
• Possible new kerbs/footpaths.
• Electrical supplies: single phase can be used for Follow-up
lighting, alarms etc but three-phase 60 A supply
will be needed for delivery vehicle pump if • Routine maintenance and monitoring of
appropriate. complete installation.
• Earth bonding/lightning protection for fences. • Cylinder changes and stock management for
ESM.
• Alarm interface/telemetry boxes at a sensible
height for viewing. • Establish system management arrangements for
vessels supplying more than one site (see Part B,
• Lagging of liquid lines. Appendix G).
• If using 200 bar unregulated cylinders for • Update MGPS operational policy and any
supply during installation or on ESM, take relevant insurance policies.
care that they are not mixed up with 137 bar
cylinders.
175
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
176
Appendix J – Upgrading surgical air systems
177
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
178
Appendix K – Signage requirements
179
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
180
Appendix K – Signage requirements
Location Signage will be determined by the equipment supplier but will usually include
VIE/ Liquid cylinders/PSA/synthetic air plant schematic, safety warnings and emergency actions
181
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
Infectious disease units flows are unsuitable for use as dental vacuum,
which operates at much higher flow rates (typically
1. Medical vacuum should neither be extended to an 300 L/min). Medical vacuum systems should not
Infectious Diseases Unit (IDU) nor provided to be used to provide dental vacuum.
such a unit from a central vacuum system.
2. Portable suction units will be required. Anaesthetic gas scavenging (AGS)
Decontamination will require specialised protocols
and the advice of the infection control officer Active AGS systems (medical)
should be sought. 6. Active anaesthetic gas scavenging systems operate
at relatively high flow rates (80–130 L/min in a
Note BS 6834:1987 system; and 50–80 L/min in an
Systems already exist whereby an IDU is, by local ISO/DIS 7396-2:2005 system).
agreement, serviced via a central vacuum system. 7. It is unlikely that receiving systems designed for use
If such agreements exist, or are to be accepted, great with these scavenging systems will operate correctly
care must be taken to ensure that the exhausts of such with a medical vacuum system. Severe spillage of
a plant are kept well away from all air intakes and the waste gases into the operating area may occur.
plant is labelled to indicate its function. Ideally, the Therefore, medical vacuum systems should not be
plant should be housed in separate accommodation used as waste anaesthetic gas disposal systems.
but, where this is not possible, safety signage and strict
operational protocols are extremely important. Active AGS (dental)
Personnel changing filters, or carrying out work 8. Active AGS systems for use with dental nasal
on such a system, should wear personal protective scavenging masks operate by maintaining a flow of
equipment and follow protocols that have been devised air through the outer layer of a specially designed
in liaison with the infection control officer. concentric nose mask. Waste gases from the patient
pass from inner to outer layers of the mask and are
carried away to the exhaust termination by this air
Laser/surgical diathermy smoke stream.
extraction 9. The flow rate necessary to achieve effective removal
3. An additional contamination hazard can arise if of waste gases by such a method is in the order of
smoke from procedures employing laser or surgical 45 L/min, which is less than the flow rate achieved
diathermy equipment is exhausted using a cannula at a medical vacuum system terminal.
attached to the vacuum system. 10. Active dental scavenging systems using this type of
4. Clinical staff should be advised against this practice mask must therefore be driven (via a special flow
and either instructed to use dedicated laser smoke adjuster) from the dental vacuum system, a
removal units (incorporating dedicated, filtered, dedicated separate high-flow vacuum system, or an
portable vacuum pumps) or a specially designed active medical AGS system. In the case of a medical
laser smoke filter fitted to a medical vacuum system AGS system, the special flow adjuster would be
terminal unit. plugged directly into an AGS system wall terminal.
A receiver (air break) system would not be used
between the wall terminal and the special flow
Dental vacuum systems adjuster.
5. Medical vacuum systems operate at relatively low
flow rates at the terminal units (~40 L/min). Such
182
Appendix M – Oxygen usage data
2000
1500
1000
Flow (L/min)
500
Upper graph shows flows to be expected when the hospital has specialties using
larger amounts of oxygen, eg those with multiple large critical care areas (>20 beds)
and an increased use of CPAP (>5 machines).
NB These graphs are issued for guidance only. There will be hospitals for which
average flows will, for a given number of beds, be higher or lower than the maxima
and minima shown here.
NB The flows are representative of oxygen provided from a VIE plant and do NOT
take into account additional consumption from compressed gas cylinders.
183
Medical gases – HTM 02-01 Medical gas pipeline systems – Part A: Design, installation, validation and verification
184
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