CEN-TC146-WG2 N0050 EN 415-3 E August 2017
CEN-TC146-WG2 N0050 EN 415-3 E August 2017
CEN-TC146-WG2 N0050 EN 415-3 E August 2017
Date: 2017-8
Secretariat: UNI
Safety of packaging machines — — Part 3: Form, fill and seal machines; fill
and seal machines
Sicherheit von Verpackungsmaschinen — — Teil 3: Form-, Füll- und Verschließmaschinen
Sécurité des Machines d'emballage — — Partie 3 : Machines d'emballage à former, remplir et sceller
ICS:
Descriptors:
Contents
Page
1 Scope ......................................................................................................................................................8
2 Normative references ............................................................................................................................9
3 Terms and definitions .........................................................................................................................11
3.1 Definition of terms ...............................................................................................................................11
3.2 Definitions of machines covered by this standard ..........................................................................14
3.2.1 Form, fill and seal machines...............................................................................................................14
3.2.2 Fill and seal machines .........................................................................................................................17
3.2.3 Filling machines ...................................................................................................................................18
3.3 Definition of machines which have similar hazards to those machines covered by this
standard ................................................................................................................................................19
4 Hazards .................................................................................................................................................21
4.1 Hazards which occur on all machines in the scope of this standard ............................................21
4.2 Hazards on a flow wrapping machine................................................................................................24
4.3 Hazards on a vertical form, fill and seal machine ............................................................................26
4.4 Hazards on typical horizontal sachet form, fill and seal machines ................................................28
4.5 Hazards on a thermoform, fill and seal machine ..............................................................................30
4.6 Hazards on a tubular bag form, fill and seal machine .....................................................................32
4.7 Hazards on a mandrel form, fill and seal machine ...........................................................................33
4.8 Hazards on a pre-made bag erect, fill and seal machine .................................................................36
4.9 Hazards on a cup or tub fill and seal machine .................................................................................37
4.10 Hazards on a sack fill and seal machine ...........................................................................................39
4.10.1 Hazards on an in-line sack fill and seal machine .............................................................................39
4.10.2 Hazards on a typical rotary sack fill and seal machine ...................................................................40
4.11 Hazards on an auger filler ...................................................................................................................41
4.12 Hazards on a volumetric cup filler .....................................................................................................42
4.13 Hazards on a nett weigher ..................................................................................................................43
4.14 Hazards on a multi-head weigher.......................................................................................................44
5 Safety requirements ............................................................................................................................46
5.1 General requirements ..........................................................................................................................46
5.1.1 Requirements to minimize mechanical risks ....................................................................................46
5.1.2 Electrical equipment ............................................................................................................................48
5.1.3 Thermal hazards ..................................................................................................................................48
5.1.4 Noise reduction ....................................................................................................................................48
5.1.5 Vibrating mechanisms ........................................................................................................................49
5.1.6 Radiation...............................................................................................................................................49
5.1.7 Products and substances used on machines which pose a risk ...................................................49
5.1.8 Ergonomic design................................................................................................................................52
5.1.9 Hygienic design requirements ...........................................................................................................53
5.2 Safety requirements for a flow-wrapping machine ..........................................................................53
5.2.1 General..................................................................................................................................................53
5.2.2 Product Feed ........................................................................................................................................54
5.2.3 Film reel unwind mechanism..............................................................................................................58
5.2.4 Longitudinal sealing mechanism .......................................................................................................60
5.2.5 Transverse sealing and cutting mechanisms ...................................................................................61
5.2.6 Discharge mechanism .........................................................................................................................61
5.2.7 Integrity of safety related control systems .......................................................................................62
5.3 Safety requirements for a vertical form, fill and seal machine .......................................................62
5.3.1 General..................................................................................................................................................62
5.3.2 Product feeding devices .....................................................................................................................63
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Foreword
This document (prEN 415-3:2017) has been prepared by Technical Committee CEN/TC 146 “Packaging
machines – Safety”, the secretariat of which is held by UNI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2018, and conflicting national standards shall be withdrawn at
the latest by December 2018.
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
See informative Annex ZA, which is an integral part of this standard, for the relationship with EU Directive(s), ,.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France (incl. Guadeloupe, Martinique, Reunion & French-Guiana),
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United
Kingdom.
Part 9: Noise measurement methods for packaging machines, packaging lines and auxiliary equipment –
Grade 2 and 3 accuracy
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Introduction
Form, fill and seal machines and fill and seal machines are used extensively in Europe, in an increasingly
wide range of industries. They contain many hazards and have the potential to cause serious injury.
The extent to which hazards are covered is indicated in the scope and clause 4 of this standard.
1 Scope
This European Standard establishes safety requirements for the main types of form, fill and seal machines, fill
and seal machines and auger fillers, volumetric cup fillers, nett weighers and multi-head weighers which are
frequently fitted to these machines.
Filling machines commonly fitted to form, fill and seal machines and fill and seal machines:
Auger filler
Nett weigher
Multi-head weigher.
Other types of form, fill and seal machine which are described in clause 3.3 have similar hazards to these
machines and clause 4 indicates which clauses of this standard are applicable to these machines.
This standard covers the safety requirements for machine design, construction and all phases of life of the
machines including installation, commissioning, operation, adjustment, maintenance and cleaning.
This part of EN 415 applies to machines manufactured after the date of issue of this standard.
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Exclusions
Cartoning machines
Thermoforming machines
This standard does consider hazards due to dust from the products being packed in these machines and
modified atmosphere gases, but does not consider other hazards caused by the product being packed.
2 Normative references
These documents, in whole or in part, are normatively referenced in this document and are indispensable for
its application. For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
EN 349:1993+A1:2008, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
EN 415-9:2009, Safety of packaging machines – Part 9: Noise measurement methods for packaging
machines, packaging lines and auxiliary equipment – Grade 2 and 3 accuracy
EN 574:1996+A1:2008 Safety of machinery. Two-hand control devices. Functional aspects. Principles for
design
EN 618:2002+A1:2010 Continuous handling equipment and systems – Safety and EMC requirements for
equipment for mechanical handling of bulk materials except fixed belt conveyors
EN 620:2002+A1:2010 Continuous handling equipment and systems – Safety and EMC requirements for fixed
belt conveyors for bulk materials
EN 1005-2: 2003+A1:2008. Safety of machinery. Human physical performance. Manual handling of machinery
and component parts of machinery
EN 1005-3: 2002+A1:2008. Safety of machinery. Human physical performance. Recommended force limits for
machinery operation
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EN 1005-5:2007. Safety of machinery. Human physical performance. Risk assessment for repetitive handling
at high frequency
EN ISO 4413:2010, Hydraulic fluid power — General rules and safety requirements for systems and their
components (ISO 4413:2010)
EN ISO 4414:2010, Pneumatic fluid power — General rules and safety requirements for systems and their
components (ISO 4414:2010)
EN ISO 7010:2012+A5:2015, Graphical symbols – Safety colours and safety signs- Registered safety signs
EN 1127-1:2011 Explosive atmospheres. Explosion prevention and protection. Basic concepts and
methodology
EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk
reduction (ISO 12100:2010)
EN ISO 13732-1:2008, Ergonomics of the thermal environment — Methods for the assessment of human
responses to contact with surfaces — Part 1: Hot surfaces
EN ISO 13849-1:2015, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design (ISO 13849-1:2006)
EN ISO 13855:2010, Safety of machinery — Positioning of safeguards with respect to the approach speeds of
parts of the human body (ISO 13855:2010)
EN ISO 13857:2008, Safety of machinery — Safety distances to prevent hazard zones being reached by
upper and lower limbs (ISO 13857:2008)
EN ISO 14119:2013, Safety of machinery. Interlocking devices associated with guards. Principles for design
and selection
EN ISO 14120: 2015, Safety of machinery — Guards — General requirements for the design and construction
of fixed and movable guards
EN ISO 14122-1:2016, Safety of machinery — Permanent means of access to machinery — Part 1: Choice of
fixed means and general requirements of access
EN ISO 14122-2:2016, Safety of machinery — Permanent means of access to machinery — Part 2: Working
platforms and walkways
EN ISO 14122-3:2016, Safety of machinery — Permanent means of access to machinery — Part 3: Stairs,
stepladders and guard-rails
EN ISO 14122-4:2016 Safety of machinery – Permanent means of access to machinery – Part 4: Fixed
ladders
EN ISO 14123-1:2015, Safety of machinery — Reduction of risks to health from hazardous substances
emitted by machinery — Part 1: Principles and specifications for machinery manufacturers
EN 15180:2014, Food processing machines – Food depositors – Safety and hygiene requirements
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EN 60204-31:2013, Safety of machinery. Electrical equipment of machines. Particular safety and EMC
requirements for sewing machines, units and systems
ISO 3864-1:2011 Graphical symbols – Safety colours and safety signs – Part 1: Design principles for safety
signs and safety markings
ISO 3864-2:2004 (R08) ED 1 Graphical symbols – Safety colours and safety signs – Part 2: Design principles
for product safety labels
ISO 3864-3:2012 Graphical symbols – Safety colours and safety signs – Part 3: Design principles for
graphical symbols for use in safety signs
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010, EN 415-1:2014
and the following apply.
3.1.1
bag
Flat or gusseted flexible container longitudinally seamed and closed at one or both ends made from paper,
plastic film, foil, laminate etc.
NOTE: Bags produced on form, fill and seal machines will typically have a seal at both ends and a longitudinal
seal running down the centre of the rear face of the bag
3.1.2
cold adhesive
adhesive that is liquid at room temperature
3.1.3
cup; tub
thin walled tapered container
3.1.4
deformable material
material which can be formed by the application of pressure alone
3.1.5
film reel; packaging material reel
continuous sheet of paper, carton board, plastics film, metal foil or flexible laminate wound on a cylindrical
core
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3.1.6
film web
continuous sheet of paper, plastics film, metal foil or laminate
3.1.7
hot melt adhesive
adhesive that is solid at room temperature and which is melted and applied at elevated temperature
3.1.8
longitudinal seal
seal made on a package in line with the direction of material travel in the machine
3.1.9
pack; package
assembly of product and packaging materials produced by a packaging machine
3.1.10
pre-made bag
pre-formed flat or gusseted flexible container longitudinally seamed and closed at one end made from paper,
plastic film, foil, laminate or a woven material
3.1.11
pre-made sack
pre-formed flat or gusseted sack longitudinally seamed and closed at one or both ends made from paper,
plastic film, laminate, or a woven material
3.1.12
product
substance, article pack or package that is handled in the packaging machine
3.1.13
PVA adhesive
water dispersible emulsion adhesive made from polyvinyl acetate
3.1.14
sachet
flat package which when formed from two webs of flexible material is sealed on four sides and when formed
from one web is sealed on three or four sides
3.1.15
transverse seal
seal made on a package at right angles to the direction of material travel in the machine
3.1.16
change parts
machine parts designed to handle a specific product, packaging material or pack size that need to be changed
when the machine is set up to handle a different product, packaging material or pack size
3.1.17
magazine
mechanical assembly designed to hold stacks of cartons, carton blanks, pre-made bags, pre-made sacks,
leaflets, labels, lids or stackable containers
3.1.18
mandrel
mechanical assembly around which a flexible package or carton is formed
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3.1.19
modified atmosphere
atmosphere where the normal atmosphere within a package is completely or partially replaced by one or more
selected gases
NOTE: Usually the objective is to extend shelf or storage life of the packaged products
3.1.20
packaging material
material used to make a package
3.1.21
packaging material transport mechanism
mechanical assembly which transports packaging material through the packaging machine
3.1.22
suction cup
cup made of an elastic material to which a vacuum can be applied to lift a product
3.1.23
reclosing feature applicator
mechanism which applies a zip or self-adhesive packaging component to a package on a packaging machine
3.1.24
sack discharge mechanism
equipment that takes filled sacks away from the machine
3.1.25
sack placer
mechanism which places an empty pre-made sack onto a filling nozzle
3.1.26
sack transfer mechanism
mechanism which takes empty sacks from a sack magazine and transfers them to a sack placer
3.1.27
manually adjustable guard
adjustable guard where the adjustment is made manually and the adjustment remains fixed during a particular
operation
NOTE: A manually adjustable guard does not comply with this definition unless it has been dimensioned and
positioned using relevant tables of EN ISO 13857
3.1.28
change part guard
fixed or interlocking guard which has made to suit one product or pack size and must be changed every time
the product or pack size is changed
NOTE: A change part guard does not comply with this definition unless it has been dimensioned and
positioned using relevant tables of EN ISO 13857
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3.1.29
fixed guard
guard affixed in such a manner (for example, by screws, nuts, and welding) that it can only be opened or
removed by the use of tools or by destruction of the means by which the guard is affixed
NOTE: A fixed guard does not comply with this definition unless it has been dimensioned and positioned using
relevant tables of EN ISO 13857
3.1.30
interlocking guard
guard associated with an interlocking device so that, together with the control system of the machine, the
following functions are performed:
— the hazardous machine functions “covered” by the guard cannot operate until the guard is closed;
— if the guard is opened while hazardous machine functions are operating, a stop command is given;
— when the guard is closed, the hazardous machine functions “covered” by the guard can operate (the
closure of the guard does not, by itself, start the hazardous machine functions)
Note 1: An interlocking guard does not comply with this definition unless it has been dimensioned and
positioned using relevant tables of EN ISO 13857
Note 2: An interlocking guard does not comply with this definition unless the interlocking device complies with
EN ISO 14119: 2015
3.1.31
automatically adjustable guard
movable guard attached to a moveable machine element (e.g. moving side of a pre-made bag magazine) and
a fixed machine element (e.g. machine frame) which moves automatically when the moveable element is
adjusted
NOTE: An automatically adjustable guard does not comply with this definition unless it has been dimensioned
and positioned using relevant tables of EN ISO 13857
3.1.32
trip guard
interlocking guard which is designed to move easily when touched by someone and which stops the machine
before a danger zone can be reached
3.1.33
tubular bag
flexible container closed at both ends and made from a flat film tube
3.2.1.1
flow-wrapping machine
horizontally operating form, fill and seal machine with material reel mounted above the operating level, the
product loaded horizontally and a longitudinal seal formed below the pack
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Figure 2 – Diagram showing the principle of operation of a typical vertical form, fill and seal machine
3.2.1.3
horizontal sachet form, fill and seal machine
horizontally operating form, fill and seal machine in which packs are formed, sealed on 2 or 3 sides, filled
vertically with product and sealed on the remaining side whilst the film web is moved horizontally with the pack
vertical
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Figure 3 – Diagram showing the principle of operation of a typical horizontal sachet form, fill and seal
machine
3.2.1.4
thermoform, fill and seal machine
machine in which a web of thermoformable material is heated and formed with pressure and/or vacuum,
before being filled vertically with product, sealed with a top film or magazine fed lid and finally cut to produce
individual packs
NOTE: Machines can produce one or more lanes of packs and may incorporate equipment to evacuate packages
before they are sealed.
Figure 4 – Diagram showing the principle of operation of a typical thermoform, fill and seal machine
3.2.1.5
tubular bag form, fill and seal machine
machine which forms a bag or sack from a reel of lay flat tubular flexible packaging film, before it is filled with
product and sealed
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Figure 5 – Diagram showing the principle of operation of a typical tubular bag form, fill and seal
machine
3.2.1.6
mandrel form, fill and seal machine
machine which forms packs from a reel of flexible material or carton blanks, on one or more mandrels, before
filling the packs with product and sealing their tops within the machine
Figure 6 - Diagram showing the principle of operation of a typical mandrel form, fill and seal machine
3.2.2.1
pre-made bag fill and seal machine
machine in which a pre-made bag is taken from a magazine, opened, filled with product and then sealed
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Figure 7 – Diagram showing the principle of operation of a typical pre-made bag fill and seal machine
3.2.2.2
sack fill and seal machine
machine in which a pre-made sack is taken from a magazine, before being opened, filled with product and
sealed
Figure 8 – Diagram showing the principle of operation of a typical in-line sack fill and seal machine
3.2.2.3
cup or tub fill and seal machine
machine in which a pre-made cup or tub is taken from a magazine, filled and then closed with a heat sealed
foil or a press-on lid
Figure 9 – Diagram showing the principle of operation of a typical cup/tub fill and seal machine
3.2.3.1
auger filling machine
filling machine which measures out a product, usually a powder, using an auger which rotates for a
predetermined number of revolutions
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3.2.3.2
volumetric cup filling machine
filling machine which measures out a product, usually free-flowing solids or powder, in a cup of predetermined
volume
3.2.3.3
nett weigher
filling machine which measures out a predetermined mass of product, usually free-flowing solids, before
dispensing it as a fill
3.2.3.4
multi-head weigher; selective combination weigher
nett weighing machine with multiple weighing units, which computes an appropriate combination of loads to
achieve the predetermined mass and discharges them together as a fill
3.3 Definition of machines which have similar hazards to those machines covered by this
standard
The following machines have similar hazards to those on the machines covered by this standard.
3.3.1
lower reel flow-wrapping machine
horizontally operating form, fill and seal machine, with film reel mounted below the operating level, the product
placed on to the film web and a longitudinal seal formed above the pack
Figure 10 – Diagram showing the method of operation of a typical lower reel flow-wrapping machine
3.3.2
stick packing machine
vertical form, fill and seal machine which produces small cross-section stick shaped packs
NOTE: Machines typically produce several lanes of packages at the same time.
3.3.3
edge sealing machine
horizontally operating form, fill and seal machine in which product is placed on a horizontal web of film before
being sealed on 3 or 4 sides to an upper web of film
NOTE: Machines can have one or two reels of film and can produce one or more lanes of packs.
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Figure 11 – Diagram showing the method of operation of a typical edge sealing machine
3.3.4
vertical sachet form, fill and seal machine
vertically operating form, fill and seal machine which uses one or two webs of film which are formed vertically,
filled with product and sealed to produce a 3 or 4 side sealed sachet
NOTE: Machines can have one or two reels of film and can produce one or more lanes of packs.
Figure 12 – Diagram showing the method of operation of a typical Vertical sachet form, fill and seal
machine
3.3.5
strip packing machine
vertically operating sachet form, fill and seal machine which produces strips of individually sealed packs joined
together in predetermined lengths
3.3.6
vertical form, fill and seal machine for cartonboard
vertically operating form fill and seal machine which uses a cartonboard laminate, which is formed, filled with
product and sealed to produce a pack resembling a carton usually filled with a liquid
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Figure 13 – Diagram showing the method of operation of a typical vertical form, fill and seal machine
for cartonboard
3.3.7
deep draw machine
machine in which a web of deformable material is formed under pressure in a die press, before being filled
vertically with product, sealed with a top film or magazine fed lid, and finally cut to produce individual packs
Figure 14 – Diagram showing the method of operation of a typical deep draw machine
3.3.8
count filling machine
filling machine which measures out solids according to a predetermined count
4 Hazards
4.1 Hazards which occur on all machines in the scope of this standard
The hazards described in tables 1, 2 and 3 can be present on all the machines in the scope of this standard.
The fourth column in each table refers to the applicable safety requirements for each hazard.
NOTE Additional hazards and hazardous situations which are specific to a certain type of machine are
provided in clauses 4.2 to 4.14. A risk assessment shall be carried out to identify any further hazards that
may be present.
Table 1 – Hazards found on all machines in the scope of this standard
Hazard Harm Examples of hazardous situations Safety
Requirement
Mechanical hazards from Crushing, cutting, Details in clauses 4.2 to 4.14 5.2 to 5.14
moving parts drawing-in, entanglement
and shearing
Mechanical hazards Crushing, cutting, and Guards trap operator’s hands or 5.1.1.2
caused by guards shearing arms
Impact Operator walks into an open guard 5.1.1.2
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Table 2 - Hazards which may be present on all the machines in the scope of this standard
Hazard Harm Examples of hazardous Safety
situations Requirement
Electrostatic Electric shock Electrostatic charges build up on 5.1.2.2
phenomena metal components and discharge
as a spark
Thermal Burns Operational tasks on heat sealing 5.1.3
mechanisms
Vibration Loss of feeling in hands Touching vibrating mechanisms 5.1.5
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Table 3 - Hazards related to work tasks which occur on all the machines in the scope of this standard
Work Task Examples of hazardous situations Harm Safety
Requirement
Transport Machine drops or falls over during Crushing 7.4
transport
Assembly installation Machine or machine assemblies drop Crushing impact 7.4
or fall over during assembly
Moving mechanisms Machine is started while someone is All hazards 5.1.1.8
while guards are open wholly or partly inside a danger zone
Setting Size parts drop or move unexpectedly Crushing impact 5.1.8.4
Size changing Lifting heavy parts Musculo-skeletal 5.1.8.4
disorders
Programming Programming error causes a hazard All mechanical 7.4
hazards
Touching live conductors in the Electric shock 5.1.2
electrical enclosure
Operation Operator removes a guard to gain All hazards 7.4
access to the machine but does not
replace it
Safety related parts of the control All mechanical 5.2.7
system fail to danger causing the hazards 5.3.12
machine to start unexpectedly 5.4.10
5.5.14
5.6.15
5.7.18
5.8.9
5.9.13
5.10.1.11
5.10.2.12
5.11.9
5.12.8
5.13.6
5.14.10
Inadequate ventilation in area where Heat exhaustion 7.4
machine is located
Fault finding Guards are removed or defeated to All hazards 7.1
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Figure 15 shows the hazard zones on a typical flow-wrapping machine and table 4 describes these hazards
and indicates which part of clause 5 of this standard provides the appropriate safety requirement. Table 5
shows the hazards on the optional equipment that is typically integrated with a flow-wrapping machine.
The hazards on a lower reel flow-wrapping machine (3.3.1) and an edge sealing machine (3.3.3) are similar to
those of a flow-wrapping machine.
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Table 5 - Hazards on optional equipment which is typically integrated with a flow-wrapping machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
zone
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- mass of products
- frequency of
movement
- operator posture
1 Automatic product Crushing Loading products 5.2.2.4
dispensing devices – for Shearing Accessing while running
example side loading
pushers or pick and
place devices
3 Automatic reel splicing Crushing Access while running 5.2.3.5
mechanism Cutting Setting up new reel
3 Powered unwind Drawing-in Accessing while running 5.2.3.4
mechanism
3 Reclosing feature Drawing-in Accessing while running 5.2.3.7
applicator
Burning Accessing while 5.1.3
threading material
3 Thermal coder Crushing and drawing-in Accessing while running 5.2.3.3
Burning
3 Laser coder Burning Direct or indirect contact 5.2.3.3
Laser radiation with laser beam
8 Hand-wheel Entanglement, impact or If the wheel rotates while 5.1.1.6
9 shearing the machine is running
Figure 16 shows the hazard zones on a typical vertical form fill and seal machine and table 6 describes these
hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement.
Table 7 shows the hazards on the optional equipment that is typically integrated with a vertical form fill and
seal machine.
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Figure 16 - Hazard zones on a typical vertical form, fill and seal machine
1 Filling machine See clauses 4.11 – 4.145.3.11 or EN 15180 for food depositors
2 Forming tube Musculo-skeletal injuries Changing the forming 5.3.11
Falling tube
Film spreader fingers Stabbing If the spreader fingers are 5.3.7
fitted to forming tube sharp or become sharp
due to wear
3 Packaging material reel Drawing-in and shearing Accessing while running 5.2.3
unwind mechanism Musculo-skeletal injuries Loading packaging 5.2.3
material reels
Slipping Packaging material left on 5.2.3
the floor
Falling from height Working at height to load 5.1.8.1
or thread film
4 Longitudinal sealing Crushing Threading new reel of film 5.3.4
mechanism Drawing-in Accessing while running
Burning Cleaning jaws 5.3.4
Threading film
5 Transverse sealing and Crushing and cutting Accessing while running 5.2.5
cutting mechanism Burning Threading film 5.2.5
Cleaning jaws
Cutting knife Cutting Maintenance 5.2.5
Threading film
6 Packaging material Drawing-in, impact and Accessing while running 5.2.5
transport mechanism Shearing
7 Discharge conveyor Drawing-in Accessing while running 5.2.6
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Table 7 - Hazards on optional equipment which is typically integrated with a vertical form, fill and seal
machine
Source of hazard Hazards Hazardous situations Safety
requirement
Typically
added to
zone
4.4 Hazards on typical horizontal sachet form, fill and seal machines
Figure 17 shows the hazard zones on a typical horizontal sachet form fill and seal machine and table 8
describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety
requirement. Table 9 shows the hazards on the optional equipment that is typically integrated with a horizontal
sachet form fill and seal machine. Figure 17 shows a linear transport system but the hazards are the same on
machines where the transport system is rotary or partly rotary.
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Figure 17 - Hazard zones on a typical horizontal sachet form, fill and seal machine
Table 8 - Hazards on a typical horizontal sachet form, fill and seal machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
Table 9 - Hazards on optional equipment which is typically integrated with a horizontal sachet form, fill
and seal machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
Zone
1 Automatic reel splicing Crushing and cutting Access while running 5.2.3.5
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Figure 18 shows the hazard zones on a typical thermoform fill and seal machine and table 10 describes these
hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement.
Table 11 shows the hazards on the optional equipment that is typically integrated with a thermoform fill and
seal machine. Figure 18 shows a linear transport system but the hazards are the same on machines where
the transport system is rotary or partly rotary.
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1 Bottom film reel unwind Drawing-in and shearing Accessing while running 5.2.3
mechanism Musculo-skeletal injuries Loading reels 5.1.8.1
Slipping or falling Loading or threading film 5.1.8.1
2 Transport mechanism Crushing and drawing-in Accessing while running 5.5.3
3 Heating or pre-heating Crushing Accessing while running 5.5.4
chamber Burning Threading film 5.5.4
4 Forming die Crushing Reaching into forming 5.5.5
Shearing area to pull lower web
5 Product loading area Musculo-skeletal injuries Loading products by 5.5.6
hand
6 Top film reel unwind Drawing-in and shearing Accessing while running 5.2.3
mechanism Musculo-skeletal injuries Loading reels 5.1.8.1
Slipping or falling Loading or threading film 5.1.8.1
7 Sealing die Crushing and drawing-in Accessing while running 5.5.9
Burning Cleaning jaws and 5.5.9
threading film
8 Cutting mechanisms Cutting Threading film 5.5.10
Maintenance
9 Scrap reels Drawing-in Accessing while running 5.5.11
10 Flat belt discharge Drawing-in Accessing while running 5.5.12
conveyor
11 Drive mechanisms Crushing, drawing-in and Accessing while running 5.1.1.5
shearing
Table 11 - Hazards on optional equipment which is typically integrated with a thermoform, fill and seal
machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
Zone
1 Automatic splicing Crushing Accessing while running 5.2.3.5
mechanism Setting up new reel
1 Powered unwind Drawing-in Accessing while running 5.2.3.4
mechanism
5 Automatic loading Crushing and impact Accessing while running 5.1.1.2
equipment – for example
pick and place or
depositor
5 Pad or leaflet inserter Crushing Accessing while running 5.1.1.2
Musculo-skeletal injuries Loading pads or leaflets 5.1.8.1
6 Thermal coder Crushing Accessing while running 5.2.3.3
Drawing-in
Burning
Impact When coder moves 5.5.8
sideways
6 Laser coder Laser radiation Direct or indirect contact 5.2.3.3
with laser beam
Impact When coder moves 5.5.8
sideways
6 Self-adhesive labelling Drawing-in Accessing while running 5.1.1.1
machine Impact When labeller moves 5.5.8
sideways
7 Modified atmosphere Asphyxiation Oxygen levels in 5.1.7.4
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Figure 19 shows the hazard zones on a typical tubular bag form, fill and seal machine and table 12 describes
these hazards and indicates which parts of clause 5 of this standard provide the appropriate safety
requirement. Table 13 describes hazards on the equipment typically integrated with a tubular bag form, fill and
seal machine.
Figure 19 - Hazard zones on a typical tubular bag form, fill and seal machine
Table 12 - Hazards on a typical tubular bag form, fill and seal machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
1 Film reel unwind Drawing-in and shearing Accessing while running 5.2.3
mechanism Musculo-skeletal injuries Loading film reels 5.1.8.1
Slipping and falling from Working at height to load 5.1.8.1
height or thread film
2 Drive Crushing, drawing-in and Accessing while running 5.6.3
mechanism shearing e.g. for maintenance
3 Transverse or corner Crushing, drawing-in and Accessing while running 5.6.3
sealing and cutting cutting
mechanism Threading film
Burning Cleaning jaws 5.6.4
Cutting knife Cutting Touching knife e.g. 5.6.5
during maintenance
4 Film draw and Drawing-in and shearing Accessing while running 5.6.6
compensator
5 Cooling mechanisms for Crushing and shearing Accessing while running 5.6.7
sealing
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Table 13 - Hazards on equipment which is typically integrated with a tubular bag form, fill and seal
machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
Zone
1 Automatic reel splicing Crushing and cutting Access while running 5.2.3.5
mechanism Setting up new reel
1 Power unwind Drawing-in Accessing while running 5.2.3.4
mechanism
1 or 4 Thermal coder Crushing, drawing-in Accessing while running 5.2.3.3
Burning
1 or 4 Laser coder Laser Direct or indirect 5.2.3.3
radiation contact with laser beam
1 or 2 Gussetting mechanism Crushing and drawing-in Accessing while running 5.6.9
Figure 20 shows the hazard zones on a typical mandrel form, fill and seal machine which may incorporate a
film reel unwind assembly or carton blank magazine or both assemblies. Table 14 describes these hazards
and indicates which parts of clause 5 of this standard provide the appropriate safety requirement. Table 15
describes hazards on the equipment typically integrated with a mandrel form, fill and seal machine.
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Figure 20 - Hazard zones on the range of mandrel form, fill and seal machines
Table 14 Hazards on the range of mandrel form, fill and seal machines
Zone Source of hazard Hazards Hazardous situations Safety
requirement
1 Packaging material reel Drawing-in and Accessing while running 5.2.3
unwind mechanism shearing
Musculo-skeletal Loading packaging 5.1.8.2
injuries material reels
Slipping Packaging material left on 5.1.8.2
the floor
2 Cutting mechanism Cutting Accessing while running 5.7.3
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10 Product feed See clauses 4.11 – 4.14 or EN 15180 for food depositors
Table 15 - Hazards on optional equipment which is typically integrated with a mandrel form, fill and
seal machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
4 Automatic carton stack Crushing, shearing, Accessing while running 5.1.1.4.1
feeding mechanism drawing-in
10 Vibration settling devices Hand or arm vibration Accessing while running 5.1.5
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Figure 21 shows the hazard zones on a typical pre-made bag erect, fill and seal machine and table 16
describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety
requirement. Table 17 shows the hazards on the optional equipment that is typically integrated with a pre-
made bag erect, fill and seal machine. Figure 21 shows a rotary transport system but the hazards are the
same on machines where the transport system is linear or partly linear.
Figure 21 - Hazard zones on a typical pre-made bag erect, fill and seal machine
Table 16 - Hazards on a typical pre-made bag erect, fill and seal machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
1 Bag magazine Drawing-in Loading bags into 5.7.5
magazine
Cutting Handling bags 7.4.4.7
Manual handling Handling bags 5.1.8.1
2 Bag dispensing and Crushing Reaching through 5.8.3
opening mechanism Shearing magazine to the
mechanism
3 Bag transport mechanism Crushing and shearing Accessing while running 5.8.4
4 Filling machine See clauses 4.11 – 4.14 or EN 15180 for food depositors
5 Product settling Vibration Touching vibrating 5.8.6
mechanism mechanism
6 Bag closing or sealing Crushing and drawing-in Accessing while running 5.8.7
mechanism Burning Touching hot surfaces 5.8.7
7 Flat belt discharge Drawing-in Accessing while running 5.8.8
conveyor
8 Drive mechanisms Crushing, drawing-in and Accessing while running 5.1.1.5
shearing
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Table 17 - Hazards on optional equipment which is typically integrated with a pre-made bag erect, fill
and seal machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
Zone
5 Modified atmosphere Asphyxiation Oxygen levels in 5.1.7.4
equipment atmosphere reduced by
release of gas
5 Hot melt glue sealing Burning and scalding Filling glue and trouble 5.7.14
equipment shooting
6 Thermal coder Crushing, drawing-in and Accessing while running 5.2.3.3
burning
6 Laser coder Laser radiation Direct or indirect contact 5.2.3.3
with laser beam
8 Hand-wheel Entanglement, impact If the wheel rotates while 5.1.1.6
and shearing the machine is running
Musculo-skeletal injuries Excessive effort turning 5.1.8.3
hand-wheel
Figure 22 shows the hazard zones on a typical cup or tub fill and seal machine equipped with a film reel
unwind mechanism and figure 23 shows the hazard zones on a typical cup or tub fill and seal machine
equipped for pre-cut foils and lids.
Table 18 describes these hazards and indicates which parts of clause 5 of this standard provides the
appropriate safety requirement. Table 19 shows the hazards on the optional equipment that is typically
integrated with a cup or tub fill and seal machine. Figures 22 and 23 show linear transport systems but the
hazards are the same on machines where the transport system is rotary or partly rotary.
Figure 22 - Hazard zones on a typical cup or tub fill and seal machine with reel fed top foil
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Figure 23 - Hazard zones on a typical cup or tub fill and seal machine for pre-cut top foils
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Table 19 - Hazards on optional equipment which is typically integrated with a cup or tub fill and seal
machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
Zone
Rotary container Drawing-in Shearing Loading containers 5.9.2
magazine during operation
In-line container Drawing-in Loading containers 5.9.2
magazine during operation
10a Foil magazine Crushing Shearing Reaching from magazine 5.9.7
into the machine
10b Foil placing mechanism Crushing Shearing Reaching from magazine 5.9.11
into the machine
11a Lid magazine Crushing Shearing Reaching from magazine 5.9.7
into the machine
11b Lid placing mechanism Crushing Shearing Reaching from magazine 5.9.11
into the machine
3 Modified atmosphere Asphyxiation Oxygen levels in 5.1.7.4
equipment atmosphere reduced by
release of gas
9 Thermal coder Crushing and drawing-in Accessing while running 5.2.3.3
Burning
9 Laser coder Laser radiation Direct or indirect contact 5.2.3.3
with laser beam
Figure 24 shows the hazard zones of a typical in-line sack fill and seal machine and the equipment typically
attached to or combined with an in-line sack fill and seal machine.
Table 20 describes the hazards and indicates which parts of clause 5 of this standard provide the appropriate
safety requirement. Table 21 describes hazards on the equipment typically attached to or combined with an
in-line sack fill and seal machine.
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Figure 24 - Hazard zones on a typical in-line pre-made sack fill and seal machine
Table 21 - Hazards on the equipment typically attached to or combined with an in-line sack fill and seal
machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
8 Sack placer Impact Crushing Access while running 5.10.1.9
Shearing
9 Sack discharge conveyor Drawing-in Accessing while running 5.10.1.10
Falling Standing on the 5.1.1.7
conveyor
Figure 25 shows the hazard zones of a typical rotary sack fill and seal machine and the equipment typically
attached to or combined with this type of machine.
Table 22 describes the hazards and indicates which parts of clause 5 of this standard provide the appropriate
safety requirement. Table 23 describes hazards on the equipment typically attached to or combined with an
rotary sack fill and seal machine.
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Figure 25 - Hazard zones on a typical rotary sack fill and seal machine
Table 22 - Hazards on a typical rotary sack fill and seal machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
1 Carousel Crushing, entanglement, Accessing while running 5.10.2.2
impact and shearing
Sack holding mechanism Crushing Accessing while running 5.10.2.3
Flow regulating Crushing and shearing Accessing while running 5.10.2.4
mechanism
Holding and positioning Impact, crushing and Accessing while running 5.10.2.5
mechanism shearing
Sealing mechanism Crushing and shearing Accessing while running 5.10.2.6
Burning Touching hot surfaces 5.1.3
Dust at filling nozzle area Various health damaging Contact with dusty 5.10.2.7
effects products
Table 23 - Hazards on equipment typically attached to or combined with a rotary sack fill and seal
machine
Zone Source of hazard Hazards Hazardous situations Safety
requirement
2 Sack magazine Crushing, impact and Accessing while running 5.10.2.8
shearing
3 Sack transfer Crushing, impact and Accessing while running 5.10.2.9
mechanism shearing
4 Sack placer Crushing, impact and Accessing while running 5.10.2.10
shearing
5 Sack discharge conveyor Drawing-in Accessing while running 5.10.2.11
Falling Standing on the 5.1.1.7
conveyor
Figure 26 shows the hazard zones on a typical auger filler and table 24 describes these hazards and indicates
which parts of clause 5 or 7 of this standard provides the appropriate safety requirement.
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Figure 27 shows the hazard zones on a typical volumetric cup filler and table 25 describes these hazards and
indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement.
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Figure 28 shows the hazard zones on a typical nett weigher and table 26 describes these hazards and
indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement.
The hazards on a count filling machine (3.3.8) are similar to those on a nett weigher.
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Figure 29 shows the hazard zones on a typical multi-head weigher. Table 27 describes these hazards and
indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement.
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5 Safety requirements
All the machines in the scope of this standard shall comply with the safety requirements and protective or risk
reduction measures in clause 5.1 and the relevant machine specific clauses 5.2 to 5.14 where the equivalent
hazard exists.
Where a machine has hazards, which are not on a typical machine and so are not described in clause 4, the
machine shall be designed according to EN 415-10: 2014.
Inherently safe design measures shall be applied as far as possible to eliminate or reduce risks, and shall
comply with the requirements of clause 5.2.1.1 of EN 415-10:2014. Clauses 5.2 to 5.14 identify some of the
mechanisms where inherently safe design measures can typically be applied, for example by limiting the
forces applied by the mechanisms.
With the exception of cutting mechanisms accessible parts of the machine shall have no sharp edges, no
sharp angles and no rough surfaces likely to cause injury.
Guards shall comply with subclauses 5.2.1.2, 5.2.1.3 and 5.2.1.4 of EN 415-10:2014.
Where the smallest dimension of a rectangular opening or diameter of a circular opening in a guard is less
than or equal to 120 mm the safety distances in tables 3, 4 and 6 of EN ISO 13857 shall apply. Where the
opening is larger than 120 mm, the safety distances shown in clause 5.2.1.3 of EN 415-10: 2014 shall apply.
When a guard is opened, it shall not be possible to reach a danger zone before the hazardous movement has
stopped. Where this objective is not achieved, a guard locking device or internal baffle which prevents direct
access to the danger zone shall be fitted.
Where guards are made of a transparent material and there is a risk of someone walking into the open guard,
the guard shall be marked or fitted with features which make the guard clearly visible when it is open.
The design of guards and interlocking devices shall avoid the risk of people being trapped inside the machine.
Pneumatic components and piping shall comply with the requirements of EN ISO 4414. Hydraulic components
and piping shall comply with the requirements of EN ISO 4413.
Where control functions are performed by hydraulic or pneumatic systems, these circuits shall comply with the
requirements of clauses 5.14 and 5.15 of EN 415-10: 2014.
Where the machine is designed to pack foodstuffs, cosmetics, pharmaceuticals or other products where
contamination is a significant risk, the design shall ensure that hydraulic oil or pneumatic lubricating oil cannot
come into contact with the product. For example compressed air can be filtered but not lubricated and
compressed air exhausts can be directed away from the product.
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The machine shall be equipped with an isolation device for each supply for fluid power. These isolation
devices shall not be located in a danger zone and shall be readily accessible, clearly labelled, and have
features to allow them to be locked in the off position. The machine shall have the facility to release stored
pneumatic and hydraulic energy in a safe manner. Pneumatic isolation valves shall comply with clause 5.2.8
of EN ISO 4414:2010 and hydraulic isolation valves shall comply with clause 5.4.7.2.1 of EN ISO 4413:2010.
The design of the machine and its guards shall ensure that danger zones on the machine are safeguarded
without the need for adjustment of safeguards, for all the product and pack sizes for which the machine has
been specified.
Where this is not possible adjustable guards or change part guards shall be used.
Where the design of guards causes shadows that prevent a good view of the process inside the machine, the
manufacturer shall provide internal lighting.
Where parts of the machine are adjusted under power, the risks presented by these powered movements
shall be eliminated using the following hierarchy of measures:
a) ensuring that the movements are not hazardous by following the safety by design principles described in
clause 5.2.1.1 of EN 415-10: 2014, or;
b) if a) is not possible by ensuring that movements can only take place when the machine’s interlocking
movable guards are closed or;
c) where it is not possible to fulfil the requirements of a) or b), the movement can only take place using a
hold-to-run control device complying with clause 5.16.3 of EN 415-10: 2014.
5.1.1.6 Hand-wheels
Where handles or hand-wheels are provided to operate mechanisms manually, they should be disconnected
when the machine runs automatically.
If the hand-wheel is designed to rotate under power during automatic operation it shall comply with clause
5.20.5 of EN 415-10: 2014.
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5.1.1.8 Tasks requiring guards to be open while mechanisms are moved under power
The design of the machine shall avoid the need to carry out any task where it is necessary to move machine
mechanisms while a guard is open. If mechanisms need to be moved in manual mode, this shall only be
possible with all the interlocking guards in the closed position.
Where for technical reasons this is not practicable, movement of the machine parts shall only be possible if all
of the requirements of clause 5.16.3 of EN 415-10 have been satisfied.
Electrical equipment fitted to machines in the scope of this standard shall comply with EN 60204-1 and
clauses 5.3, 5.5 and 5.6 of EN 415-10.
On machines where hazards may arise from the generation of static electricity, the manufacturer shall provide
sufficient earth bonding or static elimination equipment to ensure that hazardous levels of static electricity do
not occur. This equipment shall ensure that electrostatic discharge shall lead neither to any injury nor to the
ignition of potentially explosive atmospheres or combustible substances.
High voltage static elimination devices shall be protected using interlocking guards and the control system
shall ensure that the static elimination device is turned off when the interlocking guard is open.
The external temperature of exposed parts of the machine, like guards, control panels and electric motors,
shall not exceed the burn threshold temperatures stated in clause 4.2 of EN ISO 13732-1:2008, which take
into account the contact material and the foreseen contact time.
Where the machine includes parts, like heating mechanisms with a foreseeable temperature greater than the
burn thresholds described in EN ISO 13732-1, the manufacturer shall minimize the risk of accidental contact,
for instance by fitting insulation or guards to prevent unintentional contact and by fitting the “warning hot
surface” pictogram specified in 7.3 on the outside of the machine or adjacent to the hot parts (see Figure 62).
If having taken these measures, there is still a residual risk of touching hot surfaces this shall be stated in the
instructions together with the measures which can be taken to avoid burn injuries, like wearing gloves or other
personal protection equipment.
Machines in the scope of this standard shall be designed to minimize noise at its source using state of the art
noise reduction technology.
Noise shall be reduced by the methods stated in this standard. Where these measures are not applicable or
insufficient, additional measures stated in EN ISO 11688-1 shall be applied to reduce noise at source.
The criterion for assessing the efficiency of noise reduction measures is the actual noise emission values of
the machine and not the nature of the reduction measure itself.
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The method of noise measurement and wording of the noise declaration shall comply with EN 415-9. The
microphones for noise measurement shall be placed in the positions indicated in Annex A of this standard.
The running conditions of the machine shall comply with those stated in Annex A of this standard.
Machines fitted with vibrating mechanisms shall be designed so that harmful levels of vibration are not
transmitted to other parts of the machine or the surface on which the machine is fixed. The vibrating
mechanisms shall be designed so it is not necessary for operators to touch or hold the parts while they are
vibrating.
5.1.6 Radiation
Where machines incorporate radiation sources the manufacturer shall comply with the requirements of clause
5.9 of EN 415-10: 2014.
Where ultra-violet (UV) light is used to sterilise packaging materials or components, the machine shall be
designed so, that no hazardous amounts of UV-light are emitted from the machine. Where the UV light
causes thermal hazards, clause 5.1.3 shall apply.
Where the machine has been specified to pack a hazardous product, the manufacturer shall comply with the
requirements of clause 5.10 of EN 415-10: 2014.
Where the machine is specified to pack a dusty product, the manufacturer shall supply local exhaust
ventilation equipment with the machine which prevents hazardous levels of dust developing outside guarded
areas. The local exhaust ventilation equipment shall comply with EN ISO 14123-1:2016.
Where the machine is specified to pack potentially explosive dusty products, the manufacturer shall comply
with the requirements of EN 1127-1 and electrical equipment shall comply with EN 60079-14.
5.1.7.4.1 General
Where machines are fitted with modified atmosphere packing equipment, all vessels, pipes and fittings shall
be designed to safely contain the modifying gas.
The gas supply shall be fitted with an isolation valve which can be locked in the off position and with a means
to extract gas from the machine safely.
Where a space inside the machine contains a hazardous modified atmosphere and the opening of a guard
exposes the operator to this hazardous atmosphere, this guard shall be interlocked with a guard locking
device and controlled so that this guard cannot be opened until the atmosphere inside the machine is safe to
breathe. This guard door shall be released either by a sensor that can determine that the atmosphere is safe
to breathe or after a time delay which is sufficient for the harmful substances to be extracted by the local
exhaust ventilation system.
Where gases like nitrogen are used to reduce oxygen levels in packages, the design of the machine and the
gas control system shall ensure that oxygen levels within 1 m of the machine do not fall below 19%.
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Where gases harmful to health are used, the design of the machine and the gas control system shall ensure
that dangerous levels of the gas do not build up around the machine and that guard locking devices prevent
exposure to dangerous concentrations of the gas inside parts of the machine accessible by operators. The
concentration of the modifying gas shall be measured at 500 mm from possible gas emission points like the
gas chamber.
Note: For carbon dioxide (CO2), the concentration should not exceed 0,5 vol.% (5000 ml/m³ or 9000 mg/m³)
and for carbon monoxide (CO), the concentration should not exceed 0,003 vol. % (30 ml/m³ or. 35 mg/m³).
To prevent the emission of hazardous amounts of harmful gases, the manufacturer shall:
a) Fit a solenoid valve to shut off the supply of the modifying gas automatically when the machine stops.
This valve will be open during normal operation but shall not be the same valve that controls the gas
flow;
b) Fit a pressure reducer and a safety relief valve at the interface with the gas supply;
c) Fit a manual supply disconnection device at the interface to the gas supply;
d) Provide extraction equipment to remove or disperse dangerous levels of the modifying gas;
e) Where the installation incorporates flexible hoses, fit a solenoid valve upstream of each flexible hose
which can shut off the supply of the modifying gas automatically if a hose ruptures or the gas flow
exceeds normal limits;
f) Ensure the design of connections for different gases are different so it is not possible to mix them up;
g) Fit signs next to the gas supply and to the connection to the machine to indicate the kind of gas to be
used.
On machines where mixtures of gases can be selected, instrumentation shall be provided which displays the
concentration of the different gases which are being delivered to the machine.
5.1.7.4.3 Oxygen
All components which can encounter oxygen, such as pumps, hoses, pipes, fittings, instruments, seals or
containers, shall be suitable for the use with oxygen.
Devices shall be fitted to detect any leakage of oxygen that may occur during operation and to automatically
shut off the oxygen supply if a leak is detected.
The design or the control system shall prevent the generation of inflammable concentrations of gas and
ensure that the temperature of heat sealing mechanisms do not exceed 200 °C.
Where the sealing temperature is greater than 200°C, the instructions shall state that the ignition temperature
of the film shall be at least 50 K below this ignition temperature of the gas mixture and how this is to achieved.
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The design shall ensure that oxygen does not come into contact with fat or oil. Where there is a risk of contact
with fat or oil the manufacturer shall ensure that:
1. No lubricants or sealants are used which could self-ignite in contact with oxygen;
2. The flow rate of oxygen is restricted to 25 m/s;
3. Where a vacuum system is used to remove ambient atmospheres, the control system ensures that either
a) the vacuum pump is designed so it can operate safely in high concentrations of oxygen or if this is not
reasonably practicable;
b) the concentration of oxygen passing through the vacuum pump is controlled so it does not exceed
21%.
NOTE: One method of achieving this is by designing the control system so that the vacuum valve is
closed before the gas mixture can enter the vacuum chamber and before the vacuum valve opens
again no gas mixture remains in the chamber.
The instructions shall state:
Machines using hazardous substances (for example hydrogen peroxide) to sterilise or disinfect packaging
materials and components shall be designed so that all foreseen interventions inside the machine can be
carried out safely and so that airborne emissions of the sterilising substance from the machine to the work
area around the machine are kept to a minimum.
The sterilising substance shall be kept in as closed a system as possible, and the seals and gaskets fitted to
guard doors and other possible leakage points shall be made of materials that resist the sterilising substance
being used.
Movable guards shall be interlocked with guard locking devices to prevent access to areas of the machine that
contain a hazardous concentration of the sterilising substance. The guard locking shall be controlled either by
automatic concentration measurement device or by time. Where time is used the time delay shall be
determined for the worst-case conditions.
If interventions are foreseen in an area while a hazardous concentration of the sterilising substance exists,
suitable additional measures shall be provided, such as:
- fitting the machine with an extraction system to evacuate the sterilising substance;
- spraying the area with water to absorb the sterilising substance into water; or
- fitting the machine with glove boxes.
Where measures such as extraction or spraying systems are provided for the above purpose, these shall be
dimensioned to function under the worst-case conditions and shall be interlocked to prevent access to the
area if the extraction or spraying system is not functioning.
The supply system of the sterilising substance shall be designed to safely contain the sterilising substance.
Pipe connections shall be used that can only be dismounted using tools. If the sterilising substance is supplied
from an external source (i.e., not from a container) the machine shall be fitted with an isolation valve that can
be locked in the off position.
Where airborne emissions of the sterilising substance occur, for example at discharge points, measures shall
be provided to prevent the build-up of hazardous levels of the substance near the machine, such as:
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On machines where products are fed or unloaded manually, the design of the hand loading or unloading area
shall follow the ergonomic design principles indicated in EN 1005-2, EN 1005-3 and EN 1005-4 to minimize
the risk of muscular or skeletal injuries.
NOTE Information on the risk assessment for repetitive handling at high frequency is given in EN 1005–5:2007.
5.1.8.3 Hand-wheels
Where a hand-wheel is used to move a mechanism by hand, the force that must be applied to the
circumference of the hand-wheel to move the mechanism shall not exceed 20 N if one hand is used and 30 N
if two hands are used.
On machines where change parts are used, hazards from excessive effort or strain shall be eliminated or
reduced by the following measures:
a) Change parts are designed in compliance with EN 1005-2 so that they can be lifted, installed and
removed easily. Mref in table 1 of EN 1005-2:2008 is 25 kg;
b) Where the design of the machine and of the change parts allows two people to lift the parts into place, Mref
may be taken as 40 kg . If two people are required to lift or fit change parts, this shall be stated clearly in
the instruction manual.
c) Where the measures described in a) and b) are not possible for technical reasons, the manufacturer shall
provide suitable mechanical lifting or handling equipment to move the part;
d) Change parts with a mass greater than 25 kg shall be listed in the instruction manual.
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Where machines are designed or specified to pack foodstuffs, cosmetics, pharmaceuticals or other products
where hygiene is an issue, the manufacturer shall:
a) identify the level of hygienic design appropriate for the product. When the machine manufacturer is unable
to find this information, he shall define the limitation of use for the machine and clearly state this in the
instructions, for example “This machine has been designed to pack foodstuffs with the following
characteristics”;
1) use of contact materials complying with clause 5.2 of EN 1672-2:2005+A1:2009, which are
appropriate for the product, the contact time, the temperature, chemical reactions, physical
characteristics (such as abrasion) and the cleaning method and cleaning substances;
2) design food and splash areas (as defined in clauses 3.4.1 and 3.4.2 of EN 1672-2:2005+A1:2009) so
they are free from crevices and ledges;
3) designing food and splash areas so that they can be easily cleaned and inspected for cleanliness;
4) prevent lubricating oils from coming into contact with the product, for example by fitting filters to
compressed air exhausts;
c) describe appropriate and safe cleaning procedures in the instructions including information on the
cleaning or disinfection agents that shall be used;
d) design the machine so that fallen packs or spilled products or substances can be easily detected and
removed from the machine;
e) where parts of the machine must be dismounted for cleaning, design the machine and the parts so that
they can be easily removed and mounted as describe in clause 5.1.8.4.
5.2.1 General
The hazards described in 4.2 shall be eliminated or safeguarded by the following measures and those
described in 5.1.
These safety requirements also apply to a lower reel flow-wrapping machine (3.3.1) and an edge sealing
machine (3.3.3) where the equivalent hazard exists.
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On machines which are to be fed by hand, the feeding area shall be designed to eliminate shearing, crushing
and entanglement hazards, but at the same time shall allow access to the product pushing devices, using the
methods described in 5.2.2.1, 5.2.2.2 and 5.2.2.3.
The return chain run with its pushing devices and drive and tail sprockets of the chain infeed conveyor shall be
safeguarded with fixed or interlocking guards. Any openings in the guards, for example to allow debris to fall
out of the guarded area shall be dimensioned using tables 3, 4 or 6 of EN ISO 13857.
If these guards need to be removed once a day or more frequently, they shall be fitted with interlocking
devices complying with EN ISO 14119 and comply with the requirements for interlocking guards. Where
cables make this area of the machine difficult to clean, mechanical trapped key interlocking devices complying
with EN ISO 14119 type 2 can be used.
The tail sprocket guard shall be designed to avoid shearing hazards for example by creating a tunnel guard.
Where machines are equipped with product side guides which are adjustable without the need for tools,
movement of these guides shall not expose any hazard.
Product pushing devices shall be designed so that they do not present cutting, shearing or crushing hazards
in the hand loading area and where they enter the folding box.
The risk of impact between a pusher and the hand of an operator in the hand loading area can be considered
negligible if the pusher has no sharp edges, there is no risk of entanglement or drawing-in and the speed of
the conveyor is lower than 2 m/s.
Other methods of eliminating hazards from pushing devices include the following:
a) Pushing devices designed so that they come away from the chain in the event of a lateral force greater
than 135 N being applied to them. The impact force shall not exceed 180N and the static pressure on the
body surface shall not exceed 60 N/cm2.
NOTE: These limits assume that the pushing devices will be applying the force to hands or fingers.
b) Pushing devices designed so that they can bend when a lateral force greater than 135 N is applied to
them. The impact force shall not exceed 180 N and the static pressure on the body surface shall not
exceed 60 N/cm2.
NOTE: These limits assume that the pushing devices will be applying the force to hands or fingers.
c) Pushing device linkages designed so that the pushing devices are free to bend backwards as they enter
the folding box;
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d) A trip guard fitted with an interlocking device complying with EN ISO 14119 like the one in figure 31 which
stops the infeed conveyor when someone’s hand moves the trip guard. The trip guard shall comply with
the requirements of clause 5.2.1.3.9 of EN 415-10: 2014;
e) Another safeguarding method which provides at least the same or a higher level of protection.
Figure 31 – Guards and trip device fitted in front of the folding box
Where flat belt conveyors are used to feed products, the following requirements shall apply.
The drawing-in hazards between drive or support rollers and the belt shall be safeguarded in one of the
following ways:
a) A combination of the conveyor body and the conveyor belt prevent access to these rollers as shown in
figure 32;
b) Fixed shaped blocks at each drawing-in point prevent access as shown in figure 33;
c) A combination of the conveyor frame and a guard which can be removed for cleaning prevents access
as shown in figure 34.
Key
1 Drive roller
2 Tail roller
3 Conveyor belt
4 Side frame
Figure 32 - Belt conveyor — Example of using the side frame and belt to prevent access to danger
zones
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Key
1 Drive roller
2 Tail roller
3 Filling pieces
4 Conveyor belt
Figure 33 - Belt conveyor — Example of using filling pieces to prevent access to danger zones
Key
1 Drive roller
2 Tail roller
3 Tension rollers
4 Conveyor belt
5 Guard
Figure 34 - Belt conveyor — Example of using a guard to prevent access to danger zones
5.2.2.3.3 Drawing-in hazards between the moving belt and fixed parts
The gap between the moving belt and fixed parts like guide rails shall either be less than 4 mm or more than
80 mm.
Where there is a drawing-in hazard between one conveyor and another, for instance because the first
conveyor can run faster than the second or the second conveyor can stop while the first continues to run, one
of the following methods shall be used to eliminate the drawing-in hazard:
a) A deadplate is fixed between the conveyors with gaps between the conveyor belts and the deadplate
of no more than 4 mm as shown in figure 35; or
b) A gap between the conveyors of no less than 80 mm, or
c) A moveable deadplate or roller which is designed so it can pop out if someone’s fingers or clothing
are drawn into the gaps between the first conveyor belt and the deadplate or roller. The force
required to release the deadplate or roller shall not exceed 135 N.
NOTE: The pop-out roller or deadplate can be fitted with springs so it does not get lost and returns to its
correct position.
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1 2
2 3
Key
1 belt
2 deadplate
3 drive roller
Figure 35 - Belt conveyor transfer— Example of a fixed deadplate – side view
Where a belt conveyor feeds products on to a deadplate, the drawing-in hazard between the belt and the
deadplate shall be safeguarded in one of the following ways:
a) A fixed deadplate with the gap between the conveyor belt and the deadplate of no more than 4 mm; or
d) A moveable deadplate which is designed so it can pop out if someone’s fingers or clothing are drawn
into the gap between the belt and the deadplate. The force required to release the deadplate or roller
shall not exceed 135 N.
b)
NOTE: The pop-out deadplate can be fitted with springs so it does not get lost and returns to its correct
position.
Where the clearance under a conveyor is higher than 600 mm but lower than 2100 mm one of the following
measures shall be used to protect against drawing-in and entanglement hazards, especially of hair if someone
passes under the conveyor:
a) Fitting a fixed guard which prevents hair coming into contact with the moving belt or rollers, or
b) Fitting barriers under the conveyor to prevent access under the conveyor and providing a permanent
or mobile means of access to cross over the conveyor.
Where the conveyor belt requires frequent cleaning, the manufacturer shall design the belt conveyor so that
the belt can be removed easily for cleaning and describe the method of cleaning in the instruction manual.
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Where automatic product feeding mechanisms are not safe by design as defined by clause 5.2.1.1 of EN 415-
10, they shall be enclosed with interlocking guards.
5.2.3.1 General
The film reel unwind mechanism shall be designed and positioned in accordance with 5.1.8.1.
Film reel unwind mechanisms shall either be made safe by design using the measures indicated in clause
5.2.1.1 of EN 415-10: 2014 or they shall be enclosed with interlocking guards.
Where the moving film edge presents a cutting hazard, the film path shall be enclosed with fixed or
interlocking guards.
The shearing hazard between the tension roller assembly and the machine frame shall be eliminated either by
ensuring that the moving assembly is at least 25 mm from the frame or by incorporating one of the devices
shown in figure 36.
Where the film braking or compensating mechanism cannot be made safe by design, it shall be enclosed in
interlocking guards.
A - Solid piece eliminates shearing hazard B - Plate attached to the machine frame eliminates hazard
Figure 36 - Methods of safeguarding the tension roller assembly
5.2.3.3 Coders
Where a coding device is integrated with the film reel unwind mechanism, the power supplies for the coder
(for example electricity and compressed air) shall be isolated when the machine’s isolators are turned off.
Thermal coders shall be guarded or insulated so touchable surfaces do not exceed the burn thresholds
indicted in EN ISO 13732-1:2006. Where there is a residual risk of burning a “warning hot surface” pictogram
shall be fitted.
Laser coders rated as class 3 or 4 shall be mounted in a class 1 safety enclosure that complies with EN
60825-4. For all classes of laser coder, a laser hazard warning pictogram (EN ISO 7010/W004) shall be fixed
on the machine housing next to the coder or on the class 1 safety enclosure. Instructions for safe use,
adjustment and maintenance of the laser coder shall be included in the instruction manual.
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Where the coder is fitted in a hazardous area of the machine, the machine’s hazardous functions shall be
stopped and maintained in a stopped condition by a safety-related stop function, when the coder needs to be
accessed, for example because of a malfunction or to refill printing ink
Drive mechanisms for power unwind devices shall be fitted with fixed guards. The in-running nips of the film
driving rollers shall be safeguarded by one of the methods shown in figure 37 or the assembly shall be
enclosed with interlocking guards.
The clearance between the guard and roller (A in figure 37) shall be less than or equal to 4 mm. The safety
distance (C in figure 37) shall be determined according to Table 28, depending on the film opening (B in
Figure 37). The guard design shall ensure that it is not possible to access the rollers from the sides.
Table 28 – Safety distance (C) for different film openings (B) in Figure 37
Film opening (B) Safety distance (C)
0 mm < B ≤ 4 mm 2 mm
4 mm < B ≤ 6 m 10 mm
B > 6 mm See table 4 of EN ISO 13857:2008
Where the automatic splicing mechanism cannot be made safe by design using the methods described in
clause 5.2.1.1 of EN 415-10: 2014 or the mechanism incorporates a cutting device, the mechanism shall be
enclosed with an interlocking guard. This interlocking guard shall be interlocked so that the splicer cannot
operate when the splicer guard is open, but allows the main machine to continue to run.
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The design of the guards shall ensure that danger zones on the main machine cannot be reached when the
splicer’s guard is open.
Where elimination equipment presents a hazard, it shall be protected with an interlocking guard and the
control system shall ensure that the static elimination equipment is turned off when this interlocking guard is
open.
Mechanisms for attaching a reclose feature to a package shall be enclosed with interlocking guards. The
reclose feature reel unwind mechanism shall comply with 5.2.3.2. Where heat is used to attach the reclose
feature 5.1.3 shall apply.
The longitudinal sealing mechanism shall be safeguarded in one of the following ways:
a) enclosing the mechanism with an interlocking guard fitted with a trip guard as described in 5.2.2.2 (d)
and shown as “D” in figure 31 or
b) using a series of curved fixed guards in front of each set of rollers as shown in figure 38. The
clearance between the curved fixed guards “E” and the drive rollers “A” shall be less than or equal to
4 mm. Where the film opening “B” is less than or equal to 4 mm, the safety distance to the danger
zone “C” shall be at least 2mm. Where the film opening “B” is less than or equal to 6mm, the safety
distance to the danger zone “C” shall be at least 10 mm. Where the film opening is greater than 6 mm
the safety distance shall comply with table 4 of EN ISO 13857.
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D – Hinged plates
E – Curved fixed guards
When any of the interlocking guards described in 5.2.4 (a), (b) or (c) are open the control system shall ensure
that the mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be
disconnected.
The transverse sealing and cutting mechanisms shall be safeguarded with interlocking guards which prevent
access to the mechanisms through both the infeed and discharge openings as illustrated by the guards
marked as “D” and “E” in figure 30.
Where the width or height of the product infeed or discharge opening in the guards is 20 mm or less the
distance away from the nearest danger zone shall be at least 120 mm. Where the opening width or height is
greater than 20 mm but less than 200 mm, the minimum distance away from the nearest danger zone shall be
at least 850 mm. Where the opening width or height is greater than 200 mm the safety distance shall comply
with clause 5.2.1.3 of EN 415-10: 2014.
Where the transverse sealing mechanism is pneumatically operated, it shall incorporate a brake mechanism
or solenoid valve to ensure that the mechanism does not move unexpectedly when the guards are open or the
compressed air supply is disconnected.
Where the transverse sealing mechanism is heated, the requirements of 5.1.3 shall apply.
When the transverse sealing mechanism interlocking guard is open the control system shall ensure that the
mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be
disconnected.
Where the discharge mechanism is a flat belt conveyor it shall comply with 5.2.2.3. Other discharge
mechanisms which are not safe by design shall be enclosed with interlocking guards.
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The safety related control systems of flow-wrapping machines shall as a minimum comply with the following
performance levels of EN ISO 13849-1:2015.
5.3 Safety requirements for a vertical form, fill and seal machine
5.3.1 General
The hazards described in 4.3 shall be safeguarded by the following methods and those described in 5.1.
These requirements also apply to a stick packing machine (3.3.2), vertical sachet form, fill and seal machine
(3.3.4), strip packing machine (3.3.5) and vertical form, fill and seal machine for cartonboard (3.3.6) where the
equivalent hazards exists.
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The safety requirements for four typical feeding devices are described in 5.11, 5.12, 5.13 and 5.14. The
product feeding device shall be guarded and interlocked with the vertical form fill and seal machine in such a
way that it is not possible to reach danger zones inside the product feeding device from inside the guards of
the machine or danger zones inside the machine from inside the guards of the feeding device.
The requirements of clause 5.2.3 also apply to a vertical form fill and seal machine.
The longitudinal mechanism shall be guarded with interlocking guards similar to the one marked “C” in figure
40. Where the interlocking guard is open at the top, the dimensions for the guard shall be taken from table 2 of
EN ISO 13857 and consider that operators could stand on the discharge conveyor or tunnel guard.
Where the longitudinal sealing mechanism is heated, the requirements of 5.1.3 shall apply.
The longitudinal sealing mechanism shall not present a risk of burning when changing the packaging material.
NOTE – This can be achieved by making it possible to move the longitudinal sealing mechanism when
changing the packaging material.
When the longitudinal sealing mechanism interlocking guard is open the control system shall ensure that the
mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be
disconnected.
The packaging material transport mechanism shall be guarded with interlocking guards and a tunnel guard as
illustrated by the guards marked “C” and “D” in figure 40.
Where the interlocking guard is open at the top, the dimensions for the guard shall be taken from table 2 of EN
ISO 13857 and consider that operators could stand on the discharge conveyor or the tunnel guard.
The transverse sealing and associated mechanisms shall be guarded with interlocking guards and a tunnel
guard as illustrated by those marked “C” and “D” in figure 40.
Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening
in the tunnel guard to the nearest danger zone on the transverse sealing or associated mechanism shall be at
least 850 mm. Where the height of the opening is greater than 200mm the safety distances and safeguarding
solutions shown in clause 5.2.1.3 of EN 415-10 shall apply.
To prevent access by reaching with an arm under the interlocking guard, for example to remove empty
packages from the sealing mechanism, the gap under the guard and the safety distance to the nearest danger
zone shall comply with table 4 of EN ISO 13857. Where additional guards are fitted that restrict the
movement of an arm or hand, the safety distances shown in tables 3 and 6 of EN ISO 13857 can be used.
Where the transverse sealing mechanism is heated, the requirements of 5.1.3 shall apply.
The machine shall be provided with a facility to feed packaging material through the machine automatically or
the design of the sealing mechanism shall allow packaging material to be threaded through the jaws while
they are hot without a risk of burning.
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When the transverse sealing mechanism interlocking guard is open the control system shall ensure that the
mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be
disconnected.
The design of the cutting and perforating mechanism shall minimise the risk of injury during a typical operator
intervention to thread packaging material or clear a jam. This can be achieved by designing the cutting or
perforating mechanism so it retracts into an enclosed area when the interlocking guard is opened.
The machine shall be fitted with a facility to inhibit the cutting mechanism during set up or at the start of
production to ensure that empty packages will be discharged without the need for operator intervention.
Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening
in the tunnel guard to the nearest danger zone on the transverse sealing or associated mechanism shall be at
least 850 mm. Where the height of the opening is greater than 200 mm the safety distances and safeguarding
solution shown in clause 5.2.1.3 of EN 415-10 shall apply.
Where the packs are taken away from the machine with a conveyor, the conveyor shall be interlocked with the
machine so that when the interlocking guard of the machine is open the conveyor stops.
Where the conveyor forms part of the guarding, it shall either be fixed in relationship to the machine, or
interlocked so that the machine cannot operate unless the conveyor is in its correct position.
Where the discharge conveyor is a flat belt conveyor it shall comply with5.2.2.3. Other types of conveyor shall
comply with clause 5.20.4.2 of EN 415-10.
On machines where the product is discharged into bins without the use of a discharge conveyor, one of the
following safeguarding solutions shall be used.
a) the machine guards shall extend downwards round the bin far enough to prevent access to the transverse
seal and associated mechanisms whether the bin is in place or not;
b) The bin is detected with an interlocking device, conforming to EN ISO 14119 incorporated into the control
system so that the machine can only operate when a bin is in its correct position. In this case, the
combination of the bin and interlocking guards shall prevent access to the danger zones.
The manufacturer shall design the forming tube so it can be installed and removed without a manual handling
risk. Methods of achieving this include:
b) Mechanisms to support the forming tube during the installation and removal process;
Where it is likely that operators will stand on either the discharge conveyor or the tunnel guard to change the
forming tube, the manufacturer shall either design the conveyor or the tunnel guard so they are safe to stand
on or provide an alternative means of access and make it clear using the “Do not stand here” pictogram where
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it is not safe to stand. Where the tunnel guard is used as a step it shall comply with EN ISO 14122-3 which
requires handrails to be provided where a step has a height greater than or equal to 500 mm.
Figure 41 - Tunnel guard designed to be stood on when changing the forming tube
The manufacturer shall ensure that it is not possible to reach danger zones in the machine over guards when
standing on the means of access described in this clause. Where guards are open at the top the safety
distances in table 2 of EN ISO 13857: 2008 shall apply.
The safety related control systems of vertical form, fill and machines shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
5.4 Safety requirements for a horizontal sachet form, fill and seal machine
5.4.1 General
The hazards described in 4.4 shall be safeguarded by the following methods and those described in 5.1. The
drawing shows a linear transport system, but the safety requirements are the same on machines where the
transport system is rotary or partly rotary.
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The requirements of clause 5.2.3 also apply to a typical horizontal sachet form fill and seal machine.
The vertical seal mechanism shall be guarded with interlocking guards similar to those shown in figure 42.
The transport mechanism shall be guarded with interlocking guards as shown in figure 42.
The safety requirements for typical feeding devices are described in 5.11, 5.12. 5.13 and 5.14 and EN 15180:
2014.
The top seal mechanism shall be guarded with interlocking guards similar to those shown in figure 42.
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The cutting mechanism shall be enclosed with interlocking guards, interlocked so the cutting mechanism
cannot operate when the guard is open. The blade of this device shall be designed either to withdraw into a
recess or be fitted with a guard to prevent injury when the interlocking guard is open.
Where the height of the discharge opening is 20 mm or less the opening shall be a t least 120 mm away from
the nearest danger zone. Where the height of the opening is greater than 20 mm but less than 120 mm the
distance from the discharge end of the opening to the nearest danger zone shall be 850 mm, which may
require the use of a tunnel guard.
Where the discharge mechanism is a flat belt conveyor it shall comply with 5.2.2.3.
The safety related control systems of horizontal sachet form, fill and seal machines shall as a minimum
comply with the following performance levels of EN ISO 13849-1:2015.
5.5.1 General
The hazards described in 4.5 shall be safeguarded by the following methods and those described in 5.1. The
drawing shows a linear transport system but the safety requirements are the same on machines where the
transport system is rotary or partly rotary.
These requirements also apply to a deep draw machine (3.3.7) where the equivalent hazard exists.
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Figure 43 - Guarding requirements for a typical thermoform fill and seal machine
The requirements of clause 5.2.3 apply to the lower web reel unwind mechanism.
The transport mechanisms of machines of this type shall be guarded with fixed or interlocking guards.
Machines with chain and clamp transport mechanisms where products are manually fed shall be safeguarded
with fixed guards which incorporate a slot for the lower film web no wider than 4 mm. Where this cannot be
achieved the relationship between the slot width and the distance from the hazard shall comply with table 4 of
EN ISO 13857.
Where the machine is automatically fed, the mechanisms shall be guarded as in paragraph 1 or with
interlocking guards that also guard the automatic feeding mechanisms.
The machine shall be designed in such a way that when the machine stops there is no risk of the film catching
fire.
The heating chamber and forming die shall be safeguarded with interlocking guards. In addition, the control
system shall ensure that the heating chamber and forming die cannot move under gravity when the power
supplies are disconnected. This may involve fitting a mechanical or pneumatic device which prevents the die
from moving when power is removed.
The safety distance through openings in these guards shall be in accordance with table 29.
A “warning hot surface” pictogram shall be fitted to the heating chamber to warn of a residual burning hazard if
this exists.
The risk of impact from the moving parts of the packaging material transport mechanism in the loading area
can be considered negligible if the moving parts are smooth without sharp edges and the speed is lover than 2
m/s.
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The apertures for the packaging material shall be safeguarded using one of the methods described in 5.5.6.1,
5.5.6.2, 5.5.6.3, 5.5.6.4, 5.5.6.5 or 5.5.6.6.
The methods described in 5.5.6.2, 5.5.6.3, 5.5.6.4, 5.5.6.5 or 5.5.6.6. shall only be used where the stopping
time of the hazardous movement does not exceed 0,5 s.
The objective of all the safeguarding solutions described is to ensure that the machine stops before a danger
zone can be reached. The manufacturer shall check that the chosen safeguarding method achieves this
objective using the methods described in EN ISO 13855.
Where the opening is less than 20 mm the safety distances in table 4 of EN ISO 13857 shall apply.
Where the opening is greater than 200 mm the safety distances in clause 5.2.1.3 of EN 415-10: 2014 shall
apply.
Access to the forming and sealing dies shall be limited by fitting a false base in the product loading area.
Where fixed guards are used to prevent access to danger zones, the safety distance through openings in the
guards to the danger zones shall comply with dimension B in table 29.
This comprises a moveable interlocking guard which can move easily if someone reaches into the opening.
The maximum force to lift and activate the guard shall not exceed 50N. The interlocking device fitted to the
guard shall comply with EN ISO 14119: 2014 and shall be interlocked in such a way that if the guard is lifted
by 10 mm or less, the hazardous movements shall stop or reverse to a safe position. For this type of guard,
safety distance C, in table 29 and figure 44 shall be used. The stopping time of the machine shall not exceed
0.5 s.
The instructions shall warn the user that this type of guard can become ineffective if a heavy object is placed
on top of the guard.
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This comprises a moveable interlocking guard supplemented with an Active Opto-electronic Protective Device
(AOPD). The AOPD shall comply with EN 61496-2 and the interlocking device fitted to the guard shall comply
with EN ISO 14119: 2014. The control system shall ensure that if the guard is lifted 10 mm or the AOPD is
activated the hazardous movements shall stop or if safe to do so reverse. The maximum force to lift and
activate the guard shall not exceed 50N. The control circuit shall comply with PL “d” of EN ISO 13849-1:
2015.
For this type of guard, safety distance D, in table 29 and figure 45 shall be used. The AOPD shall be set at 20
mm from the trip guard. The stopping time of the machine shall not exceed 0.5 s.
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This comprises a moveable interlocking guard supplemented with electro-sensitive protective equipment
(ESPE) which monitors the whole opening. The ESPE shall comply with EN 61496-1 type 4, the interlocking
device shall comply with EN ISO 14119: 2014. The control system shall ensure that if the guard is lifted 10
mm or the ESPE is activated the hazardous movements shall stop or if safe to do so reverse. The maximum
force to lift and activate the guard shall not exceed 50N. The control circuit shall comply with PL “d” of EN ISO
13849-1: 2015.
The distance E shown in table 29 and figure 46 shall be used. The stopping time of the machine shall not
exceed 0.5 s.
This comprises a guard which is attached to the moving part of the forming or sealing die mechanism which
moves into place when the hazardous movements of the forming or sealing dies begin. The guard shall be
interlocked with the machine to stop hazardous movements/or bring the die into a safe position, if there is an
obstruction is detected. The control system shall ensure that if the guard is lifted 10 mm the hazardous
movements shall stop or if safe to do so reverse. The maximum force to lift and activate the guard shall not
exceed 50N. The control circuit shall comply with PL “d” of EN ISO 13849-1: 2015.
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Where the force of the guard exceeds those listed in clause 5.2.1.1 of EN 415-10:2014, a pressure sensitive
device, complying with EN 1760-2 shall be fitted to the guard, that will stop the hazardous movement if an
obstruction is detected.
The interlocking device shall comply with EN ISO 14119: 2014 and the control circuit shall comply with PL “d”
of EN ISO 13849-1: 2015.
The distance between the vertical part of the linked automatic guard and fixed parts shall not exceed 4
mm in any position.
For a linked automatic guard, the safety distance F, in table 29 and figure 47 shall be used.
The automatic guard is powered independently of other movements on the machine and moves into
place after the transport cycle ends and before the forming and sealing cycles start. Dimension “G”
applies when the automatic guard is completely closed.
The control system shall ensure that the forming and sealing cycles cannot start until the automatic guard is
completely closed and shall comply with PL “d” of EN ISO 13849-1: 2015.
Where the force of the automatic guard exceeds those forces listed in clause 5.2.1.1 of EN 415-
10:2014, a pressure sensitive device, complying with EN 1760-2 shall be fitted to the guard, that will
stop the movement of the automatic guard if an obstruction is detected.
For an automatic guard the safety distance G, in table 29 and figure 48 shall be used.
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Where the automatic feeding device is a belt conveyor it shall comply with 5.2.2.3.
The requirements of clause 5.2.3 shall apply to the upper web reel unwind mechanism.
Where the coder moves across the film web to apply several codes, the coding assembly shall either be made
safe by design as indicated in clause 5.2.1.1 of EN 415-10 or it shall be enclosed with interlocking guards.
The sealing die shall be safeguarded with interlocking guards. Where the sealing die is heated clause 5.1.3
applies.
Rotary and reciprocating cutting devices shall be safeguarded with interlocking guards similar to those shown
in figure 43.
The drawing-in hazard on the scrap reel shall be reduced in one of the following ways:
- Limiting the torque of the reel drive mechanism, so that the reel stops when a force of 60 N is applied to it.
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Where the discharge mechanism is a flat belt conveyor it shall comply with 5.2.2.3. Access to danger zones
inside the machine from the discharge opening shall be prevented using a tunnel guard or interlocked trip
guard which provides an 850 mm safety distance.
The safety related control systems of thermoform, fill and seal machines shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
5.6 Safety requirements for a tubular bag form, fill and seal machine
5.6.1 General
The hazards described in 4.6 shall be safeguarded by the following methods and those described in 5.1.
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Figure 49 - Guarding requirements for a typical tubular bag form fill and seal machine
The requirements of clause 5.2.3 apply to the film reel unwind mechanism.
If the film reel loading mechanism is not guarded, it shall be provided with a hold to run control placed where
there is a clear view of the danger zone.
The design of the machine shall allow the film reel to be transported and loaded into the film reel unwind
mechanism using standard lifting equipment such as a fork lift truck. If film reels can only be lifted using
specially designed lifting equipment, the manufacturer shall supply this special lifting equipment with the
machine.
This mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by “C” in
figure 49. Where the sealing mechanism is heated clause 5.1.3 shall apply.
The safety distance from any openings in the guards shall be as follows:
The filling station shall be guarded with a combination of fixed and interlocking guards as indicated by “C” in
figure 49.
Where the machine is specified to pack a hazardous or dusty product, clause 5.10.2.1 of EN 415-10:2014
shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer
shall provide a detailed specification for the local exhaust ventilation system in the instructions which includes
the details for the connection and the required airflow at the connection point.
The bag opening mechanism shall be guarded with a combination of fixed and interlocking guards as
indicated by “C” in figure 49.
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The product settling mechanism shall be guarded with a combination of fixed and interlocking guards as
indicated by “C” in figure 49.
This mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by “C” in
figure 49. Where the bag sealing mechanism is heated clause 5.1.3 shall apply.
Where the conveyor adjustment mechanism is not guarded or safe by design, as defined by clause 5.2.1.2 of
EN 415-10:2014, it shall be fitted with a hold to run control device which shall be located where there is a
clear view of the danger zone.
On automatic machines, the bag transport mechanism shall be guarded by a combination of fixed and
interlocking guards similar to those shown as “C” in figure 49.
Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening
to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200mm
the safety distances and safeguarding solution shown in clause of 5.2.1.3 EN 415-10 shall be used.
The safety related control systems of tubular bag form, fill and seal machines shall as a minimum comply with
the following performance levels of EN ISO 13849-1:2015.
5.7 Safety requirements for a mandrel form, fill and seal machine
5.7.1 General
The hazards described in 4.7 shall be safeguarded by the following methods and those described in 5.1.
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On machines fitted with a reel unwind mechanism, the requirements of clause 5.2.3 shall apply.
On machines fitted with a cutting mechanism, the cutting mechanism shall be enclosed with interlocking
guards, interlocked so the cutting mechanism cannot operate when the guard is open. The blade of this
device shall be designed either to withdraw into a recess or be fitted with a guard to prevent injury when the
interlocking guard is open.
Where the closing medium is heat or hot melt adhesive, 5.1.3 shall apply.
Hot melt gluing systems shall comply with clause 5.20.7 of EN 415-10.
Where a spray gluing system or hot melt gluing system is fitted, the guards shall be capable of containing any
foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN 415-10:
2014.
On machines fitted with a carton blank magazine that is loaded by hand, the following requirements shall
apply:
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a) Where the carton magazine is adjustable for different sizes of carton, the design shall ensure that it is
not possible to reach around the stack of cartons to danger zones in the machine for every size of
carton for which the machine has been specified;
NOTE - It is preferable for the guards around the carton magazine to be self-adjusting guards, which
are fixed to the size adjustment parts so that they are adjusted automatically when the size
adjustment part is moved as shown in figure 51;
b) Where change part guards or manually adjustable guards are used, interlocking devices complying
with EN IS0 14119: 2014 shall be fitted to prevent the machine from running when these guards are
not in place or not adjusted correctly;
c) The carton magazine shall be fitted with a system of carton sensing devices, for instance electro-
sensitive protection devices complying with EN 61496-1 which stop the machine when a pre-
determined number of cartons are left in the carton magazine or if the cartons are removed from the
magazine, exposing the carton transfer mechanism;
d) The carton sensing system shall be designed to minimise the risk of being deliberately defeated.
Methods of minimizing the risk of deliberate defeat include:
a. sensors mounted on both sides of the magazine or above and on one side of the magazine;
Where the carton blank magazine is fitted with an automatic carton loading mechanism, this mechanism
shall be guarded with interlocking guards.
A – Self-adjusting guard
B – Carton sensor
C – Carton magazine
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The safety requirements for typical feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.4.
The product feed device and the connection to the machine shall be designed so that it is not possible to
reach hazard zones in the machine from the product feed device and vice versa. Where these hazard zones
could be reached through interlocking guards the interlocking shall stop both the machine and the product
feed device. Movable elements like hoppers that will be opened once a week or more often shall be
interlocked in the same way.
Where the device uses vibration to the settle the product, the requirements of clauses 5.1.5 shall apply.
This mechanism shall be guarded with interlocking guards, interlocked so that the vibration devices stop
vibrating when the guards are opened.
This mechanism shall be safeguarded with fixed or interlocking guards and shall comply with relevant
requirements of clause 5.1.7.
Where the closing medium is heat or hot melt adhesive, 5.1.3 shall apply.
Hot melt gluing systems shall comply with clause 5.20.7 of EN 415-10.
Where a spray gluing system or hot melt gluing system, is fitted the guards shall be capable of containing any
foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN 415-10:
2014.
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Where the discharge conveyor is a flat belt conveyor it shall comply with 5.2.2.3. Where the discharge
conveyor applies compression to the packs it shall be fitted with interlocking guards and a tunnel guard which
provides an 850mm safety distance from the discharge end of the tunnel guard to the nearest danger zone.
Belt conveyors shall comply with 5.2.2.3 and other types of conveyor shall comply with clause 5.20.4 of EN
415-10:2014.
The safety related control systems of mandrel form, fill and seal machines shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
5.8 Safety requirements for a pre-made bag, erect, fill and close machine
5.8.1 General
The hazards described in 4.8 shall be safeguarded by the following methods and those described in 5.1. The
drawing shows a rotary transport system but the safety requirements are the same on machines where the
transport system is linear or partly linear.
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A – Bag magazine
B – Interlocked guards
C – Product feed device
D – Tunnel guard and discharge conveyor
E - Drive mechanisms guards
Figure 52 - Guarding requirements for a typical pre-made bag fill and seal machine
This mechanism shall be guarded with interlocking guards similar to those shown in figure 52.
This mechanism shall be guarded with interlocking guards similar to those shown in figure 52.
The safety requirements for typical feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14 and EN
15180: 2014.
The product feed and the connection to the machine shall be designed so that it is not possible to reach
hazard zones in the machine from the product feed and vice versa. Where these hazard zones could be
reached through interlocking guards the interlocking shall stop both the machine and the product feed.
Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the
same way.
This mechanism shall be guarded with interlocking guards similar to those shown in figure 52, interlocked so
that the vibration devices stop vibrating when the guards are opened.
The bag closing mechanism shall be guarded with interlocking guards similar to those shown in figure 52.
Where a spray gluing system or hot melt gluing system, is fitted the guards shall be capable of containing any
foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN 415-10:
2014.
Where the closing medium is heat or hot melt adhesive, clause 5.1.3 shall apply.
Hot melt gluing systems shall comply with clause 5.20.7 of EN 415-10.
Where the discharge conveyor is a flat belt conveyor it shall comply with 5.2.2.3. Where the discharge
conveyor applies compression to the packs it shall be fitted with interlocking guards and a tunnel guard which
provides an 850 mm safety distance from the discharge end of the tunnel guard to the nearest danger zone.
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The safety related control systems of bag erect, fill and seal machines shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
5.9 Safety requirements for a cup or tub fill and seal machine
5.9.1 General
The hazards described in 4.9 shall be safeguarded by the following methods and those described in 5.1. The
drawing shows a linear transport system but the safety requirements are the same on machines where the
transport system is rotary or partly rotary.
A – Cup magazine
B – Interlocking guards
C - Product feed devices
D – Lid magazine
E = Tunnel guard/discharge conveyor
F – Drive mechanism guards
Figure 53 - Guarding requirements for a typical cup fill and seal machine
Change part guards like the one in figure 55 shall be provided for each type of cup, dimensioned using table 4
of EN ISO 13857 so it is not possible to reach danger zones around the stacks of cups.
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The magazine shall be fitted with an interlocking device, for example an electro-sensitive protection device
complying with EN 61496-1 which stops the machine before the last few cups are removed from the
magazine, exposing the cup dispensing and transport mechanisms.
Where the machine incorporates automatic cup or tub stack loading mechanisms, these mechanisms shall be
guarded with interlocking guards, or electro-sensitive protective equipment complying with EN 61496-1 during
the cycle when the stack is moved.
Access to the hazardous movements of the cup or tray dispensing mechanism through the cup or tray
magazine shall be prevented by one of the following methods:
a) Enclosing the cup magazine in a combination of fixed and interlocked guards as shown in figure 54;
b) Designing the cup or tray guides as tubes or funnels complying with 5.1.1.2 as shown in figure 55.
Where change part guards are used or to assist product changing guides must be removed, these
parts shall be fitted with interlocking devices to prevent the machine from running when these parts
are not in place.
Where the dimensions of the guards do not comply with 5.1.1.2, a system of safety protection devices, for
example a combination of electro-sensitive protection devices complying with EN 61496-1 capable of
measuring distance to objects shall be used. These devices shall stop the machine when only a pre-
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determined number of cups or trays is in the magazine or if the cups or trays are removed from the magazine,
exposing the hazard zone.
The cup sensing system shall be designed to minimise the risk of being deliberately defeated. Methods of
minimizing the risk of deliberate defeat include:
a. sensors mounted on both sides of the magazine or above and on one side of the magazine;
This mechanism shall be guarded with interlocking guards like those shown in figure 54.
The safety requirements for volumetric piston depositors can be found in EN 15180: 2014. The safety
requirements for other feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14.
This mechanism shall be guarded with interlocking guards like those shown in figure 54.
The discharge mechanism and conveyor shall be fitted with interlocking guards and a tunnel guard which
provides an 850 mm safety distance from the discharge end of the tunnel guard to the nearest danger zone.
Where the discharge conveyor is a flat belt conveyor is shall comply with 5.2.2.3.
The safety related control systems of cup or tub fill and seal machines shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
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Stopping the cup, foil or lid magazine when the interlocking guard is opened and/or d
electro-sensitive protection devices are actuated
Stopping all hazardous processes by the emergency stop circuit c
5.10.1 Safety requirements for an in-line sack fill and seal machine
5.10.1.1 General
The hazards described in 4.10.1 shall be safeguarded by the following methods and those described in 5.1.
Figure 55 - Guarding requirements for a typical in-line sack fill and seal machine
The safety requirements for typical product feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14.
The product feed and the connection to the machine shall be designed so that it is not possible to reach
hazard zones in the machine from the product feed and vice versa. Where these hazard zones could be
reached through interlocking guards the interlocking shall stop both the machine and the product feed.
Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the
same way.
On automatic machines, this mechanism shall be guarded with fixed and interlocking guards.
a) Ensuring the gap between the holding mechanism and the filling nozzle is no greater than 5 mm;
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b) Where the gap is greater than 5 mm, ensuring the static force applied by the mechanism is no greater
than 135 N and the pressure applied is no greater than 60 N/cm²;
c) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control
system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of
the two hand control devices is released;
d) Electro-sensitive protective equipment (ESPE) that complies with EN 61496-1. This ESPE shall be
positioned and designed according to EN ISO 13855.
On automatic machines, this mechanism shall be guarded with fixed and interlocking guards.
a) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control
system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of
the two hand control devices is released;
b) Electro-sensitive protective equipment (ESPE) that complies with EN 61496-1. This ESPE shall be
positioned and designed according to EN ISO 13855.
The machine shall be fitted with a local exhaust ventilation system complying with clause 5.1.7.2.
Where the machine is specified to pack a hazardous or dusty product, clause 5.10.2.1 of EN 415-10:2014
shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer
shall provide a detailed specification for the local exhaust ventilation system in the instructions which includes
the details for the connection and the required airflow at the connection point.
Where the machine is specified to pack a hazardous product or a product which has a temperature greater
than 55 °C, the filling nozzle shall be fitted with a sack sensor which ensures that filling cannot start if there is
no sack on the filing nozzle.
On semi-automatic machines, where the sack holding mechanism cannot be made safe by design as defined
by Clause 5.2 of EN 415-10: 2014, at least one of the following measures shall be applied:
a) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control
system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of
the two hand control devices is released
b) Electro-sensitive protective equipment (ESPE) that complies with EN ISO 61496-2. This ESPE shall
be positioned and designed according to EN ISO 13855.
On automatic machines, this mechanism shall be guarded with fixed or interlocking guards.
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The control system shall ensure that all hazardous movements of the sack placer are stopped before the in-
line sack fill and seal machine can be operated in manual mode.
Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening
to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200mm
the safety distances and safeguarding solution shown in EN 415-10 clause 5.2.1.3 shall apply.
The safety related control systems of an in-line sack fill and seal machine shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
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5.10.2 Safety requirements for a rotary sack fill and seal machine
5.10.2.1 General
The hazards described in 4.10.2 shall be safeguarded by the following methods and those described in
Clause 5.1.
Figure 56 - Guarding requirements for a typical rotary sack fill and seal machine
5.10.2.2 Carousel
On automatic machines, access to the carousel shall be prevented by a combination of fixed and interlocking
guards like those marked "G" and "E" in figure 57.
Where it is necessary to move around the carousel inside the guards, the minimum distance between these
guards and parts of the carousel shall be 600 mm. Where there is insufficient space to allow this method of
access, the carousel guard “E” shall comprise as series of interlocking guards so the carousel can be
accessed from outside the guards.
In the area for manual sack placing “H”, the distance between the guards and the carousel shall be at least
1000 mm. Access to areas where there is less than 1000 mm clearance shall be prevented by a trip guard like
the one marked "F" in figure 57.
The trip guard “F” shall be designed so that it can move easily both in the direction of rotation of the carousel
and in the opposite direction if it is pushed by the operator. The trip guard “F” shall be interlocked and
positioned following the requirements of EN ISO 13855 and clause 5.14.7 of EN 415-10: 2014 to ensure that
the carousel has stopped before the operator can reach a danger zone.
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In addition to the emergency stop device on the control panel, a pull-cord operated emergency stop device
shall be installed in the interior of the safeguarded area all around the machine.
On machines where sacks are placed manually, the holding mechanism shall be safeguarded by a trip guard
like the one marked "F" in figure 57.
On machines where sacks are placed manually, the flow regulating mechanism shall be safeguarded by a trip
guard like the one marked "F" in figure 57.
On machines where manual sack placing is foreseeable, the holding and positioning mechanism shall be
safeguarded by a trip guard like the one marked "F" in figure 57.
On machines where manual sack placing is foreseeable, the sealing mechanism shall be safeguarded by a
trip guard like the one marked "F" in figure 57.
Where the machine is specified to pack a hazardous or dusty product, clause 5.10.2.1 of EN 415-10:2014
shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer
shall provide a detailed specification for a suitable local exhaust ventilation system in the instructions which
includes details for the connection to the machine and the required airflow at the connection point.
On machines where manual sack placing is foreseeable, the filling process shall only be started in the zone
which is safeguarded by the trip guard marked "F" in figure 57.
The sack transfer mechanism shall be safeguarded with fixed and interlocking guards.
On automatic machines, the sack placing mechanism shall be safeguarded with an interlocking guard.
The sack placing mechanism shall not operate when the machine is in manual mode. The sack placing
mechanism shall only operate when the interlocked access door marked "G" in figure 57 is closed.
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The discharge conveyor shall comply with clause 5.20.4.1 of EN 415-10: 2014.
Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening
to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200 mm
the safety distances and safeguarding solutions shown in EN 415-10 clause 5.2.1.3 shall apply.
The safety related control systems of a rotary sack fill and seal machine shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
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5.11.1 General
The hazards described in 4.11 shall be safeguarded by the following methods and those shown in 5.1. These
requirements apply when an auger filler is fitted to one of the machines in the scope of this standard.
The hopper and top cover of the auger filler shall act as a guard for the auger and stirring mechanisms. Where
the hopper can be removed from the top cover without the use of a tool it shall be fitted with an interlocking
device which complies with EN ISO 14119, integrated with the control system so that the auger cannot run
unless the hopper is fitted correctly.
The screw feeder shall be guarded with fixed guards. The socks that connect the screw feeder to the auger
and the screw feeder to the product feed system shall be attached with fixings which can only be removed
using a tool.
The control system of the auger shall be integrated with the form, fill and seal or fill and seal machine in such
a way that the auger and cut-off devices cannot run when the interlocking guards of the form fill and seal or fill
and seal machine or fill and seal machine are open.
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The power supplies for the auger shall be integrated with those of the form fill and seal or fill and seal machine
so that the auger is isolated when the form fill and seal or fill and seal machine is isolated.
The hopper, auger, auger funnel and any other components which must be removed regularly for cleaning,
shall be designed to avoid the risk of injury due to excessive effort. Where the mass of such components is
greater than 25 kg, the manufacturer shall design the parts so that two operators can lift them or so that lifting
equipment can be used to lift them into and out of position.
If the filler is mounted in a position where it cannot be reached for cleaning or maintenance from the floor, one
of the following shall be provided.
a) A permanent means of access complying with EN ISO 14122-2 and EN ISO 14122-3, or;
b) A permanent platform around the filler which complies with EN ISO 14122-2 that can be accessed safely
from mobile steps that comply with EN ISO 14122-3.
Where the product being packed produces a hazardous amount of dust, the machine shall be enclosed with
interlocking guards and local exhaust ventilation (LEV) shall be provided. The interlocked guards shall be
fitted with guard locking devices that will only release the doors when either a sensor indicates that the
atmosphere inside the guards is safe to breathe or after a time delay long enough for the LEV system to
remove the hazardous dust. Clause 5.1.7.2 shall apply.
The safety related control systems of the auger filler shall as a minimum comply with the following
performance levels of EN ISO 13849-1:2015.
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5.12.1 General
The hazards described in 4.12 shall be safeguarded by the following methods and the requirements in 5.1.
These requirements apply when a volumetric cup filler is fitted to one of the machines in the scope of this
standard.
A – Interlocking guard
B – Interlocking hopper guard
C – Infeed hopper
E – Drive mechanism guard
D – Discharge hopper
Figure 58 - Guarding requirements on a volumetric cup filler
5.12.2 Hopper
Where the hopper is fed automatically, the connection between the feeding equipment and the hopper shall
be fixed and any openings shall be dimensioned and positioned using appropriate tables of EN ISO 13857 so
it is not possible to reach danger zones in the machine through the hopper.
Where the hopper is fed from a mezzanine floor above the hopper, it is foreseeable that someone may put
their feet into the hopper and so in that case table 7 of EN ISO 13857 shall be used to determine safety
distances when designing fixed or interlocking guards.
Where the hopper is fed manually, the hopper shall either be fitted with a fixed mesh or fixed bars
dimensioned using table 4 of EN ISO 13857, or fitted with an interlocking guard as shown in by “B” in figure 59
or with ESPE complying with EN 61496-1.
The cup plates shall be enclosed with fixed or interlocking guards as shown as “A” in figure 59.
To avoid an accident during cleaning, the cup filler shall either be equipped with an isolator, accessible from
the cleaning area or the discharge hopper and other guards giving access to the shearing hazard, shall be
interlocked with devices complying with EN ISO 14119: 2013 to prevent the machine operating when the
hopper or guards are removed.
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The discharge hopper shall be designed to prevent access to danger zones in the cup filler when it is fitted in
place on the form fill and seal or fill and seal machine and shall either be fixed with fixings which can only be
undone with a tool or fitted with an interlocking device which complies with EN ISO 14119: 2013.
The hopper, cups, cup plates and any other components which must be removed regularly for cleaning, shall
be designed to avoid the risk of injury due to excessive effort. Where the mass of such components is greater
than 25 kg, the manufacturer shall design the parts so that two operators can lift them or so that lifting
equipment can be used to lift them into and out of position.
If the cup filler is mounted in a position where it cannot be reached for cleaning or maintenance from the floor,
clause 5.11.7 shall apply.
Where the product being packed produces a hazardous amount of dust, the cup filler shall be enclosed with
interlocking guards and local exhaust ventilation shall be provided. Clause 5.1.7.2 shall apply.
The safety related control systems of a cup filling machine shall as a minimum comply with the following
performance levels of EN ISO 13849-1:2015.
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5.13.1 General
The hazards described in 4.13 shall be safeguarded by the following methods and those described in 5.1.
These requirements also apply to a count filling machine (3.3.8) where the equivalent hazard exists.
Where the feed conveyor is a flat belt conveyor it shall comply with 5.2.2.3. Other types of feed conveyor shall
comply with clause 5.20.4.5 of EN 415-10:2014.
The feed conveyor shall be equipped with its own isolator.
The feed conveyor and it’s isolator shall be accessible from floor level or by the means of access for the
weigher as stated in 5.13.5 without the need for an additional means of access.
The vibration tray linkages shall either be safe by design as defined by clause 5.2.1.1 of EN 415-10, or
designed in accordance with EN 349 to ensure that they do not present crushing hazards or they shall be
enclosed with fixed or interlocking guards. The method of mounting of these mechanisms shall ensure that no
hazardous vibration is transmitted to the supporting structures.
Where the opening and closing mechanisms of the weigh hopper are not safe by design, as defined by clause
5.2.1.1 of EN 415-10 they shall be enclosed with a fixed or an interlocking guard.
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if the weigher is mounted in a position where it cannot be reached for cleaning or maintenance from the floor,
clause 5.11.7 shall apply.
For nett weighers which are mounted on moveable packaging machines, the means of access may be a fixed
ladder complying with EN ISO 14122-4.
The safety related control systems of a nett weigher shall as a minimum comply with the following
performance levels of EN ISO 13849-1:2015.
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5.14.1 General
The hazards described in 4.14 shall be safeguarded by the following methods and the requirements in 5.1.
These requirements apply when a multi-head weigher is fitted to one of the machines in the scope of this
standard.
A – Feed conveyor
B – Interlocking guard
C – Support platform
D – Hand-rails
E – Timing hopper guard
Figure 60 - Guarding requirements on multi-head weigher
5.14.2 Feed conveyor
Where the feed conveyor is a flat belt conveyor it shall comply with clause 5.2.2.3. Where the feed conveyor
is a trough belt it shall comply with EN 620. Where the feed conveyor is some other kind of bulk feed conveyor
it shall comply with EN 618.
The feed conveyor shall be equipped with its own isolator which is accessible from the weigher support
platform without the need for mobile steps.
The vibration tray linkages shall either be designed in accordance with EN 349 to ensure that they do not
present crushing hazards or enclosed with fixed guards. The method of mounting of these mechanisms shall
ensure that no hazardous vibration is transmitted to the supporting structures.
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Where the opening and closing mechanisms of the pool and weigh hoppers are not safe by design, as defined
by clause 5.2.1.1 of EN 415-10 they shall be enclosed with interlocking guards as shown by “B” in figure 61.
Where the opening and closing mechanisms of the timing hopper is not safe by design, as defined by clause
5.2.1.1 of EN 415-10 it shall be enclosed with an interlocking guard as shown by “E” in figure 61.
Where the weigher components need to be dismantled and cleaned more than two times a week, provision for
cleaning shall be provided on the same level as the multi-head weigher so it is not necessary to carry
components up and down access stairs.
The support platform shall comply with EN ISO 14122-2 and shall be provided with access stairs and
handrails which comply with EN ISO 14122-3.
Where the product being weighed produces a hazardous amount of dust the feed conveyor and weigher shall
be enclosed with interlocking guards and local exhaust ventilation shall be provided.
Where the sound pressure level of the weigher running with the specified product is potentially hazardous, the
manufacturer shall:
a) Reduce noise at source by reducing product falling heights, using servomotors to close flaps or
changing contact materials or;
b) Enclosing the weigher in an acoustic enclosure which reduces the sound pressure level outside the
enclosure to a safe level.
The safety related control systems of a multi-head weigher shall as a minimum comply with the following
performance levels of EN ISO 13849-1: 2015.
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6.1 General
The following verification procedures shall be adhered to for each machine unless stated otherwise hereafter.
Check that mechanical components are securely fixed and all unnecessary sharp edges have been removed.
Check that pneumatic components and piping conform to the safety requirements of EN ISO 4414 and are
correctly installed.
Check that hydraulic components and piping conform to the safety requirements of EN ISO 4413 and are
correctly installed.
6.2.5 Guards
Check that all guards are in place and securely fixed and that the guards and their dimensions are suitable for
the hazards expected and their dimensions are according to the design. Check that all interlocking devices are
fitted. Check that adjustable guards can be properly adjusted to the specified products and pack sizes.
Check for each type of machine, that the design features stipulated in Clause 5 have been incorporated.
Check for each type of machine, that the appropriate design requirements for the packaging materials
intended to be used and the product intended to be packed have been followed.
Check that the required markings and warning signs are fitted permanently and at the required position.
6.3.1 Guards
For every type of machine, check that the dimensions of the guards comply with the relevant part of clause 5
and that the relationship between the size of any openings in the guards and their safety distance from the
nearest hazard zone comply with the requirements.
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6.4.1 Guards
Check with the machine running that the guards conform to the safety requirements and that the interlocking
movable guards and ESPE are working correctly.
Check the operation of all safety related functions. Check that following the operation of an emergency stop or
interlocking device all hazardous functions cease within the required stopping time and that the machine does
not restart without resetting the emergency stop device or the interlocking devices and without an intentional
start command.
For each type of machine check that stored energy is either dissipated automatically or a manual means of
releasing this stored energy has been provided.
For each machine, carry out the functional tests stated in clause 18.6 of EN 60204-1:2006.
For each type of machine, measure the noise emission values as stated in EN415-9.
6.5.3 Temperature
For every type of machine, with the machine fully warmed up, identify all the areas of the machine where the
temperature will be greater than the burn thresholds indicated in EN ISO 13732-1.
Verification procedures for each safety requirement detailed in 5.1 are shown in Table 28. Verification
procedures for form, fill and seal machines are in table 29. Verification procedures for fill and seal machines
are in table 30. Verification procedures for filling machines are in table 31.
Visual inspection
Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
Safety
Safety
5.1.1.1 X X X X 5.1.2 X X X X
5.1.1.2 X X X 5.1.3 X X X
5.1.1.3 X X X X 5.1.4 X X X
5.1.1.4 X X X 5.1.5 X X
5.1.1.5 X X X 5.1.6 X X X
5.1.1.6 X 5.1.7 X X X X
5.1.1.7 X X X 5.1.8 X X X X
5.1.1.8 X X X 5.1.9 X X X
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Visual inspection
Visual inspection
Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
Safety
Safety
5.2 Flow-wrapping machine 5.5 Thermoform fill and seal machine
5.2.2 X X X 5.5.2 X X X
5.2.3 X X X 5.5.3 X X X
5.2.4 X X X 5.5.4 X X X
5.2.5 X X X 5.5.5 X X X
5.2.6 X X X 5.5.6 X X X
5.2.7 X X 5.5.7 X X X
5.5.8 X X X
5.3 Vertical form, fill and seal machine 5.5.9 X X X
5.3.3 X X X 5.5.10 X X X
5.3.4 X X X 5.5.11 X X X
5.3.5 X X X 5.5.12 X X X
5.3.6 X X X 5.5.13 X X X
5.3.7 X X X 5.5.14 X x
5.3.8 X X X 5.6 Tubular bag form, fill and seal machine
5.3.9 X X X 5.6.2 X X X
5.3.10 X X X 5.6.3 X X X
5.3.11 X X X 5.6.4 X X X
5.3.12 X X 5.6.5 X X X
5.6.6 X X X
5.6.7 X X X
5.6.8 x x x
5.4 Horizontal sachet form, fill and seal machine 5.6.9 X X X
5.4.2 X X X 5.6.10 X X X
5.4.3 X X X 5.6.11 X X X
5.4.4 X X X 5.6.12 X X X
5.4.5 X X X 5.6.13 X X X
5.4.6 X X X 5.6.14 X X X
5.4.7 X X X 5.6.15 X X
5.4.8 X X X
5.4.9 X X X
5.4.10 X X
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requirement
requirement
Measureme
Measureme
Calculation
Calculation
inspection
inspection
Function
Function
Safety
Safety
Visual
Visual
test
test
nt
nt
5.7.2 X X X 5.7.11 X X X
5.7.3 X X X 5.7.12 X X X
5.7.4 X X X 5.7.13 X X X
5.7.5 X X X 5.7.14 X X X
5.7.6 X X X 5.7.15 X X X
5.7.7 X X X 5.7.16 X X X
5.7.8 X X X 5.7.17 X X X
5.7.9 X X X 5.7.18 X X
5.7.10 X X X
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
inspection
inspection
Safety
Safety
Visual
Visual
5.8 Pre-made bag fill and seal machine 5.10.1 In-line sack fill and seal machine
5.8.2 X X X 5.10.1.2 X X X
5.8.3 X X X 5.10.1.3 X X X
5.8.4 X X X 5.10.1.4 X X X
5.8.5 X X X X X X
5.8.6 X X X 5.10.1.5 X X X
5.8.7 X X X 5.10.1.6 X X X
5.8.8 X X X 5.10.1.7 X X X
5.8.9 X X 5.10.1.8 X X X
5.10.1.9 X X X
5.9 Cup or tub fill and seal machine 5.10.1.10 X X X
5.10.1.11 X X
5.9.2 X X X 5.10.2 Rotary sack fill and seal machine
5.9.3 X X X 5.10.2.2 X X X
5.9.4 X X X 5.10.2.3 X X X
5.9.5 X X X 5.10.2.4 X X X
5.9.6 X X X 5.10.2.5 X X X
5.9.7 X X X 5.10.2.6 X X X
5.9.8 X X X 5.10.2.7 X X X
5.9.9 X X X 5.10.2.8 X X X
5.9.10 X X X 5.10.2.9 X X X
5.9.11 X X X 5.10.2.10 X X X
5.9.12 X X X 5.10.2.11 X X X
5.9.13 X X 5.10.2.12 X X
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Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
inspection
inspection
Safety
Safety
Visual
Visual
5.11 Auger filling machine 5.13 Nett weigher
5.11.2 X X X 5.13.2 X X X
5.11.3 X X X 5.13.3 X X X
5.11.4 X X X 5.13.4 X X X
5.11.5 X X X 5.13.5 X X X
5.11.6 X X X 5.13.6 X x
5.11.8 X X X
5.11.9 X X
7 Information
7.1 General
The information provided by the manufacturer with the machine shall comply with the following clauses and
EN ISO 12100:2010, 6.4.
7.2 Marking
All machinery in the scope of this standard shall be marked visibly legibly and indelibly with the following
minimum information:
a) the business name and full address of the manufacturer and, where applicable, his authorized
representative;
f) year of construction, that is the year in which the manufacturing process is completed;
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h) rating information required for lifting equipment, if appropriate, e.g. carrying capacity, working load limit,
centre of gravity, gross weight.
Where required in Clause 5 the following pictograms shall be fitted to the machine permanently and in such a
way that the related hazard is clearly identifiable. These warning pictograms shall comply with EN ISO 7010:
2012, reproduced below. The shape and colour of these warning pictograms shall comply with ISO 3864-1,
ISO 3864-2 and ISO 3864-3.
7.4.1 General
The instructions shall contain all the information listed in clause 6.4.5.1 of EN ISO 12100:2010, where the
equivalent hazard exists. In addition, the instructions shall contain the information that is specific to the
machines in the scope of this standard as stated in 7.4.4.2 to 7.4.4.12.
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f) where there is a risk of products or liquids spilling onto the floor around the machine, the
instructions shall indicate the importance of clearing these spills to avoid slip hazards;
g) where access is required above floor level to parts of the machine, the instructions shall explain
how this can be done safely without the risk of slipping, tripping and falling;
h) details of how to install steps and platforms supplied with the machine;
i) details of temporary means of access that the user is to provide for other purposes than
operation, cleaning or routine maintenance;
j) a description of any tests that shall be carried out before the machine is used for the first time;
k) Instructions on how to fit change parts, the fitting of change part guards and the adjustment of
adjustable guards so that the machine is safe to use following a size or product change;
l) a record and explanation of all the warning devices, signs or pictograms attached to the machine
and the warning signals provided by the machine;
m) details of the control systems including circuit diagrams for the electrical, pneumatic and
hydraulic systems. The diagrams shall show the interfaces between all permanently wired parts
and programmable devices. Wiring diagrams and documentation of the electrical equipment shall
comply with EN 60204-1:2006, Clause 17;
o) where appropriate, instructions on how the machine shall be installed to minimize noise;
p) where harmful dusts, smoke, aerosols, gas or fumes may be emitted by the machine, the
manufacturer shall provide information on a suitable collection and extraction system for these
substances, including the required air speed at the emission point;
q) specifications of fluids to be used in the machine e.g. lubricating oil, hydraulic fluid;
s) a statement indicating whether the machine is or is not suitable for use in a potentially explosive
atmosphere.
Where the machine is intended for use with food, cosmetics or pharmaceuticals or other products which can
be contaminated if hygienic design principles are neglected, the instructions shall indicate how the machine
shall be cleaned and disinfected, together with details of appropriate and inappropriate cleaning and
disinfecting materials. The instructions shall indicate any limitation for use with these products.
In addition to the requirements of 7.4, the instructions for a flow-wrapping machine shall include the following
information:
a) Where removable feeding devices are fitted, information on how the machine can be operated safely when
the devices have been removed;
b) The correct way to lift film reels onto the film reel unwind mechanism to avoid strain injuries;
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c) The method of earthing the reel unwind mechanisms to avoid static build up;
d) The correct temperature for the sealing jaws for each packaging material to avoid the risk of fire;
f) The correct method for controlling modified controlled atmosphere packing systems;
In addition to the requirements of 7.4, the instructions for a vertical form, fill and seal machine shall include the
following information where the equivalent hazard exists.
b) The correct way to lift film reels onto the film reel unwind mechanism to avoid strain injuries;
c) The method of earthing the reel unwind mechanisms to avoid static build up;
d) The correct parameters for sealing each packaging material to avoid the risk of fire;
In addition to the requirements of 7.4, the instructions for a horizontal sachet form, fill and seal machine shall
include the following information.
b) The correct way to lift film reels onto the film reel unwind mechanism to avoid strain injuries;
c) The method of earthing the reel unwind mechanisms to avoid static build up;
d) The correct temperature for each packaging material for the sealing jaws to avoid the risk of fire;
In addition to the requirements of 7.4, the instructions for a thermoform, fill and seal machine shall include the
following information.
b) The correct way to lift film reels onto the film reel unwind mechanisms to avoid strain
injuries;
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d) The correct temperature for each packaging material for the heating chamber and sealing dies to avoid the
risk of fire;
In addition to the requirements of 7.4, the instructions for a tubular bag form, fill and seal machine shall
include the following information.
b) The correct way to lift film reels onto the film reel unwind mechanism to avoid strain injuries;
c) The method of earthing the film reel unwind mechanisms to avoid static build up;
d) The correct temperature for each packaging material for the sealing jaws and adhesive heating devices to
avoid the risk of fire;
In addition to the requirements of 7.4, the instructions for a mandrel form, fill and seal machine shall include
the following information.
b) The correct way to lift film reels onto the film reel unwind mechanism to avoid strain injuries;
c) The method of earthing the film reel unwind mechanisms to avoid static build up;
d) The correct temperature for each packaging material for the sealing jaws and adhesive heating devices to
avoid the risk of fire;
In addition to the requirements of 7.4, the instructions for a pre-made bag fill and close machine shall include
the following information.
d) The correct temperature for each packaging material for the sealing jaws to avoid the risk of fire;
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In addition to the requirements of 7.4, the instructions for a cup or tub fill and seal machine shall include the
following information.
c) The correct way to load film reels onto the film reel unwind mechanisms to avoid strain
injuries;
e) The correct temperature for each packaging material for the heating chamber and sealing dies to avoid
the risk of fire;
In addition to the requirements of 7.4, the instructions for a sack fill and seal machine shall include the
following information.
b) The way to load sacks into the sack magazine to avoid strain injuries;
c) The method of earthing the reel unwind mechanisms to avoid static build up;
In addition to the requirements of 7.4, the instructions for an auger filler shall include the following information.
a) The method of installing the filler onto a form, fill and seal or fill and seal machine;
b) The way to clean the filler to avoid strain injuries and the risk of falls;
In addition to the requirements of 7.4, the instructions for a volumetric cup filler shall include the following
information.
a) The method of installing the filler onto a form, fill and seal or fill and seal machine;
b) The way to clean the filler to avoid strain injuries and the risk of falls;
In addition to the requirements of 7.4, the instructions for a nett weigher shall include the following information.
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a) The method of installing the filler onto a form, fill and seal or fill and seal machine;
b) The way to clean the weigher to avoid strain injuries and the risk of falls;
In addition to the requirements of 7.4, the instructions for a multi-head weigher shall include the following
information.
a) The method of installing the weigher onto a form, fill and seal or fill and seal machine;
b) The way to clean the weigher to avoid strain injuries and the risk of falls;
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Annex A
(normative)
A1 General
The noise output from machines in the scope of this standard shall be measured using the methods shown in
EN 415-9.
Measurements shall be carried out on a packaging machine with it making empty packs at its normal speed
and making filled packages with either the specified product or if this is not practicable for instance because
the specified product is fragile or the machine has been specified to pack a wide range of products, a product
that is known to generate a similar amount of noise to the specified product(s).
Measurements shall be carried out on a filling machine with it running without product at its normal speed and
with either the specified product or if this is not practicable for instance because the specified product is fragile
or frozen or the machine has been specified to fill a wide range of products, a product that is known to
generate a similar amount of noise to the specified product(s).
Sound power level measurements shall be made using the methods described in EN 415-9.
The measurement positions for sound pressure level measurements shall comply with the following machine
specific requirements.
The sound pressure level measurements shall be made with the machine at floor level at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m;
On machines that are fed manually, 0.5 m from the machine guards in the centre of the manual
loading area at a height of 1.6 m.
A.3 Vertical form, fill and machine
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
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The sound pressure level measurements shall be made with the machine at floor level at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m;
On machines that are fed manually, 0.5 m from the machine guards in the centre of the loading area
at a height of 1.; m.
A.6 Tubular bag form, fill and seal machine
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurements shall be made with the machine at floor level and fitted with its
product filling device at the following points:
0,75 m normal distance from the main control panel at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m;
On machines where the sack is placed on the filling spout manually, 0.5 m from the machine guards
in the centre of the loading area at a height of 1.6 m.
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The sound pressure level measurement shall be made with the machine supported 2.0 m above floor level
and at the following points:
1.0 m normal distance from the centre line of the front of the machine’s guards at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
A.12 Volumetric cup filler
The sound pressure level measurement shall be made with the machine supported 2.0 m above floor level
and at the following points:
1.0 m normal distance from the centre line of the front of the machine’s guards at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurement shall be made with the machine supported 2.0 m above floor level
and at the following points:
1.0 m normal distance from the centre line of the front of the machine’s guards at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
The sound pressure level measurement shall be made with the machine supported 2.5 m above floor level
and at the following points:
1.0 m normal distance from the centre line of the front of the machine’s guards at a height of 1.6 m;
1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
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Annex ZA
(informative)
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 2006/42/EC on machinery.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity
with the relevant Essential Requirements of that Directive and associated EFTA regulations.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
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