INTERNATIONAL ISO

STANDARD 10555-1

Second edition
2013-06-15
Corrected version
2014-01-15

Intravascular catheters — Sterile and

single-use catheters —
Part 1:
General requirements
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 1: Exigences générales
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ISO 10555-1:2013
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a144025ae0b9/iso-10555-1-2013

Reference number
ISO 10555-1:2013(E)

© ISO 2013
ISO 10555-1:2013(E)


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ISO 10555-1:2013
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 ISO 10555-1:2013(E)


Contents Page

Foreword......................................................................................................................................................................................................................................... iv
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 1
4 Requirements........................................................................................................................................................................................................... 4
4.1 General............................................................................................................................................................................................................ 4
4.2 Radio-detectability............................................................................................................................................................................... 4
4.3 Biocompatibility..................................................................................................................................................................................... 4
4.4 Surface............................................................................................................................................................................................................. 4
4.5 Corrosion resistance........................................................................................................................................................................... 4
4.6 Peak tensile force................................................................................................................................................................................... 4
4.7 Freedom from leakage....................................................................................................................................................................... 5
4.8 Hubs.................................................................................................................................................................................................................. 5
4.9 Flowrate......................................................................................................................................................................................................... 5
4.10 Power injection........................................................................................................................................................................................ 5
4.11 Side holes...................................................................................................................................................................................................... 5
4.12 Distal tip......................................................................................................................................................................................................... 5
5 Designation of nominal size...................................................................................................................................................................... 5
5.1 Outside diameter.................................................................................................................................................................................... 5
5.2 iTeh STANDARD PREVIEW
Nominal effective length.................................................................................................................................................................. 6
6 Information to be supplied by the manufacturer................................................................................................................ 6
6.1
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General............................................................................................................................................................................................................ 6
6.2
Marking on the device and/or primary packaging................................................................................................... 6
6.3 ISO 10555-1:2013
Instructions for use.............................................................................................................................................................................. 7
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Marking on the secondary packaging.................................................................................................................................. 7
6.4
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Annex A (normative) Test method for corrosion resistance........................................................................................................ 8
Annex B (normative) Method for determining peak tensile force......................................................................................... 9
Annex C (normative) Test method for liquid leakage under pressure...........................................................................11
Annex D (normative) Test method for air leakage into hub assembly during aspiration..........................13
Annex E (normative) Determination of flowrate through catheter...................................................................................15
Annex F (normative) Test for burst pressure under static conditions...........................................................................17
Annex G (normative) Power injection test for flowrate and device pressure(only for products
indicated for power injection).............................................................................................................................................................19
Annex H (informative) Units of measurement systems other than those specified in this part of
ISO 10555, which may additionally be used..........................................................................................................................22
Bibliography.............................................................................................................................................................................................................................. 24

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ISO 10555-1:2013(E)


Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10555-1 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 10555-1:1995), which has been technically
revised. It also incorporates the amendments ISO 10555-1:1995/Amd 1:1999 and ISO 10555-1:1995/Amd
2:2004. iTeh STANDARD PREVIEW
(standards.iteh.ai)
ISO 10555 consists of the following parts, under the general title Intravascular catheters — Sterile and
single-use catheters:
ISO 10555-1:2013
— Part 1: General requirements
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a144025ae0b9/iso-10555-1-2013
— Part 3: Central venous catheters
— Part 4: Balloon dilatation catheters
— Part 5: Over-needle peripheral catheters
The following part is under preparation:
— Part 6: Subcutaneous implanted ports
The following part has been withdrawn and the content has been included in ISO 10555‑1:
— Part 2: Angiographic catheters
Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with
intravascular catheters.
This corrected version of ISO 10555-1:2013 incorporates an editorial correction in H.3.

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INTERNATIONAL STANDARD ISO 10555-1:2013(E)

Intravascular catheters — Sterile and single-use

catheters —
Part 1:
General requirements

1 Scope
This part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile
condition and intended for single use, for any application.
lt is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.

2 Normative references
The following 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.
iTeh STANDARD PREVIEW
ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
(standards.iteh.ai)
equipment — Part 1: General requirements1)
ISO 594-2, Conical fittings with 6 % (Luer) ISO taper for syringes, needles and certain other medical equipment —
10555-1:2013
Part 2: Lock fittingshttps://standards.iteh.ai/catalog/standards/sist/971b16cc-1c10-478b-8003-
1)

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ISO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.
3.1
intravascular catheter
tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the
cardiovascular system for diagnostic and/or therapeutic purposes
3.2
distal end
end of the catheter inserted furthest into the patient
3.3
distal end configuration
shape of the catheter which is designed to facilitate its manual manipulation through the cardiovascular
system and the placement and anchoring of the distal tip in the chosen location

1) Upon its publication, ISO 80369-7 will replace ISO 594-1 and ISO 594-2.

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3.4
proximal end
access end
end of the catheter to which connection can be made
3.5
hub
connector(s) at the proximal end of the catheter which may either be integral with the catheter or be
capable of being securely fitted to the proximal end of the catheter
3.6
effective length
l
length of the catheter, or pre- and post-hydration lengths
of hydratable catheters that can be inserted into the body

SEE: Figure 1.
3.7
outside diameter
largest diameter of the catheter or pre- and post-hydration largest diameters of hydratable catheters
that can be inserted into the vessel
3.8
junction iTeh STANDARD PREVIEW
the joining of one tube or more tubes, where the assembly of the tubes provide mechanical support in
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tension/compression during clinical use
3.9
hydratable intravascular catheter ISO 10555-1:2013
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intravascular catheter consisting of a material that manifests clinically significant hydration when
subjected to an aqueous medium a144025ae0b9/iso-10555-1-2013

3.10
post-hydration
state of a hydratable intravascular catheter after immersion in aqueous medium at (37 ± 2) °C for a
clinically appropriate period of time
3.11
clinically significant hydration
hydrated state in which either the post-hydration effective length is greater than the pre-hydration
effective length by more than 1 % of the effective length, or the post-hydration outside diameter is
greater than the pre-hydration outside diameter by 10 % or more
3.12
power injection
rapid injection of fluid at high pressure
3.13
primary packaging
packaging which has direct contact with the device and/or maintains the sterility of the product
3.14
secondary packaging
packaging designed to contain one or more primary packages

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Key
l effective length
1 catheter hub
2 catheter strain reinforcement
3 length mark
4 junction
5 pre-connected port

Figure 1 — Examples of effective length of catheters

3.15
angiographic catheter
intravascular catheter used for the injection of contrast media and/or fluids and which may be used for
pressure measurements and to obtain blood samples or insertion of coaxial inner catheter, occlusion
coils or other devices

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4 Requirements

4.1 General
The catheter shall have been sterilized by an appropriate validated method, and shall comply with 4.2
to 4.8 in the sterile condition.

4.2 Radio-detectability
Parts of the catheter shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as ASTM F640-12 or DIN 13273-
7.

4.3 Biocompatibility
The catheter shall be free from biological hazard.
NOTE See ISO 10993-1 for the selection of appropriate test methods.

4.4 Surface
When examined by normal or corrected to normal vision, with a minimum x 2,5 magnification the
external surface of the effective length of the catheter shall appear free from extraneous matter.
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The external surface of the effective length of the catheter, including the distal end, shall be free from
(standards.iteh.ai)
process and surface defects which could cause trauma to vessels during use.
If the catheter is lubricated, the lubricant shall ISO not10555-1:2013
be visible as drops of fluid on the external surface
when the catheter is examined under normal or corrected to normal vision.
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4.5 Corrosion resistance
When tested in accordance with the method given in Annex A, metallic components of the catheter
intended for fluid path contact shall show no signs of corrosion.

4.6 Peak tensile force

When tested in accordance with the method given in Annex B, the peak tensile force of each test piece
shall be as given in Table 1.

Table 1 — Peak tensile force of catheter test pieces

Smallest outside diameter of tubular Minimum peak tensile force
portion of test piece
N
mm
      ≥ 0,55 < 0,75 3
      ≥ 0,75 < 1,15 5
      ≥ 1,15 < 1,85 10
≥ 1,85 15
NOTE This part of ISO 10555 does not specify requirements for peak tensile force for
tubing of less than 0,55 mm outside diameter (prehydration outside diameter for hydratable
intravascular catheters) or for a distal tip and its junction to the shaft tube. These values
should be determined by the manufacturer based on risk assessment.

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4.7 Freedom from leakage

4.7.1 The hub or connection fitting assembly or any other part of the catheter shall not leak liquid when
tested in accordance with the method given in Annex C.

For hydratable intravascular catheters, this requirement shall be met in both the pre- and post-hydration
states.

4.7.2 Air shall not leak into the hub assembly during aspiration when tested in accordance with the
method given in Annex D.

For hydratable intravascular catheters, this requirement shall be met in both the pre- and post-hydration
states.

4.8 Hubs
If the catheter is supplied with either an integral or a separate hub, it shall be a female hub that shall
comply with ISO 594-1 and ISO 594-2.

4.9 Flowrate
For devices for which flow rate is defined, when tested in accordance with Annex E, the flow rate for each
lumen shall be a minimum of 80 % of that stated by the manufacturer for catheters of nominal outside
diameter less than 1,0 mm or a minimum of 90 % of that stated by the manufacturer for catheters of
iTeh STANDARD PREVIEW
nominal outside diameter equal to 1,0 mm or greater.
(standards.iteh.ai)
If the flowrate through hydratable catheters is determined, it shall be determined in post-hydration
states.
ISO 10555-1:2013
4.10 Power injection https://standards.iteh.ai/catalog/standards/sist/971b16cc-1c10-478b-8003-
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If the catheter is indicated for power injection, the catheter burst pressure shall exceed the peak pressure
present in the catheter at maximum flow conditions as determined by Annexes F and G.

4.11 Side holes

The design, number and positioning of side holes shall be such as to minimize adverse effects on the
catheter and trauma to the tissues.

4.12 Distal tip

The distal tip shall be smooth, rounded, tapered or similarly finished in order to minimize trauma to
vessels during use.

5 Designation of nominal size

The nominal size of the catheter shall be designated as specified in 5.1 and 5.2.

5.1 Outside diameter

Unless otherwise specified in one other part of this International Standard for a particular type of
catheter, the outside diameter shall be expressed as the nominal dimension in millimetres, rounded
upwards to the nearest 0,01 mm or 0,1 mm.
For devices which are not round by design, the size shall be designated by the dimension of the largest
axis. Where relevant, manufacturers may choose to report additional information regarding the device
profile, such as the dimension of the second axis for an oval shape.

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5.2 Nominal effective length

The nominal effective length shall be expressed in millimetres for effective lengths of less than 100 mm.
The nominal effective length shall be expressed in millimetres or centimetres for effective lengths of
100 mm or more.
NOTE Tolerances to the effective length are not specified.

6 Information to be supplied by the manufacturer

6.1 General
Each device shall be accompanied by the information needed to use it safely and properly. All dimensions
given shall be expressed in SI units of measurement.
Units of measurement systems other than those specified may additionally be used.
Where appropriate, ISO 15223-1 should be used.

6.2 Marking on the device and/or primary packaging

NOTE The primary packaging is often transparent. Therefore, for the purposes of this subclause, the
combination of marking of the device which is visible through the package and the primary packaging itself are to
be considered. iTeh STANDARD PREVIEW
The information listed below shall be specified on the first practical level in the following order: device,
(standards.iteh.ai)
primary packaging, instructions for use:
a) the name or trade name and address of the ISO manufacturer
10555-1:2013 and/or his authorized representative;
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b) the details strictly necessary to identify the device (including the nominal size as designated
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in Clause 5) and the contents of the packaging and, if applicable, the guidewire that is intended by the
manufacturer for use with the catheter;
c) the word “STERILE” or the appropriate symbol in ISO 15223-1;
d) the method of sterilization;
e) the batch code, preceded by the word ‘LOT’, or the serial number or the appropriate symbol in
ISO 15223-1;
f) an indication of the date by which the device should be used, in safety, expressed as, at a minimum,
the year and month (e.g. as YYYY-MM);
g) an indication that the device is for single use;
h) any special storage and/or handling conditions;
i) if the intended purpose of the device is not obvious to the user, the manufacturer shall clearly
state it (where a device is provided with separate instructions for use, this requirement may be omitted
from the primary packaging);
j) where appropriate, an indication to consult the instructions for use;
k) for angiographic catheters, a depiction or description of the distal end configuration, if not
identifiable through the package.

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6.3 Instructions for use

When a separate instruction for use is provided, it shall at least contain information on the following:
a) the details referred to in 6.2 with the exception of d) f), j) and k);
b) precautions to be taken and any warnings (e.g. to cleaning agents, if relevant);
c) if the device is intended to be connected to other devices or accessories in order to operate as
required for its intended purpose, sufficient details of its characteristics to identify the correct
devices in order to obtain a safe combination;
d) description of additives or coatings;
e) any unique requirements for disposal of device, taking into account item d) above;
f) if applicable, special claims made because of the presence of an additive or coating, and as applicable:
— description of the additive or coating material,
— duration of effectiveness in use,
— any contra-indications, warnings and precautions based on the additive or coating material(s);
g) if applicable, known reactions between the catheter and magnetic resonance imaging (MRI);
h) date of issue or the latest revision of the instructions for use;
i)
iTeh STANDARD PREVIEW
for devices indicated for power injection, the following information shall be included:
—
(standards.iteh.ai)
recommended power injector pressure limit setting(s);
— maximum flow rates for a rangeISO 10555-1:2013
of clinically applicable viscocities and/or specific injectates.
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6.4 Marking on the secondary packaging
Where devices are provided in secondary packaging, the marking on the secondary packaging shall
include the details referred to in 6.2, if appropriate.

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Annex A
(normative)

Test method for corrosion resistance

A.1 Principle
The catheter is immersed in sodium chloride solution, then in boiling distilled water, and afterwards
examined visually for evidence of corrosion.

A.2 Reagents

A.2.1 Saline solution, comprising a solution of analytical reagent grade sodium chloride in freshly
prepared distilled water [c(NaCl) = 0,15 mol/l].

A.2.2 Distilled or deionized water.

A.3 Apparatus iTeh STANDARD PREVIEW

A.3.1 Borosilicate glass beakers. (standards.iteh.ai)

ISO 10555-1:2013
A.4 Procedure https://standards.iteh.ai/catalog/standards/sist/971b16cc-1c10-478b-8003-
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Immerse the catheter in the saline solution (A.2.1) in a glass beaker (A.3.1) at room temperature for 5 h.
Remove the test specimen and immerse it in boiling distilled water (A.2.2) for 30 min. Allow the water
and the test specimen to cool to 37° C, and maintain them at this temperature for 48 h. Remove the
test specimen and allow it to dry at room temperature. Disassemble specimens that have two or more
components which are intended to be separable in use. Do not strip away or cut open any coatings on
metallic components. Inspect the specimen visually for signs of corrosion.

A.5 Test report

The test report shall include the following information:
a) identity of the catheter;
b) statement as to whether corrosion occurred during the test.

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