EN ISO 10555-1:2013

SLOVENSKI STANDARD
01-november-2013
Nadomešča:
SIST EN ISO 10555-1:2009
SIST EN ISO 10555-2:2000
SIST EN ISO 10555-2:2000/AC:2002
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve
(ISO 10555-1:2013, popravljena verzija 2014-01-15)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO 10555-1:2013, Corrected version 2014-01-15)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2014-01-15)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
générales (ISO 10555-1:2013, Version corrigé 2014-01-15)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2013
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10555-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2013
ICS 11.040.25 Supersedes EN ISO 10555-1:2009, EN ISO 10555-2:1997
English Version
Intravascular catheters - Sterile and single-use catheters - Part
1: General requirements (ISO 10555-1:2013, Corrected version
2014-01-15)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 1: Exigences générales (ISO 10555- Verwendung - Teil 1: Allgemeine Anforderungen (ISO
1:2013, Version corrigé 2014-01-15) 10555-1:2013, korrigierte Fassung 2014-01-15)
This European Standard was approved by CEN on 29 May 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2013 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC .4

Foreword
This document (EN ISO 10555-1:2013, Corrected version 2014-01-15) has been prepared by Technical
Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” in
collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is
held by DIN.
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 January 2014, and conflicting national standards shall be withdrawn at
the latest by January 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-1:2009, EN ISO 10555-2:1997.
This document 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).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10555-1:2013, Corrected version 2014-01-15 has been approved by CEN as EN ISO 10555-
1:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive
2007/47/EEC
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
Directive 93/42/EEC amended by Directive 2007/47/EEC.
Once this standard is cited in the Official Journal of the European Union 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 given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1— Correspondence between this European Standard and Directive 93/42/EEC amended by
Directive 2007/47/EEC
Essential Requirements (ERs) of Directive Clause(s)/sub-clause(s) of this
93/42/EEC EN ISO 10555-1
7.3 4.5*
4.9
4.10*
7.5 4.4*
8.1 4.1*
6.2 c) and d)*
8.3 4.1*
6.2 c) and d)*
8.4 4.1****
6.2 d)*
9.1 4.8
4.9
4.10
6.3 b), c) and i)
9.2 4.2
4.4
4.6
4.7
4.8
4.9
4.10
4.11
4.12
12.7.1** 4.4
4.6
4.7
4.9
4.10
4.11
4.12
12.7.4 4.9
4.10
12.8.1 4.9
4.10
13.1 6.1
6.2 a), b), f), g), h), i), j), k)
6.4
13.2 6.1
13.3 a) 6.2 a)
13.3 b) 6.2 b)
13.3 c) 6.2 c)
13.3 d) 6.2 e)
13.3 e) 6.2 f)
13.3 f) 6.2 g)
13.3 i) 6.2 h)
13.3 j) 6.2 i) and j)
6.3 c) and i)
13.3 k) 6.3 b) and f)
13.3 m) 6.2 d)
13.4 6.2 i)
6.3 a)
13.6 a) 6.3 a) ***
13.6 b) 6.3 b)
13.6 c) 6.3 c) and f)
13.6 e) 6.3 f)
13.6 f) 6.3 g)
13.6 g) 6.3 d)
13.6 k) 6.3 b) and f)
13.6 l) 6.3 b) and g)
13.6 n) 6.3 e)
13.6 q) 6.3 h)
(*) Not fully covered as the requirements are depended on the specific product.
(**) For the user, only 4.7 is applicable.
(***) Method of sterilisation not required in the instruction for use as it is required on the device
or primary packing.
(****) Only concerning sterilisation aspects.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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
Reference number
ISO 10555-1:2013(E)
©
ISO 2013
ISO 10555-1:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Published in Switzerland
ii © ISO 2013 – All rights reserved

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 Nominal effective length . 6
6 Information to be supplied by the manufacturer . 6
6.1 General . 6
6.2 Marking on the device and/or primary packaging . 6
6.3 Instructions for use . 7
6.4 Marking on the secondary packaging. 7
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
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.
ISO 10555 consists of the following parts, under the general title Intravascular catheters — Sterile and
single-use catheters:
— Part 1: General requirements
— 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.
iv © ISO 2013 – All rights reserved

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.
ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
1)
equipment — Part 1: General requirements
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
1)
Part 2: Lock fittings
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.
ISO 10555-1:2013(E)
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
the joining of one tube or more tubes, where the assembly of the tubes provide mechanical support in
tension/compression during clinical use
3.9
hydratable intravascular catheter
intravascular catheter consisting of a material that manifests clinically significant hydration when
subjected to an aqueous medium
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
2 © ISO 2013 – All rights reserved

ISO 10555-1:2013(E)
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
ISO 10555-1:2013(E)
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.
The external surface of the effective length of the catheter, including the distal end, shall be free from
process and surface defects which could cause trauma to vessels during use.
If the catheter is lubricated, the lubricant shall not be visible as drops of fluid on the external surface
when the catheter is examined under normal or corrected to normal vision.
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.
4 © ISO 2013 – All rights reserved

ISO 10555-1:2013(E)
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
nominal outside diameter equal to 1,0 mm or greater.
If the flowrate through hydratable catheters is determined, it shall be determined in post-hydration
states.
4.10 Power injection
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.
ISO 10555-1:2013(E)
5.2 Nominal effective length
The nominal effective length shall be expressed in millimetres for e
...