EN ISO 10555-1:2023

SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 10555-1:2013
SIST EN ISO 10555-1:2013/A1:2018
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve
(ISO 10555-1:2023)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO 10555-1:2023)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO 10555-1:2023)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
générales (ISO 10555-1:2023)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2023
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.

EN ISO 10555-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 10555-1:2013
English Version
Intravascular catheters - Sterile and single-use catheters -
Part 1: General requirements (ISO 10555-1:2023)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 1: Exigences générales (ISO einmaligen Verwendung - Teil 1: Allgemeine
10555-1:2023) Anforderungen (ISO 10555-1:2023)
This European Standard was approved by CEN on 24 November 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10555-1:2023) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and 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 May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-1:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10555-1:2023 has been approved by CEN as EN ISO 10555-1:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 10555-1
Third edition
2023-11
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 10555-1:2023(E)
ISO 10555-1:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10555-1:2023(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 5
4.1 Risk approach . 5
4.2 Usability engineering . . 5
4.3 Sterilization . 5
4.4 Shelf life. 5
4.5 Detectability . 5
4.6 Biocompatibility . 5
4.7 Surface . 5
4.8 Corrosion resistance . 6
4.9 Peak tensile force . 6
4.10 Freedom from leakage during pressurization . 7
4.11 Freedom from leakage during aspiration . 7
4.12 Hubs . . 7
4.13 Flowrate . 8
4.14 Power injection burst pressure . 8
4.15 Packaging system . . 8
4.16 Simulated use, kink and/or torque testing to consider depending on device design,
intended use, and risk analysis . 8
4.17 Coating integrity and/or particulate testing to consider depending on device
design, intended use, and risk analysis . 9
4.18 Distal tip stiffness testing to consider for neurovascular applications . 9
5 Designation of nominal size . 9
5.1 Nominal outside diameter . 9
5.2 Nominal inside diameter . 9
5.3 Nominal effective length . 9
6 Information to be supplied with the catheter .10
6.1 General . 10
6.2 Marking on the device and/or primary packaging . 10
6.3 Instructions for use . 11
6.4 Marking on the secondary packaging . 11
Annex A (normative) Test method for corrosion resistance .12
Annex B (normative) Method for determining peak tensile force .13
Annex C (normative) Test method for liquid leakage under pressure.16
Annex D (normative) Test method for air leakage into hub assembly during aspiration .18
Annex E (normative) Determination of flowrate through catheter .20
Annex F (normative) Test for burst pressure under static conditions .22
Annex G (normative) Power injection tests for flowrate and device pressure (only for
products indicated for power injection) .25
Annex H (informative) Units of measurement systems other than those specified in
this document .30
Annex I (normative) Test method for air leakage under water .32
Annex J (informative) Rationale and guidance .34
Annex K (informative) Test methods for distal tip stiffness for neurovascular applications .41
iii
ISO 10555-1:2023(E)
Bibliography .
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