Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)

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.

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2014-01-15)

Dieser Teil der ISO 10555 legt allgemeine Anforderungen an intravaskuläre Katheter jedes Verwendungszwecks fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind. Sie gilt nicht für Zubehörteile zu intravaskulären Kathetern, die in einer gesonderten Norm erfasst werden. Diese Norm behandelt nicht die Eigenschaften von Beschichtungen.

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2013, Version corrigé 2014-01-15)

L'ISO 10555-1:2013 spécifie les exigences générales relatives aux cathéters intravasculaires fournis en condition stérile, non réutilisables, pour toute application.

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:2013, popravljena verzija 2014-01-15)

Ta del standarda ISO 10555 določa splošne zahteve za žilne katetre, dobavljene v sterilnem stanju in namenjene za enkratno uporabo, za katero koli vrsto uporabe. Ne uporablja se za dodatke žilnih katetrov, na primer tiste, ki jih zajema ISO 11070.

General Information

Status
Withdrawn
Public Enquiry End Date
19-Jan-2012
Publication Date
08-Oct-2013
Withdrawal Date
08-Feb-2024
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
31-Jan-2024
Due Date
23-Feb-2024
Completion Date
09-Feb-2024

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:2013, popravljena verzija 2013-07-01)Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2013-07-01)Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2013, Version corrigé 2013-07-01)Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2013-07-01)11.040.25Injekcijske brizge, igle in katetriSyringes, needles an cathetersICS:Ta slovenski standard je istoveten z:EN ISO 10555-1:2013SIST EN ISO 10555-1:2013en01-november-2013SIST EN ISO 10555-1:2013SLOVENSKI
STANDARDSIST EN ISO 10555-1:20091DGRPHãþD



SIST EN ISO 10555-1:2013



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 10555-1
July 2013 ICS 11.040.25 Supersedes EN ISO 10555-1:2009English Version
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2013-07-01)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2013, Version corrigé 2013-07-01)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2013-07-01) 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
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-1:2013: ESIST EN ISO 10555-1:2013



EN ISO 10555-1:2013 (E) 2 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
SIST EN ISO 10555-1:2013



EN ISO 10555-1:2013 (E) 3 Foreword This document (EN ISO 10555-1:2013, Corrected version 2013-07-01) 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. 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, Portu
...

SLOVENSKI STANDARD
SIST EN ISO 10555-1:2013
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
SIST EN ISO 10555-1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10555-1:2013

---------------------- Page: 2 ----------------------
SIST EN ISO 10555-1:2013

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.

---------------------- Page: 3 ----------------------
SIST EN ISO 10555-1:2013
EN ISO 10555-1:2013 (E)
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

2

---------------------- Page: 4 ----------------------
SIST EN ISO 10555-1:2013
EN ISO 10555-1:2013 (E)
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 10555-1:2011
01-december-2011
Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO/DIS 10555-
1:2011)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO/DIS 10555-1:2011)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO/DIS 10555-1:2011)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
généralesv (ISO/DIS 10555-1:2011)
Ta slovenski standard je istoveten z: prEN ISO 10555-1 rev
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 10555-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10555-1:2011

---------------------- Page: 2 ----------------------
oSIST prEN ISO 10555-1:2011


EUROPEAN STANDARD
DRAFT
prEN ISO 10555-1 rev
NORME EUROPÉENNE

EUROPÄISCHE NORM

September 2011
ICS 11.040.25 Will supersede EN ISO 10555-1:2009
English Version
Intravascular catheters - Sterile and single-use catheters - Part
1: General requirements (ISO/DIS 10555-1:2011)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 1: Exigences généralesv (ISO/DIS Verwendung - Teil 1: Allgemeine Anforderungen (ISO/DIS
10555-1:2011) 10555-1:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 10555-1 rev:2011: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN ISO 10555-1:2011
prEN ISO 10555-1:2011 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------
oSIST prEN ISO 10555-1:2011
prEN ISO 10555-1:2011 (E)
Foreword
This document (prEN ISO 10555-1:2011) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 10555-1:2009.
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).
Endorsement notice
The text of ISO/DIS 10555-1:2011 has been approved by CEN as a prEN ISO 10555-1:2011 without any
modification.
3

---------------------- Page: 5 ----------------------
oSIST prEN ISO 10555-1:2011

---------------------- Page: 6 ----------------------
oSIST prEN ISO 10555-1:2011

DRAFT INTERNATIONAL STANDARD ISO/DIS 10555-1
ISO/TC 84 Secretariat: DS
Voting begins on Voting terminates on

2011-09-29 2012-02-29
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION


Intravascular catheters — Sterile and single-use catheters —
Part 1:
General requirements
Ca
...

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