SIST EN ISO 10555-1:2009
(Main)Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
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 does not apply to intravascular catheter accessories, which will be covered by a separate Standard.
Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995, einschließlich Änderung 1:1999 und Änderung 2:2004)
Dieser Teil der ISO 10555 legt allgemeine Anforderungen für intravaskulären 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.
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales (ISO 10555-1:1995, y compris Amd 1:1999 et Amd 2:2004)
La présente partie de l'ISO 10555 fixe les prescriptions générales relatives aux cathéters intravasculaires fournis dans des conditions stériles, non réutilisables, pour toute application. Elle n'est pas applicable aux accessoires de cathéters intravasculaires, qui feront l'objet d'une norme distincte.
Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:1995, vključno z Amd 1:1999 in Amd 2:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10555-1:2009
01-september-2009
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Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-
1:1995, including Amd 1:1999 and Amd 2:2004)
Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine
Anforderungen (ISO 10555-1:1995, einschließlich Änderung 1:1999 und Änderung
2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales
(ISO 10555-1:1995, y compris Amd 1:1999 et Amd 2:2004)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2009
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10555-1:2009
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SIST EN ISO 10555-1:2009
EUROPEAN STANDARD
EN ISO 10555-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.25 Supersedes EN ISO 10555-1:1996
English Version
Sterile, single-use intravascular catheters - Part 1: General
requirements (ISO 10555-1:1995, including Amd 1:1999 and
Amd 2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie Sterile intravaskuläre Katheter zur einmaligen Verwendung
1: Prescriptions générales (ISO 10555-1:1995, y compris -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995,
Amd 1:1999 et Amd 2:2004) einschließlich Änderung 1:1999 und Änderung 2:2004)
This European Standard was approved by CEN on 19 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2009: E
worldwide for CEN national Members.
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SIST EN ISO 10555-1:2009
EN ISO 10555-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 10555-1:2009
EN ISO 10555-1:2009 (E)
Foreword
The text of ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004 has been prepared by Technical
Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 10555-1:2009 by 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 10555-1:1996.
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 EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995, einschließlich Änderung 1:1999 und Änderung 2:2004)Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales (ISO 10555-1:1995, y compris Amd 1:1999 et Amd 2:2004)Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)11.040.25Injekcijske brizge, igle in katetriSyringes, needles an cathetersICS:Ta slovenski standard je istoveten z:prEN ISO 10555-1kSIST prEN ISO 10555-1:2009en01-marec-2009kSIST prEN ISO 10555-1:2009SLOVENSKI
STANDARD
kSIST prEN ISO 10555-1:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 10555-1December 2008ICS 11.040.25Will supersede EN ISO 10555-1:1996
English VersionSterile, single-use intravascular catheters - Part 1: Generalrequirements (ISO 10555-1:1995, including Amd 1:1999 andAmd 2:2004)Cathéters intravasculaires stériles, non réutilisables - Partie1: Prescriptions générales (ISO 10555-1:1995, Amd 1:1999et Amd 2:2004 inclus)Sterile intravaskuläre Katheter zur einmaligen Verwendung-Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995,einschließlich Änderung 1:1999 und Änderung 2:2004)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 205.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate 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 languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 10555-1:2008: EkSIST prEN ISO 10555-1:2009
prEN ISO 10555-1:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 10555-1:2009
prEN ISO 10555-1:2008 (E) 3 Foreword The text of ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004 has been prepared by Technical Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 10555-1:2008 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 10555-1:1996. 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 EC Directive(s). For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004 has been approved by CEN as a prEN ISO 10555-1:2008 without any modification. kSIST prEN ISO 10555-1:2009
prEN ISO 10555-1:2008 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/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 the New Approach Directive 93/42/EEC on medical devices. 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 clause
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