SIST EN ISO 10555-1:2009

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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