EN ISO 10555-1:1996/A2:2004
(Amendment)Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1996/AM 2:2004)
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1996/AM 2:2004)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Please contact Trevor Vyze x 850 when progressing this project through any stage
Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995/AMD 2:2004)
Der Text von ISO 10555-1:1995/FDAM 2:2004 wurde vom CEN als EN ISO 10555-1:1996/prA2:2004 ohne irgendeine Abänderung genehmigt.
ANMERKUNG Die normativen Verweisungen auf Internationale Normen sind im Anhang ZA, B, C, oder D (normativ) aufgeführt.
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales (ISO 10555-1:1996/AM 2:2004)
Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve – Dopolnilo A2 (ISO 10555-1:1996/AM 2:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10555-1:2000/A2:2004
01-november-2004
Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve – Dopolnilo A2
(ISO 10555-1:1996/AM 2:2004)
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-
1:1996/AM 2:2004)
Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine
Anforderungen (ISO 10555-1:1995/AMD 2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales
(ISO 10555-1:1996/AM 2:2004)
Ta slovenski standard je istoveten z: EN ISO 10555-1:1996/A2:2004
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-1:2000/A2:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10555-1:2000/A2:2004
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SIST EN ISO 10555-1:2000/A2:2004
EUROPEAN STANDARD
EN ISO 10555-1:1996/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.20
English version
Sterile, single-use intravascular catheters - Part 1: General
requirements (ISO 10555-1:1996/AM 2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie Sterile intravaskuläre Katheter zur einmaligen Verwendung
1: Prescriptions générales (ISO 10555-1:1996/AM 2:2004) -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995/AM
2:2004)
This amendment A2 modifies the European Standard EN ISO 10555-1:1996; it was approved by CEN on 3 May 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the Central Secretariat or to any CEN member.
This amendment 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 Central Secretariat has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:1996/A2:2004: E
worldwide for CEN national Members.
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SIST EN ISO 10555-1:2000/A2:2004
EN ISO 10555-1:1996/A2:2004 (E)
Foreword
This document (EN ISO 10555-1:1996/A2:2004) has been prepared by Technical Committee
ISO/TC 84 "Medical devices for injections" in collaboration with Technical Committee CEN/TC
205 "Non-active medical devices", the secretariat of which is held by BSI.
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 2004, and conflicting national
standards shall be withdrawn at the latest by November 2004.
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,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 10555-1:1996 has been approved by CEN as EN ISO 10555-1:1996/A2:2004
without any modifications.
2
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SIST EN ISO 10555-1:2000/A2:2004
EN ISO 10555-1:1996/A2:2004 (E)
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.
Once this standard is cited in the Official Journal of the European Communitie
...
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