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SIST EN 1422:2000/kprA1:2009
01-marec-2009
Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in
preskusne metode
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test
methods
Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und
Prüfverfahren
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et
méthodes d'essai
Ta slovenski standard je istoveten z: EN 1422:1997/prA1
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 1422:2000/kprA1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 1422:2000/kprA1:2009
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SIST EN 1422:2000/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 1422:1997
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2008
ICS 11.080.10
English Version
Sterilizers for medical purposes - Ethylene oxide sterilizers -
Requirements and test methods
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde Sterilisatoren für medizinische Zwecke - Ethylenoxid-
d'éthylène - Exigences et méthodes d'essai Sterilisatoren - Anforderungen und Prüfverfahren
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 102.
This draft amendment A1, if approved, will modify the European Standard EN 1422:1997. If this draft becomes an amendment, 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.
This draft amendment 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 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.
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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1422:1997/prA1:2008: E
worldwide for CEN national Members.
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SIST EN 1422:2000/kprA1:2009
EN 1422:1997/prA1:2008 (E)
Contents Page
Foreword .3
1 Modifications to Annex ZA .4
2
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SIST EN 1422:2000/kprA1:2009
EN 1422:1997/prA1:2008 (E)
Foreword
This document (EN 1422:1997/prA1:2008) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
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.
3
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SIST EN 1422:2000/kprA1:2009
EN 1422:1997/prA1:2008 (E)
1 Modifications to Annex ZA
Delete the title of Annex ZA and substitute the following:
"Relationship between this European Standard and the Essential Requirements of EU Directive
93/42/EEC".
Delete the introductory text to Table ZA and substitute the following:
"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 clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presu
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