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CEN

EN 1422:1997/prA1

(Amendment)

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

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

Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metode

General Information

Status
Not Published
ICS
11.080 - Sterilization and disinfection
11.080.10 - Sterilizing equipment
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 6 - Gas sterilizers
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
11-Mar-2009
Completion Date
11-Mar-2009
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 1422:2000/kprA1:2009 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Relations

Merged Into
EN 1422:1997+A1:2009 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Effective Date
23-Mar-2009
Amends
EN 1422:1997 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
1 Modifications to Annex ZA .4

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.
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
...

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