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CEN

EN 1422:1997

(Main)

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

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

This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.

Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prüfverfahren

Diese Europäische Norm legt Mindestleistungsanforderungen und Prüfverfahren an zwei Typen von Sterilisatoren fest, die Ethylenoxid, entweder als reines Gas oder als Gas im Gemisch mit anderen Gasen, als Sterilisiermittel verwenden (dabei kann das Gemisch in fertigem Zustand geliefert oder erst am Einsatzort hergestellt werden). Diese Sterilisatoren dienen zum Einsatz in der Allgemeinen-, Zahn- oder Tiermedizin, in der Pharmazie, der Industrie oder zu anderen verwandten Zwecken.

Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai

La présente norme européenne spécifie les exigences minimales de fonctionnement et les méthodes d'essai applicables à deux types de stérilisateurs employant de l'oxyde d'éthylène comme agent stérilisant, soit sous forme de gaz pur, soit mélangé à d'autres gaz (que l'agent stérilisant soit déjà mélangé lorsqu'il est livré ou qu'il soit mélangé sur place avant utilisation) dans une chambre hermétiquement close de façon temporaire. Ces stérilisateurs sont destinés à être utilisés à des fins médicales, dentaires, pharmaceutiques, vétérinaires et industrielles ou à des fins connexes.

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

General Information

Status
Withdrawn
Publication Date
16-Sep-1997
Withdrawal Date
12-May-2009
ICS
11.080 - Sterilization and disinfection
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 6 - Gas sterilizers
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
13-May-2009
Completion Date
13-May-2009
Directive
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 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Relations

Amended By
EN 1422:1997/prA1 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Effective Date
22-Dec-2008
Merged Into
EN 1422:1997+A1:2009 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Effective Date
18-Jan-2023
Revised
EN 1422:2014 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Effective Date
22-Dec-2008
Corrected By
EN 1422:1997/AC:2002 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Effective Date
22-Dec-2008

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metodeSterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und PrüfverfahrenStérilisateurs a usage médical - Stérilisateurs a l'oxyde d'éthylene - Exigences et méthodes d'essaiSterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 1422:1997SIST EN 1422:2000en01-januar-2000SIST EN 1422:2000SLOVENSKI
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SIST EN 1422:2000



SIST EN 1422:2000



SIST EN 1422:2000



SIST EN 1422:2000



SIST EN 1422:2000



SIST EN 1422:2000



SIST EN 1422:2000



SIST EN 1422:200
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This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
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