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ISO 11135:1994

Medical devices — Validation and routine control of ethylene oxide sterilization

Jan 27, 1994
95.99   Withdrawal of Standard   Jul 17, 2008

General information

95.99     Jul 17, 2008

ISO

ISO/TC 198

International Standard

11.080.01  

French   English  

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Scope

Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.

Life cycle

NOW

WITHDRAWN
ISO 11135:1994
95.99 Withdrawal of Standard
Jul 17, 2008

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 11135:1994/Cor 1:1994

REVISED BY

WITHDRAWN
ISO 11135-1:2007

WITHDRAWN
ISO/TS 11135-2:2008

National adoptions

SRPS ISO 11135:1998  
ISS

Medical devices — Validation and routine control of ethylene oxide sterilization

95.99   Withdrawal of Standard

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