ISO 11135:1994

Medical devices — Validation and routine control of ethylene oxide sterilization

Publication date: 27 jan 1994

95.99 Withdrawal of Standard 17 korr 2008

General information

Current stage: 95.99 Effective date: 17 korr 2008

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Gjuha: frëngjisht anglisht

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Statusi: Shfuqizuar

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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WITHDRAWN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
17 korr 2008

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 11135:1994/Cor 1:1994

REVISED BY

WITHDRAWN
ISO 11135-1:2007

WITHDRAWN
ISO/TS 11135-2:2008