Standard

ISO 11135:1994

Jan 1994 Withdrawn

Note: Latest version: ISO 11135:2014

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Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrigendum 1 Withdrawn ISO 11135:1994/Cor 1:1994 Corrigendum from Publication date: Oct 1994 Language: English Services: Online, Online + Pdf

Abstract

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.

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Standard from ISO
Published: January 27 1994
Withdrawn: July 17 2008
Period for objection until: April 10 1993
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Revised by: ISO/TS 11135-2:2008
Revised by: ISO 11135-1:2007

ISO 11135:1994

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ISO/DIS 11135

ISO/DIS 11135

ISO 11135:2014

ISO 11135:1994

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Version history Related Corrigenda and Amendments (1)

ISO 11135:1994/Cor 1:1994

Version history History (4)

ISO/DIS 11135

ISO/DIS 11135

ISO 11135:2014

ISO 11135:1994

Abstract

Products specifications

Product Relations

Product life cycle