Standard

ISO 11135-1:2007

Apr 2007 Withdrawn

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Abstract

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

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Standard from ISO
Published: April 27 2007
Withdrawn: July 7 2014
Period for objection until: January 22 2006
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 11135:2014
Adopted by: SN EN ISO 11135-1:2007
Adopted by: NF EN ISO 11135-1:2007
Revises: ISO 11135:1994
Split from: ISO/DIS 11135

ISO 11135-1:2007

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ISO 11135-1:2007

ISO 11135:1994/Cor 1:1994

ISO 11135:1994

Abstract

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Version history History (3)

ISO 11135-1:2007

ISO 11135:1994/Cor 1:1994

ISO 11135:1994

Abstract

Products specifications

Product Relations

Product life cycle