Reference number
ISO 11135-1:2007
ISO 11135-1:2007
© ISO 2024
ISO 11135-1:2007
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Edition 1
2007-05
2007-05
Withdrawn
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.
General information
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Status: WithdrawnPublication date: 2007-05
Corrected version (en): 2007-10
Corrected version (fr): 2007-10Stage: Withdrawal of International Standard [95.99] -
Edition: 1Number of pages: 41
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Technical Committee :ISO/TC 198ICS :11.080.01
- RSS updates
Life cycle
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Previously
WithdrawnISO 11135:1994
WithdrawnISO 11135:1994/Cor 1:1994
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Now
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Revised by
PublishedISO 11135:2014