ISO-11135 › Historical Revision Information
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
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Document Number
ISO 11135:2014
Revision Level
2ND EDITION
Status
Current
Publication Date
July 7, 2014
Committee Number
ISO/TC 198