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ANSI/AAMI/ISO 11135:2014

Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

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.


Content Provider
Association for the Advancement of Medical Instrumentation [aami]


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ISO 11135:2014/Amd1:2018
- Amendment 1: Revision of Annex E, Single batch release
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