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AAMI TIR74:2016 (R2021)

Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

Provides summary of differences between the new 2014 version and the 2007 version of ISO 11135. Provides end users with a quick reference when evaluating and implementing the 2014 version of ISO 11135 in their facilities.

Association for the Advancement of Medical Instrumentation [aami]

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