AAMI TIR74:2016, Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene Oxide

This technical information report provides a summary of differences between the new 2014 version of 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 and the previous 2007 version of this standard.

It also provides end users with a quick reference when evaluating and implementing the 2014 version of ISO 11135 in their facilities.


Published: July 2016; 11 pages

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