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AAMI TIR16:2009 (R2013) (AAMI TIR 16:2009 (R2013))

Microbiological aspects of ethylene oxide sterilization

This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

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Association for the Advancement of Medical Instrumentation [aami]

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