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AAMI TIR16:2009

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/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.

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

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Document History
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