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AAMI TIR16:2017

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 11135:2014 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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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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