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AAMI TIR14:2009

Contract sterilization using ethylene oxide

This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.

Content Provider
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.