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AAMI TIR14:1997 and AAMI TIR14:1997/A1:2004

Contract sterilization for ethylene oxide

This AAMI Technical Information Report (TIR) provides additional guidance to augment ANSI/AAMI/IS0 11135, Medical devices-Validation and routine control of ethylene oxide sterilization for both medical device manufacturers that use contract sterilization facilities and contract sterilization operations. The TIR addresses how ANSI/AAMI/ISO 11135 applies to ethylene oxide sterilization operations for devices marketed in the United States.

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Association for the Advancement of Medical Instrumentation [aami]

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