Historical
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.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]