Historical
AAMI TIR14:2009 (AAMI TIR 14:2009)
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]
Association for the Advancement of Medical Instrumentation [aami]