This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.
AAMI TIR14:2016/(R)2024
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Contract sterilization using ethylene oxide
Association for the Advancement of Medical Instrumentation , 06/05/2016
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