Contract sterilization using ethylene oxide
|Publication Date:||1 January 2016|
This AAMI TIR provides guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135:2014 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
EO contract sterilization guidance for health care providers is not specifically covered in this TIR.