Description

This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical devicemanufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses howANSI/AAMI/ISO 11135-1:2007applies to contract ethylene oxide (EO) sterilization operations for devices marketed inthe United States.

EO contract sterilization guidance for health care providers is not specifically covered in this TIR.

Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.