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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.
Product Details
- Published:
- 06/05/2016
- ISBN(s):
- 1570206139
- Number of Pages:
- 19
- File Size:
- 1 file , 300 KB