AAMI TIR14:2016

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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

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