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.
Document identifier
AAMI TIR14:2016
Title
Contract sterilization using ethylene oxide
AAMI Category
EO and Chemical Disinfection
Publication date
2016-06-05
International Relationship
History of version
AAMI TIR14:2016 * AAMI TIR14:2009 * AAMI TIR14:1997/A1:2004 * AAMI TIR14:1997
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131 vnd |
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