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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/14/2015 Sterility 14-478 ANSI AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
12/23/2016 Sterility 14-311 ANSI AAMI ST55:2010/(R)2014 Table-top steam sterilizers
01/27/2015 Sterility 14-165 ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
08/06/2013 Sterility 14-383 ASTM ISO 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing
03/16/2012 Sterility 14-325 ANSI AAMI ISO TIR 11139:2006 Sterilization of health care products - Vocabulary
ISO /TS 11139 Second edition 2006-01-15 Sterilization of health care products - Vocabulary
03/16/2012 Sterility 14-354 ANSI AAMI ISO 18472:2006/(R)2010 Sterilization of health care products - Biological and chemical indicators - Test equipment
ISO 18472 First edition 2006-06-01 Sterilization of health care products - Biological and chemical indicators - Test equipment
03/16/2012 Sterility 14-332 ANSI AAMI ISO 11140-5:2007/(R)2012 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
ISO 11140-5 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
06/07/2018 Sterility 14-511 ANSI AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
08/21/2017 Sterility 14-361 ANSI AAMI ISO 14160:2011/ (R)2016 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14160 Second edition 2011-07-01 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
04/04/2016 Sterility 14-277 ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2:2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
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