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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/09/2014 Sterility 14-290 ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
12/23/2019 Sterility 14-536 USP 42-NF37:2019 <55> Biological Indicators -- Resistance Performance Tests
06/07/2018 Sterility 14-511 ANSI AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
08/14/2015 Sterility 14-460 ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
08/14/2015 Sterility 14-463 ASTM ISO 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
09/09/2008 Sterility 14-191 ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
09/09/2008 Sterility 14-240 ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
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
08/06/2013 Sterility 14-388 ANSI AAMI ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
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