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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
06/07/2018 Sterility 14-511 ANSI AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
09/17/2018 Sterility 14-293 ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
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
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
12/23/2016 Sterility 14-499 ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
04/04/2016 Sterility 14-333 ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
01/30/2014 Sterility 14-427 ANSI AAMI ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
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