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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
01/15/2013 Sterility 14-359 ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
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
06/27/2016 Sterility 14-344 ASTM F2825-10 (Reapproved 2015) Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
04/04/2016 Sterility 14-340 ANSI AAMI ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016 Sterility 14-337 ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
01/30/2014 Sterility 14-336 ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
01/30/2014 Sterility 14-334 ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
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
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
04/04/2016 Sterility 14-327 ANSI AAMI ISO 11737-2:2009/(R)2014 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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