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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
08/06/2013 Sterility 14-381 ASTM ISO 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
09/17/2018 Sterility 14-517 ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
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
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
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
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
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
07/09/2014 Sterility 14-282 ASTM F2338-09 (Reapproved 2013) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
07/09/2014 Sterility 14-286 ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
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