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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 14-212 AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
01/14/2019 Sterility 14-396 ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
12/23/2016 Sterility 14-169 ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
01/27/2015 Sterility 14-243 ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
07/09/2014 Sterility 14-437 ASTM ISO 52701 First edition 2013-11-15 Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
07/09/2014 Sterility 14-256 ASTM F2095-07 (Reapproved 2013) Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates
07/09/2014 Sterility 14-435 ASTM F2251-13 (Reapproved 2018) Standard Test Method for Thickness Measurement of Flexible Packaging Material
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.
01/27/2015 Sterility 14-379 ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
01/27/2015 Sterility 14-389 ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
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