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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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
01/30/2014 Sterility 14-413 AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
01/27/2015 Sterility 14-242 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
01/30/2014 Sterility 14-429 ASTM ISO 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
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)
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
08/21/2017 Sterility 14-502 ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
01/30/2014 Sterility 14-424 ANSI AAMI ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)]
ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)]
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)]
04/04/2016 Sterility 14-409 ANSI AAMI ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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