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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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Title of Standard
 
 
04/04/2016 Sterility 14-277 ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2:2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
09/17/2018 Sterility 14-275 ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
07/09/2014 Sterility 14-257 ASTM D3078-02 (Reapproved 2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
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
01/27/2015 Sterility 14-243 ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
01/27/2015 Sterility 14-242 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
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
09/09/2008 Sterility 14-239 ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
01/15/2013 Sterility 14-217 AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
01/15/2013 Sterility 14-215 AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
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