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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 14-498 ASTM F2097-16 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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
01/15/2013 Sterility 14-359 ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
01/15/2013 Sterility 14-213 AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
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
01/15/2013 Sterility 14-217 AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
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 14-405 ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
08/14/2015 Sterility 14-478 ANSI AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
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