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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/06/2013 Sterility 14-388 ANSI AAMI ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
01/14/2019 Sterility 14-521 USP 41-NF36:2018 <71> Sterility Tests
01/14/2019 Sterility 14-518 ANSI AAMI ST55:2016 Table-top steam sterilizers
01/27/2015 Sterility 14-166 ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
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
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
01/30/2014 Sterility 14-404 ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
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
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