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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
Recognition
 
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Standard Designation
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Title of Standard
 
 
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
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
12/23/2016 Sterility 14-500 ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
12/23/2016 Sterility 14-499 ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
12/23/2016 Sterility 14-498 ASTM F2097-16 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
12/23/2016 Sterility 14-497 ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/23/2016 Sterility 14-496 ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
06/27/2016 Sterility 14-482 ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
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