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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
 
 
07/06/2020 Sterility 14-539 ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
01/15/2013 Sterility 14-313 ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
01/30/2014 Sterility 14-395 ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014 Sterility 14-397 AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014 Sterility 14-399 AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014 Sterility 14-400 ASTM F2203-13 (Reapproved 2018) Standard Test Method for Linear Measurement Using Precision Steel Rule
01/30/2014 Sterility 14-401 ASTM F2217/F2217M- (Reapproved 2018) Standard Practice for Coating/Adhesive Weight Determination
01/30/2014 Sterility 14-402 ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
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