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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date
 

Title of Standard
 
 
07/06/2020 Sterility 14-545 ASTM ISO 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
07/06/2020 Sterility 14-549 ASTM F3004-13e1 Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
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
12/23/2019 Sterility 14-538 ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
12/21/2020 Sterility 14-554 ASTM F17-20 Standard Terminology Relating to Flexible Barrier Packaging
01/14/2019 Sterility 14-519 ASTM F17-18 Standard Terminology Relating to Flexible Barrier Packaging
12/21/2020 Sterility 14-559 USP 43-NF38:2020 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/21/2020 Sterility 14-560 USP 43-NF38:2020 <71> Sterility Tests
12/21/2020 Sterility 14-561 USP 43-NF38:2020 <85> Bacterial Endotoxins Test
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