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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 14-547 USP 42-NF37:2019 <71> Sterility Tests
07/06/2020 Sterility 14-546 USP 42-NF37:2019 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
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 14-544 ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
07/06/2020 Sterility 14-543 ANSI AAMI ISO TIR 11139:2006 Sterilization of health care products - Vocabulary
ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
07/06/2020 Sterility 14-542 ASTM ISO 52628 Second edition 2020-04 Standard practice for dosimetry in radiation processing
07/06/2020 Sterility 14-541 ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
07/06/2020 Sterility 14-540 ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020 Sterility 14-539 ASTM F2475-20 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
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