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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/21/2020 Sterility 14-554 ASTM F17-20 Standard Terminology Relating to Flexible Barrier Packaging
12/21/2020 Sterility 14-555 USP 43-NF38:2020 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/21/2020 Sterility 14-556 USP 43-NF38:2020 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/21/2020 Sterility 14-557 USP 43-NF38:2020 <55> Biological Indicators -- Resistance Performance Tests
12/21/2020 Sterility 14-558 USP 43-NF38:2020 <1229.5> Biological Indicators for Sterilization
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
12/21/2020 Tissue Engineering 15-64 ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
12/21/2020 Tissue Engineering 15-65 ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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