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U.S. Department of Health and Human Services

Recognized Consensus Standards
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12/21/2020 Sterility 14-550 ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
01/14/2019 Sterility 14-314 ANSI AAMI ST67:2011/(R)2017 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
12/21/2020 Sterility 14-551 ISO 14160 Third edition 2020-09 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
08/21/2017 Sterility 14-361 ANSI AAMI ISO 14160:2011/ (R)2016 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 14160 Second edition 2011-07-01 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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
12/23/2016 Sterility 14-498 ASTM F2097-16 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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