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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
07/15/2019 Sterility 14-527 ASTM F2638-18 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
01/14/2019 Sterility 14-519 ASTM F17-18 Standard Terminology Relating to Flexible Barrier Packaging
01/14/2019 Sterility 14-518 ANSI AAMI ST55:2016 Table-top steam sterilizers
09/17/2018 Sterility 14-517 ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
09/17/2018 Sterility 14-516 ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
07/06/2020 Sterility 14-515 ANSI AAMI ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17664 Second edition 2017-10 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
09/17/2018 Sterility 14-514 ANSI AAMI ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products
ISO 11737-1 Third edition 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
09/17/2018 Sterility 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
09/17/2018 Sterility 14-512 ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
06/07/2018 Sterility 14-511 ANSI AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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