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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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 14-516 ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
07/15/2019 Sterility 14-529 ANSI AAMI ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
07/15/2019 Sterility 14-530 ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
07/15/2019 Sterility 14-531 ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
01/14/2019 Sterility 14-518 ANSI AAMI ST55:2016 Table-top steam sterilizers
07/09/2014 Sterility 14-257 ASTM D3078-02 (Reapproved 2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
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