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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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01/27/2015 Sterility 14-456 Complete ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
07/09/2014 Sterility 14-437 Complete ISO ASTM 52701 First edition 2013-11-15 (R2020) Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
07/09/2014 Sterility 14-435 Complete ASTM F2251-13 (Reapproved 2023) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-434 Complete ASTM F2228-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014 Sterility 14-433 Complete ASTM F2227-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
07/09/2014 Sterility 14-432 Complete ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
01/30/2014 Sterility 14-430 Complete ISO ASTM 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
01/30/2014 Sterility 14-429 Complete ISO ASTM 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
01/30/2014 Sterility 14-427 Complete ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
01/30/2014 Sterility 14-413 Complete AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
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