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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
Recognition
 
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Standard Designation
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Title of Standard
 
 
03/16/2012 Sterility 14-325 ANSI AAMI ISO TIR 11139:2006 Sterilization of health care products - Vocabulary
ISO /TS 11139 Second edition 2006-01-15 Sterilization of health care products - Vocabulary
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"
01/15/2013 Sterility 14-313 ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
12/23/2016 Sterility 14-311 ANSI AAMI ST55:2010/(R)2014 Table-top steam sterilizers
06/07/2018 Sterility 14-295 ANSI AAMI ST81:2004/(R)2016 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
09/17/2018 Sterility 14-294 ANSI AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
09/17/2018 Sterility 14-293 ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
07/09/2014 Sterility 14-290 ANSI AAMI ST24:1999/(R)2013 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
07/09/2014 Sterility 14-286 ANSI AAMI ST65:2008/(R)2013 Processing of reusable surgical textiles for use in health care facilities
07/09/2014 Sterility 14-282 ASTM F2338-09 (Reapproved 2013) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
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