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U.S. Department of Health and Human Services

Recognized Consensus Standards

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01/27/2015 Sterility 14-390 ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
01/27/2015 Sterility 14-389 ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
08/06/2013 Sterility 14-388 ANSI AAMI ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
08/06/2013 Sterility 14-383 ASTM ISO 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing
08/06/2013 Sterility 14-382 ASTM ISO 51276 Second edition 2012-07-15 Practice for use of a polymethylmethacrylate dosimetry system
08/06/2013 Sterility 14-381 ASTM ISO 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
01/27/2015 Sterility 14-379 ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
01/15/2013 Sterility 14-377 ASTM F2638-12 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
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
12/23/2016 Sterility 14-360 ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
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