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U.S. Department of Health and Human Services

Recognized Consensus Standards

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01/30/2014 Sterility 14-424 ANSI AAMI ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)]
ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)]
01/30/2014 Sterility 14-413 AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
01/30/2014 Sterility 14-412 AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
01/30/2014 Sterility 14-411 ASTM ISO 51818 Third edition 2013-06-01 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
01/30/2014 Sterility 14-410 ASTM F17-13a Standard Terminology Relating to Flexible Barrier Packaging
04/04/2016 Sterility 14-409 ANSI AAMI ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
01/30/2014 Sterility 14-408 ANSI AAMI ISO 10993-7:2008(R)2012 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
04/04/2016 Sterility 14-407 ANSI AAMI ISO 11737-1:2006 (R)2011 Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of microorganisms on product
ISO 11737-1 Second edition 2006-04-01 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013 Hospital steam sterilizers
01/30/2014 Sterility 14-405 ASTM F2252/F2252M-13e1 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
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