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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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09/17/2018 Sterility 14-512 Complete ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
09/09/2008 Sterility 14-239 Complete ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
09/09/2008 Sterility 14-191 Complete ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
09/09/2008 Sterility 14-240 Complete ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
12/20/2021 Sterility 14-563 Complete ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
08/06/2013 Sterility 14-388 Complete ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ANSI AAMI ISO 13408-7:2012 (R2018) Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
01/14/2019 General I (QS/
RM)		 5-122 Complete ASME V&V 40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
11/08/2005 InVitro Diagnostics 7-113 Complete CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
07/06/2020 InVitro Diagnostics 7-298 Complete CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
08/06/2013 InVitro Diagnostics 7-234 Partial CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
06/07/2018 Materials 8-464 Complete ISO TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
05/29/2023 General Plastic Surgery/
General Hospital		 6-486 Complete ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
01/14/2019 Dental/
ENT		 4-254 Complete ANSI ADA Standard No. 99-2001 (R2023) Athletic Mouth Protectors and Materials
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
03/18/2009 Software/
Informatics		 13-26 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
07/06/2020 Sterility 14-541 Complete ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
05/29/2024 Anesthesiology 1-173 Partial ISO 18562-1 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
06/07/2018 Anesthesiology 1-134 Partial ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
05/29/2024 Anesthesiology 1-174 Complete ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
06/07/2018 Anesthesiology 1-135 Complete ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
06/07/2018 Anesthesiology 1-136 Complete ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
05/29/2024 Anesthesiology 1-175 Complete ISO 18562-3 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
05/29/2024 Anesthesiology 1-176 Complete ISO 18562-4 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
06/07/2018 Anesthesiology 1-137 Partial ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
06/07/2021 Biocompatibility 2-290 Partial ISO TS 37137-1 First edition 2021-03 Biological evaluation of absorbable medical devices - Part 1: General requirements.
12/19/2022 Biocompatibility 2-296 Partial ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
07/15/2019 Biocompatibility 2-268 Complete ISO TS 21726 First edition 2019-02 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
01/14/2019 Biocompatibility 2-258 Partial ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
07/26/2016 Biocompatibility 2-174 Complete ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
09/17/2018 Biocompatibility 2-255 Complete ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
07/26/2016 Biocompatibility 2-191 Partial ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/19/2022 Biocompatibility 2-289 Complete ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016 Biocompatibility 2-169 Partial ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016 Biocompatibility 2-170 Complete ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
12/21/2020 Biocompatibility 2-288 Partial ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
06/07/2018 Biocompatibility 2-249 Complete ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
07/26/2016 Biocompatibility 2-237 Partial ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
12/18/2023 Biocompatibility 2-303 Partial ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
12/19/2022 Biocompatibility 2-298 Partial ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
07/06/2020 Biocompatibility 2-276 Partial ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
12/21/2020 Biocompatibility 2-281 Complete ISO TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
05/29/2023 Biocompatibility 2-300 Complete ISO 10993-2 Third edition 2022-11 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-222 Complete ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-240 Partial ANSI AAMI ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO TS 10993-20 First edition 2006-08-01 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
06/07/2021 Biocompatibility 2-291 Partial ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
07/26/2016 Biocompatibility 2-228 Partial ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
07/26/2016 Biocompatibility 2-243 Partial ISO TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
12/23/2016 Biocompatibility 2-245 Complete ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
07/06/2020 Biocompatibility 2-275 Complete ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
07/06/2020 Biocompatibility 2-273 Complete ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
 
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