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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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(click for recognition information)
 
07/09/2014 Dental/
ENT		 4-211 Complete ANSI ASA S3.46-2013 (Reaffirmed 2023) American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
01/14/2019 Dental/
ENT		 4-171 Complete ANSI ASA S3.37-1987 (Reaffirmed 2020) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
01/14/2019 Dental/
ENT		 4-162 Complete ANSI ASA S3.4-2007 (Reaffirmed 2020) American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/27/2015 Dental/
ENT		 4-185 Complete ANSI ASA S3.45-2009 (Reaffirmed 2019) American National Standard Procedures for Testing Basic Vestibular Function
04/04/2016 General II (ES/
EMC)		 19-17 Complete IEEE ANSI C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
09/17/2018 General II (ES/
EMC)		 19-31 Complete IEEE ANSI C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
01/14/2019 Dental/
ENT		 4-217 Complete ANSI ASA S3.36-2012 (Reaffirmed 2022) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
08/14/2015 Dental/
ENT		 4-220 Complete ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/06/2013 Dental/
ENT		 4-90 Complete ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
08/06/2013 Dental/
ENT		 4-204 Complete ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
12/21/2020 Anesthesiology 1-147 Complete ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
08/14/2015 Anesthesiology 1-103 Partial ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment - Breathing sets and connectors
03/16/2012 Anesthesiology 1-62 Complete ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
ANSI AAMI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
06/07/2018 Anesthesiology 1-130 Complete ISO 18082 First edition 2014-06-15 Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
01/14/2019 Anesthesiology 1-120 Complete ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
12/21/2020 Anesthesiology 1-149 Complete ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
06/07/2018 Anesthesiology 1-129 Complete ISO 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
07/15/2019 Anesthesiology 1-126 Complete ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
12/18/2023 Anesthesiology 1-164 Complete ISO 5361 Fourth edition 2023-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/23/2016 Anesthesiology 1-118 Complete ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
05/29/2023 Anesthesiology 1-161 Complete ISO 16628 Second edition 2022-06 Anaesthetic and respiratory equipment - Tracheobronchial tubes
01/14/2019 Anesthesiology 1-117 Complete ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
07/15/2019 Anesthesiology 1-122 Complete ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
03/16/2012 Anesthesiology 1-75 Complete ISO 5362 Fourth edition 2006-06-01 Anaesthetic Reservoir Bags
ANSI AAMI ISO 5362:2006 Anaesthetic Reservoir Bags
07/15/2019 Anesthesiology 1-116 Complete ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
05/30/2022 InVitro Diagnostics 7-312 Complete CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
01/14/2019 General I (QS/
RM)		 5-120 Complete IEC 60812 Edition 3.0 2018-08 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
08/21/2017 InVitro Diagnostics 7-270 Complete CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
08/14/2015 Ophthalmic 10-99 Complete ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
07/09/2014 InVitro Diagnostics 7-175 Complete CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
01/15/2013 Software/
Informatics		 13-35 Complete ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
08/06/2013 Software/
Informatics		 13-42 Complete ANSI AAMI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
08/06/2013 Software/
Informatics		 13-44 Complete ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
06/27/2016 Software/
Informatics		 13-82 Complete ANSI AAMI ISO TIR 80001-2-6:2014 Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
08/06/2013 Software/
Informatics		 13-40 Complete ANSI AAMI IEC TIR 80001-2-1 2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
IEC TR 80001-2-1 Edition 1.0 2012-07 Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
01/27/2015 Software/
Informatics		 13-70 Complete ANSI AAMI IEC TIR80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC TR 80001-2-5 Edition 1.0 2014-12 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
12/04/2017 Software/
Informatics		 13-102 Complete IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
12/04/2017 Software/
Informatics		 13-103 Complete IEC TR 80001-2-9 Edition 1.0 2017-01 Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
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)]
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 (R2013) 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
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
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
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
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 2-191 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
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
08/21/2017 Biocompatibility 2-247 Complete ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
08/21/2017 Biocompatibility 2-248 Complete ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
07/09/2014 InVitro Diagnostics 7-48 Complete CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
01/30/2014 InVitro Diagnostics 7-244 Complete CLSI NBS01-A6 (Replaces LA04-A5) Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
01/14/2019 Cardiovascular 3-44 Complete ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
08/06/2013 General Plastic Surgery/
General Hospital		 6-295 Complete AAMI ANSI BF7:2012 Blood transfusion microfilters
09/09/2008 InVitro Diagnostics 7-163 Complete CLSI H56-A (Replaces H56-P) Body Fluid Analysis for Cellular Composition; Approved Guideline.
12/21/2020 Dental/
ENT		 4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
03/31/2006 Radiology 12-141 Complete IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
01/30/2014 Cardiovascular 3-63 Complete ISO 11318:2002 Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
 
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