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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
09/17/2018 General I (QS/
RM)
5-42 Complete ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
01/27/2015 General I (QS/
RM)
5-62 Complete ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
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
01/30/2014 General I (QS/
RM)
5-47 Complete ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
08/21/2017 General I (QS/
RM)
5-107 Complete IEC 80369-5: Edition 1.0 2016-03 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
ANSI AAMI ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
07/15/2019 General I (QS/
RM)
5-123 Complete ISO 80369-3 First Edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
01/30/2014 General I (QS/
RM)
5-84 Complete AAMI TIR 49:2013/(R)2020 Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
01/27/2015 General I (QS/
RM)
5-48 Complete ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
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)
12/19/2022 General I (QS/
RM)
5-140 Complete ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12/21/2020 General I (QS/
RM)
5-131 Complete IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
12/21/2020 General I (QS/
RM)
5-133 Complete ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
12/23/2016 General I (QS/
RM)
5-113 Complete ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
07/06/2020 General I (QS/
RM)
5-130 Complete ISO 7010 Third edition 2019-07 Graphical symbols - Safety colours and safety signs - Registered safety signs
04/04/2016 General I (QS/
RM)
5-98 Complete ANSI ESD S20.20-2014 Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
12/23/2019 General I (QS/
RM)
5-125 Complete ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
12/19/2022 General I (QS/
RM)
5-141 Complete ASME V&V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
12/20/2021 General I (QS/
RM)
5-134 Complete ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
05/29/2024 General I (QS/
RM)
5-142 Complete ISO 780 Fifth edition 2015-12-01 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages
12/19/2022 General I (QS/
RM)
5-137 Complete IEC TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
12/19/2022 General I (QS/
RM)
5-136 Complete ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022 General I (QS/
RM)
5-138 Complete AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/19/2022 General I (QS/
RM)
5-139 Complete ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
07/09/2014 General I (QS/
RM)
5-88 Complete ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
06/27/2016 General I (QS/
RM)
5-108 Complete ISO 80369-6 First Edition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
07/06/2020 General I (QS/
RM)
5-129 Complete IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
12/21/2020 General I (QS/
RM)
5-132 Complete IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
06/27/2016 General I (QS/
RM)
5-57 Partial ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
12/18/2023 Dental/
ENT
4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
12/18/2023 Dental/
ENT
4-322 Complete ISO 18675 First edition 2022-05 Dentistry - Machinable ceramic blanks
12/18/2023 Dental/
ENT
4-323 Complete ISO 5139 First edition 2023-05 Dentistry - Polymer-based composite machinable blanks
12/18/2023 Dental/
ENT
4-324 Complete ISO TS 16506 First edition 2017-07 Corrected version 2018-03 Dentistry - Polymer-based luting materials containing adhesive components
07/09/2014 Dental/
ENT
4-160 Complete ANSI ASA S3.1-1999 (Reaffirmed 2023) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
06/07/2021 Dental/
ENT
4-281 Complete ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
01/30/2014 Dental/
ENT
4-181 Complete ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
05/29/2023 Dental/
ENT
4-299 Complete ISO 3107 Fifth edition 2022-09 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
ANSI ADA Standard No. 30-2023 Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
01/30/2014 Dental/
ENT
4-198 Complete ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
ANSI ADA Standard No. 30-2013 (R2018) Dental Zinc Oxide-Eugenol and Zinc Oxide
05/29/2023 Dental/
ENT
4-300 Complete ISO 22674 Third edition 2022-08 Dentistry - Metallic materials for fixed and removable restorations and appliances
ANSI ADA Standard No. 134-2023 Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances
12/20/2021 Dental/
ENT
4-289 Complete ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT
4-290 Complete ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
12/20/2021 Dental/
ENT
4-291 Complete ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
12/20/2021 Dental/
ENT
4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
12/19/2022 Dental/
ENT
4-296 Complete ISO 9873 Fourth edition 2019-03 Dentistry - Intra-oral mirrors
ANSI ADA Standard No. 191-2020 Intra-Oral Mirrors
12/20/2021 Dental/
ENT
4-292 Complete ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
12/20/2021 Dental/
ENT
4-285 Complete ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
05/29/2023 Dental/
ENT
4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
12/19/2022 Dental/
ENT
4-297 Complete ISO 20126 Third edition 2022-03 Dentistry - Manual toothbrushes - General requirements and test methods
01/27/2015 Dental/
ENT
4-218 Complete ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
12/19/2022 Dental/
ENT
4-294 Complete ANSI ADA Standard No. 139-2020 Dental Base Polymers
12/21/2020 Dental/
ENT
4-271 Complete ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/21/2020 Dental/
ENT
4-272 Complete ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
05/30/2022 Dental/
ENT
4-293 Complete ANSI ADA Standard No. 119-2021 Manual Toothbrushes
12/20/2021 Dental/
ENT
4-287 Complete ANSI ADA Standard No. 116-2020 Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
06/07/2021 Dental/
ENT
4-278 Complete ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
05/29/2023 Dental/
ENT
4-301 Complete ISO 21563 Second edition 2021-08 Dentistry - Hydrocolloid impression materials
ANSI ADA Standard No. 128-2022 Hydrocolloid Impression Materials
06/27/2016 Dental/
ENT
4-227 Complete ISO 22674 Second edition 2016-01-15 Dentistry - Metallic materials for fixed and removable restorations and appliances
ANSI ADA Standard No. 134-2018 Metallic Materials for Fixed and Removable Restorations and Appliances
06/07/2021 Dental/
ENT
4-279 Complete ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT
4-283 Complete ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
12/19/2022 Dental/
ENT
4-295 Complete ANSI ADA Standard No. 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
12/21/2020 Dental/
ENT
4-269 Complete ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
ANSI ADA Standard No. 158-2020 Coupling Dimensions for Dental Handpiece Connectors
05/29/2023 Dental/
ENT
4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
04/04/2016 Dental/
ENT
4-224 Complete ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
12/18/2023 Dental/
ENT
4-316 Complete ISO 20127 Second edition 2020-08 Dentistry - Physical properties of powered toothbrushes
ANSI ADA Standard No.120-2022 Dentistry - Physical Properties of Powered Toothbrushes
08/21/2017 Dental/
ENT
4-238 Complete ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
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
4-217 Complete ANSI ASA S3.36-2012 (Reaffirmed 2022) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
12/18/2023 Dental/
ENT
4-320 Complete ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
05/29/2024 Dental/
ENT
4-325 Complete ANSI ADA Standard No. 96-2020 Dental Water-based Cements
12/18/2023 Dental/
ENT
4-314 Complete ISO 7494-2 Third edition 2022-07 Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
04/04/2016 Dental/
ENT
4-221 Complete ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
01/27/2015 Dental/
ENT
4-219 Complete ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
09/17/2018 Dental/
ENT
4-244 Complete ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
01/14/2019 Dental/
ENT
4-254 Complete ANSI ADA Standard No. 99-2001 (R2023) Athletic Mouth Protectors and Materials
05/29/2023 Dental/
ENT
4-302 Complete ISO 10477 Fourth edition 2020-10 Dentistry - Polymer-based crown and veneering materials
ANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials
03/16/2012 Dental/
ENT
4-173 Complete ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
05/29/2024 Dental/
ENT
4-326 Complete ISO 9687 Second edition 2015-02 Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)]
05/29/2024 Dental/
ENT
4-327 Complete ISO 21531 First edition 2009-02 Dentistry - Graphical symbols for dental instruments
05/29/2023 Dental/
ENT
4-307 Complete ISO 13504 First edition 2012-07 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
01/14/2019 Dental/
ENT
4-248 Complete ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
01/30/2014 Dental/
ENT
4-137 Complete ISO 6877 Second edition 2006-04-01 Dentistry - Root-canal obturating points
ANSI ADA Standard No. 78-2013 Dental obturating cones
12/18/2023 Dental/
ENT
4-310 Complete ISO 22112 Second edition 2017-08 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2021 Artificial Teeth for Dental Prostheses
12/18/2023 Dental/
ENT
4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
08/21/2017 Dental/
ENT
4-215 Complete ANSI ADA Standard No. 96-2012 Dental Water-based Cements
12/18/2023 Dental/
ENT
4-312 Complete ANSI ASA S3.35-2021 American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
09/17/2018 Dental/
ENT
4-246 Complete ISO 20749 First edition 2017-03 Dentistry - Pre-capsulated dental amalgam
ANSI ADA Standard No. 144-2018 Alloy for Dental Amalgam
01/30/2014 Dental/
ENT
4-151 Complete ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
01/30/2014 Dental/
ENT
4-188 Complete ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements
05/29/2023 Dental/
ENT
4-308 Complete ISO 14708-7 Second edition 2019-12 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
12/18/2023 Dental/
ENT
4-313 Complete ISO 27020 Second edition 2019-06 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2020 Orthodontic Brackets and Tubes
07/09/2014 Dental/
ENT
4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
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
4-163 Complete ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
12/21/2020 Dental/
ENT
4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
01/30/2014 Dental/
ENT
4-153 Complete ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014 Dental/
ENT
4-180 Complete ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
01/30/2014 Dental/
ENT
4-199 Complete ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
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)
12/21/2020 Dental/
ENT
4-265 Complete ISO 10271 Third edition 2020-08 Dentistry - Corrosion test methods for metallic materials
ANSI ADA Standard No. 97-2020 Corrosion Test Methods for Metallic Materials
12/21/2020 Dental/
ENT
4-264 Complete ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
05/29/2023 Dental/
ENT
4-304 Complete ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
 
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