Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 01/14/2019 | Cardiovascular | 3-52 | Partial | ANSI AAMI | EC12:2000/(R)2015 | Disposable ECG electrodes |
| 12/20/2021 | Cardiovascular | 3-174 | Partial | ISO | 5840-1 Second edition 2021-01 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| 07/06/2020 | Cardiovascular | 3-123 | Partial | IEC | 80601-2-30: Edition 2.0 2018-03 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ANSI AAMI IEC | 80601-2-30:2018 | Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers | ||||
| 05/29/2023 | Cardiovascular | 3-185 | Partial | ANSI AAMI | PC76:2021 | Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
| 01/14/2019 | Cardiovascular | 3-86 | Partial | ASTM | F2394-07 (Reapproved 2017) | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| 12/23/2019 | Cardiovascular | 3-163 | Partial | ISO | 18242 First edition 2016-09-01 | Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps |
| 12/23/2024 | Cardiovascular | 3-195 | Partial | ISO | 5910 Second edition 2024-07 | Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 12/21/2020 | Cardiovascular | 3-169 | Partial | IEC | 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ANSI AAMI IEC | 60601-2-4:2010/A1:2018 (Consolidated Text) | Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 | ||||
| 06/07/2021 | Cardiovascular | 3-166 | Partial | ISO | 81060-2 Third edition 2018-11 [Including AMD1:2020] | Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)] |
| 05/29/2023 | Cardiovascular | 3-188 | Partial | ISO | 81060-3 First edition 2022-12 | Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
| 06/07/2021 | Cardiovascular | 3-129 | Partial | ANSI AAMI | EC53:2013/(R)2020 | ECG trunk cables and patient leadwires |
| 12/23/2024 | Cardiovascular | 3-196 | Partial | ISO | 81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] | Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)] |
| 01/14/2019 | Cardiovascular | 3-159 | Partial | ISO | 5910 First edition 2018-06 | Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 06/07/2021 | Cardiovascular | 3-168 | Partial | IEEE | Std 1708-2014 | Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| 06/07/2021 | Dental/ ENT |
4-276 | Partial | ISO | 14457 Second edition 2017-10 | Dentistry - Handpieces and motors |
| ANSI ADA | Standard No. 35-2019 | Dental Handpieces and Motors | ||||
| 01/14/2019 | Dental/ ENT |
4-257 | Partial | ISO | 17730 First edition 2014-11-01 | Dentistry - Fluoride varnishes |
| 07/15/2019 | Dental/ ENT |
4-259 | Partial | ISO | 14801 Third edition 2016-11-01 | Dentistry - Implants - Dynamic loading test for endosseous dental implants |
| ANSI ADA | Standard No. 127-2018 | Dynamic Loading Test for Endosseous Dental Implants | ||||
| 05/29/2023 | Dental/ ENT |
4-306 | Partial | ISO | 22052 First edition 2020-06 | Dentistry - Compressed air source equipment |
| ANSI ADA | Standard No. 94-2021 | Central Compressed Air Source Equipment | ||||
| 06/07/2021 | Dental/ ENT |
4-280 | Partial | ANSI ADA | Standard No. 117-2018 | Fluoride varnishes |
| 12/18/2023 | Dental/ ENT |
4-319 | Partial | ISO | 17730 Second edition 2020-09 | Dentistry - Fluoride varnishes |
| ANSI ADA | Standard No. 117-2022 | Dentistry - Fluoride Varnishes | ||||
| 05/29/2023 | Dental/ ENT |
4-305 | Partial | ISO | 10637 Second edition 2018-05 | Dentistry - Central suction source equipment |
| ANSI ADA | Standard No. 177-2020 | Central Suction Source Equipment | ||||
| 01/14/2019 | Dental/ ENT |
4-251 | Complete | ISO | 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] | Dentistry - Ceramic materials |
| ANSI ADA | Standard No. 69-2020 | Dental Ceramic | ||||
| 12/23/2024 | Dental/ ENT |
4-330 | Complete | ANSI ADA | Standard No. 63-2020 | Endodontic Instruments - Auxillary |
| 01/14/2019 | Dental/ ENT |
4-248 | Complete | ISO | 10477 Third edition 2018-06 | Dentistry - Polymer-based crown and veneering materials |
| 05/29/2023 | Dental/ ENT |
4-303 | Complete | ISO | 9333 Third edition 2022-08 | Dentistry - Brazing 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 |
| 12/21/2020 | Dental/ ENT |
4-267 | Complete | ISO | 21606 First edition 2007-06 | Dentistry - Elastomeric auxiliaries for use in orthodontics |
| ANSI ADA | Standard No. 105-2010 (R2015) | Orthodontic Elastomeric Materials | ||||
| 12/21/2020 | Dental/ ENT |
4-266 | Complete | ISO | 19023 First edition 2018-02 | Dentistry - Orthodontic anchor screws |
| ANSI ADA | Standard No. 178-2019 | Orthodontic Anchor Screws | ||||
| 12/21/2020 | Dental/ ENT |
4-268 | Complete | ISO | 15841 Second edition 2014-08 | Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
| ANSI ADA | Standard No. 32-2017 | Orthodontic Wires | ||||
| 12/23/2019 | Dental/ ENT |
4-261 | Complete | ISO | 7405 Third edition 2018-10 Corrected version 2018-12 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| 12/23/2019 | Dental/ ENT |
4-262 | Complete | IEC | 80601-2-60 Edition 2.0 2019-06 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| 12/23/2019 | Dental/ ENT |
4-260 | Complete | ANSI ASA | S12.2-2019 (Reaffirmed 2023) | American National Standard for Criteria for Evaluating Room Noise |
| 07/15/2019 | Dental/ ENT |
4-258 | Complete | ISO | 10139-2 Third edition 2016-06-15 | Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
| ANSI ADA | Standard No. 160-2020 | Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use | ||||
| 06/07/2021 | Dental/ ENT |
4-274 | Complete | ANSI ASA | S3.2-2020 | American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| 12/23/2024 | Dental/ ENT |
4-331 | Complete | ISO | 28399 Third edition 2021-03 | Dentistry - External tooth bleaching products |
| ANSI ADA | Standard No. 136-2022 | Dentistry - External Tooth Bleaching Products | ||||
| 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 | ||||
| 12/23/2024 | Dental/ ENT |
4-332 | Complete | ADA ANSI | Standard No. 206-2024 | Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File |
| 12/23/2024 | Dental/ ENT |
4-333 | Complete | ISO | 3630-4 Second edition 2023-08 | Dentistry - Endodontic instruments - Part 4: Auxiliary instruments |
| 05/30/2022 | Dental/ ENT |
4-293 | Complete | ANSI ADA | Standard No. 119-2021 | Manual Toothbrushes |
| 01/14/2019 | Dental/ ENT |
4-255 | Complete | ANSI ADA | Standard No. 131-2015 (R2020) | Dental CAD/CAM Machinable Zirconia Blanks |
| 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) |
| 12/18/2023 | Dental/ ENT |
4-309 | Complete | ISO | 6877 Third edition 2021-09 | Dentistry - Endodontic obturating materials |
| ANSI ADA | Standard No. 78-2021 | Dentistry - Endodontic Obturating Materials | ||||
| 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 |
| 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 |
4-300 | 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 | ||||
| 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 |
4-278 | 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 | ||||
| 01/14/2019 | Dental/ ENT |
4-250 | Complete | ISO | 7494-1 Third edition 2018-06 | Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 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 | ||||
| 04/04/2016 | Dental/ ENT |
4-222 | Complete | ISO | 6874 Third edition 2015-09-01 | Dentistry - Polymer-based pit and fissure sealants |
| ANSI ADA | Standard No. 39-2020 | Pit and Fissure Sealants | ||||
| 06/07/2021 | Dental/ ENT |
4-277 | Complete | ANSI IEEE | C63.19-2019 | American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids |
| 09/17/2018 | Dental/ ENT |
4-242 | Complete | ISO | 10139-1 Third edition 2018-03 | Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use |
| ANSI ADA | Standard No. 75-2020 | Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials | ||||
| 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 | ||||
| 01/14/2019 | Dental/ ENT |
4-252 | Complete | ISO | 10650 Second edition 2018-08 | Dentistry - Powered polymerization activators |
| ANSI ADA | Standard No. 48-2020 | Curing Lights (Powered Polymerization Activators) | ||||
| 01/14/2019 | Dental/ ENT |
4-256 | Complete | ANSI ADA | Standard No. 132-2015 | Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 06/27/2016 | Dental/ ENT |
4-228 | Complete | ANSI ASA | S3.20-2015 (Reaffirmed 2020) | American National Standard Bioacoustical Terminology |
| 06/27/2016 | Dental/ ENT |
4-202 | Complete | ANSI ADA | Standard No. 58-2010 (R2015) | Root Canal Files, Type H (Hedstrom) |
| 05/29/2024 | Dental/ ENT |
4-325 | Complete | ANSI ADA | Standard No. 96-2020 | Dental Water-based Cements |
| 06/07/2021 | Dental/ ENT |
4-273 | Complete | ANSI ASA | S3.7-2016 (Reaffirmed 2023) | American National Standard Method for Coupler Calibration of Earphones |
| 06/07/2021 | Dental/ ENT |
4-275 | Complete | ANSI ASA | S3.6-2018 (Reaffirmed 2023) | American National Standard for Specification for Audiometers |
| 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 | ||||
| 12/20/2021 | Dental/ ENT |
4-286 | Complete | ANSI ADA | Standard No. 87-1995 (R2014) | Dental Impression Trays |
| 12/23/2024 | Dental/ ENT |
4-336 | Complete | ISO | 18397 First edition 2016-01 | Dentistry - Powered scaler |
| ANSI ADA | Standard No. 157-2020 | Powered Dental Scaler Handpieces and Tips | ||||
| 08/14/2015 | Dental/ ENT |
4-130 | Complete | ANSI ADA | Standard No. 17-1983 (R2014) | Denture Base Temporary Relining Resins |
| 12/21/2020 | Dental/ ENT |
4-271 | Complete | ANSI ADA | Standard No. 34-2013 | Dental Cartridge Syringes |
| 07/09/2014 | Dental/ ENT |
4-165 | Complete | ANSI ASA | S3.13-1987 (Reaffirmed 2024) | American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 08/21/2017 | Dental/ ENT |
4-232 | Complete | ISO | 20795-1 Second edition 2013-03-01 | Dentistry - Base polymers - Part 1: Denture base polymers |
| 08/21/2017 | Dental/ ENT |
4-239 | Complete | ANSI AAMI | CI86:2017 | Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 01/27/2015 | Dental/ ENT |
4-136 | Complete | ASTM | F2504-05 (Reapproved 2022) | Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
| 07/09/2014 | Dental/ ENT |
4-149 | Complete | ANSI ADA | Standard No. 39-2006 (R2011) | Pit and Fissure Sealants |
| 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 |
| 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) |
| 12/20/2021 | Dental/ ENT |
4-285 | Complete | ANSI ADA | Standard No. 37-1986 (R2020) | Dental Abrasive Powders |
| 12/19/2022 | Dental/ ENT |
4-294 | Complete | ANSI ADA | Standard No. 139-2020 | Dental Base Polymers |
| 12/19/2022 | Dental/ ENT |
4-295 | Complete | ANSI ADA | Standard No. 41-2020 | Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 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 | ||||
| 12/19/2022 | Dental/ ENT |
4-297 | Complete | ISO | 20126 Third edition 2022-03 | Dentistry - Manual toothbrushes - General requirements and test methods |
| 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 | ||||
| 12/23/2024 | Dental/ ENT |
4-334 | Complete | ISO | 11143 Second edition 2008-07 | Dentistry - Amalgam separators |
| ANSI ADA | Standard No. 108-2009, Addendum (R2022) | Amalgam Separators | ||||
| 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) |
| 12/20/2021 | Dental/ ENT |
4-288 | Complete | ISO | 7488 Second edition 2018-04 | Dentistry - Mixing machines for dental amalgam |
| ANSI ADA | Standard No. 43-2020 | Electrically Powered Dental Amalgamators | ||||
| 12/20/2021 | Dental/ ENT |
4-289 | Complete | ISO | 18556 Frist edition 2016-04 | Dentistry - Intraoral spatulas |
| 12/21/2020 | Dental/ ENT |
4-270 | Complete | ANSI ADA | Technical Report No. 146-2018 | CAD/CAM Abutments in Dentistry |
| 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 |
| 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 |
| 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 | ||||
| 12/18/2023 | 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 | ||||
| 01/30/2014 | Dental/ ENT |
4-181 | Complete | ISO | 4049 Fourth edition 2009-10-01 | Dentistry - Polymer-based restorative materials |
| 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 | ||||
| 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 | ||||
| 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 |
| 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 |
4-301 | Complete | ISO | 21563 Second edition 2021-08 | Dentistry - Hydrocolloid impression materials |
| ANSI ADA | Standard No. 128-2022 | Hydrocolloid Impression Materials | ||||
| 06/07/2018 | Dental/ ENT |
4-240 | Complete | ISO | 21563 First edition 2013-08-15 | Dentistry - Hydrocolloid impression materials |
| ANSI ADA | Standard No. 128-2015 | Hydrocolloid Impression 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 | ||||
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