Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 06/27/2016 | Dental/ ENT |
4-202 | Complete | ANSI ADA | Standard No. 58-2010 (R2015) | Root Canal Files, Type H (Hedstrom) |
| 07/09/2014 | Dental/ ENT |
4-165 | Complete | ANSI ASA | S3.13-1987 (Reaffirmed 2020) | American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 08/14/2015 | Dental/ ENT |
4-130 | Complete | ANSI ADA | Standard No. 17-1983 (R2014) | Denture Base Temporary Relining Resins |
| 07/09/2014 | Dental/ ENT |
4-177 | Complete | ANSI ASA | S12.65-2006 (Reaffirmed 2020) | American National Standard For Rating Noise with Respect to Speech Interference |
| 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 |
| 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 |
| 01/14/2019 | Dental/ ENT |
4-248 | Complete | ISO | 10477 Third edition 2018-06 | Dentistry - Polymer-based crown and veneering materials |
| 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 | ||||
| 08/21/2017 | Dental/ ENT |
4-239 | Complete | ANSI AAMI | CI86:2017 | Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 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 |
| 08/21/2017 | Dental/ ENT |
4-215 | Complete | ANSI ADA | Standard No. 96-2012 | Dental Water-based Cements |
| 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 | ||||
| 01/30/2014 | Dental/ ENT |
4-188 | Complete | ISO | 9917-2 Second edition 2010-04-15 | Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 09/17/2018 | Dental/ ENT |
4-244 | Complete | ISO | 8325 Second edition 2004-09-15 | Dentistry - Test methods for rotary instruments |
| 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 | ||||
| 12/18/2023 | Dental/ ENT |
4-317 | Complete | ISO | 8325 Third edition 2023-03 | Dentistry - Test methods for rotary instruments |
| 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 | ||||
| 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 | ||||
| 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 | ||||
| 01/30/2014 | 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 | ||||
| 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 | ||||
| 09/17/2018 | Dental/ ENT |
4-247 | Complete | ISO | 28319 Second edition 2018-04 | Dentistry - Laser welding and filler materials |
| ANSI ADA | Standard No. 84-2020 | Laser Welding and Filler Materials in Dentistry | ||||
| 01/27/2015 | Dental/ ENT |
4-185 | Complete | ANSI ASA | S3.45-2009 (Reaffirmed 2019) | American National Standard Procedures for Testing Basic Vestibular Function |
| 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 |
| 04/04/2016 | Dental/ ENT |
4-224 | Complete | ISO | 24234 Second edition 2015-05-01 | Dentistry - Dental Amalgam |
| 04/04/2016 | Dental/ ENT |
4-190 | Complete | ANSI ASA | S3.35-2010 (Reaffirmed 2020) | American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions |
| 08/14/2015 | Dental/ ENT |
4-220 | Complete | ANSI ASA | S3.22-2014 (Reaffirmed 2020) | American National Standard Specification of Hearing Aid Characteristics |
| 08/14/2015 | Dental/ ENT |
4-184 | Complete | ANSI ASA | S3.25-2009 (Reaffirmed 2019) | American National Standard For an Occluded Ear Simulator |
| 09/09/2008 | Dental/ ENT |
4-145 | Complete | ISO | 22803 First edition 2004-09-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
| 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 | ||||
| 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 |
| 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 | ||||
| 12/18/2023 | Dental/ ENT |
4-311 | Complete | ISO | 9917-2 Third edition 2017-09 | Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 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 | ||||
| 07/06/2020 | Dental/ ENT |
4-263 | Complete | ISO | 9693 Third edition 2019-10 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ANSI ADA | Standard No. 38-2020 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems | ||||
| 12/19/2022 | Dental/ ENT |
4-294 | Complete | ANSI ADA | Standard No. 139-2020 | Dental Base Polymers |
| 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 | ||||
| 12/23/2019 | 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 |
| 12/21/2020 | Dental/ ENT |
4-270 | Complete | ANSI ADA | Technical Report No. 146-2018 | CAD/CAM Abutments in Dentistry |
| 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 | ||||
| 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 | ||||
| 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 |
| 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 |
4-291 | 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 | ||||
| 12/23/2019 | 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 |
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