Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 08/14/2015 | Dental/ ENT |
4-130 | Complete | ANSI ADA | Standard No. 17-1983 (R2014) | Denture Base Temporary Relining Resins |
| 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 |
| 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 | ||||
| 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 |
| 07/09/2014 | Dental/ ENT |
4-149 | Complete | ANSI ADA | Standard No. 39-2006 (R2011) | Pit and Fissure Sealants |
| 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 |
4-153 | Complete | ISO | 9917-1 Second edition 2007-10-01 | Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 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 |
| 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 |
| 01/14/2019 | Dental/ ENT |
4-163 | Complete | ANSI ASA | S3.5-1997 (Reaffirmed 2020) | American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 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 |
| 08/06/2013 | Dental/ ENT |
4-167 | Complete | ANSI ASA | S3.21-2004 (Reaffirmed 2019) | American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
| 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 |
| 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 |
| 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 |
| 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 |
4-181 | Complete | ISO | 4049 Fourth edition 2009-10-01 | Dentistry - Polymer-based restorative materials |
| 08/14/2015 | Dental/ ENT |
4-184 | Complete | ANSI ASA | S3.25-2009 (Reaffirmed 2019) | American National Standard For an Occluded Ear Simulator |
| 01/27/2015 | Dental/ ENT |
4-185 | Complete | ANSI ASA | S3.45-2009 (Reaffirmed 2019) | American National Standard Procedures for Testing Basic Vestibular Function |
| 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 |
| 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 |
| 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 | ||||
| 01/30/2014 | Dental/ ENT |
4-199 | Complete | ISO | 6876 Third edition 2012-06-01 | Dentistry -- Root canal sealing materials |
| 06/27/2016 | Dental/ ENT |
4-202 | Complete | ANSI ADA | Standard No. 58-2010 (R2015) | Root Canal Files, Type H (Hedstrom) |
| 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) |
| 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 |
| 08/21/2017 | Dental/ ENT |
4-215 | Complete | ANSI ADA | Standard No. 96-2012 | Dental Water-based Cements |
| 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 |
| 01/27/2015 | 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 | ||||
| 01/27/2015 | Dental/ ENT |
4-219 | Complete | ISO | 29022 First edition 2013-06-01 | Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 08/14/2015 | Dental/ ENT |
4-220 | Complete | ANSI ASA | S3.22-2014 (Reaffirmed 2020) | American National Standard Specification of Hearing Aid Characteristics |
| 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 |
| 04/04/2016 | Dental/ ENT |
4-222 | Complete | ISO | 6874 Third edition 2015-09-01 | Dentistry - Polymer-based pit and fissure sealants |
| 04/04/2016 | Dental/ ENT |
4-224 | Complete | ISO | 24234 Second edition 2015-05-01 | Dentistry - Dental Amalgam |
| 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 | ||||
| 06/27/2016 | Dental/ ENT |
4-228 | Complete | ANSI ASA | S3.20-2015 (Reaffirmed 2020) | American National Standard Bioacoustical Terminology |
| 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 |
4-233 | Complete | ISO | 20795-2 Second edition 2013-03-01 | Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 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 | ||||
| 08/21/2017 | Dental/ ENT |
4-239 | Complete | ANSI AAMI | CI86:2017 | Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 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 | ||||
| 06/07/2018 | Dental/ ENT |
4-241 | Complete | ISO | 7491 Second edition 2000-09-01 | Dental materials - Determination of colour stability |
| ANSI ADA | Standard No. 80-2001 (R2020) | Dental Materials-Determination of Color Stability | ||||
| 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 | ||||
| 09/17/2018 | Dental/ ENT |
4-244 | Complete | ISO | 8325 Second edition 2004-09-15 | Dentistry - Test methods for rotary instruments |
| 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 | ||||
| 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 | ||||
| 01/14/2019 | Dental/ ENT |
4-248 | Complete | ISO | 10477 Third edition 2018-06 | Dentistry - Polymer-based crown and veneering materials |
| 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 |
| 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 | ||||
| 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) | ||||
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