|
|
|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
| 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 |
| 05/26/2025 |
Dental/ ENT |
4-339 |
Complete |
ANSI ADA |
Standard No. 119-2023 |
Dentistry-Manual Toothbrushes |
| 05/30/2022 |
Dental/ ENT |
4-293 |
Complete |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
| 05/26/2025 |
Dental/ ENT |
4-340 |
Complete |
ANSI ADA |
Standard No. 46-2016 |
Dental Patient Chair |
| 05/26/2025 |
Dental/ ENT |
4-341 |
Complete |
ANSI ADA |
Standard No. 47-1-2021 |
Stationary Dental Units and Patient Chairs-Part 1: General Requirements |
| 05/26/2025 |
Dental/ ENT |
4-342 |
Complete |
ANSI ADA |
Standard No. 47-2-2021 |
Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems |
| 05/26/2025 |
Dental/ ENT |
4-343 |
Complete |
ANSI ADA |
Standard No. 105-2024 |
Elastomeric Auxiliaries for Use in Orthodontics |
| 05/26/2025 |
Dental/ ENT |
4-346 |
Complete |
ISO |
9680 Fourth edition 2021-11 |
Dentistry - Operating lights |
| ANSI ADA |
Standard No. 89-2023 |
Dentistry - Dental Operating Lights |
| 12/20/2021 |
Dental/ ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
| 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 |
| 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 |
4-294 |
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 |
| 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 |
| 06/07/2021 |
Dental/ ENT |
4-279 |
Complete |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 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 |
| 06/07/2021 |
Dental/ ENT |
4-273 |
Complete |
ANSI ASA |
S3.7-2016 (Reaffirmed 2025) |
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 Specification for Audiometers |
| 12/19/2022 |
Dental/ ENT |
4-297 |
Complete |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
| 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 |
| 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 |
4-165 |
Complete |
ANSI ASA |
S3.13-1987 (Reaffirmed 2024) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 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 |
| 12/23/2024 |
Dental/ ENT |
4-337 |
Complete |
ISO |
20608 First edition 2018-04 |
Dentistry - Powder jet handpieces and powders |
| 12/21/2020 |
Dental/ ENT |
4-271 |
Complete |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
| 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 |
| 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 |
| 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 |
| 01/14/2019 |
Dental/ ENT |
4-254 |
Complete |
ANSI ADA |
Standard No. 99-2001 (R2023) |
Athletic Mouth Protectors and Materials |
| 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 |
| 12/20/2021 |
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 |
| 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 |
| 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 |
| 05/26/2025 |
Dental/ ENT |
4-345 |
Complete |
ANSI ADA |
Standard No. 187-2024 |
Dentistry - Dental CAD/CAM Machinable Ceramic Blanks |
| 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 |
| 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 |
| 12/20/2021 |
Dental/ ENT |
4-285 |
Complete |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
| 08/06/2013 |
Dental/ ENT |
4-90 |
Complete |
ANSI ASA |
S3.39:1987 (Reaffirmed 2025) |
American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
| 12/18/2023 |
Dental/ ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
| 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 |
| 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 |
| 01/27/2015 |
Dental/ ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2024) |
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 |
| 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 |
| 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 |
| 08/06/2013 |
Dental/ ENT |
4-204 |
Complete |
ANSI ASA |
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2025) |
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 |
4-97 |
Complete |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
| 01/27/2015 |
Dental/ ENT |
4-219 |
Complete |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 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 |
| 12/23/2019 |
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 |
| 06/27/2016 |
Dental/ ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2025) |
American National Standard Bioacoustical Terminology |
| 01/14/2019 |
Dental/ ENT |
4-171 |
Complete |
ANSI ASA |
S3.37-1987 (Reaffirmed 2025) |
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids |
| 12/19/2022 |
General I (QS/ RM) |
5-138 |
Complete |
AAMI |
TIR66: 2017/(R)2025 |
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 12/19/2022 |
General I (QS/ RM) |
5-135 |
Complete |
ISO |
20417 First edition 2021-04 Corrected version 2021-12 |
Medical devices - Information to be supplied by the manufacturer |
| 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)] |
| 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)] |
| 12/23/2016 |
General I (QS/ RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 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) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 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 |
| 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) |
| 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 |
| 07/06/2020 |
General I (QS/ RM) |
5-127 |
Complete |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
| 07/06/2020 |
General I (QS/ RM) |
5-128 |
Complete |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
| 07/06/2020 |
General I (QS/ RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 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 |
| 12/20/2021 |
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 |
| 08/14/2015 |
General I (QS/ RM) |
5-97 |
Complete |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| ANSI AAMI ISO |
80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 12/23/2019 |
General I (QS/ RM) |
5-124 |
Complete |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 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 |
| 05/26/2025 |
General I (QS/ RM) |
5-145 |
Complete |
IEC |
60417:2025 DB |
Graphical symbols for use on equipment |
| 12/23/2024 |
General I (QS/ RM) |
5-143 |
Complete |
ISO |
14630 Fffth edition 2024-09 |
Non-active surgical implants -- General requirements |
| 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 |
| 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) |
5-132 |
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 |
| 05/26/2025 |
General I (QS/ RM) |
5-144 |
Complete |
ISO |
80369-20 Second edition 2024-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 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 |
| 01/30/2014 |
General I (QS/ RM) |
5-47 |
Complete |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
| 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. |
| 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 |
| 01/27/2015 |
General I (QS/ RM) |
5-62 |
Complete |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
| 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 |
| 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)]. |
| 01/14/2019 |
General I (QS/ RM) |
5-121 |
Complete |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 06/27/2016 |
General I (QS/ RM) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
| 12/20/2021 |
General II (ES/ EMC) |
19-43 |
Partial |
IEC |
61326-2-6 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 12/21/2020 |
General II (ES/ EMC) |
19-36 |
Partial |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
| 12/21/2020 |
General II (ES/ EMC) |
19-38 |
Partial |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 05/29/2024 |
General II (ES/ EMC) |
19-50 |
Partial |
IEC |
TS 60601-4-2 Edition 1.0 2024-03 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 09/17/2018 |
General II (ES/ EMC) |
19-19 |
Partial |
IEC |
TR 60601-4-2 Edition 1.0 2016-05 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 12/20/2021 |
General II (ES/ EMC) |
19-42 |
Partial |
IEC |
61326-1 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |