|
|
|
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)
|
| 05/29/2024 |
Cardiovascular |
3-192 |
Complete |
ISO |
22679 First edition 2021-11 |
Cardiovascular implants - Transcatheter cardiac occluders
|
| 01/14/2019 |
Cardiovascular |
3-66 |
Complete |
ASTM |
F2081-06 (Reapproved 2017) |
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 12/20/2021 |
Cardiovascular |
3-172 |
Complete |
AAMI |
TIR42:2021 |
Evaluation of Particulates Associated with Vascular Medical Devices |
| 09/17/2018 |
Cardiovascular |
3-154 |
Complete |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
| 12/23/2019 |
Cardiovascular |
3-162 |
Complete |
ASTM |
F3374-19 |
Standard Guide for Active Fixation Durability of Endovascular Prostheses |
| 12/20/2021 |
Cardiovascular |
3-179 |
Complete |
ASTM |
F3172-15 (Reapproved 2021) |
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
| 12/20/2021 |
Cardiovascular |
3-176 |
Complete |
ISO |
18193 First edition 2021-08 |
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
| 07/06/2020 |
Cardiovascular |
3-167 |
Complete |
ISO |
TS 81060-5 First edition 2020-02 |
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |
| 09/17/2018 |
Cardiovascular |
3-110 |
Complete |
AAMI |
TIR41:2011/(R)2025 |
Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators |
| 12/19/2022 |
Cardiovascular |
3-183 |
Complete |
ISO |
11658 First edition 2012-05-15 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ANSI AAMI ISO |
11658: 2012 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| 09/17/2018 |
Cardiovascular |
3-153 |
Complete |
ASTM |
F2743-11 |
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
| 12/23/2016 |
Cardiovascular |
3-144 |
Complete |
ISO |
7198 Second edition 2016-08-01 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| ANSI AAMI ISO |
7198:2016 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| 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 |
| 12/20/2021 |
Cardiovascular |
3-174 |
Partial |
ISO |
5840-1 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| 12/22/2025 |
Cardiovascular |
3-201 |
Complete |
IEC |
60601-2-31 Edition 3.0 2020-01 |
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| 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)] |
| 12/23/2024 |
Cardiovascular |
3-195 |
Partial |
ISO |
5910 Second edition 2024-07 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 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 |
3-129 |
Partial |
ANSI AAMI |
EC53:2013/(R)2020 |
ECG trunk cables and patient leadwires |
| 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 |
| 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)] |
| 12/18/2023 |
Cardiovascular |
3-105 |
Partial |
IEC |
60601-2-25 Edition 2.0 2011-10 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| ANSI AAMI IEC |
60601-2-25:2011/(R)2016 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| 01/14/2019 |
Cardiovascular |
3-52 |
Partial |
ANSI AAMI |
EC12:2000/(R)2015 |
Disposable ECG electrodes |
| 12/22/2025 |
Cardiovascular |
3-203 |
Partial |
IEC |
80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| 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 |
| 12/18/2023 |
Cardiovascular |
3-126 |
Partial |
IEC |
60601-2-27 Edition 3.0 2011-03 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
| ANSI AAMI IEC |
60601-2-27:2011(R)2016 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| 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 |
| 06/07/2021 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| 12/23/2019 |
Cardiovascular |
3-163 |
Partial |
ISO |
18242 First edition 2016-09-01 |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps |
| 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 |
| 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 |
| 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 |
| 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 |
| 12/22/2025 |
Dental/ ENT |
4-354 |
Partial |
ISO |
17730 Third edition 2025-09 |
Dentistry - Fluoride varnishes |
| ANSI ADA |
Standard No. 117-2022 |
Dentistry - Fluoride Varnishes |
| 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 |
| 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 |
| 12/23/2024 |
Dental/ ENT |
4-335 |
Complete |
ISO |
11499 Third edition 2014-06 |
Dentistry - Single-use cartridges for local anaesthetics |
| ANSI ADA |
Standard No. 190-2020 |
Single-Use Dental Cartridges for Local Anesthetics |
| 12/23/2024 |
Dental/ ENT |
4-337 |
Complete |
ISO |
20608 First edition 2018-04 |
Dentistry - Powder jet handpieces and powders |
| 06/27/2016 |
Dental/ ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 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 |
| 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) |
| 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 |
| 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 |
| 12/23/2024 |
Dental/ ENT |
4-338 |
Complete |
ISO |
22683 First edition 2022-05 |
Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems |
| 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 |
| 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 |
4-311 |
Complete |
ISO |
9917-2 Third edition 2017-09 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 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 |
| 08/21/2017 |
Dental/ ENT |
4-215 |
Complete |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
| 12/18/2023 |
Dental/ ENT |
4-318 |
Complete |
ISO |
20749 Second edition 2023-06 |
Dentistry - Pre-capsulated dental amalgam |
| 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 |
| 12/23/2024 |
Dental/ ENT |
4-328 |
Complete |
ANSI ADA |
Standard No. 57-2021 |
Endodontic Sealing Materials |
| 05/26/2025 |
Dental/ ENT |
4-344 |
Complete |
ANSI ADA |
Standard No. 186-2024 |
Dentistry - Polymer-based Machinable Blanks |
| 05/26/2025 |
Dental/ ENT |
4-345 |
Complete |
ANSI ADA |
Standard No. 187-2024 |
Dentistry - Dental CAD/CAM Machinable Ceramic Blanks |
| 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 |
| 06/27/2016 |
Dental/ ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2025) |
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 |
| 08/06/2013 |
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) |
| 12/18/2023 |
Dental/ ENT |
4-315 |
Complete |
ISO |
24234 Third edition 2021-08 |
Dentistry - Dental Amalgam |
| 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 |
4-298 |
Complete |
ISO |
4049 Fifth edition 2019-05 |
Dentistry - Polymer-based restorative materials |
| ANSI ADA |
Standard No. 27-2022 |
Polymer-based Restorative Materials |
| 12/23/2024 |
Dental/ ENT |
4-332 |
Complete |
ANSI ADA |
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 |
| 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 |
| 12/21/2020 |
Dental/ ENT |
4-272 |
Complete |
ANSI ADA |
Standard No. 63-2013 |
Root Canal Barbed Broaches and Rasps |
| 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 |
| 05/26/2025 |
Dental/ ENT |
4-347 |
Complete |
ISO |
22254 First edition 2005-08 |
Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection |
| 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 |
4-331 |
Complete |
ISO |
28399 Third edition 2021-03 |
Dentistry - External tooth bleaching products |
| ANSI ADA |
Standard No. 136-2022 |
Dentistry - External Tooth Bleaching Products |
| 12/23/2024 |
Dental/ ENT |
4-334 |
Complete |
ISO |
11143 Second edition 2008-07 |
Dentistry - Amalgam separators |
| ANSI ADA |
Standard No. 108-2009, Addendum (R2022) |
Amalgam Separators |
| 07/09/2014 |
Dental/ ENT |
4-97 |
Complete |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
| 12/23/2024 |
Dental/ ENT |
4-329 |
Complete |
ISO |
6872 Fifth edition 2024-08 |
Dentistry - Ceramic materials |
| 05/29/2024 |
Dental/ ENT |
4-326 |
Complete |
ISO |
9687 Second edition 2015-02 |
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
| 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 |
| 08/21/2017 |
Dental/ ENT |
4-233 |
Complete |
ISO |
20795-2 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 08/06/2013 |
Dental/ ENT |
4-167 |
Complete |
ANSI ASA |
S3.21-2004 (Reaffirmed 2023) |
American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
| 01/30/2014 |
Dental/ ENT |
4-180 |
Complete |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
| 05/29/2024 |
Dental/ ENT |
4-327 |
Complete |
ISO |
21531 First edition 2009-02 |
Dentistry - Graphical symbols for dental instruments |
| 12/22/2025 |
Dental/ ENT |
4-364 |
Complete |
ISO |
3990 First edition 2023-07 |
Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials |
| 12/23/2019 |
Dental/ ENT |
4-260 |
Complete |
ANSI ASA |
S12.2-2019 (Reaffirmed 2023) |
American National Standard for Criteria for Evaluating Room Noise |
| 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 |
| 05/29/2023 |
Dental/ ENT |
4-303 |
Complete |
ISO |
9333 Third edition 2022-08 |
Dentistry - Brazing materials |
| 05/29/2023 |
Dental/ ENT |
4-304 |
Complete |
ISO |
21606 Second edition 2022-08 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
4-252 |
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 |
| 01/14/2019 |
Dental/ ENT |
4-162 |
Complete |
ANSI ASA |
S3.4-2007 (Reaffirmed 2025) |
American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 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 |
4-278 |
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 |
| 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 |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |