|
|
|
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)
|
| 05/25/2026 |
Anesthesiology |
1-203 |
Complete |
ISO |
10079-1 Fourth edition 2022-03 [Including AMD1:2026] |
Medical suction equipment - Part 1: Electrically powered suction equipment [Including Amendment 1 (2026)] |
| 05/25/2026 |
Biocompatibility |
2-313 |
Partial |
ISO |
10993-1 Sixth edition 2025-11 |
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
|
| 05/25/2026 |
Biocompatibility |
2-314 |
Complete |
ISO |
10993-12 Fifth edition 2021-01 [Including AMD1:2025] |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials [Including AMENDMENT 1 (2025)] |
| 05/25/2026 |
Cardiovascular |
3-204 |
Complete |
ISO |
5840-3 Second edition 2021-01 [Including AMD1:2025] |
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques [Including: AMENDMENT 1 (2025)] |
| 05/25/2026 |
Cardiovascular |
3-205 |
Partial |
ISO |
5840-1 Second edition 2021-01 01 [Including AMD1:2025] |
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements [Including: AMENDMENT 1 (2025)] |
| 05/25/2026 |
Cardiovascular |
3-206 |
Complete |
ISO |
5840-2 Second edition 2021-01 [Including AMD1:2025] |
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes [Including: AMENDMENT 1 (2025)] |
| 05/25/2026 |
Cardiovascular |
3-207 |
Complete |
ASTM |
F2942-25 |
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents |
| 05/25/2026 |
Dental/
ENT |
4-368 |
Complete |
ISO |
4823 Sixth edition 2025-06 |
Dentistry - Elastomeric impression and bite registration materials |
| 05/25/2026 |
Dental/
ENT |
4-369 |
Complete |
ANSI ADA |
Standard No. 113-2015 |
Periodontal Curettes, Dental Scalers and Excavators |
| 05/25/2026 |
Dental/
ENT |
4-370 |
Complete |
ANSI ADA |
Standard No. 126-2015 (R2023) |
Casting Investments and Refractory Die Materials |
| 05/25/2026 |
Dental/
ENT |
4-371 |
Complete |
ANSI ADA |
Standard No. 135-2015 (R2020) |
Denture Adhesives |
| 05/25/2026 |
Dental/
ENT |
4-372 |
Complete |
ANSI ADA |
Standard No. 141-2013 (R2023) |
Dentistry-Dental Duplicating Material |
| 05/25/2026 |
Dental/
ENT |
4-373 |
Complete |
ANSI ADA |
Standard No. 170-2019 |
Periodontal Probes - Dental Excavators - Discoid Type: General Requirements |
| 05/25/2026 |
Dental/
ENT |
4-374 |
Complete |
ANSI ADA |
Standard No. 195-2021 |
Dental Tweezers |
| 05/25/2026 |
Dental/
ENT |
4-375 |
Complete |
ANSI ADA |
Standard No. 197-2021 |
Spoons and Bone Curettes in Dentistry |
| 05/25/2026 |
Dental/
ENT |
4-376 |
Complete |
ISO |
7492 Fourth edition 2019-03 |
Dentistry - Dental explorer |
| 05/25/2026 |
Dental/
ENT |
4-377 |
Complete |
ISO |
9173-1 Third edition 2016-10 |
Dentistry - Extraction forceps - Part 1: General requirements |
| 05/25/2026 |
Dental/
ENT |
4-378 |
Complete |
ISO |
9173-2 First edition 2010-05 |
Dentistry - Extraction forceps - Part 2: Designation |
| 05/25/2026 |
Dental/
ENT |
4-379 |
Complete |
ISO |
9173-3 First edition 2014-05 |
Dentistry - Extraction forceps - Part 3: Design |
| 05/25/2026 |
Dental/
ENT |
4-380 |
Complete |
ISO |
13017 Second edition 2020-07 |
Dentistry - Magnetic attachments |
| ANSI ADA |
Standard No. 201-2022 |
Dentistry - Magnetic Attachments |
| 05/25/2026 |
Dental/
ENT |
4-381 |
Complete |
ISO |
13078 First edition 2013-02 |
Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple |
| ANSI ADA |
Standard No.163-2018 |
Dental Furnance, Part 1: Test Method for Temperature Measurement with Separate Thermocouple |
| 05/25/2026 |
Dental/
ENT |
4-382 |
Complete |
ISO |
13078-2 First edition 2016-07 |
Dentistry - Dental furnace - Part 2: Test method for evaluation of furnace programme via firing glaze |
| ANSI ADA |
Standard No. 164-2018 (R2023) |
Dental Furnance, Part 2: Test Method for Evaluation of Furnace Program via Firing Glaze |
| 05/25/2026 |
Dental/
ENT |
4-383 |
Complete |
ISO |
13078-3 First edition 2023-05 |
Dentistry - Dental furnace - Part 3: Test method for the evaluation of high temperature sintering furnace measurement with a separate thermocouple |
| ANSI ADA |
Standard No. 209-2024 |
Dentistry - Test Method for the Evaluation of High Temperature Sintering Furnace Measurement with a Separate Thermocouple |
| 05/25/2026 |
Dental/
ENT |
4-384 |
Complete |
ISO |
13397-1 First edition 1995-12 |
Periodontal curettes, dental scalers and excavators - Part 1: General requirements |
| 05/25/2026 |
Dental/
ENT |
4-385 |
Complete |
ISO |
13397-2 Second edition 2005-06 [Including AMD1:2012] |
Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)] |
| 05/25/2026 |
Dental/
ENT |
4-386 |
Complete |
ISO |
13397-3 First edition 1996-09 |
Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type |
| 05/25/2026 |
Dental/
ENT |
4-387 |
Complete |
ISO |
13397-5 First edition 2015-09 |
Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers |
| 05/25/2026 |
Dental/
ENT |
4-388 |
Complete |
ISO |
14356 Second edition 2024-10 |
Dentistry - Duplicating material |
| 05/25/2026 |
Dental/
ENT |
4-389 |
Complete |
ISO |
15098 Second edition 2024-07 |
Dentistry - Dental tweezers |
| 05/25/2026 |
Dental/
ENT |
4-390 |
Complete |
ISO |
15912 Second edition 2016-01 |
Dentistry - Refractory investment and die material |
| 05/25/2026 |
Dental/
ENT |
4-391 |
Complete |
ISO |
16498 First edition 2013-07 |
Dentistry - Minimal dental implant data set for clinical use |
| ANSI ADA |
Standard No. 172-2019 |
Minimal Dental Implant Data Set for Clinical Use |
| 05/25/2026 |
Dental/
ENT |
4-392 |
Complete |
ISO |
17254 First edition 2016-07 [Including AMD1:2020] |
Dentistry - Coiled springs for use in orthodontics [Including AMENDMENT 1 (2020)] |
| 05/25/2026 |
Dental/
ENT |
4-393 |
Complete |
ISO |
21533 Second edition 2018-01 |
Dentistry - Reprocessable cartridge syringes for intraligamentary injections |
| ANSI ADA |
Standard No. 183-2020 |
Reprocessable Cartridge Syringes for Intraligamentary Injections |
| 05/25/2026 |
Dental/
ENT |
4-394 |
Complete |
ISO |
21672-1 First edition 2012-04 |
Dentistry - Periodontal probes - Part 1: General requirements |
| ANSI ADA |
Standard No. 169-2019 |
Periodontal Probes: General Requirements |
| 05/25/2026 |
Dental/
ENT |
4-395 |
Complete |
ISO |
21850-1 First edition 2020-04 |
Dentistry - Materials for dental instruments - Part 1: Stainless steel |
| ANSI ADA |
Standard No. 196-2021 |
Materials for Dental Instruments - Part 1: Stainless Steel |
| 05/25/2026 |
Dental/
ENT |
4-396 |
Complete |
ISO |
22570 First edition 2020-02 |
Dentistry - Spoons and bone curettes |
| 05/25/2026 |
Dental/
ENT |
4-397 |
Complete |
ISO |
23298 First edition 2023-05 |
Dentistry - Test methods for machining accuracy of computer-aided milling machines |
| 05/25/2026 |
Dental/
ENT |
4-398 |
Complete |
ISO |
23940 First edition 2021-04 |
Dentistry - Excavators |
| 05/25/2026 |
Dental/
ENT |
4-399 |
Complete |
ANSI ADA |
Standard No. 182-2021 |
Test Method for the Bonding Test Between Polymer Teeth and Denture Base Polymer |
| ISO |
TS 19736 First edition 2017-09 |
Dentistry - Bonding test between polymer teeth and denture base materials |
| 05/25/2026 |
General I (QS/
RM) |
5-149 |
Complete |
ISO |
20417 Second edition 2026-03 |
Medical devices - Information to be supplied by the manufacturer |
| 05/25/2026 |
General Plastic Surgery/
General Hospital |
6-521 |
Complete |
IEC |
60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories [Including: Amendment 1 (2023), Interpretation Sheet 1 (2025)] |
| 05/25/2026 |
Materials |
8-647 |
Complete |
ASTM |
F3260-25 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 05/25/2026 |
Materials |
8-648 |
Complete |
ASTM |
F799-25 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
| 05/25/2026 |
Materials |
8-649 |
Complete |
ASTM |
F2503-26 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 05/25/2026 |
Materials |
8-650 |
Complete |
ASTM |
F3766-25 |
Standard Guide for Content and Format of Test Report Summaries for Medical and Surgical Materials and Device Standards |
| 05/25/2026 |
Nanotechnology |
18-25 |
Complete |
ISO |
21362 First edition 2026-02 |
Nanotechnologies -- Analysis of nano-objects using asymmetrical flow and centrifugal field-flow fractionation |
| 05/25/2026 |
Neurology |
17-23 |
Partial |
IEC |
80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION |
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-152 |
Partial |
ISO |
23500-1 Second edition 2024-08 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-153 |
Complete |
ISO |
23500-2 Second edition 2024-07 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-154 |
Complete |
ISO |
23500-3 Second edition 2024-04 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-155 |
Partial |
ISO |
23500-4 Second edition 2024-04 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-156 |
Complete |
ISO |
23500-5 Second edition 2024-04 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| 05/25/2026 |
Orthopedic |
11-441 |
Complete |
ASTM |
F2789-25 |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 05/25/2026 |
Orthopedic |
11-442 |
Complete |
ISO |
7206-12 Second edition 2025-11 |
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for press-fit acetabular components |
| 05/25/2026 |
Orthopedic |
11-443 |
Complete |
ASTM |
F2706-25 |
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model |
| 05/25/2026 |
Orthopedic |
11-444 |
Complete |
ISO |
18192-3 Second edition 2025-11 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses |
| 05/25/2026 |
Orthopedic |
11-445 |
Complete |
ASTM |
F2009-25 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 05/25/2026 |
Orthopedic |
11-446 |
Complete |
ASTM |
F3574-25 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
| 05/25/2026 |
Physical Medicine |
16-240 |
Complete |
ISO |
7176-21 Third edition 2025-04 |
Wheelchairs -- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| 05/25/2026 |
Physical Medicine |
16-241 |
Complete |
ISO |
7176-31 First edition 2023-05 |
Wheelchairs -- Part 31: Lithium-ion battery systems and chargers for powered wheelchairs--Requirements and test methods |
| 05/25/2026 |
Radiology |
12-386 |
Complete |
IEC |
63465 Edition 1.0 2026-01 |
Calibration and quality control in the use of radionuclide calibrators |
| 05/25/2026 |
Software/
Informatics |
13-140 |
Complete |
FIRST |
CVSS v4.0 |
Common Vulnerability Scoring System version 4.0 |
| 05/25/2026 |
Software/
Informatics |
13-157 |
Complete |
IEEE |
Std 11073-10207-2017 [Including Cor 1-2025] |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication [Including Corrigendum 1 (2025)] |
| 05/25/2026 |
Software/
Informatics |
13-158 |
Complete |
IEEE |
1752.1-2021 |
Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures |
| 05/25/2026 |
Tissue Engineering |
15-70 |
Complete |
ASTM |
F2064-25 |
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| 12/22/2025 |
Anesthesiology |
1-197 |
Complete |
ISO |
17510 Second Edition 2025-11 |
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories |
| 12/22/2025 |
Anesthesiology |
1-198 |
Complete |
ISO |
7376 Third edition 2020-08 [Including AMD1:2025] |
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements [Including Amendment 1 (2025)] |
| 12/22/2025 |
Anesthesiology |
1-199 |
Complete |
ISO |
80601-2-70 Third edition 2025-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 12/22/2025 |
Anesthesiology |
1-200 |
Complete |
ISO |
7376-2 First edition 2025-09 |
Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes |
| 12/22/2025 |
Anesthesiology |
1-201 |
Complete |
ISO |
19223-2 First edition 2025-04 |
Lung ventilators and related equipment - Vocabulary and semantics - Part 2: High frequency and jet ventilation. |
| 12/22/2025 |
Anesthesiology |
1-202 |
Complete |
ISO |
19223-3 First edition 2025-09 |
Lung ventilators and related equipment - Vocabulary and semantics - Part 3: Respiratory care |
| 12/22/2025 |
Biocompatibility |
2-308 |
Complete |
ASTM |
F1984-25 |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| 12/22/2025 |
Biocompatibility |
2-309 |
Complete |
ASTM |
F895-25 |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
| 12/22/2025 |
Biocompatibility |
2-310 |
Complete |
ASTM |
F748-25 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| 12/22/2025 |
Biocompatibility |
2-311 |
Complete |
ISO |
10993-4 Third edition 2017-04 [Including AMD1:2025] |
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)] |
| 12/22/2025 |
Biocompatibility |
2-312 |
Complete |
ASTM |
F720-24 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
| 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 |
| 12/22/2025 |
Cardiovascular |
3-202 |
Complete |
IEC |
60601-2-34 Edition 4.0 2024-10 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| 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 |
| 12/22/2025 |
Dental/
ENT |
4-348 |
Complete |
ISO |
9917-1 Third Edition 2025-05 |
Dentistry - Water-based cements - Part 1: Acid-base cements |
| 12/22/2025 |
Dental/
ENT |
4-349 |
Complete |
ANSI ADA |
Standard No. 34-2025 |
Dental Cartridge Syringes |
| 12/22/2025 |
Dental/
ENT |
4-350 |
Complete |
ANSI ASA |
S3.6-2025 |
American National Standard Specification for Audiometers |
| 12/22/2025 |
Dental/
ENT |
4-351 |
Complete |
ISO |
6877 Fourth edition 2025-08 |
Dentistry - Endodontic obturating materials |
| 12/22/2025 |
Dental/
ENT |
4-352 |
Complete |
ANSI ASA |
S3.35-2025 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/22/2025 |
Dental/
ENT |
4-353 |
Complete |
ISO |
20127 Third edition 2025-05 |
Dentistry - Physical properties of powered toothbrushes |
| 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 |
| 12/22/2025 |
Dental/
ENT |
4-355 |
Complete |
ISO |
18397 Second edition 2025-07 |
Dentistry - Powered scaler |
| 12/22/2025 |
Dental/
ENT |
4-356 |
Complete |
ANSI ADA |
Standard No. 32-2024 |
Dentistry - Orthodontic Wires |
| 12/22/2025 |
Dental/
ENT |
4-357 |
Complete |
ANSI ADA |
Standard No. 54-1986 (R2024) |
Double-Pointed, Parenteral, Single Use Needles for Dentistry |
| 12/22/2025 |
Dental/
ENT |
4-358 |
Complete |
ANSI ADA |
Standard No. 95-2020 |
Endodontics Instruments - Enlargers |
| 12/22/2025 |
Dental/
ENT |
4-359 |
Complete |
ANSI ADA |
Standard No. 159-2024 |
Dentistry - Coiled Springs for Use in Orthodontics |
| 12/22/2025 |
Dental/
ENT |
4-360 |
Complete |
ISO |
3630-1 Third edition 2019-08 |
Dentistry - Endodontic instruments - Part 1: General requirements |
| ANSI ADA |
Standard No. 101-2021 |
Endodontic Instruments - General Requirements |
| 12/22/2025 |
Dental/
ENT |
4-361 |
Complete |
ISO |
3630-2 Fourth edition 2023-02 |
Dentistry - Endodontic instruments - Part 2: Enlargers |
| 12/22/2025 |
Dental/
ENT |
4-362 |
Complete |
ISO |
3630-3 Third edition 2021-06 Corrected version 2023-05 |
Dentistry - Endodontic instruments - Part 3: Compactors |
| ANSI ADA |
Standard No. 71-2022 |
Dentistry - Endodontic Instruments: Compactors |
| 12/22/2025 |
Dental/
ENT |
4-363 |
Complete |
ISO |
3630-5 Second edition 2020-08 |
Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments |
| ANSI ADA |
Standard No. 28-2021 |
Endodontic Instruments - Shaping and Cleaning 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 |
| 12/22/2025 |
Dental/
ENT |
4-365 |
Complete |
ISO |
6873 Third edition 2013-04 |
Dentistry - Gypsum products |
| ANSI ADA |
Standards No. 25-2015 (R2021) |
Dental Gypsum Products |
| 12/22/2025 |
Dental/
ENT |
4-366 |
Complete |
ISO |
7551 Second edition 2023-05 |
Dentistry - Endodontic absorbent points |
| ANSI ADA |
Standard No. 73-2024 |
Dentistry - Endodontic Absorbent Points |
| 12/22/2025 |
Dental/
ENT |
4-367 |
Complete |
ISO |
9997 Third edition 2020-01 |
Dentistry - Cartridge Syringes |
| 12/22/2025 |
General I (QS/
RM) |
5-146 |
Complete |
ISO |
80369-6 Second edition 2025-05 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications |
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