|
|
|
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)
|
| 12/22/2025 |
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 |
| 12/20/2021 |
Physical Medicine |
16-232 |
Complete |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| 12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 05/29/2023 |
Materials |
8-597 |
Complete |
ASTM |
F2003-02(2022) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 05/26/2025 |
Radiology |
12-375 |
Complete |
ANSI UL |
122-2019 |
Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019] |
| 12/22/2025 |
Dental/
ENT |
4-349 |
Complete |
ANSI ADA |
Standard No. 34-2025 |
Dental Cartridge Syringes |
| 12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
| 12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
| 12/20/2021 |
Sterility |
14-566 |
Complete |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
| 12/20/2021 |
Sterility |
14-567 |
Complete |
USP-NF |
M7414_01_01 |
<1229.5> Biological Indicators for Sterilization |
| 12/20/2021 |
Sterility |
14-568 |
Complete |
USP-NF |
M98800_01_01 |
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests |
| 12/20/2021 |
Sterility |
14-569 |
Complete |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
| 12/20/2021 |
Sterility |
14-570 |
Complete |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
| 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 |
| 06/07/2021 |
Anesthesiology |
1-151 |
Complete |
ISO |
80601-2-70 Second edition 2020-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 12/19/2022 |
General I (QS/
RM) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 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 |
| 12/22/2025 |
Biocompatibility |
2-310 |
Complete |
ASTM |
F748-25 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| 06/07/2021 |
General II (ES/
EMC) |
19-40 |
Complete |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
| 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 |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-136 |
Complete |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| 12/23/2019 |
Physical Medicine |
16-215 |
Complete |
RESNA ANSI |
WC-2:2019 Section 9 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs |
| 09/17/2018 |
Orthopedic |
11-199 |
Complete |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 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 |
| 05/30/2022 |
Radiology |
12-344 |
Complete |
IEC |
62563-2 Edition 1.0 2021-11 |
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays |
| 12/20/2021 |
Cardiovascular |
3-171 |
Complete |
ASTM |
F2514-21 |
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
| 12/20/2021 |
Cardiovascular |
3-172 |
Complete |
AAMI |
TIR42:2021 |
Evaluation of Particulates Associated with Vascular Medical Devices |
| 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 |
| 12/22/2025 |
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 |
General Plastic Surgery/
General Hospital |
6-519 |
Complete |
ASTM |
F2101-25 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 05/30/2022 |
Dental/
ENT |
4-293 |
Complete |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
| 07/06/2020 |
Biocompatibility |
2-274 |
Complete |
ASTM |
F749-20 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| 05/30/2022 |
InVitro Diagnostics |
7-312 |
Complete |
CLSI |
M39 5th Edition |
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
| 12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 05/26/2025 |
Dental/
ENT |
4-339 |
Complete |
ANSI ADA |
Standard No. 119-2023 |
Dentistry-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 |
Anesthesiology |
1-195 |
Complete |
ISO |
80369-2 First edition 2024-09 |
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications |
| 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 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
| 12/20/2021 |
InVitro Diagnostics |
7-310 |
Complete |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
| 12/20/2021 |
InVitro Diagnostics |
7-311 |
Complete |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-428 |
Complete |
ASTM |
F1541-24 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
| 12/20/2021 |
Dental/
ENT |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
| 12/19/2022 |
Dental/
ENT |
4-296 |
Complete |
ISO |
9873 Fourth edition 2019-03 |
Dentistry - Intra-oral mirrors |
| ANSI ADA |
Standard No. 191-2020 |
Intra-Oral Mirrors |
| 12/19/2022 |
Dental/
ENT |
4-297 |
Complete |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
| 12/20/2021 |
Cardiovascular |
3-177 |
Complete |
ASTM |
F2606-08 (Reapproved 2021) |
Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |
| 04/04/2016 |
Materials |
8-399 |
Complete |
ASTM |
F90-14 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| 08/06/2013 |
Software/
Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 12/22/2025 |
Materials |
8-632 |
Complete |
ASTM |
F1058-25 |
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
| 08/21/2017 |
Materials |
8-449 |
Complete |
ASTM |
F1058-16 |
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
| 12/19/2022 |
Ophthalmic |
10-133 |
Complete |
ISO |
11979-10 Second edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes. |
| 12/20/2021 |
Cardiovascular |
3-176 |
Complete |
ISO |
18193 First edition 2021-08 |
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
| 12/19/2022 |
Sterility |
14-580 |
Complete |
ISO |
11137-2 Third edition 2013-06 [Including AMD1:2022] |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
| 12/20/2021 |
Cardiovascular |
3-178 |
Complete |
ASTM |
F3067-14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
| 12/23/2024 |
Anesthesiology |
1-188 |
Complete |
ISO |
80601-2-84 Second edition 2023-11 |
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| 05/26/2025 |
Radiology |
12-376 |
Complete |
IEC |
61689 Edition 4.0 2022-03 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
| 12/19/2022 |
Software/
Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
| 12/19/2022 |
Software/
Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
| 12/19/2022 |
Software/
Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
| 04/04/2016 |
Materials |
8-200 |
Complete |
ASTM |
F2003-02 (Reapproved 2015) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 12/23/2016 |
Materials |
8-441 |
Complete |
ASTM |
F3109-16 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 05/26/2025 |
Radiology |
12-374 |
Complete |
ISO |
24013 Second edition 2023-06 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
| 01/30/2014 |
Radiology |
12-266 |
Complete |
IEC |
61689 Edition 3.0 2013-02 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
| 05/26/2025 |
Radiology |
12-377 |
Complete |
IEC |
62127-03 Edition 2.0 2022-12 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 07/09/2014 |
Radiology |
12-279 |
Complete |
IEC |
62127-03 Edition 1.1 2013-05 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 12/19/2022 |
Sterility |
14-582 |
Complete |
AAMI ISO |
TIR11137-4:2022 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
| ISO |
TS 11137-4 First edition 2020-06 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
| 12/19/2022 |
Sterility |
14-583 |
Complete |
ANSI AAMI |
ST98:2022 |
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
| 05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
| 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) |
| 12/18/2023 |
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 |
| 05/26/2025 |
Radiology |
12-372 |
Complete |
ISO |
14880-3 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 12/19/2007 |
Radiology |
12-172 |
Complete |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 05/26/2025 |
Radiology |
12-373 |
Complete |
ISO |
14880-4 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 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 |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
Complete |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 09/17/2018 |
Orthopedic |
11-185 |
Complete |
ASTM |
F2267-04 (Reapproved 2018) |
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 12/22/2025 |
Orthopedic |
11-424 |
Complete |
ASTM |
F983-24 |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| 09/17/2018 |
Orthopedic |
11-197 |
Complete |
ASTM |
F983-86 (Reapproved 2018) |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| 12/22/2025 |
Orthopedic |
11-425 |
Complete |
ASTM |
F565-21 |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 12/20/2021 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 12/23/2019 |
Anesthesiology |
1-145 |
Complete |
ISO |
19223 First edition 2019-07 |
Lung ventilators and related equipment - Vocabulary and semantics. |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-437 |
Complete |
ISO |
23907-2 First edition 2019-11 |
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
| 05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 08/20/2012 |
Cardiovascular |
3-103 |
Complete |
ISO |
25539-3 First edition 2011-12-01 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| ANSI AAMI ISO |
25539-3:2011 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| 05/26/2025 |
Cardiovascular |
3-199 |
Complete |
ASTM |
F1841-25 |
Standard Practice for Assessment of Hemolysis in Blood Pumps |
| 09/17/2018 |
Anesthesiology |
1-140 |
Complete |
ISO |
80601-2-55 Second edition 2018-02 |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 12/21/2020 |
Sterility |
14-553 |
Complete |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-423 |
Complete |
IEC |
60601-2-6 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| 05/30/2022 |
Materials |
8-588 |
Complete |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| 12/19/2022 |
General II (ES/
EMC) |
19-48 |
Complete |
IEEE ANSI |
USEMCSC C63.27-2021 |
American National Standard for Evaluation of Wireless Coexistence |
| 12/19/2022 |
InVitro Diagnostics |
7-313 |
Complete |
CLSI |
EP27 2nd Edition |
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-142 |
Complete |
ASTM |
D1894-14 |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
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