|
|
|
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)
|
| 12/23/2024 |
Radiology |
12-366 |
Complete |
IEC |
61223-3-6 Edition 1.0 2020-02 |
Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 12/23/2024 |
Orthopedic |
11-417 |
Complete |
ASTM |
F3090-24 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements |
| 12/22/2025 |
Ophthalmic |
10-139 |
Complete |
ISO |
11980 Fourth edition 2025-06 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 12/22/2025 |
Materials |
8-638 |
Complete |
ASTM |
F2313-24 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
| 12/22/2025 |
Materials |
8-643 |
Complete |
ASTM |
F2820-24 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 12/22/2025 |
Orthopedic |
11-439 |
Complete |
ASTM |
F3437-23 |
Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation |
| 12/22/2025 |
Materials |
8-629 |
Complete |
ASTM |
F67-24 |
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
| 12/22/2025 |
Dental/
ENT |
4-353 |
Complete |
ISO |
20127 Third edition 2025-05 |
Dentistry - Physical properties of powered toothbrushes |
| 05/26/2025 |
Radiology |
12-378 |
Complete |
ISO |
12609-1 Second edition 2021-10 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 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 |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-484 |
Complete |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
| 05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
| 07/28/2025 |
General II (ES/
EMC) |
19-57 |
Complete |
IEC |
61326-2-6 Edition 4.0 2025-06 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 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 |
| 12/22/2025 |
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 |
| 05/26/2025 |
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 |
| 12/18/2023 |
Materials |
8-608 |
Complete |
ASTM |
F2214-23 |
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| 12/18/2023 |
Sterility |
14-591 |
Complete |
ISO |
14644-10 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
| 12/22/2025 |
Orthopedic |
11-423 |
Complete |
ASTM |
F2267-24 |
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 01/14/2019 |
Biocompatibility |
2-141 |
Complete |
ASTM |
F1984-99 (Reapproved 2018) |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| 12/18/2023 |
Sterility |
14-592 |
Complete |
ISO |
13408-1 Third edition 2023-08 |
Aseptic processing of health care products - Part 1: General requirements |
| 12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 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 |
4-365 |
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 |
| 09/17/2018 |
Materials |
8-475 |
Complete |
ASTM |
F2026-17 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 01/30/2014 |
Sterility |
14-427 |
Complete |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
| 05/29/2024 |
Radiology |
12-357 |
Complete |
IEC |
63145-20-10 Edition 1.0 2019-08 |
Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties |
| 05/29/2024 |
Radiology |
12-358 |
Complete |
IEC |
63145-20-20 Edition 1.0 2019-09 |
Eyewear display - Part 20-20: Fundamental measurement methods - Image quality |
| 05/29/2024 |
Radiology |
12-359 |
Complete |
IEC |
63145-22-10 Edition 1.0 2020-01 |
Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 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 |
| 05/29/2023 |
Biocompatibility |
2-299 |
Complete |
ASTM |
F1904-23 |
Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo |
| 07/26/2016 |
Biocompatibility |
2-213 |
Complete |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
| 05/26/2025 |
Anesthesiology |
1-196 |
Complete |
ISO |
80601-2-90 First edition 2021-08 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
| 05/29/2024 |
Sterility |
14-598 |
Complete |
ISO |
14644-3 Second edition 2020-06 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 12/23/2016 |
Anesthesiology |
1-118 |
Complete |
ISO |
5361 Third edition 2016-09-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
| 12/18/2023 |
Anesthesiology |
1-165 |
Complete |
ISO |
80601-2-13 Second edition 2022-04 |
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-490 |
Complete |
ISO |
10555-6 First edition 2015-04-15 [Including AMD1:2019] |
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-495 |
Complete |
ISO |
20698 First Edition 2018-07 |
Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| 05/29/2024 |
Software/
Informatics |
13-135 |
Complete |
ISO IEEE |
11073-10407 Second edition 2022-12 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| IEEE |
Std 11073-10407-2020 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| 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 |
| 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 |
| 12/19/2022 |
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 |
| 12/20/2021 |
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 |
| 01/14/2019 |
InVitro Diagnostics |
7-285 |
Complete |
CLSI |
M48-A 2nd Edition |
Laboratory Detection and Identification of Mycobacteria |
| 07/15/2019 |
Anesthesiology |
1-143 |
Complete |
ISO |
80601-2-79 First edition 2018-07 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 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 |
| 05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
| 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 |
| 08/21/2017 |
Biocompatibility |
2-248 |
Complete |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| 07/06/2020 |
InVitro Diagnostics |
7-297 |
Complete |
ISO |
TS 20914 First edition 2019-07 |
Medical laboratories - Practical guidance for the estimation of measurement uncertainty |
| 05/30/2022 |
Materials |
8-591 |
Complete |
ASTM |
F2229-21 |
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) |
| 12/20/2021 |
Orthopedic |
11-391 |
Complete |
ASTM |
F2722-21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| 12/19/2022 |
Biocompatibility |
2-297 |
Complete |
ASTM |
F763-22 |
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| 05/30/2022 |
Materials |
8-587 |
Complete |
ISO |
5832-3 Fifth Edition 2021-11 |
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 12/20/2021 |
Materials |
8-572 |
Complete |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| 12/19/2022 |
Anesthesiology |
1-157 |
Complete |
ISO |
10079-1 Fourth edition 2022-03 |
Medical suction equipment - Part 1: Electrically powered suction equipment |
| 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 |
Orthopedic |
11-430 |
Complete |
ASTM |
F564-24 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 05/29/2023 |
Sterility |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 03/16/2012 |
Anesthesiology |
1-73 |
Complete |
ISO |
10651-4 First edition 2002-03-01 |
Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
| 05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
| 01/27/2015 |
Sterility |
14-379 |
Complete |
ISO |
14644-8 Second edition 2013-02-15 |
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-486 |
Complete |
ISO |
10535 Third edition 2021-10 |
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods |
| 12/18/2023 |
Dental/
ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
| 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 |
| 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 |
| 07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| 05/26/2025 |
Cardiovascular |
3-200 |
Complete |
ASTM |
F2477-24 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular 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 |
| 12/22/2025 |
Dental/
ENT |
4-349 |
Complete |
ANSI ADA |
Standard No. 34-2025 |
Dental Cartridge Syringes |
| 05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
| 05/29/2024 |
Dental/
ENT |
4-325 |
Complete |
ANSI ADA |
Standard No. 96-2020 |
Dental Water-based Cements |
| 07/15/2019 |
Anesthesiology |
1-144 |
Complete |
ISO |
80601-2-80 First edition 2018-07 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
| 12/18/2023 |
Orthopedic |
11-404 |
Complete |
ASTM |
F2887-23 |
Standard Specification for Total Elbow Prostheses |
| 12/18/2023 |
Orthopedic |
11-406 |
Complete |
ASTM |
F3141-23 |
Standard Guide for Total Knee Replacement Loading Profiles |
| 06/27/2016 |
Cardiovascular |
3-143 |
Complete |
ISO |
12417-1 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-512 |
Complete |
IEC |
60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 05/26/2025 |
InVitro Diagnostics |
7-329 |
Complete |
CLSI |
EP06-EG 2nd Edition |
Developer Validation of Linearity, Establishment Guide |
| 12/19/2022 |
Orthopedic |
11-394 |
Complete |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
| 05/30/2022 |
Radiology |
12-345 |
Complete |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-185 |
Complete |
ASTM |
F881-94 (Reapproved 2022) |
Standard Specification for Silicone Elastomer Facial Implants |
| 01/14/2019 |
Materials |
8-482 |
Complete |
ASTM |
D1505-18 |
Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| 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 |
| 08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 05/26/2025 |
Radiology |
12-380 |
Complete |
IEC |
60601-2-37 Edition 3.0 2024-07 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 06/27/2016 |
Radiology |
12-293 |
Complete |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 09/17/2018 |
Biocompatibility |
2-256 |
Complete |
ASTM |
F720-17 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
| 12/18/2023 |
Sterility |
14-593 |
Complete |
ASTM |
F3039-23 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
| 06/07/2021 |
Ophthalmic |
10-126 |
Complete |
IEC |
80601-2-58 Edition 2.0 2014-09 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| ANSI AAMI IEC |
80601-2-58:2014 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
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