|
|
|
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)
|
| 08/21/2017 |
General II (ES/
EMC) |
19-22 |
Complete |
AAMI |
TIR69:2017/(R2020) |
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. |
| 01/30/2014 |
Orthopedic |
11-74 |
Complete |
ISO |
5838-2 First edition 1991-01-15 |
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
| 01/30/2014 |
Orthopedic |
11-75 |
Complete |
ISO |
5838-3 First edition 1993-09-15 |
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-86 |
Complete |
ISO |
16037 First edition 2002-05-15 (Amendment 1 2011-02-15) |
Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)] |
| 06/07/2018 |
Radiology |
12-314 |
Complete |
ISO |
11554 Fourth edition 2017-07 |
Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics |
| 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 |
| 12/22/2025 |
Dental/
ENT |
4-349 |
Complete |
ANSI ADA |
Standard No. 34-2025 |
Dental Cartridge Syringes |
| 05/26/2025 |
InVitro Diagnostics |
7-331 |
Complete |
CLSI |
AUTO02-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition |
| 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 |
| 09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
| 12/21/2020 |
Dental/
ENT |
4-271 |
Complete |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
| 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 |
| 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 |
Dental/
ENT |
4-350 |
Complete |
ANSI ASA |
S3.6-2025 |
American National Standard Specification for Audiometers |
| 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. |
| 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 |
| 07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| 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 |
| 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 |
| 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 |
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 |
| 12/20/2021 |
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 |
| 05/29/2023 |
Dental/
ENT |
4-301 |
Complete |
ISO |
21563 Second edition 2021-08 |
Dentistry - Hydrocolloid impression materials |
| ANSI ADA |
Standard No. 128-2022 |
Hydrocolloid Impression Materials |
| 12/22/2025 |
Tissue Engineering |
15-68 |
Complete |
ASTM |
F2212-25 |
Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| 05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 12/22/2025 |
Materials |
8-628 |
Complete |
ASTM |
F754-24 |
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
| 12/22/2025 |
Tissue Engineering |
15-69 |
Complete |
ASTM |
F2944-20 |
Standard Practice for Automated Colony Forming Unit (CFU) Assays - Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture |
| 12/19/2022 |
Dental/
ENT |
4-294 |
Complete |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
| 12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
| 12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
| 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 |
Materials |
8-630 |
Complete |
ASTM |
F90-24 |
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) |
| 05/30/2022 |
Anesthesiology |
1-152 |
Complete |
ISO |
80601-2-87 First edition 2021-04 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
| 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 |
| 12/23/2024 |
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 |
| 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) |
| 12/23/2019 |
Physical Medicine |
16-229 |
Complete |
RESNA ANSI |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
| 12/23/2024 |
InVitro Diagnostics |
7-322 |
Complete |
CLSI |
M47 2nd Edition |
Principles and Procedures for Blood Cultures |
| 07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
| 12/22/2025 |
Biocompatibility |
2-309 |
Complete |
ASTM |
F895-25 |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
| 08/06/2013 |
Ophthalmic |
10-77 |
Complete |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
| 12/21/2020 |
Orthopedic |
11-375 |
Complete |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| 12/23/2019 |
Materials |
8-508 |
Complete |
ASTM |
F2579-18 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 12/23/2019 |
Physical Medicine |
16-227 |
Complete |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
| 06/07/2021 |
Orthopedic |
11-383 |
Complete |
ASTM |
F3143-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator |
| 12/23/2024 |
Anesthesiology |
1-189 |
Complete |
ISO |
4135 Fourth edition 2022-01 |
Anaesthetic and respiratory equipment - Vocabulary |
| 08/21/2017 |
Materials |
8-455 |
Complete |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 12/22/2025 |
Materials |
8-634 |
Complete |
ASTM |
F2066-23 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 12/20/2021 |
Cardiovascular |
3-172 |
Complete |
AAMI |
TIR42:2021 |
Evaluation of Particulates Associated with Vascular Medical Devices |
| 05/30/2022 |
InVitro Diagnostics |
7-312 |
Complete |
CLSI |
M39 5th Edition |
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
| 12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 12/23/2024 |
Radiology |
12-364 |
Complete |
IEC |
61223-3-8 Edition 1.0 2024-03 |
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
|
| 12/23/2024 |
Orthopedic |
11-414 |
Complete |
ASTM |
F382-24 |
Standard Specification and Test Method for Metallic Bone Plates |
| 07/15/2019 |
Orthopedic |
11-356 |
Complete |
ISO |
15142-2 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
| 06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-510 |
Complete |
IEC |
80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
Complete |
IEC |
80601-2-77 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| ANSI AAMI IEC |
80601-2-77:2020 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| 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 |
| 12/23/2024 |
General II (ES/
EMC) |
19-51 |
Complete |
UL |
1642 Sixth Edition September 29, 2020 |
Standard For Safety Lithium Batteries |
| 07/15/2019 |
Materials |
8-517 |
Complete |
ISO |
17327-1 First edition 2018-02 |
Non-active surgical implants - Implant coating - Part 1: General requirements |
| 06/07/2021 |
Dental/
ENT |
4-275 |
Complete |
ANSI ASA |
S3.6-2018 (Reaffirmed 2023) |
American National Standard Specification for Audiometers |
| 12/22/2025 |
Dental/
ENT |
4-351 |
Complete |
ISO |
6877 Fourth edition 2025-08 |
Dentistry - Endodontic obturating materials |
| 12/18/2023 |
Dental/
ENT |
4-309 |
Complete |
ISO |
6877 Third edition 2021-09 |
Dentistry - Endodontic obturating materials |
| ANSI ADA |
Standard No. 78-2022 |
Dentistry - Endodontic Obturating Materials |
| 12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
| 12/23/2024 |
Cardiovascular |
3-194 |
Complete |
ISO |
7199 Fourth edition 2024-09 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| 06/07/2018 |
Cardiovascular |
3-150 |
Complete |
ISO |
7199 Third edition 2016-11-15 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| ANSI AAMI ISO |
7199:2016 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| 05/30/2022 |
Sterility |
14-577 |
Complete |
ISO |
11737-1 Third edition 2018-01 [Including AMD1:2021] |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
| 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. |
| 12/19/2022 |
Software/
Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
| 12/23/2024 |
Cardiovascular |
3-193 |
Complete |
ISO |
12417-1 Second edition 2024-02 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 05/26/2025 |
InVitro Diagnostics |
7-339 |
Complete |
CLSI |
AUTO09-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| 12/21/2020 |
Materials |
8-550 |
Complete |
ASTM |
F2181-20 |
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants |
| 12/21/2020 |
Materials |
8-553 |
Complete |
ISO ASTM |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 01/30/2014 |
Cardiovascular |
3-118 |
Complete |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
| 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 |
| 12/23/2019 |
Materials |
8-484 |
Complete |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 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 |
| 12/18/2023 |
Dental/
ENT |
4-312 |
Complete |
ANSI ASA |
S3.35-2021 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 07/06/2020 |
Nanotechnology |
18-16 |
Complete |
ISO |
TS 21362 First edition 2018-06 |
Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation |
| 07/06/2020 |
Radiology |
12-330 |
Complete |
NEMA |
Standards Publication XR 28-2018 (R2023) |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
| 12/23/2019 |
Physical Medicine |
16-222 |
Complete |
RESNA ANSI |
WC-1:2019 Section 20 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-223 |
Complete |
RESNA ANSI |
WC-1:2019 Section 22 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures |
| 12/23/2019 |
Physical Medicine |
16-224 |
Complete |
RESNA ANSI |
WC-2:2019 Section 21 |
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters |
| 05/26/2025 |
InVitro Diagnostics |
7-334 |
Complete |
CLSI |
AUTO05-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
| 12/23/2024 |
General II (ES/
EMC) |
19-53 |
Complete |
IEC |
TS 60601-4-6 Edition 1.0 2024-04 |
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances |
| 12/21/2020 |
Biocompatibility |
2-279 |
Complete |
ASTM |
F750-20 |
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |
| 12/23/2019 |
Physical Medicine |
16-211 |
Complete |
RESNA ANSI |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
| 12/19/2022 |
Software/
Informatics |
13-128 |
Complete |
IEEE UL |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
| 05/26/2025 |
Software/
Informatics |
13-143 |
Complete |
AAMI |
TIR45:2023 |
Guidance on the use of AGILE practices in the development of medical device software |
| 12/22/2025 |
Dental/
ENT |
4-353 |
Complete |
ISO |
20127 Third edition 2025-05 |
Dentistry - Physical properties of powered toothbrushes |
| 12/23/2024 |
InVitro Diagnostics |
7-324 |
Complete |
CLSI |
M07 12th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
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