|
|
|
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)
|
| 07/15/2019 |
Orthopedic |
11-353 |
Complete |
ISO |
18192-3 First edition 2017-06 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
| 07/15/2019 |
Materials |
8-514 |
Complete |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
| 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 |
Ophthalmic |
10-140 |
Complete |
ANSI |
Z80.1-2020 |
American National Standard for Ophthalmics - Prescription Ophthalmic Lenses - Recommendations |
| 12/21/2020 |
Orthopedic |
11-373 |
Complete |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
| 12/22/2025 |
Orthopedic |
11-437 |
Complete |
ASTM |
F2033-25 |
Standard Specification for Hip Joint Replacement Bearing Surfaces |
| 06/07/2021 |
Orthopedic |
11-376 |
Complete |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| 12/21/2020 |
Anesthesiology |
1-150 |
Complete |
ISO |
8836 Fifth edition 2019-12 |
Suction catheters for use in the respiratory tract |
| 06/07/2021 |
Ophthalmic |
10-124 |
Complete |
ISO |
11979-1 Fourth edition 2018-11 |
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-444 |
Complete |
ASTM |
D7103-19(2023) |
Standard Guide for Assessment of Medical Gloves |
| 12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| 07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
| 06/07/2021 |
InVitro Diagnostics |
7-307 |
Complete |
CLSI |
POCT05 2nd Edition |
Performance Metrics for Continuous Interstitial Glucose Monitoring |
| 06/07/2021 |
Orthopedic |
11-381 |
Complete |
ASTM |
F2582-20 |
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components |
| 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 |
| 01/30/2014 |
Sterility |
14-412 |
Complete |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
| 12/22/2025 |
Orthopedic |
11-438 |
Complete |
ASTM |
F2502-24 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/20/2021 |
Ophthalmic |
10-127 |
Complete |
ANSI |
Z80.21-2020 |
American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| 12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
| 12/19/2022 |
Dental/
ENT |
4-294 |
Complete |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
| 12/19/2022 |
Dental/
ENT |
4-295 |
Complete |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 12/23/2019 |
Materials |
8-498 |
Complete |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 12/22/2025 |
Materials |
8-636 |
Complete |
ASTM |
F688-25 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
| 12/23/2019 |
Materials |
8-507 |
Complete |
ASTM |
F688-19 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
| 12/22/2025 |
Materials |
8-639 |
Complete |
ASTM |
F1091-25 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
Complete |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 12/21/2020 |
Tissue Engineering |
15-65 |
Complete |
ISO |
22442-2 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| 12/22/2025 |
Sterility |
14-612 |
Complete |
USP-NF |
M16015_02_01 |
<86> Bacterial Endotoxins Test Using Recombinant Reagents |
| 12/22/2025 |
Materials |
8-631 |
Complete |
ASTM |
F1854-25 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Using Digital Images |
| 04/04/2016 |
Materials |
8-400 |
Complete |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
| 08/21/2017 |
Dental/
ENT |
4-239 |
Complete |
ANSI AAMI |
CI86:2017/(R)2025 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 07/09/2014 |
Dental/
ENT |
4-160 |
Complete |
ANSI ASA |
S3.1-1999 (Reaffirmed 2023) |
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
| 08/14/2015 |
Dental/
ENT |
4-220 |
Complete |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
| 08/14/2015 |
Dental/
ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2024) |
American National Standard For an Occluded Ear Simulator |
| 12/23/2019 |
Materials |
8-521 |
Complete |
ASTM |
F2313-18 |
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 |
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 |
Physical Medicine |
16-237 |
Complete |
ASME |
A18.1-2023 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 09/17/2018 |
Physical Medicine |
16-203 |
Complete |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 12/04/2017 |
Software/
Informatics |
13-102 |
Complete |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
| 04/04/2016 |
General II (ES/
EMC) |
19-17 |
Complete |
IEEE ANSI |
C63.18-2014 |
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
| 01/14/2019 |
Ophthalmic |
10-114 |
Complete |
ANSI |
Z80.28-2017 |
American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes |
| 12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
| 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 |
| 01/14/2019 |
Ophthalmic |
10-115 |
Complete |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| 01/14/2019 |
Software/
Informatics |
13-106 |
Complete |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
| 01/14/2019 |
Software/
Informatics |
13-107 |
Complete |
ISO IEEE |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
| IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services |
| 12/22/2025 |
Software/
Informatics |
13-154 |
Complete |
IEEE |
Std 11073-10429-2022 |
Health informatics - Device Interoperability - Part 10429: Personal Health Device Communication - Device Specialization - Spirometry |
| 05/26/2025 |
Biocompatibility |
2-306 |
Complete |
ASTM |
F1439-24 |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 07/15/2019 |
Biocompatibility |
2-265 |
Complete |
ASTM |
F2901-19 |
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
Complete |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 12/22/2025 |
Software/
Informatics |
13-156 |
Complete |
ISO IEEE |
11073-10471 Second Edition 2024-09 |
Health Informatics - Device Interoperability - Part 10471: Personal Health Device Communication - Device Specialization-Independent Living Activity Hub |
| IEEE |
Std 11073-10471-2023 |
Health Informatics - Device interoperability - Part 10471: Personal health device communication - Device specialization - Independent living activity hub |
| 05/26/2025 |
Biocompatibility |
2-307 |
Complete |
ASTM |
F1877-24 |
Standard Practice for Characterization of Particles |
| 01/14/2019 |
Cardiovascular |
3-158 |
Complete |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 01/14/2019 |
Dental/
ENT |
4-255 |
Complete |
ANSI ADA |
Standard No. 131-2015 (R2020) |
Dental CAD/CAM Machinable Zirconia Blanks |
| 07/15/2019 |
Orthopedic |
11-355 |
Complete |
ISO |
15142-1 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails |
| 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 |
| 08/20/2012 |
Cardiovascular |
3-102 |
Complete |
IEC |
60601-2-31 Edition 2.1 2011-09 |
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 |
Software/
Informatics |
13-152 |
Complete |
ISO |
TS 5615:2025 |
Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics |
| 07/15/2019 |
Orthopedic |
11-358 |
Complete |
ISO |
14242-4 First edition 2018-05 |
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-450 |
Complete |
IEC |
60601-2-50 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| 07/06/2020 |
General I (QS/
RM) |
5-130 |
Complete |
ISO |
7010 Third edition 2019-07 |
Graphical symbols - Safety colours and safety signs - Registered safety signs |
| 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 |
| 07/15/2019 |
Materials |
8-495 |
Complete |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
| 06/07/2021 |
Dental/
ENT |
4-279 |
Complete |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 06/27/2016 |
Software/
Informatics |
13-83 |
Complete |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |
| 12/22/2025 |
Software/
Informatics |
13-155 |
Complete |
IEEE |
Std 11073-10442-2023 |
Health informatics - Device Interoperability Part 10442: Personal health device communication - Device specialization - Strength fitness equipment |
| 07/06/2020 |
Biocompatibility |
2-275 |
Complete |
ISO |
10993-7 Second edition 2008-10-15 |
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] |
| 12/21/2020 |
General II (ES/
EMC) |
19-37 |
Complete |
IEC |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
| 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 |
| 12/22/2025 |
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 |
| 08/06/2013 |
Cardiovascular |
3-115 |
Complete |
IEC |
60601-2-34 Edition 3.0 2011-05 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment |
| 12/23/2024 |
Radiology |
12-362 |
Complete |
IEC |
61674 Edition 3.0 2024-07 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 01/30/2014 |
Radiology |
12-259 |
Complete |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-505 |
Complete |
ISO |
21649 Second Edition 2023-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 06/07/2021 |
Orthopedic |
11-380 |
Complete |
ASTM |
F2979-20 (Reapproved 2025) |
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses |
| 07/06/2020 |
General I (QS/
RM) |
5-129 |
Complete |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-273 |
Complete |
ISO |
23908 First edition 2011-06-11 |
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 05/26/2025 |
Biocompatibility |
2-305 |
Complete |
ASTM |
E1262-24 |
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 07/06/2020 |
Radiology |
12-333 |
Complete |
IEC |
TR 63183 Edition 1.0 2019-12 |
Guidance on error and warning messages for software used in radiotherapy |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-479 |
Complete |
ISO |
11608-5:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions |
| 01/14/2019 |
Biocompatibility |
2-136 |
Complete |
ASTM |
E1262-88 (Reapproved 2018) |
Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 05/29/2023 |
Materials |
8-599 |
Complete |
ASTM |
F1295-22 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 12/22/2025 |
Software/
Informatics |
13-153 |
Complete |
AAMI |
CR515:2025 |
Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices |
| 07/09/2014 |
Software/
Informatics |
13-68 |
Complete |
ISO |
11073-90101 First edition 2008-01-15 |
Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test |
| 08/14/2015 |
Software/
Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| 08/06/2013 |
Software/
Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
| 01/30/2014 |
Radiology |
12-228 |
Complete |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| 01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
| 01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
| 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 |
Radiology |
12-365 |
Complete |
IEC |
60627 Edition 3.0 2013-07 |
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| 07/15/2019 |
Materials |
8-510 |
Complete |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-124 |
Complete |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
| 10/04/2010 |
Radiology |
12-213 |
Complete |
IEC |
62220-1-2 Edition 1.0 2007-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| 05/29/2024 |
Anesthesiology |
1-177 |
Complete |
ISO |
80601-2-74 Second edition 2021-07 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 04/04/2016 |
Sterility |
14-337 |
Complete |
ISO |
14937 Second edition 2009-10-15 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ANSI AAMI ISO |
14937:2009/(R)2013 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices |
| 06/07/2018 |
Tissue Engineering |
15-53 |
Complete |
ASTM |
F3206-17 |
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
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