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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
05/25/2026 Dental/
ENT
4-372 Complete ANSI ADA Standard No. 141-2013 (R2023) Dentistry-Dental Duplicating Material
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
07/15/2019 Orthopedic 11-352 Complete ISO 14242-1 Third edition 2014-10-15 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
01/14/2019 Dental/
ENT
4-217 Complete ANSI ASA S3.36-2012 (Reaffirmed 2022) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
12/20/2021 Orthopedic 11-393 Complete ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
12/20/2021 Orthopedic 11-390 Complete ISO 23089-2 First edition 2021-05 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
12/20/2021 Orthopedic 11-385 Complete ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
05/25/2026 Radiology 12-386 Complete IEC 63465 Edition 1.0 2026-01 Calibration and quality control in the use of radionuclide calibrators
05/29/2023 Sterility 14-587 Complete AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
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
ANSI ADA Standard No. 213-2024 Dentistry - Intra Oral Camera
12/18/2023 Orthopedic 11-402 Complete ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
05/26/2025 Sterility 14-610 Complete ISO 11138-7 First edition 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
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
05/29/2023 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
01/30/2014 Sterility 14-336 Complete ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
08/06/2013 Software/
Informatics
13-44 Complete ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
12/18/2023 Orthopedic 11-408 Complete ASTM F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
12/18/2023 Orthopedic 11-409 Complete ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
01/27/2015 Software/
Informatics
13-70 Complete ANSI AAMI IEC TIR80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC TR 80001-2-5 Edition 1.0 2014-12 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
08/06/2013 Software/
Informatics
13-60 Complete IEC TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
12/18/2023 Dental/
ENT
4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
12/18/2023 Materials 8-610 Complete ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-483 Complete ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
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)]
05/29/2023 Cardiovascular 3-186 Complete ISO 14708-2 Third edition 2019-09 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023 Cardiovascular 3-187 Complete ISO 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
05/26/2025 Sterility 14-611 Complete ISO 11137-1 Second edition 2025-04 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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
12/18/2023 Anesthesiology 1-166 Complete ISO 11195 Second edition 2018-01 Gas mixers for medical use - Stand-alone gas mixers
12/18/2023 Sterility 14-589 Complete ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
05/25/2026 Software/
Informatics
13-140 Complete FIRST CVSS v4.0 Common Vulnerability Scoring System version 4.0
05/26/2025 Software/
Informatics
13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
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
12/22/2025 Dental/
ENT
4-348 Complete ISO 9917-1 Third Edition 2025-05 Dentistry - Water-based cements - Part 1: Acid-base cements
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
12/18/2023 Materials 8-606 Complete ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
01/27/2015 Sterility 14-141 Complete ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
12/18/2023 Sterility 14-590 Complete ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
07/15/2019 Sterility 14-528 Complete ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
09/17/2018 Materials 8-412 Complete ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
12/18/2023 Materials 8-607 Complete ASTM F2082/F2082M-23 Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
05/25/2026 Software/
Informatics
13-158 Complete IEEE Std 1752.1-2021 Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures
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
12/23/2016 Orthopedic 11-316 Complete ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
08/21/2017 Materials 8-451 Complete ASTM F2214-16 Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
12/18/2023 Materials 8-609 Complete ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
05/26/2025 Neurology 17-20 Complete IEC 60601-2-40 Third edition 2024-12 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
05/25/2026 Dental/
ENT
4-390 Complete ISO 15912 Second edition 2016-01 Dentistry - Refractory investment and die material
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
05/25/2026 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
09/17/2018 Orthopedic 11-324 Complete ASTM F366-17 Standard Specification for Fixation Pins and Wires
08/06/2013 Software/
Informatics
13-57 Complete ISO IEEE 11073-10407 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
IEEE Std 11073-10407-2008 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
05/29/2023 ObGyn/
Gastroenterology/
Urology
9-145 Complete ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
05/29/2023 ObGyn/
Gastroenterology/
Urology
9-146 Complete ISO 8600-4 Third Edition 2023-01 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
12/18/2023 Materials 8-605 Complete ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
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)
12/19/2022 Anesthesiology 1-156 Complete ISO 10079-3 Fourth edition 2022-03 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
12/19/2022 Anesthesiology 1-158 Complete ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements
05/26/2025 General I (QS/
RM)
5-145 Complete IEC 60417:2025 DB Graphical symbols for use on equipment
05/26/2025 General II (ES/
EMC)
19-54 Complete IEC 60086-5 Edition 5.0 2021-09 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)]
08/21/2017 General II (ES/
EMC)
19-24 Complete IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
12/22/2025 Anesthesiology 1-200 Complete ISO 7376-2 First edition 2025-09 Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes
04/03/2023 General II (ES/
EMC)
19-34 Complete IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
12/19/2022 General Plastic Surgery/
General Hospital
6-485 Complete ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/20/2021 Orthopedic 11-386 Complete ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/22/2025 Orthopedic 11-431 Complete ASTM F384-24 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-326 Complete ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
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
12/20/2021 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
06/07/2021 Dental/
ENT
4-281 Complete ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
05/29/2023 Dental/
ENT
4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
12/19/2022 General I (QS/
RM)
5-140 Complete ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
09/17/2018 Materials 8-470 Complete ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
06/07/2018 Tissue Engineering 15-51 Complete ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Materials 8-113 Complete ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
09/17/2018 Orthopedic 11-338 Complete ISO 11491 First edition 2017-07 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-117 Complete ISO 16038 Second edition 2017-11 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
09/17/2018 ObGyn/
Gastroenterology/
Urology
9-120 Complete ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
09/17/2018 Physical Medicine 16-202 Complete ISO 7176-2 Third edition 2017-10 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
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
04/04/2016 Radiology 12-195 Complete NEMA MS 6-2008 (R2014, R2020) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
07/09/2014 Radiology 12-273 Complete IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
09/17/2018 Dental/
ENT
4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
04/04/2016 Orthopedic 11-304 Complete ASTM F3107-14 (Reapproved 2023) Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
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 Dental/
ENT
4-349 Complete ANSI ADA Standard No. 34-2025 Dental Cartridge Syringes
01/14/2019 Orthopedic 11-272 Complete ASTM F1714-96 (Reapproved 2025) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
 
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