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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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12/22/2025 General I (QS/
RM)
5-148 Complete ISO 15223-1 Fourth edition 2021-07 [Including AMD1: 2025] Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)]
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
12/22/2025 Dental/
ENT
4-362 Complete ISO 3630-3 Third edition 2021-06 Corrected version 2023-05 Dentistry - Endodontic instruments - Part 3: Compactors
ANSI ADA Standard No. 101-3-2025 Dentistry - Endodontic Instruments - Part 3: Compactors
09/17/2018 Materials 8-475 Complete ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
12/18/2023 Dental/
ENT
4-314 Complete ISO 7494-2 Third edition 2022-07 Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
12/22/2025 General I (QS/
RM)
5-147 Complete ISO 80369-1 Third edition 2025-10 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
01/14/2019 General I (QS/
RM)
5-121 Complete ISO 80369-1 Second edition 2018-11 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
05/26/2025 Radiology 12-381 Complete IEC 60601-2-68 Edition 2.0 2025-02 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
09/17/2018 Radiology 12-319 Complete IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
05/29/2023 Cardiovascular 3-184 Complete ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
05/26/2025 Orthopedic 11-420 Complete ASTM F2580-24 Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
12/20/2021 General I (QS/
RM)
5-134 Complete ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
12/22/2025 Physical Medicine 16-238 Complete ISO 11199-1 Second edition 2021-05 Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames
05/29/2023 Materials 8-601 Complete ASTM F2516-22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
07/15/2019 Materials 8-506 Complete ASTM F2516-18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
05/29/2023 Materials 8-603 Complete ASTM F1472-23 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
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
01/14/2019 Orthopedic 11-344 Complete ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
12/22/2025 General Plastic Surgery/
General Hospital
6-514 Complete ISO 1135-4 Seventh edition 2025-05 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017 General Plastic Surgery/
General Hospital
6-384 Complete ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
12/20/2021 General Plastic Surgery/
General Hospital
6-471 Complete USP-NF M88880_05_01 Sterile Water for Irrigation
12/20/2021 Sterility 14-571 Complete ISO 11138-8 First edition 2021-07 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
12/23/2016 InVitro Diagnostics 7-267 Complete CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
05/30/2022 Materials 8-584 Complete ASTM F2146-22 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
05/30/2022 Materials 8-585 Complete ASTM F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
05/30/2022 Materials 8-586 Complete ASTM F2989-21 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
12/20/2021 Materials 8-570 Complete ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
05/26/2025 Orthopedic 11-422 Complete ASTM F1798-24 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
01/15/2013 Software/
Informatics
13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
05/25/2026 Dental/
ENT
4-373 Complete ANSI ADA Standard No. 170-2019 Periodontal Probes - Dental Excavators - Discoid Type: General Requirements
05/25/2026 Dental/
ENT
4-374 Complete ANSI ADA Standard No. 195-2021 Dental Tweezers
05/25/2026 Dental/
ENT
4-381 Complete ISO 13078 First edition 2013-02 Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple
ANSI ADA Standard No.163-2018 Dental Furnance, Part 1: Test Method for Temperature Measurement with Separate Thermocouple
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
08/06/2013 Software/
Informatics
13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
12/23/2024 Sterility 14-606 Complete ANSI AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
12/23/2016 Radiology 12-303 Complete IEC 61303 Edition 1.0 1994-09 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
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
 
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