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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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
07/15/2019 Sterility 14-533 Complete ISO TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
04/04/2016 Materials 8-399 Complete ASTM F90-14 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)
12/22/2025 Materials 8-632 Complete ASTM F1058-25 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
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)
12/21/2020 Sterility 14-553 Complete ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
12/23/2019 Cardiovascular 3-161 Complete ISO 14117 Second edition 2019-09 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
07/15/2019 General Plastic Surgery/
General Hospital
6-423 Complete IEC 60601-2-6 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
08/06/2013 Orthopedic 11-254 Complete ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
06/07/2021 Radiology 12-337 Complete NEMA NU 1-2018 Performance Measurements of Gamma Cameras
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
12/20/2021 Cardiovascular 3-175 Complete ISO 5840-2 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
05/30/2022 Sterility 14-574 Complete ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
12/19/2022 Materials 8-596 Complete ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
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
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
12/21/2020 General II (ES/
EMC)
19-39 Complete IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)]
12/23/2019 Physical Medicine 16-220 Complete RESNA ANSI WC-1:2019 Section 15 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling
12/19/2022 General Plastic Surgery/
General Hospital
6-483 Complete IEC 60601-2-35 Edition 2.0 2020-09 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
07/15/2019 Materials 8-516 Complete ISO 13779-4 Second edition 2018-12 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
12/23/2019 Physical Medicine 16-215 Complete RESNA ANSI WC-2:2019 Section 9 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs
12/23/2024 InVitro Diagnostics 7-324 Complete CLSI M07 12th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
07/15/2019 Materials 8-517 Complete ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
05/26/2025 Radiology 12-372 Complete ISO 14880-3 Second edition 2024-11 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/19/2007 Radiology 12-172 Complete ISO 14880-3:2006 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
05/26/2025 Radiology 12-373 Complete ISO 14880-4 Second edition 2024-11 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007 Radiology 12-173 Complete ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
05/26/2025 Radiology 12-374 Complete ISO 24013 Second edition 2023-06 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
03/16/2012 Radiology 12-175 Complete ISO 24013 First edition 2006-11-15 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
12/23/2019 Physical Medicine 16-221 Complete RESNA ANSI WC-1:2019 Section 16 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods
12/21/2020 Nanotechnology 18-17 Complete ISO 21363 First edition 2020-06 Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
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
05/26/2025 Radiology 12-375 Complete ANSI UL 122-2019 Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019]
07/06/2020 General Plastic Surgery/
General Hospital
6-441 Complete ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
07/06/2020 Orthopedic 11-364 Complete ISO 14243-1 Second edition 2009-11-15 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
01/14/2019 Software/
Informatics
13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
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
12/22/2025 Dental/
ENT
4-355 Complete ISO 18397 Second edition 2025-07 Dentistry - Powered scaler
03/16/2012 Radiology 12-177 Complete UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
12/22/2025 General Plastic Surgery/
General Hospital
6-517 Complete ASTM F3502-25 Standard Specification for Barrier Face Coverings
12/23/2019 Software/
Informatics
13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-138 Complete ISO 20695 First edition 2020-03 Enteral feeding systems - Design and testing
12/21/2020 Ophthalmic 10-121 Complete ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
07/15/2019 Orthopedic 11-349 Complete ISO 14242-3 First edition 2009-03-15 Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
09/17/2018 Orthopedic 11-185 Complete ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
12/22/2025 Orthopedic 11-424 Complete ASTM F983-24 Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
12/19/2022 Anesthesiology 1-159 Complete ISO 18778 Second edition 2022-06 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
12/22/2025 Orthopedic 11-425 Complete ASTM F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
05/26/2025 Radiology 12-376 Complete IEC 61689 Edition 4.0 2022-03 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
06/07/2018 General Plastic Surgery/
General Hospital
6-406 Complete ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
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
07/09/2014 Radiology 12-282 Complete ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
05/26/2025 Radiology 12-379 Complete IEC 62127-2 Edition 2.0 2025-01 Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
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
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
01/15/2013 Software/
Informatics
13-36 Complete AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
06/07/2018 Neurology 17-16 Complete IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
12/21/2020 General I (QS/
RM)
5-133 Complete ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
12/23/2019 Physical Medicine 16-219 Complete RESNA ANSI WC-2:2019 Section 14 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
12/23/2019 Physical Medicine 16-213 Complete RESNA ANSI WC-1:2019 Section 7 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions
05/26/2025 Neurology 17-22 Complete IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
12/21/2020 Orthopedic 11-371 Complete ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
06/07/2021 Sterility 14-562 Complete ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
06/07/2021 Materials 8-558 Complete ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
05/26/2025 Software/
Informatics
13-148 Complete IEEE Std 11073-10417-2023 Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
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
12/22/2025 Materials 8-637 Complete ASTM F2579-24 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
12/21/2020 Materials 8-540 Complete ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
12/22/2025 Materials 8-640 Complete ASTM F961-25 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
12/21/2020 Materials 8-544 Complete ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
12/22/2025 Materials 8-641 Complete ASTM F629-24 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-134 Complete ISO 23500-2 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
ANSI AAMI ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
12/21/2020 Sterility 14-552 Complete ISO ASTM 51818 Fourth edition 2020-06 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
12/23/2019 Physical Medicine 16-214 Complete RESNA ANSI WC-1:2019 Section 8 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths
09/17/2018 Orthopedic 11-340 Complete ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
06/07/2021 Radiology 12-339 Complete IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
01/14/2019 Dental/
ENT
4-250 Complete ISO 7494-1 Third edition 2018-06 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
12/21/2020 Materials 8-551 Complete ASTM F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
12/22/2025 Materials 8-643 Complete ASTM F2820-24 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/20/2021 Materials 8-574 Complete ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/23/2019 InVitro Diagnostics 7-293 Complete CLSI QMS01, 5th ed. June 2019 (Replaces QMS01-A4) A Quality Management System Model for Laboratory Services.
12/23/2019 Cardiovascular 3-162 Complete ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/23/2019 InVitro Diagnostics 7-295 Complete CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
12/23/2019 Physical Medicine 16-208 Complete RESNA ANSI WC-2:2019 Section 2 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs
12/23/2019 Physical Medicine 16-212 Complete RESNA ANSI WC-2:2019 Section 6 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically 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
12/20/2021 Ophthalmic 10-128 Complete ASTM D882-18 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
 
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