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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2018 Tissue Engineering 15-54 Complete ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
12/23/2019 General Plastic Surgery/
General Hospital		 6-424 Complete ASTM D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
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
05/26/2025 Ophthalmic 10-137 Complete ISO 11979-2 Third edition 2024-10 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
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
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 Orthopedic 11-397 Complete ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
04/03/2023 General II (ES/
EMC)		 19-49 Complete IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
09/17/2018 Ophthalmic 10-112 Complete ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
09/17/2018 General Plastic Surgery/
General Hospital		 6-123 Complete ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
09/17/2018 General Plastic Surgery/
General Hospital		 6-409 Complete ASTM F703-18 (Reapproved 2022) Standard Specification for Implantable Breast Prostheses
05/30/2022 Materials 8-593 Complete ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 Implants for surgery - Hydroxyapatite - Part 6: Powders
07/09/2014 InVitro Diagnostics 7-213 Complete CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
03/16/2012 Radiology 12-142 Complete ISO 11146-2 First edition 2005-02-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
05/26/2025 Software/
Informatics		 13-145 Complete IEEE Std 11073-10419:2023 Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
12/20/2021 Cardiovascular 3-178 Complete ASTM F3067-14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/19/2022 Materials 8-594 Complete ISO 5832-6 Third Edition 2022-03 Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
06/27/2016 Materials 8-427 Complete ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
12/23/2016 Physical Medicine 16-199 Complete ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
08/21/2017 Materials 8-458 Complete ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
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.
01/30/2014 Sterility 14-402 Complete ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
05/26/2025 Anesthesiology 1-194 Complete ISO 27427 Fourth edition 2023-07 Anaesthetic and respiratory equipment - Nebulizing systems and components
12/19/2022 Orthopedic 11-398 Complete ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
12/20/2021 General II (ES/
EMC)		 19-44 Complete IEEE ANSI C63.24-2021 American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
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
12/20/2021 General Plastic Surgery/
General Hospital		 6-472 Complete USP-NF M36660_04_01 Heparin Lock Flush Solution
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
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
09/17/2018 InVitro Diagnostics 7-279 Complete CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 Complete CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
12/23/2024 General Plastic Surgery/
General Hospital		 6-504 Complete ASTM F1862/F1862M-24 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
08/14/2015 Ophthalmic 10-98 Complete ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
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
12/21/2020 Biocompatibility 2-279 Complete ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
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 8-556 Complete ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
08/21/2017 Orthopedic 11-175 Complete ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
08/21/2017 Orthopedic 11-309 Complete ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
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)
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-264 Complete NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
06/07/2018 Radiology 12-312 Complete IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
05/26/2025 Radiology 12-371 Complete ISO 14880-2 Second edition 2024-11 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
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 3-193 Complete ISO 12417-1 Second edition 2024-02 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
12/21/2020 Biocompatibility 2-281 Complete ISO TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
12/21/2020 Dental/
ENT		 4-269 Complete ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
ANSI ADA Standard No. 158-2020 Coupling Dimensions for Dental Handpiece Connectors
12/23/2019 Physical Medicine 16-207 Complete RESNA ANSI WC-1:2019 Section 1 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability
12/23/2019 Physical Medicine 16-209 Complete RESNA ANSI WC-1:2019 Section 3 American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes
12/23/2019 Physical Medicine 16-210 Complete RESNA ANSI WC-2:2019 Section 4 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range
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
08/14/2015 General Plastic Surgery/
General Hospital		 6-353 Complete ASTM F2051-00 (Reapproved 2022) Standard Specification for Implantable Saline Filled Breast Prosthesis
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
01/30/2014 Physical Medicine 16-164 Complete ISO 7176-10 Second edition 2008-11-01 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
09/17/2018 Ophthalmic 10-84 Complete ANSI Z80.11-2012 (R2022) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
09/17/2018 Ophthalmic 10-113 Complete ANSI Z80.30-2018 (R2023) American National Standard for Ophthalmics - Toric Intraocular Lenses
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
06/27/2016 Dental/
ENT		 4-228 Complete ANSI ASA S3.20-2015 (Reaffirmed 2025) American National Standard Bioacoustical Terminology
06/27/2016 Dental/
ENT		 4-202 Complete ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
01/30/2014 Physical Medicine 16-167 Complete ISO 7176-9 Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
01/30/2014 Radiology 12-262 Complete ISO 11670 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)]
07/09/2014 InVitro Diagnostics 7-48 Complete CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
07/09/2014 InVitro Diagnostics 7-221 Complete CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
01/27/2015 Sterility 14-166 Complete ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
12/23/2016 Materials 8-442 Complete ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
12/23/2016 Materials 8-444 Complete ISO 17296-2 First edition 2015-01-15 Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
08/14/2015 Dental/
ENT		 4-130 Complete ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
07/09/2014 Dental/
ENT		 4-165 Complete ANSI ASA S3.13-1987 (Reaffirmed 2024) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-88 Complete ISO 29942 First edition 2011-07-01 Prophylatic dams -- Requirements and test methods
08/21/2017 Biocompatibility 2-155 Complete ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
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
08/21/2017 General Plastic Surgery/
General Hospital		 6-70 Complete ASTM E825-98 (Reapproved 2023) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
08/21/2017 General Plastic Surgery/
General Hospital		 6-124 Complete ASTM E1104-98 (Reapproved 2023) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017 Materials 8-333 Complete ASTM F2393-12 (Reapproved 2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
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
09/17/2018 Sterility 14-293 Complete ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
04/04/2016 Materials 8-413 Complete ASTM F2819-10 (Reapproved 2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
12/23/2019 Physical Medicine 16-216 Complete RESNA ANSI WC-2:2019 Section 10 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
12/23/2019 Physical Medicine 16-217 Complete RESNA ANSI WC-1:2019 Section 11 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins
08/14/2015 InVitro Diagnostics 7-253 Complete CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
06/27/2016 Radiology 12-297 Complete ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
06/27/2016 Radiology 12-298 Complete NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
08/21/2017 General Plastic Surgery/
General Hospital		 6-125 Complete ASTM E1965-98 (Reapproved 2023) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
12/21/2020 Materials 8-540 Complete ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
09/21/2016 General Plastic Surgery/
General Hospital		 6-379 Complete ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
08/14/2015 ObGyn/
Gastroenterology/
Urology		 9-108 Complete ISO 8009 Second edition 2014-11-15 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
08/14/2015 Ophthalmic 10-94 Complete ISO 14730 Second edition 2014-10-01 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/14/2015 Ophthalmic 10-95 Complete ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
08/06/2013 Orthopedic 11-252 Complete ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
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
08/21/2017 General Plastic Surgery/
General Hospital		 6-400 Complete ASTM F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
12/04/2017 Software/
Informatics		 13-98 Complete ISO IEC 646 Third edition 1991-12-15 (R2018) Information technology - ISO 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991 (R2018) Information technology - ISO 7-bit coded character set for information interchange
 
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