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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/22/2025 Materials 8-633 Complete ASTM F2902-24 Standard Guide for Assessment of Absorbable Polymeric Implants
07/06/2020 Software/
Informatics		 13-115 Complete ISO IEC IEEE 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
07/15/2019 Biocompatibility 2-263 Complete ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
07/06/2020 Materials 8-531 Complete ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
12/21/2020 Dental/
ENT		 4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
04/04/2016 Materials 8-404 Complete ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
04/04/2016 ObGyn/
Gastroenterology/
Urology		 9-110 Complete ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
04/04/2016 InVitro Diagnostics 7-260 Complete CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
04/04/2016 Materials 8-107 Complete ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
04/04/2016 Materials 8-115 Complete ASTM F2256-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
04/04/2016 Materials 8-136 Complete ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
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
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
12/23/2019 Dental/
ENT		 4-260 Complete ANSI ASA S12.2-2019 (Reaffirmed 2023) American National Standard for Criteria for Evaluating Room Noise
07/15/2019 Ophthalmic 10-118 Complete ANSI Z80.38-2017 (R2021) American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery
07/15/2019 Dental/
ENT		 4-258 Complete ISO 10139-2 Third edition 2016-06-15 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
ANSI ADA Standard No. 160-2020 Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
07/06/2020 Radiology 12-332 Complete IEC 62464-1 Edition 2.0 2018-12 Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
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
06/07/2018 Materials 8-463 Complete ISO ASTM 52901 First edition 2017-08 Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
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)]
08/21/2017 Biocompatibility 2-246 Complete ASTM F1877-16 Standard Practice for Characterization of Particles
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
07/06/2020 Sterility 14-540 Complete ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI AAMI ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020 Sterility 14-541 Complete ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
09/17/2018 Tissue Engineering 15-55 Complete ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-116 Complete ISO 29943-2 First edition 2017-07 Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.
06/07/2018 Dental/
ENT		 4-241 Complete ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
09/17/2018 Biocompatibility 2-255 Complete ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018 Materials 8-465 Complete ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
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
12/23/2024 Cardiovascular 3-194 Complete ISO 7199 Fourth edition 2024-09 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
06/07/2018 Cardiovascular 3-150 Complete ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
09/17/2018 InVitro Diagnostics 7-276 Complete CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 Orthopedic 11-337 Complete ISO 16087 First edition 2013-10-01 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
09/17/2018 Orthopedic 11-339 Complete ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
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		 6-409 Complete ASTM F703-18 (Reapproved 2022) Standard Specification for Implantable Breast Prostheses
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
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
03/16/2012 Radiology 12-241 Complete IEC 62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
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
12/23/2019 Cardiovascular 3-162 Complete ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
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
09/09/2008 Radiology 12-166 Complete NEMA XR 23-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
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
10/04/2010 Radiology 12-214 Complete IEC 62220-1-3 Edition 1.0 2008-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
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 Orthopedic 11-362 Complete ISO 22622 First edition 2019-07 Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
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
12/22/2025 InVitro Diagnostics 7-346 Complete CLSI EP32 2nd Edition Implementation of Metrological Traceability in Laboratory Medicine
05/26/2025 General Plastic Surgery/
General Hospital		 6-509 Complete ASTM F3186-24 Standard Specification for Adult Portable Bed Rails and Related Products
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
04/04/2016 Orthopedic 11-247 Complete ASTM F2789-10 (Reapproved 2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
05/29/2024 Anesthesiology 1-175 Complete ISO 18562-3 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
06/07/2021 Tissue Engineering 15-66 Complete ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
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
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
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
01/14/2019 InVitro Diagnostics 7-286 Complete CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019 Cardiovascular 3-79 Complete ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
01/14/2019 InVitro Diagnostics 7-139 Complete CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
05/29/2024 Dental/
ENT		 4-327 Complete ISO 21531 First edition 2009-02 Dentistry - Graphical symbols for dental instruments
03/16/2012 Ophthalmic 10-70 Complete ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
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
12/21/2020 InVitro Diagnostics 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
01/30/2014 Cardiovascular 3-118 Complete ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
06/07/2021 Dental/
ENT		 4-273 Complete ANSI ASA S3.7-2016 (Reaffirmed 2025) American National Standard Method for Coupler Calibration of Earphones
08/06/2013 Software/
Informatics		 13-42 Complete ANSI AAMI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
01/27/2015 Dental/
ENT		 4-185 Complete ANSI ASA S3.45-2009 (Reaffirmed 2024) American National Standard Procedures for Testing Basic Vestibular Function
07/09/2014 Dental/
ENT		 4-211 Complete ANSI ASA S3.46-2013 (Reaffirmed 2023) American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
05/26/2025 InVitro Diagnostics 7-333 Complete CLSI AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
05/26/2025 InVitro Diagnostics 7-334 Complete CLSI AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
05/26/2025 InVitro Diagnostics 7-335 Complete CLSI POCT01-A2 Point-of-Care Connectivity - Second Edition
05/26/2025 InVitro Diagnostics 7-336 Complete CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition.
05/26/2025 InVitro Diagnostics 7-340 Complete CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition.
05/26/2025 InVitro Diagnostics 7-338 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
05/26/2025 InVitro Diagnostics 7-339 Complete CLSI AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
05/29/2024 Anesthesiology 1-178 Complete ISO 23747 Second edition 2015-08 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
05/29/2024 Neurology 17-18 Complete IEEE Std 2010-2023 Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems
07/15/2019 Materials 8-509 Complete ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-126 Complete ISO CIE 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
01/27/2015 Software/
Informatics		 13-72 Complete ISO IEEE 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
05/26/2025 InVitro Diagnostics 7-332 Complete CLSI AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
03/16/2012 Radiology 12-115 Complete ISO 13695:2004 Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
05/26/2025 InVitro Diagnostics 7-343 Complete CLSI AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
05/26/2025 InVitro Diagnostics 7-345 Complete CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
05/26/2025 InVitro Diagnostics 7-337 Complete CLSI AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline
01/30/2014 InVitro Diagnostics 7-239 Complete CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
12/22/2025 InVitro Diagnostics 7-347 Complete CLSI EP21 3rd Edition Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
12/22/2025 InVitro Diagnostics 7-348 Complete CLSI EP37 2nd Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 InVitro Diagnostics 7-284 Complete CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
 
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