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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/15/2019 Biocompatibility 2-266 Complete ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
12/23/2019 Materials 8-500 Complete ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
07/15/2019 Software/
Informatics		 13-108 Complete IEEE Std 11073-20701-2018 Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/23/2019 General Plastic Surgery/
General Hospital		 6-426 Complete ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
07/06/2020 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
12/21/2020 Orthopedic 11-372 Complete ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
12/23/2024 Orthopedic 11-417 Complete ASTM F3090-24 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
06/07/2021 Orthopedic 11-380 Complete ASTM F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
06/07/2021 Orthopedic 11-381 Complete ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
01/14/2019 Dental/
ENT		 4-162 Complete ANSI ASA S3.4-2007 (Reaffirmed 2025) American National Standard Procedure for the Computation of Loudness of Steady Sounds
07/06/2020 General I (QS/
RM)		 5-129 Complete IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
12/21/2020 Ophthalmic 10-119 Complete ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
06/07/2021 Orthopedic 11-383 Complete ASTM F3143-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
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
07/09/2014 Radiology 12-280 Complete IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
12/21/2020 Anesthesiology 1-150 Complete ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
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
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
08/06/2013 Radiology 12-253 Complete IEC 60976 Edition 2.0 2007-10 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
08/06/2013 Radiology 12-255 Complete IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
09/17/2018 Anesthesiology 1-140 Complete ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
05/26/2025 Software/
Informatics		 13-143 Complete AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software
07/15/2019 Sterility 14-529 Complete ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
ANSI AAMI ISO 11135:2014/A1:2018 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
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
07/15/2019 Materials 8-518 Complete ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
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
07/06/2020 General Plastic Surgery/
General Hospital		 6-447 Complete ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
12/23/2019 Materials 8-519 Complete ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
12/23/2019 Materials 8-520 Complete ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
01/30/2014 Sterility 14-412 Complete AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
12/23/2024 General I (QS/
RM)		 5-143 Complete ISO 14630 Fffth edition 2024-09 Non-active surgical implants -- General requirements
07/09/2014 Radiology 12-281 Complete IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
07/09/2014 Radiology 12-283 Complete ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
03/14/2011 Radiology 12-226 Complete IEC 61223-2-6 Second Edition 2006-11 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray 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.
12/23/2024 Anesthesiology 1-189 Complete ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary
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
12/23/2019 Materials 8-508 Complete ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
12/23/2019 Sterility 14-538 Complete ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
07/15/2019 Ophthalmic 10-117 Complete ANSI Z80.37-2017 (R2021) American National Standard for Ophthalmics - Slit-Lamp Microscopes
07/15/2019 InVitro Diagnostics 7-287 Complete CLSI M44-S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
07/09/2014 General II (ES/
EMC)		 19-11 Complete UL 2054 2nd Edition Household and Commercial Batteries
12/23/2024 General II (ES/
EMC)		 19-53 Complete IEC TS 60601-4-6 Edition 1.0 2024-04 Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
12/23/2024 Cardiovascular 3-197 Complete ISO 25539-4 First edition 2021-11 Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
12/23/2016 Biocompatibility 2-189 Complete ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-68 Complete ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-111 Complete ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
07/06/2020 Materials 8-535 Complete ISO ASTM 52911-2: First Edition 2019-09 Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
03/16/2012 Radiology 12-177 Complete UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
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
01/30/2014 Radiology 12-266 Complete IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
07/06/2020 Materials 8-536 Complete ISO ASTM 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
07/06/2020 Tissue Engineering 15-61 Complete ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
12/23/2019 Materials 8-523 Complete ASTM F3275-19 Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
05/26/2025 Radiology 12-378 Complete ISO 12609-1 Second edition 2021-10 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
09/17/2018 InVitro Diagnostics 7-279 Complete CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
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
01/30/2014 Sterility 14-403 Complete ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-430 Complete ISO ASTM 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
01/14/2019 Materials 8-487 Complete ISO ASTM 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
05/26/2025 Biocompatibility 2-305 Complete ASTM E1262-24 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
01/14/2019 Biocompatibility 2-136 Complete ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
05/29/2023 Materials 8-599 Complete ASTM F1295-22 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
07/15/2019 Materials 8-510 Complete ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
03/16/2012 Radiology 12-105 Complete NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
07/15/2019 Materials 8-513 Complete ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
05/26/2025 Cardiovascular 3-200 Complete ASTM F2477-24 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
05/27/2005 Radiology 12-121 Complete IEC 61847: 1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
06/07/2018 General Plastic Surgery/
General Hospital		 6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
05/26/2025 General Plastic Surgery/
General Hospital		 6-508 Complete IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-127 Complete ISO CIE 11664-4 First edition 2019-06 Colorimetry - Part 4: CIE 1976 L*a*b* colour space
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-129 Complete ISO CIE 61966-2-1 First edition 1999-10 Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
08/14/2015 Radiology 12-290 Complete IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
12/18/2023 Radiology 12-352 Complete NEMA PS 3.1 - 3.20 2023e Digital Imaging and Communications in Medicine (DICOM) Set
07/15/2019 General II (ES/
EMC)		 19-35 Complete UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
01/14/2019 Software/
Informatics		 13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
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
12/23/2024 Radiology 12-364 Complete IEC 61223-3-8 Edition 1.0 2024-03 Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
12/23/2024 Orthopedic 11-414 Complete ASTM F382-24 Standard Specification and Test Method for Metallic Bone Plates
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 Radiology 12-363 Complete NEMA PS 3.1 - 3.20 2024e Digital Imaging and Communications in Medicine (DICOM) Set
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
12/21/2020 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
12/23/2019 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
12/23/2024 Radiology 12-366 Complete IEC 61223-3-6 Edition 1.0 2020-02 Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation
12/23/2024 General II (ES/
EMC)		 19-51 Complete UL 1642 Sixth Edition September 29, 2020 Standard For Safety Lithium Batteries
07/15/2019 Materials 8-493 Complete ISO 13779-2 Third edition 2018-12 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
06/07/2021 Orthopedic 11-376 Complete ASTM F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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)]
 
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