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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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)]
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)]
07/06/2020 Biocompatibility 2-273 Complete ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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
07/15/2019 Materials 8-517 Complete ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
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
03/16/2012 Radiology 12-105 Complete NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
12/21/2020 Ophthalmic 10-120 Complete ISO TR 22979 Second Edition 2017-05 Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
08/21/2017 Software/
Informatics		 13-94 Complete ISO IEEE 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
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
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
12/19/2007 Radiology 12-171 Complete ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-132 Complete ASTM F623-19 Standard Performance Specification for Foley Catheter
06/07/2021 Cardiovascular 3-170 Complete ISO 14708-5 Second edition 2020-05 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
12/21/2020 Materials 8-545 Complete ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
07/06/2020 Anesthesiology 1-146 Complete ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
06/07/2021 InVitro Diagnostics 7-306 Complete CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
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
06/27/2016 Cardiovascular 3-143 Complete ISO 12417-1 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
12/21/2020 InVitro Diagnostics 7-302 Complete CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-305 Complete ISO 17511 Second edition 2020-04 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
07/15/2019 Biocompatibility 2-268 Complete ISO TS 21726 First edition 2019-02 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
07/06/2020 General I (QS/
RM)		 5-126 Complete ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
12/21/2020 Materials 8-546 Complete ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
05/26/2025 Dental/
ENT		 4-343 Complete ANSI ADA Standard No. 105-2024 Elastomeric Auxiliaries for Use in Orthodontics
05/26/2025 Dental/
ENT		 4-346 Complete ISO 9680 Fourth edition 2021-11 Dentistry - Operating lights
ANSI ADA Standard No. 89-2023 Dentistry - Dental Operating Lights
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
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.
12/21/2020 Materials 8-549 Complete ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
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 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
05/26/2025 Dental/
ENT		 4-339 Complete ANSI ADA Standard No. 119-2023 Dentistry-Manual Toothbrushes
05/30/2022 Dental/
ENT		 4-293 Complete ANSI ADA Standard No. 119-2021 Manual Toothbrushes
05/26/2025 Dental/
ENT		 4-340 Complete ANSI ADA Standard No. 46-2016 Dental Patient Chair
05/26/2025 Dental/
ENT		 4-341 Complete ANSI ADA Standard No. 47-1-2021 Stationary Dental Units and Patient Chairs-Part 1: General Requirements
05/26/2025 Dental/
ENT		 4-342 Complete ANSI ADA Standard No. 47-2-2021 Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems
12/21/2020 Anesthesiology 1-149 Complete ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/21/2020 Anesthesiology 1-150 Complete ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
06/07/2021 Ophthalmic 10-124 Complete ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
12/21/2020 Ophthalmic 10-119 Complete ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
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
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
05/26/2025 InVitro Diagnostics 7-338 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
12/23/2019 Physical Medicine 16-229 Complete RESNA ANSI WC-4:2017 Section 20 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles
12/21/2020 Sterility 14-550 Complete ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
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
12/23/2024 InVitro Diagnostics 7-323 Complete CLSI EP19 3rd Edition A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
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
12/23/2019 Physical Medicine 16-227 Complete RESNA WC-4:2017 Section 18 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles.
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
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
12/20/2021 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
12/19/2022 Software/
Informatics		 13-122 Complete IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
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
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
05/30/2022 Materials 8-592 Complete ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
05/30/2022 Cardiovascular 3-182 Complete ASTM F3036-21 Standard Guide for Testing Absorbable Stents
05/26/2025 InVitro Diagnostics 7-339 Complete CLSI AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
06/27/2016 Software/
Informatics		 13-84 Complete ISO IEEE 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
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
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
01/14/2019 Dental/
ENT		 4-256 Complete ANSI ADA Standard No. 132-2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
05/26/2025 Software/
Informatics		 13-146 Complete IEEE 11073-10103 Second edition 2023 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
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 7-345 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
05/30/2022 Ophthalmic 10-131 Complete ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices
04/04/2016 Sterility 14-340 Complete ISO 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/30/2022 General Plastic Surgery/
General Hospital		 6-476 Complete ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
01/14/2019 Materials 8-485 Complete ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
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 Radiology 12-369 Complete ISO 11146-1 Second edition 2021-07 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
03/16/2012 Radiology 12-134 Complete ISO 11146-1 First edition 2005-01-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
05/26/2025 InVitro Diagnostics 7-341 Complete CLSI AUTO03-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition
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 7-344 Complete CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition.
12/19/2022 Radiology 12-346 Complete ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
12/20/2021 InVitro Diagnostics 7-310 Complete ISO 19238 Second edition 2014-02-01 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021 InVitro Diagnostics 7-311 Complete CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
01/14/2019 Ophthalmic 10-115 Complete ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
01/14/2019 Software/
Informatics		 13-106 Complete IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/14/2019 Software/
Informatics		 13-107 Complete ISO IEEE 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
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
 
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