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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/20/2021 InVitro Diagnostics 7-309 ISO 17099 First edition 2014-11-15 Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/20/2021 General I (QS/
RM)
5-134 ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
08/21/2017 General I (QS/
RM)
5-117 ANSI AAMI ISO 15223-1:2016 Medical devices - Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements
ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
06/27/2016 Radiology 12-300 NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set
04/04/2016 General Plastic Surgery/
General Hospital
6-355 ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots
01/27/2015 Radiology 12-230 NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/27/2015 Radiology 12-286 NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
09/17/2018 Materials 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
04/04/2016 Materials 8-404 ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
04/04/2016 Materials 8-406 ISO 5832-11 Second edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
04/04/2016 ObGyn/
Gastroenterology/
Urology
9-110 ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
07/26/2016 Biocompatibility 2-214 ASTM F619-14 Standard Practice for Extraction of Medical Plastics
06/07/2021 Sterility 14-562 ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
06/07/2021 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/15/2019 Orthopedic 11-357 ISO 15142-3 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
12/21/2020 Dental/
ENT
4-272 ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
12/20/2021 Materials 8-566 ASTM F1813-21 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
06/07/2021 Materials 8-558 ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
06/07/2021 Materials 8-555 ASTM F1472-20a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
12/19/2007 Ophthalmic 10-35 ISO 10939 Second edition 2007-02-01 Ophthalmic instruments - Slit-lamp microscopes
12/21/2020 Orthopedic 11-374 ISO 7207-2 Second edition 2011-07-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
01/30/2014 Radiology 12-270 IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
01/14/2019 Radiology 12-102 ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
01/14/2019 Radiology 12-321 ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
12/21/2020 InVitro Diagnostics 7-305 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
12/20/2021 Nanotechnology 18-19 ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
07/15/2019 Materials 8-517 ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
12/21/2020 Biocompatibility 2-278 ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
04/04/2016 Sterility 14-340 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
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
09/09/2008 Sterility 14-239 ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
06/07/2018 Anesthesiology 1-132 ISO 10079-2 Third Edition 2014-05-01 Medical suction equipment - Part 2: Manually powered suction equipment
06/07/2018 Neurology 17-15 ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
06/07/2021 Dental/
ENT
4-275 ANSI ASA S3.6-2018 American National Standard Specification for Audiometers
01/14/2019 Cardiovascular 3-44 ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
08/21/2017 General Plastic Surgery/
General Hospital
6-385 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
09/17/2018 Orthopedic 11-339 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 Orthopedic 11-340 ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
09/17/2018 Ophthalmic 10-112 ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
12/23/2019 Materials 8-491 ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
12/23/2019 General Plastic Surgery/
General Hospital
6-438 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
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
07/06/2020 Materials 8-526 ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance
08/06/2013 Dental/
ENT
4-203 ANSI ASA S3.6-2010 American National Standard Specification for Audiometers
06/07/2021 Dental/
ENT
4-274 ANSI ASA S3.2-2020 American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
06/07/2018 Dental/
ENT
4-241 ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
09/17/2018 Biocompatibility 2-255 ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018 Orthopedic 11-333 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
09/17/2018 Biocompatibility 2-256 ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
09/17/2018 Materials 8-465 ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
09/17/2018 Materials 8-112 ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
01/30/2014 Biocompatibility 14-408 ANSI AAMI ISO 10993-7:2008(R)2012 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
01/30/2014 Cardiovascular 3-118 ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
06/07/2018 ObGyn/
Gastroenterology/
Urology
9-114 IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
07/09/2014 General II (ES/
EMC)
19-9 IEC 60601-1-10 Edition 1.1 2013-11 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
01/30/2014 General Plastic Surgery/
General Hospital
6-321 IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
08/20/2012 Cardiovascular 3-103 ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/06/2013 Cardiovascular 3-116 ANSI AAMI ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-2 Second edition 2012-12-01 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
06/15/2016 Cardiovascular 3-132 ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
04/04/2016 Cardiovascular 3-125 ANSI AAMI ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
09/17/2018 InVitro Diagnostics 7-278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
07/15/2019 Sterility 14-527 ASTM F2638-18 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
06/07/2021 Physical Medicine 16-231 ISO 10328 Second edition 2016-06-01 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
09/17/2018 InVitro Diagnostics 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
09/17/2018 Orthopedic 11-336 ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
09/17/2018 Orthopedic 11-338 ISO 11491 First edition 2017-07 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
09/17/2018 Orthopedic 11-341 ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
12/21/2020 Dental/
ENT
4-266 ANSI ADA Standard No. 178-2019 Orthodontic Anchor Screws
ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
12/21/2020 Dental/
ENT
4-268 ANSI ADA Standard No. 32-2017 Orthodontic Wires
ISO 15841 Second edition 2014-08 Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
01/27/2015 Dental/
ENT
4-183 ANSI ASA S3.2-2009 (Reaffirmed 2014) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
06/07/2021 Dental/
ENT
4-277 ANSI IEEE C63.19-2019 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
12/21/2020 Materials 8-549 ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
12/23/2019 Physical Medicine 16-211 ANSI RESNA 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
06/27/2016 General II (ES/
EMC)
19-15 IEC 60601-1-12 Edition 1.0 2014-06 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
07/06/2020 Biocompatibility 2-273 ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/26/2016 Biocompatibility 2-122 ASTM F719-81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
08/21/2017 General Plastic Surgery/
General Hospital
6-386 ANSI AAMI IEC 60601-2-20:2009/A1:2016 Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)]
IEC 60601-2-20 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)]
12/21/2020 General II (ES/
EMC)
19-39 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
07/15/2019 Materials 8-516 ISO 13779-4 Second edition 2018-12 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
07/15/2019 General Plastic Surgery/
General Hospital
6-423 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
12/21/2020 Biocompatibility 2-283 ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
12/23/2019 Software/
Informatics
13-112 AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
07/15/2019 Orthopedic 11-356 ISO 15142-2 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
12/21/2020 Ophthalmic 10-121 ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
07/15/2019 Orthopedic 11-349 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)]
07/15/2019 Orthopedic 11-351 ISO 18192-1 Second edition 2011-03-01 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
07/15/2019 Orthopedic 11-352 ISO 14242-1 Third edition 2014-10-15 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
12/23/2019 Radiology 12-317 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
06/27/2016 Tissue Engineering 15-46 ISO 22442-2 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
07/06/2020 Biocompatibility 2-274 ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/26/2016 Biocompatibility 2-197 ASTM F749-13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/15/2019 Sterility 14-532 ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
12/21/2020 General I (QS/
RM)
5-133 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
06/07/2021 Materials 8-559 ASTM D412-16e1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
06/07/2021 General II (ES/
EMC)
19-40 IEC 60086-4 Edition 5.0 2019-04 Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
08/21/2017 General II (ES/
EMC)
19-23 IEC 60086-4 Edition 4.0 2014-09 Primary batteries - Part 4: Safety of lithium batteries
12/23/2019 Physical Medicine 16-219 ANSI RESNA 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
06/07/2021 Orthopedic 11-380 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
01/27/2015 Orthopedic 11-286 ASTM F2979-14 Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
06/07/2021 Orthopedic 11-381 ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
 
 
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