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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
09/08/2009 Software/
Informatics
13-29 CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
03/16/2012 Radiology 12-117 ISO 15367-1 First edition 2003-09-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
01/15/2013 Sterility 14-212 AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
08/14/2015 Orthopedic 11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
01/30/2014 General Plastic Surgery/
General Hospital
6-305 ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
06/07/2018 Radiology 12-313 IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
08/14/2015 Radiology 12-289 IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
04/04/2016 Physical Medicine 16-196 ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
08/14/2015 Anesthesiology 1-105 ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
04/04/2016 Materials 8-415 ASTM F2778-09 (Reapproved 2020) Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
06/07/2018 Materials 8-464 ISO \TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
12/21/2020 General Plastic Surgery/
General Hospital
6-452 USP 43-NF38:2020 Sodium Chloride Injection
09/17/2018 Orthopedic 11-333 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
06/07/2018 Physical Medicine 16-201 ISO 7176-19 Second Edition 2008-07-15 Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]
06/07/2018 Tissue Engineering 15-51 ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Tissue Engineering 15-52 ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Materials 8-113 ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
09/17/2018 Orthopedic 11-335 ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
12/23/2016 Cardiovascular 3-145 ANSI AAMI ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
ISO 5840-1 First edition 2015-09-15 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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
01/25/2013 Cardiovascular 3-105 ANSI AAMI IEC 60601-2-25:2011/(R)2016 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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 Dental/
ENT
4-247 ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
12/23/2016 Software/
Informatics
13-86 IEC ISO 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
09/17/2018 Sterility 14-514 ANSI AAMI ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products
ISO 11737-1 Third edition 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
08/21/2017 Orthopedic 11-269 ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
12/23/2016 Software/
Informatics
13-87 IEC ISO 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
06/27/2016 Materials 8-426 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
01/27/2015 Materials 8-385 ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
01/14/2019 Physical Medicine 16-204 ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
07/06/2020 Sterility 14-539 ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
12/23/2016 Orthopedic 11-316 ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
09/17/2018 General I (QS/
RM)
5-118 AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/23/2016 Sterility 14-500 ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
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)]
12/23/2016 Radiology 12-304 IEC 60731 Edition 3.1 2016-04 Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
04/04/2016 Materials 8-409 ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
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)]
12/21/2020 Anesthesiology 1-147 ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
12/21/2020 Ophthalmic 10-120 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
01/30/2014 InVitro Diagnostics 7-220 CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
07/09/2014 Dental/
ENT
4-160 ANSI ASA S3.1-1999 (Reaffirmed 2018) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
01/14/2019 Dental/
ENT
4-252 ANSI ADA Standard No. 48-2-2010 (R2015) LED Curing Lights
ISO 10650 Second edition 2018-08 Dentistry - Powered polymerization activators
01/14/2019 Cardiovascular 3-44 ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
08/06/2013 Dental/
ENT
4-204 ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2017) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
01/14/2019 Orthopedic 11-346 ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
01/27/2015 Radiology 12-287 NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
12/21/2020 Biocompatibility 2-287 USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
01/14/2019 Tissue Engineering 15-56 ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
01/30/2014 General Plastic Surgery/
General Hospital
6-306 ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
12/21/2020 Nanotechnology 18-18 ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
07/26/2016 Biocompatibility 2-169 ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/06/2020 Materials 8-536 ASTM ISO 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
04/04/2016 Anesthesiology 1-106 ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
01/14/2019 General I (QS/
RM)
5-120 IEC 60812 Edition 3.0 2018-08 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
07/06/2020 General Plastic Surgery/
General Hospital
6-445 ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
07/06/2020 Materials 8-525 ISO /TS 17137 Second edition 2019-09 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
07/15/2019 Biocompatibility 2-264 ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
12/23/2016 General I (QS/
RM)
5-114 ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
12/21/2020 General Plastic Surgery/
General Hospital
6-454 USP 43-NF38:2020 <881> Tensile Strength
12/21/2020 General Plastic Surgery/
General Hospital
6-455 USP 43-NF38:2020 <861> Sutures - Diameter
12/21/2020 General Plastic Surgery/
General Hospital
6-456 USP 43-NF38:2020 <871> Sutures - Needle Attachment
12/21/2020 General Plastic Surgery/
General Hospital
6-457 USP 43-NF38:2020 Sterile Water for Irrigation
12/21/2020 General Plastic Surgery/
General Hospital
6-458 USP 43-NF38:2020 Heparin Lock Flush Solution
12/21/2020 Biocompatibility 2-282 ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
12/23/2019 Radiology 12-328 IEC 61223-3-5 Edition 2.0 2019-09 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)]
07/15/2019 Dental/
ENT
4-259 ANSI ADA Standard No. 127-2018 Dynamic Loading Test for Endosseous Dental Implants
ISO 14801 Third edition 2016-11-01 Dentistry - Implants - Dynamic loading test for endosseous dental implants
08/21/2017 Software/
Informatics
13-67 IEEE ISO 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-124 CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
07/09/2014 Radiology 12-281 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
01/14/2019 Anesthesiology 1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-128 CIE ISO 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
07/15/2019 Materials 8-509 ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
12/21/2020 Sterility 14-553 ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
10/17/2014 ObGyn/
Gastroenterology/
Urology
9-95 CEN EN 1615:2000 Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
12/21/2020 Anesthesiology 1-148 ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
06/07/2021 Cardiovascular 3-170 ISO 14708-5 Second edition 2020-05 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
01/30/2014 Orthopedic 11-270 ASTM F2502-11 Standard Specification and Test Methods for Methods for Absorbable Plates and Screws for Internal Fixation Implants
06/07/2021 Orthopedic 11-379 ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
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
07/26/2016 Biocompatibility 2-237 ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
06/07/2021 Ophthalmic 10-123 ISO 15004-1 Second edition 2020-5 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
01/14/2019 Sterility 14-314 ANSI AAMI ST67:2011/(R)2017 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
12/21/2020 Sterility 14-552 ASTM ISO 51818 Fourth edition 2020-06 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
12/21/2020 Neurology 17-17 ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
06/07/2021 General Plastic Surgery/
General Hospital
6-389 ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
12/21/2020 InVitro Diagnostics 7-299 CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
06/07/2021 Cardiovascular 3-168 IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
12/21/2020 Materials 8-548 ASTM ISO 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2
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
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
09/17/2018 General II (ES/
EMC)
19-8 ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
07/15/2019 Sterility 14-533 ISO /TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
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
07/26/2016 Biocompatibility 2-191 ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/21/2020 Biocompatibility 2-286 USP 43-NF38:2020 <88> Biological Reactivity Tests, In Vivo
06/27/2016 Radiology 12-299 IEC 62563-1 Edition 1.1 2016-03 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
 
 
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