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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
12/23/2019 Dental/
ENT		 4-260 ANSI ASA S12.2-2019 American National Standard Criteria for Evaluating Room Noise
08/06/2013 Software/
Informatics		 13-61 IEC 62443-2-1 Edition 1.0 2010-11 Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
01/14/2019 Anesthesiology 1-117 ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
03/16/2012 Radiology 12-105 NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
07/06/2020 Orthopedic 11-364 ISO 14243-1 Second edition 2009-11-15 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
01/14/2019 Nanotechnology 18-8 ASTM E2578-07 (Reapproved 2022) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions
07/15/2019 Materials 8-493 ISO 13779-2 Third edition 2018-12 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
06/27/2016 Materials 8-429 ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
01/27/2015 Sterility 14-379 ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
04/04/2016 Materials 8-116 ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
04/04/2016 Materials 8-200 ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
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
12/23/2019 Software/
Informatics		 13-111 IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
06/07/2021 InVitro Diagnostics 7-306 CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
12/21/2020 Materials 8-538 ASTM F2759-19 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
07/26/2016 Biocompatibility 2-227 ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
01/14/2019 Dental/
ENT		 4-248 ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
08/21/2017 Software/
Informatics		 13-88 IEEE ISO 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
08/21/2017 Software/
Informatics		 13-93 IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Materials 8-453 ASTM F1295-16 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
08/21/2017 Dental/
ENT		 4-233 ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
09/17/2018 Physical Medicine 16-202 ISO 7176-2 Third edition 2017-10 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
07/06/2020 Orthopedic 11-366 ASTM F2381-19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
08/21/2017 General Plastic Surgery/
General Hospital		 6-388 ANSI AAMI IEC 60601-2-21:2009/A1:2016 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
IEC 60601-2-21 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
09/17/2018 Physical Medicine 16-203 ASME A18.1-2017 Safety Standard for Platform Lifts and Stairway Chairlifts
09/17/2018 Cardiovascular 3-156 ISO 14708-1 Second edition 2014-08-15 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018 Cardiovascular 3-154 ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
09/17/2018 Sterility 14-294 ANSI AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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
01/14/2019 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 Materials 8-527 ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
12/21/2020 Sterility 14-551 ISO 14160 Third edition 2020-09 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
01/14/2019 InVitro Diagnostics 7-232 CLSI MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
08/06/2013 Software/
Informatics		 13-38 ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
07/06/2020 Orthopedic 11-369 ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
01/14/2019 Orthopedic 11-342 ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
01/14/2019 Orthopedic 11-343 ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
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
08/21/2017 Dental/
ENT		 4-239 ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01/14/2019 Biocompatibility 2-141 ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
01/15/2013 InVitro Diagnostics 7-238 CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
04/04/2016 Dental/
ENT		 4-221 ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
01/15/2013 Software/
Informatics		 13-35 ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
01/15/2013 Software/
Informatics		 13-36 AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
01/15/2013 Sterility 14-213 AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/30/2014 Dental/
ENT		 4-181 ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
09/17/2018 InVitro Diagnostics 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-117 ISO 16038 Second edition 2017-11 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-120 ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
12/21/2020 General I (QS/
RM)		 5-132 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
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)]
09/17/2018 Sterility 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
04/04/2016 Materials 8-413 ASTM F2819-10 (Reapproved 2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
08/06/2013 Software/
Informatics		 13-53 IEEE ISO 11073-10415 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
01/30/2014 Dental/
ENT		 4-153 ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014 Dental/
ENT		 4-180 ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
01/30/2014 Dental/
ENT		 4-188 ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements
06/07/2021 General Plastic Surgery/
General Hospital		 6-462 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
04/04/2016 General I (QS/
RM)		 5-98 ANSI ESD S20.20-2014 Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
12/21/2020 Materials 8-549 ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
08/14/2015 Dental/
ENT		 4-220 ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 Dental/
ENT		 4-184 ANSI ASA S3.25-2009 (Reaffirmed 2019) American National Standard For an Occluded Ear Simulator
09/09/2008 Dental/
ENT		 4-145 ISO 22803 First edition 2004-09-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
08/14/2015 Ophthalmic 10-98 ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015 Ophthalmic 10-97 ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
01/30/2014 InVitro Diagnostics 7-244 CLSI NBS01-A6 (Replaces LA04-A5) Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
01/30/2014 InVitro Diagnostics 7-224 CLSI EP28-A3c (Formerly C28-A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
01/30/2014 InVitro Diagnostics 7-223 CLSI QMS06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline - Third Edition
01/27/2015 Sterility 14-389 ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
01/27/2015 Sterility 14-390 ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
08/21/2017 General II (ES/
EMC)		 19-22 AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
01/30/2014 Orthopedic 11-74 ISO 5838-2 First edition 1991-01-15 Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
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
12/21/2020 General Plastic Surgery/
General Hospital		 6-450 IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
10/19/2020 Software/
Informatics		 13-116 FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
04/04/2016 Dental/
ENT		 4-224 ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
04/04/2016 Ophthalmic 10-100 ISO 18259 First Edition 2014-10-01 Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
08/14/2015 Materials 8-389 ISO 15309 First edition 2013-12-01 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
08/14/2015 Orthopedic 11-294 ASTM F1357 -14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
08/14/2015 Radiology 12-292 IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
06/07/2018 Ophthalmic 10-109 ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
01/30/2014 Anesthesiology 1-81 CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
07/09/2014 Radiology 12-194 ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
06/07/2021 Anesthesiology 1-151 ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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
12/21/2020 Materials 8-552 ASTM F3434-20 Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing
01/14/2019 InVitro Diagnostics 7-178 CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
07/09/2014 Sterility 14-282 ASTM F2338-09 (Reapproved 2020) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
01/15/2013 Sterility 14-215 AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
08/06/2013 Software/
Informatics		 13-57 IEEE ISO 11073-10407 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
01/30/2014 Orthopedic 11-75 ISO 5838-3 First edition 1993-09-15 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
08/14/2015 Software/
Informatics		 13-78 IEC INCITS ISO 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
06/07/2018 Radiology 12-311 IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
05/30/2022 General Plastic Surgery/
General Hospital		 6-479 ISO 11608-5:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
08/06/2013 Dental/
ENT		 4-204 ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) 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)
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/15/2013 Sterility 14-217 AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
03/16/2012 Anesthesiology 1-72 ANSI AAMI ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
08/06/2013 Ophthalmic 10-78 ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
01/27/2015 Sterility 14-242 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
 
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