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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
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
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
06/07/2021 Biocompatibility 2-290 ISO /TS 37137-1 First edition 2021-03 Biological evaluation of absorbable medical devices - Part 1: General requirements.
06/07/2021 Biocompatibility 2-291 ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
06/07/2021 Cardiovascular 3-129 ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
06/07/2021 Cardiovascular 3-166 ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
06/07/2021 Cardiovascular 3-168 IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
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
06/07/2021 Dental/
ENT		 4-273 ANSI ASA S3.7-2016 (Reaffirmed 2020) American National Standard Method for Coupler Calibration of Earphones
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
06/07/2021 Dental/
ENT		 4-275 ANSI ASA S3.6-2018 American National Standard Specification for Audiometers
06/07/2021 Dental/
ENT		 4-276 ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
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
06/07/2021 Dental/
ENT		 4-278 ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
06/07/2021 Dental/
ENT		 4-279 ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT		 4-280 ANSI ADA Standard No. 117-2018 Fluoride varnishes
06/07/2021 Dental/
ENT		 4-281 ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
06/07/2021 Dental/
ENT		 4-282 ANSI ADA Standard No. 135-2015 Denture Adhesives
ISO 10873 First edition 2010-09 Dentistry - Denture adhesives
06/07/2021 Dental/
ENT		 4-283 ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
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)]
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
06/07/2021 General Plastic Surgery/
General Hospital		 6-461 IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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
06/07/2021 General Plastic Surgery/
General Hospital		 6-463 IEC 60601-2-21 Edition 3.0 2020-09 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
06/07/2021 InVitro Diagnostics 7-236 CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
06/07/2021 InVitro Diagnostics 7-262 CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
06/07/2021 InVitro Diagnostics 7-292 CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
06/07/2021 InVitro Diagnostics 7-306 CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
06/07/2021 InVitro Diagnostics 7-307 CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
06/07/2021 InVitro Diagnostics 7-308 CLSI M100, 31st Edition Performance Standards for Antimicrobial Susceptibility Testing
06/07/2021 Materials 8-555 ASTM F1472-20a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
06/07/2021 Materials 8-556 ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
06/07/2021 Materials 8-557 ASTM F3268-18a Standard Guide for in vitro Degradation Testing of Absorbable Metals
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 8-559 ASTM D412-16e1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
06/07/2021 Materials 8-560 ASTM D1415-18 Standard Test Method for Rubber Property - International Hardness
06/07/2021 Materials 8-561 ASTM ISO 52950 First edition 2021-01 Additive manufacturing - General principles - Overview of data processing
06/07/2021 Materials 8-562 ASTM ISO 52904 First edition 2019-08 Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-131 ISO 8600-5 Second Edition 2020-10 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-132 ASTM F623-19 Standard Performance Specification for Foley Catheter
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-133 ANSI AAMI ISO 23500-1:2019 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
ISO 23500-1 First edition 2019-02 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-134 ANSI AAMI ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
ISO 23500-2 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-135 ANSI AAMI ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
ISO 23500-3 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-136 ANSI AAMI ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-4 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-137 ANSI AAMI ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-5 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-138 ISO 20695 First edition 2020-03 Enteral feeding systems - Design and testing
06/07/2021 Ophthalmic 10-122 ISO 10939 Third edition 2017-05 Ophthalmic instruments - Slit-lamp microscopes
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
06/07/2021 Ophthalmic 10-124 ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
06/07/2021 Ophthalmic 10-125 ISO 11979-7 Fourth edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
06/07/2021 Ophthalmic 10-126 ANSI AAMI IEC 80601-2-58:2014 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
IEC 80601-2-58 Edition 2.0 2014-09 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
06/07/2021 Orthopedic 11-376 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 Orthopedic 11-377 ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis
06/07/2021 Orthopedic 11-378 ASTM F2502-17 Standard Specification and Test 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
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
06/07/2021 Orthopedic 11-381 ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
06/07/2021 Orthopedic 11-382 ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
06/07/2021 Orthopedic 11-383 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
06/07/2021 Orthopedic 11-384 ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
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
06/07/2021 Radiology 12-335 IEC 60336 Edition 5.0 2020-12 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
06/07/2021 Radiology 12-336 IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
06/07/2021 Radiology 12-337 NEMA NU 1-2018 Performance Measurements of Gamma Cameras
06/07/2021 Radiology 12-338 IEC 60601-2-1 Edition 4.0 2020-10 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
06/07/2021 Radiology 12-339 IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
06/07/2021 Radiology 12-340 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
06/07/2021 Software/
Informatics		 13-117 IEEE Std 11073-40101-2020 Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
06/07/2021 Software/
Informatics		 13-118 IEEE Std 11073-40102:2020 Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
06/07/2021 Software/
Informatics		 13-119 ANSI ISA 62443-4-1-2018 Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
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
06/07/2021 Tissue Engineering 15-66 ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
06/07/2021 Tissue Engineering 15-67 ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
03/01/2021 General Plastic Surgery/
General Hospital		 6-460 ASTM F3502-21 Standard Specification for Barrier Face Coverings
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 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
12/21/2020 Anesthesiology 1-149 ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
12/21/2020 Anesthesiology 1-150 ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
12/21/2020 Biocompatibility 2-277 ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
12/21/2020 Biocompatibility 2-278 ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
12/21/2020 Biocompatibility 2-279 ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
12/21/2020 Biocompatibility 2-280 ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
12/21/2020 Biocompatibility 2-281 ISO /TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
12/21/2020 Biocompatibility 2-282 ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
12/21/2020 Biocompatibility 2-283 ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
12/21/2020 Biocompatibility 2-284 USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/21/2020 Biocompatibility 2-285 USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro - Elution Test
12/21/2020 Biocompatibility 2-286 USP 43-NF38:2020 <88> Biological Reactivity Tests, In Vivo
12/21/2020 Biocompatibility 2-287 USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
12/21/2020 Biocompatibility 2-288 ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
12/21/2020 Cardiovascular 3-169 ANSI AAMI IEC 60601-2-4:2010/A1:2018 (Consolidated Text) Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
12/21/2020 Dental/
ENT		 4-264 ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
12/21/2020 Dental/
ENT		 4-265 ANSI ADA Standard No. 97-2020 Corrosion Test Methods for Metallic Materials
ISO 10271 Third edition 2020-08 Dentistry - Corrosion test methods for metallic materials
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		 4-267 ANSI ADA Standard No. 105-2010 (R2015) Orthodontic Elastomeric Materials
ISO 21606 First edition 2007-06 Dentistry - Elastomeric auxiliaries for use in orthodontics
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)]
12/21/2020 Dental/
ENT		 4-269 ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
12/21/2020 Dental/
ENT		 4-270 ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
12/21/2020 Dental/
ENT		 4-271 ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/21/2020 Dental/
ENT		 4-272 ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
 
 
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