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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
12/20/2021 Cardiovascular 3-178 Complete ASTM F3067-14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/20/2021 Cardiovascular 3-179 Complete ASTM F3172-15 (Reapproved 2021) Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
12/20/2021 Cardiovascular 3-180 Complete ASTM F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
12/20/2021 Dental/
ENT
4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
12/20/2021 Dental/
ENT
4-285 Complete ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
12/20/2021 Dental/
ENT
4-286 Complete ANSI ADA Standard No. 87-1995 (R2014) Dental Impression Trays
12/20/2021 Dental/
ENT
4-287 Complete ANSI ADA Standard No. 116-2020 Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
12/20/2021 Dental/
ENT
4-288 Complete ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
ANSI ADA Standard No. 43-2020 Electrically Powered Dental Amalgamators
12/20/2021 Dental/
ENT
4-289 Complete ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT
4-290 Complete ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
12/20/2021 Dental/
ENT
4-291 Complete ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
12/20/2021 Dental/
ENT
4-292 Complete ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
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
12/20/2021 General II (ES/
EMC)
19-41 Complete ANSI UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
12/20/2021 General II (ES/
EMC)
19-42 Partial IEC 61326-1 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/20/2021 General II (ES/
EMC)
19-43 Partial IEC 61326-2-6 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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 Plastic Surgery/
General Hospital
6-464 Complete ISO 11040-4 Third edition 2015-04-01 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
12/20/2021 General Plastic Surgery/
General Hospital
6-465 Complete USP-NF M76090_03_01 Sodium Chloride Irrigation
12/20/2021 General Plastic Surgery/
General Hospital
6-466 Complete USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital
6-467 Complete USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital
6-468 Complete USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital
6-469 Complete USP-NF M99650_02_01 <861> Sutures - Diameter
12/20/2021 General Plastic Surgery/
General Hospital
6-470 Complete USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 General Plastic Surgery/
General Hospital
6-471 Complete USP-NF M88880_05_01 Sterile Water for Irrigation
12/20/2021 General Plastic Surgery/
General Hospital
6-472 Complete USP-NF M36660_04_01 Heparin Lock Flush Solution
12/20/2021 General Plastic Surgery/
General Hospital
6-473 Complete USP-NF M80190_04_01 Absorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital
6-474 Partial ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/20/2021 InVitro Diagnostics 7-309 Complete 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 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
12/20/2021 Materials 8-563 Complete ASTM F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
12/20/2021 Materials 8-564 Complete ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
12/20/2021 Materials 8-565 Complete ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
12/20/2021 Materials 8-566 Complete ASTM F1813-21 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021 Materials 8-568 Complete ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
12/20/2021 Materials 8-569 Complete ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
12/20/2021 Materials 8-570 Complete ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/20/2021 Materials 8-571 Complete ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
12/20/2021 Materials 8-572 Complete ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
12/20/2021 Materials 8-573 Complete ASTM F2695-12(2020) Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
12/20/2021 Materials 8-574 Complete ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/20/2021 Materials 8-575 Complete ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
12/20/2021 Materials 8-576 Complete ASTM F451-21 Standard Specification for Acrylic Bone Cement
12/20/2021 Materials 8-577 Complete ISO 13179-1 Second Edition 2021-09 Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
12/20/2021 Materials 8-578 Complete ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
12/20/2021 Materials 8-579 Complete ISO 13779-3 Second Edition 2018-12 Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
12/20/2021 Nanotechnology 18-19 Complete ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
12/20/2021 Nanotechnology 18-20 Complete ASTM E3275-21 Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
12/20/2021 Ophthalmic 10-127 Complete ANSI Z80.21-2020 American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
12/20/2021 Ophthalmic 10-128 Complete ASTM D882-18 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
12/20/2021 Ophthalmic 10-129 Complete ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
12/20/2021 Ophthalmic 10-130 Complete ANSI Z80.36-2021 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
12/20/2021 Orthopedic 11-385 Complete ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
12/20/2021 Orthopedic 11-386 Complete ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/20/2021 Orthopedic 11-388 Complete ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/20/2021 Orthopedic 11-389 Complete ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
12/20/2021 Orthopedic 11-390 Complete ISO 23089-2 First edition 2021-05 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
12/20/2021 Orthopedic 11-391 Complete ASTM F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
12/20/2021 Orthopedic 11-392 Complete ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
12/20/2021 Orthopedic 11-393 Complete ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
12/20/2021 Physical Medicine 16-232 Complete IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
12/20/2021 Radiology 12-341 Complete IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
12/20/2021 Software/
Informatics
13-120 Complete ANSI AAMI 2700-1:2019 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
12/20/2021 Sterility 14-563 Complete ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
12/20/2021 Sterility 14-564 Complete USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/20/2021 Sterility 14-565 Complete USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/20/2021 Sterility 14-566 Complete USP-NF M98795_02_01 <55> Biological Indicators -- Resistance Performance Tests
12/20/2021 Sterility 14-567 Complete USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization
12/20/2021 Sterility 14-568 Complete USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
12/20/2021 Sterility 14-570 Complete USP-NF M98830_02_01 <85> Bacterial Endotoxins Test
12/20/2021 Sterility 14-571 Complete ISO 11138-8 First edition 2021-07 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
06/07/2021 Anesthesiology 1-151 Complete 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 2-290 Partial ISO TS 37137-1 First edition 2021-03 Biological evaluation of absorbable medical devices - Part 1: General requirements.
06/07/2021 Biocompatibility 2-291 Partial ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
06/07/2021 Cardiovascular 3-166 Partial 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 Partial IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
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
06/07/2021 Dental/
ENT
4-273 Complete ANSI ASA S3.7-2016 (Reaffirmed 2023) American National Standard Method for Coupler Calibration of Earphones
06/07/2021 Dental/
ENT
4-274 Complete 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 Complete ANSI ASA S3.6-2018 American National Standard for Specification for Audiometers
06/07/2021 Dental/
ENT
4-276 Partial ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
ANSI ADA Standard No. 35-2019 Dental Handpieces and Motors
06/07/2021 Dental/
ENT
4-277 Complete 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 Complete ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
06/07/2021 Dental/
ENT
4-279 Complete ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT
4-280 Partial ANSI ADA Standard No. 117-2018 Fluoride varnishes
06/07/2021 Dental/
ENT
4-281 Complete ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
06/07/2021 Dental/
ENT
4-283 Complete ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
06/07/2021 General II (ES/
EMC)
19-40 Complete 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 Partial 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
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
06/07/2021 General Plastic Surgery/
General Hospital
6-461 Complete 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 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
06/07/2021 General Plastic Surgery/
General Hospital
6-463 Complete 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 Partial CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
06/07/2021 InVitro Diagnostics 7-262 Partial 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 Partial CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
 
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