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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 General Plastic Surgery/
General Hospital		 6-470 USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 General Plastic Surgery/
General Hospital		 6-471 USP-NF M88880_05_01 Sterile Water for Irrigation
12/20/2021 General Plastic Surgery/
General Hospital		 6-472 USP-NF M36660_04_01 Heparin Lock Flush Solution
12/20/2021 General Plastic Surgery/
General Hospital		 6-473 USP-NF M80190_04_01 Absorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital		 6-474 ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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 InVitro Diagnostics 7-310 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 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 ASTM F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
12/20/2021 Materials 8-564 ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
12/20/2021 Materials 8-565 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 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 ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021 Materials 8-568 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 ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
12/20/2021 Materials 8-570 ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/20/2021 Materials 8-571 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 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 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 ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/20/2021 Materials 8-575 ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
12/20/2021 Materials 8-576 ASTM F451-21 Standard Specification for Acrylic Bone Cement
12/20/2021 Materials 8-577 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 ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
12/20/2021 Materials 8-579 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 Materials 8-580 IEC 63145-20-10 Edition 1.0 2019-08 Eyewear display -- Part 20-10: Fundamental measurement methods -- Optical properties
12/20/2021 Materials 8-581 IEC 63145-20-20 Edition 1.0 2019-09 Eyewear display -- Part 20-20: Fundamental measurement methods -- Image quality
12/20/2021 Materials 8-582 IEC 63145-22-10 Edition 1.0 2020-01 Eyewear display -- Part 22-10: Specific measurement methods for AR type -- Optical properties
12/20/2021 Nanotechnology 18-19 ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
12/20/2021 Nanotechnology 18-20 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 ANSI Z80.21-2020 American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
12/20/2021 Ophthalmic 10-128 ASTM D882-18 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
12/20/2021 Ophthalmic 10-129 ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
12/20/2021 Ophthalmic 10-130 ANSI Z80.36-2021 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
12/20/2021 Orthopedic 11-385 ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
12/20/2021 Orthopedic 11-386 ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 Orthopedic 11-387 ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/20/2021 Orthopedic 11-388 ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/20/2021 Orthopedic 11-389 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 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 ASTM F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
12/20/2021 Orthopedic 11-392 ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
12/20/2021 Orthopedic 11-393 ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
12/20/2021 Physical Medicine 16-232 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 IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
12/20/2021 Radiology 12-342 NEMA PS 3.1 - 3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set
12/20/2021 Software/
Informatics		 13-120 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 ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
12/20/2021 Sterility 14-564 USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/20/2021 Sterility 14-565 USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/20/2021 Sterility 14-566 USP-NF M98795_02_01 <55> Biological Indicators -- Resistance Performance Tests
12/20/2021 Sterility 14-567 USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization
12/20/2021 Sterility 14-568 USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/20/2021 Sterility 14-569 USP-NF M98810_01_01 <71> Sterility Tests
12/20/2021 Sterility 14-570 USP-NF M98830_02_01 <85> Bacterial Endotoxins Test
12/20/2021 Sterility 14-571 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 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 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 ANSI ADA Standard No. 35-2019 Dental Handpieces and Motors
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 ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
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 ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
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 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
 
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