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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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 Materials 8-580 Complete 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 Complete 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 Complete 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 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
02/07/2022 General II (ES/
EMC)
19-45 Complete AIM Standard 7351731 Rev. 3.00 2021-06-04 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
05/30/2022 Anesthesiology 1-152 Complete ISO 80601-2-87 First edition 2021-04 Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
05/30/2022 Cardiovascular 3-181 Complete ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
05/30/2022 Cardiovascular 3-182 Complete ASTM F3036-21 Standard Guide for Testing Absorbable Stents
05/30/2022 Dental/
ENT
4-293 Complete ANSI ADA Standard No. 119-2021 Manual Toothbrushes
05/30/2022 General II (ES/
EMC)
19-46 Complete ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
05/30/2022 General II (ES/
EMC)
19-47 Complete ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
05/30/2022 General Plastic Surgery/
General Hospital
6-475 Complete ISO 11608-4:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
05/30/2022 General Plastic Surgery/
General Hospital
6-476 Complete ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
05/30/2022 General Plastic Surgery/
General Hospital
6-477 Complete ISO 11608-3:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022 General Plastic Surgery/
General Hospital
6-478 Complete ISO 11608-1:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
05/30/2022 General Plastic Surgery/
General Hospital
6-479 Complete ISO 11608-5:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
05/30/2022 General Plastic Surgery/
General Hospital
6-480 Complete ISO 11608-6:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022 General Plastic Surgery/
General Hospital
6-481 Complete ANSI AAMI CN27:2021 General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022 General Plastic Surgery/
General Hospital
6-482 Complete AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
05/30/2022 InVitro Diagnostics 7-312 Complete CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
05/30/2022 Materials 8-583 Complete ASTM F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
05/30/2022 Materials 8-584 Complete ASTM F2146-22 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
05/30/2022 Materials 8-585 Complete ASTM F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
05/30/2022 Materials 8-586 Complete ASTM F2989-21 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
05/30/2022 Materials 8-587 Complete ISO 5832-3 Fifth Edition 2021-11 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
05/30/2022 Materials 8-588 Complete ASTM F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
05/30/2022 Materials 8-589 Complete ASTM F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
05/30/2022 Materials 8-590 Complete ISO TS 17137 Third edition 2021-09 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
05/30/2022 Materials 8-591 Complete ASTM F2229-21 Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
05/30/2022 Materials 8-592 Complete ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
05/30/2022 Materials 8-593 Complete ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 Implants for surgery - Hydroxyapatite - Part 6: Powders
05/30/2022 ObGyn/
Gastroenterology/
Urology
9-139 Complete CIE ISO 11664-5:2016 Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
05/30/2022 Ophthalmic 10-131 Complete ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices
05/30/2022 Physical Medicine 16-166 Partial ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
05/30/2022 Radiology 12-344 Complete IEC 62563-2 Edition 1.0 2021-11 Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
 
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