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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
05/30/2022 Anesthesiology 1-152 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 Biocompatibility 2-296 ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
05/30/2022 Cardiovascular 3-181 ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
05/30/2022 Cardiovascular 3-182 ASTM F3036-21 Standard Guide for Testing Absorbable Stents
05/30/2022 Dental/
ENT		 4-293 ANSI ADA Standard No. 119-2021 Manual Toothbrushes
05/30/2022 General II (ES/
EMC)		 19-46 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 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 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 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 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 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 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 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 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 AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
05/30/2022 InVitro Diagnostics 7-303 CLSI M60 2nd Edition Performance Standards for Antifungal Susceptibility Testing of Yeast
05/30/2022 InVitro Diagnostics 7-312 CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
05/30/2022 Materials 8-583 ASTM F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
05/30/2022 Materials 8-584 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 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 ASTM F2989-21 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
05/30/2022 Materials 8-587 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 ASTM F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
05/30/2022 Materials 8-589 ASTM F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
05/30/2022 Materials 8-590 ISO TS 17137 Third edition 2021-09 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
05/30/2022 Materials 8-591 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 ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
05/30/2022 Materials 8-593 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 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 ISO 15798 Fourth edition 2022-01 Ophthalmic implants - Ophthalmic viscosurgical devices
05/30/2022 Physical Medicine 16-166 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 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 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
05/30/2022 Radiology 12-345 IEC 61223-3-7 Edition 1.0 2021-12 Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
05/30/2022 Sterility 14-572 ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
05/30/2022 Sterility 14-573 ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier Materials
05/30/2022 Sterility 14-574 ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
05/30/2022 Sterility 14-575 ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
05/30/2022 Sterility 14-576 ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
05/30/2022 Sterility 14-577 ANSI AAMI ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products
ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
05/30/2022 Sterility 14-578 ISO 17664-1 First edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
05/30/2022 Sterility 14-579 ISO 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
02/07/2022 General I (QS/
RM)		 5-135 ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
02/07/2022 General II (ES/
EMC)		 19-45 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
12/20/2021 Biocompatibility 2-292 USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021 Biocompatibility 2-293 USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Elution Test
12/20/2021 Biocompatibility 2-294 USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
12/20/2021 Biocompatibility 2-295 USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
12/20/2021 Cardiovascular 3-171 ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/20/2021 Cardiovascular 3-172 AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
12/20/2021 Cardiovascular 3-173 ISO 5840-3 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
12/20/2021 Cardiovascular 3-174 ISO 5840-1 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
12/20/2021 Cardiovascular 3-175 ISO 5840-2 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
12/20/2021 Cardiovascular 3-176 ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/20/2021 Cardiovascular 3-177 ASTM F2606 - 08 (Reapproved 2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021 Cardiovascular 3-178 ASTM F3067 - 14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/20/2021 Cardiovascular 3-179 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 ASTM F3505 - 21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
12/20/2021 Dental/
ENT		 4-284 ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
12/20/2021 Dental/
ENT		 4-285 ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
12/20/2021 Dental/
ENT		 4-286 ANSI ADA Standard No. 87-1995 (R2014) Dental Impression Trays
12/20/2021 Dental/
ENT		 4-287 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 ANSI ADA Standard No. 43-2020 Electrically Powered Dental Amalgamators
ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
12/20/2021 Dental/
ENT		 4-289 ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT		 4-290 ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
12/20/2021 Dental/
ENT		 4-291 ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
12/20/2021 Dental/
ENT		 4-292 ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
12/20/2021 General I (QS/
RM)		 5-134 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 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 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 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 ANSI IEEE 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 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 USP-NF M76090_03_01 Sodium Chloride Irrigation
12/20/2021 General Plastic Surgery/
General Hospital		 6-466 USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital		 6-467 USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital		 6-468 USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital		 6-469 USP-NF M99650_02_01 <861> Sutures - Diameter
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
 
 
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