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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
05/29/2023 Anesthesiology 1-161 ISO 16628 Second edition 2022-06 Anaesthetic and respiratory equipment - Tracheobronchial tubes
05/29/2023 Biocompatibility 2-299 ASTM F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
05/29/2023 Biocompatibility 2-300 ISO 10993-2 Third edition 2022-11 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
05/29/2023 Biocompatibility 2-301 ASTM F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
05/29/2023 Cardiovascular 3-184 ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
05/29/2023 Cardiovascular 3-185 ANSI AAMI PC76:2021 Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
05/29/2023 Cardiovascular 3-186 ISO 14708-2 Third edition 2019-09 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023 Cardiovascular 3-187 ISO 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
05/29/2023 Cardiovascular 3-188 ISO 81060-3 First edition 2022-12 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
05/29/2023 Dental/
ENT		 4-298 ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
05/29/2023 Dental/
ENT		 4-299 ISO 3107 Fifth edition 2022-09 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
05/29/2023 Dental/
ENT		 4-300 ISO 22674 Third edition 2022-08 Dentistry - Metallic materials for fixed and removable restorations and appliances
05/29/2023 Dental/
ENT		 4-301 ANSI ADA Standard No. 128-2022 Hydrocolloid Impression Materials
ISO 21563 Second edition 2021-08 Dentistry - Hydrocolloid impression materials
05/29/2023 Dental/
ENT		 4-302 ANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials
ISO 10477 Fourth edition 2020-10 Dentistry - Polymer-based crown and veneering materials
05/29/2023 Dental/
ENT		 4-303 ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
05/29/2023 Dental/
ENT		 4-304 ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
05/29/2023 Dental/
ENT		 4-305 ANSI ADA Standard No. 177-2020 Central Suction Source Equipment
ISO 10637 Second edition 2018-05 Dentistry - Central suction source equipment
05/29/2023 Dental/
ENT		 4-306 ANSI ADA Standard No. 94-2021 Central Compressed Air Source Equipment
ISO 22052 First edition 2020-06 Dentistry - Compressed air source equipment
05/29/2023 Dental/
ENT		 4-307 ISO 13504 First edition 2012-07 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
05/29/2023 Dental/
ENT		 4-308 ISO 14708-7 Second edition 2019-12 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
05/29/2023 General Plastic Surgery/
General Hospital		 6-486 ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
05/29/2023 General Plastic Surgery/
General Hospital		 6-487 ANSI AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-488 ASTM F1671/F1671M-22 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
05/29/2023 General Plastic Surgery/
General Hospital		 6-489 IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
05/29/2023 General Plastic Surgery/
General Hospital		 6-490 ISO 10555-6 First edition 2015-04-15 [Including AMD1:2019] Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
05/29/2023 General Plastic Surgery/
General Hospital		 6-491 ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2023 General Plastic Surgery/
General Hospital		 6-492 ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks
05/29/2023 General Plastic Surgery/
General Hospital		 6-493 ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
05/29/2023 General Plastic Surgery/
General Hospital		 6-494 ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-495 ISO ISO 20698 First Edition 2018-07 Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
05/29/2023 General Plastic Surgery/
General Hospital		 6-496 ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
05/29/2023 InVitro Diagnostics 7-315 CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance
05/29/2023 InVitro Diagnostics 7-316 CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening
05/29/2023 InVitro Diagnostics 7-317 CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
05/29/2023 Materials 8-597 ASTM F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
05/29/2023 Materials 8-598 ASTM F3109-22 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
05/29/2023 Materials 8-599 ASTM F1295-22 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
05/29/2023 Materials 8-600 ASTM F1978-22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
05/29/2023 Materials 8-601 ASTM F2516-22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
05/29/2023 Materials 8-602 ASTM F2503-23 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
05/29/2023 Materials 8-603 ASTM F1472-23 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
05/29/2023 Materials 8-604 ASTM F2257-22 Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
05/29/2023 Nanotechnology 18-23 ASTM E3025-22 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-143 ISO 20696 First edition 2018-06; Corrected 2019-12 Sterile urethral catheters for single use
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-145 ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-146 ISO 8600-4 Third Edition 2023-01 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-147 CIE ISO 11664-2 First edition 2022-08 Colorimetry - Part 2: CIE standard illuminants
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-148 CIE ISO 11664-6 Second edition 2022-08 Colorimetry - Part 6: CIEDE2000 colour-difference formula
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
05/29/2023 Orthopedic 11-399 ASTM F1357 - 23 Standard Specification for Articulating Total Wrist Implants
05/29/2023 Physical Medicine 16-234 ISO 7176-14 Third Edition 2022 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
05/29/2023 Physical Medicine 16-235 ISO 7176-25 Second Edition 2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
05/29/2023 Physical Medicine 16-236 ISO 7176-19 Third Edition 2022 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
05/29/2023 Radiology 12-347 IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
05/29/2023 Radiology 12-350 IEC 60806 Edition 2.0 2022-11 Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis
05/29/2023 Radiology 12-351 IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
05/29/2023 Sterility 14-584 ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
05/29/2023 Sterility 14-585 ISO /TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
05/29/2023 Sterility 14-586 ISO 22441 First edition 2022-08 Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/29/2023 Sterility 14-587 AAMI /TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
05/29/2023 Sterility 14-588 AAMI /TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
04/03/2023 General II (ES/
EMC)		 19-34 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
04/03/2023 General II (ES/
EMC)		 19-49 IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
02/20/2023 Sterility 14-575 ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/19/2022 Anesthesiology 1-153 NFPA 99:2021 Health Care Facilities Code
12/19/2022 Anesthesiology 1-154 ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
12/19/2022 Anesthesiology 1-155 ISO 10079-2 Fourth edition 2022-03 Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022 Anesthesiology 1-156 ISO 10079-3 Fourth edition 2022-03 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
12/19/2022 Anesthesiology 1-157 ISO 10079-1 Fourth edition 2022-03 Medical suction equipment - Part 1: Electrically powered suction equipment
12/19/2022 Anesthesiology 1-158 ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements
12/19/2022 Anesthesiology 1-159 ISO 18778 Second edition 2022-06 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
12/19/2022 Anesthesiology 1-160 ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
12/19/2022 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/19/2022 Biocompatibility 2-296 ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
12/19/2022 Biocompatibility 2-297 ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/19/2022 Biocompatibility 2-298 ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
12/19/2022 Cardiovascular 3-183 ANSI AAMI ISO 11658: 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 11658 First edition 2012-05-15 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022 Dental/
ENT		 4-294 ANSI ADA Standard No. 139-2020 Dental Base Polymers
12/19/2022 Dental/
ENT		 4-295 ANSI ADA Standard No. 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
12/19/2022 Dental/
ENT		 4-296 ANSI ADA Standard No. 191-2020 Intra-Oral Mirrors
ISO 9873 Fourth edition 2019-03 Dentistry - Intra-oral mirrors
12/19/2022 Dental/
ENT		 4-297 ISO 20126 Third edition 2022-03 Dentistry - Manual toothbrushes - General requirements and test methods
12/19/2022 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
12/19/2022 General I (QS/
RM)		 5-136 ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022 General I (QS/
RM)		 5-137 IEC /TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice
12/19/2022 General I (QS/
RM)		 5-138 AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/19/2022 General I (QS/
RM)		 5-139 ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/19/2022 General I (QS/
RM)		 5-140 ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12/19/2022 General I (QS/
RM)		 5-141 ASME V&V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
12/19/2022 General II (ES/
EMC)		 19-48 ANSI IEEE USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
12/19/2022 General Plastic Surgery/
General Hospital		 6-483 IEC 60601-2-35 Edition 2.0 2020-09 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
12/19/2022 General Plastic Surgery/
General Hospital		 6-484 ASTM F3502-22a Standard Specification for Barrier Face Coverings
12/19/2022 General Plastic Surgery/
General Hospital		 6-485 ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/19/2022 InVitro Diagnostics 7-313 CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
12/19/2022 InVitro Diagnostics 7-314 CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/19/2022 Materials 8-594 ISO 5832-6 Third Edition 2022-03 Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
12/19/2022 Materials 8-595 ISO 5832-5 Fourth Edition 2022-03 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
12/19/2022 Materials 8-596 ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
12/19/2022 Nanotechnology 18-21 ISO /TS 80004-6 Second edition 2021-03 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
12/19/2022 Nanotechnology 18-22 ISO 17200 First edition 2020-09 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-140 ANSI AAMI ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ISO 8637-2 First Edition 2018-07 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
 
 
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