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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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12/21/2020 Biocompatibility 2-277 Complete ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
06/07/2021 Radiology 12-340 Complete IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
08/06/2013 Radiology 12-205 Complete IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
06/07/2021 Materials 8-556 Complete ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
05/29/2023 Materials 8-604 Complete 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)
06/07/2018 General Plastic Surgery/
General Hospital		 6-406 Complete ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
12/19/2022 General I (QS/
RM)		 5-137 Complete IEC TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
07/06/2020 Anesthesiology 1-146 Complete ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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		 6-472 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 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/19/2022 General I (QS/
RM)		 5-140 Complete ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12/20/2021 Orthopedic 11-388 Complete ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/19/2022 General I (QS/
RM)		 5-136 Complete ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022 General Plastic Surgery/
General Hospital		 6-485 Complete ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/20/2021 Biocompatibility 2-292 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021 Biocompatibility 2-293 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Elution Test
03/18/2009 InVitro Diagnostics 7-189 Complete CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline
07/15/2019 Radiology 12-326 Complete NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs
05/26/2025 Radiology 12-383 Complete NEMA NU 1-2023 Performance Measurements of Gamma Cameras
06/07/2021 Radiology 12-337 Complete NEMA NU 1-2018 Performance Measurements of Gamma Cameras
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
12/19/2022 Software/
Informatics		 13-122 Complete IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
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
01/30/2014 Sterility 14-429 Complete ISO ASTM 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
12/22/2025 Biocompatibility 2-309 Complete ASTM F895-25 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/23/2016 Biocompatibility 2-189 Complete ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
04/03/2023 General II (ES/
EMC)		 19-34 Complete 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
05/29/2023 Dental/
ENT		 4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
12/20/2021 Sterility 14-564 Complete USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
10/04/2010 Radiology 12-215 Complete IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
08/20/2012 Cardiovascular 3-104 Complete ASTM F2914-12 (Reapproved 2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
01/15/2013 Sterility 14-212 Complete AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/06/2013 Physical Medicine 16-190 Complete ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
09/17/2018 InVitro Diagnostics 7-283 Complete CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
12/22/2025 Materials 8-642 Complete ASTM F2895-24 Standard Practice for Digital Radiography of Cast Metallic Implants
12/18/2023 Cardiovascular 3-189 Complete ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
05/26/2025 Radiology 12-376 Complete IEC 61689 Edition 4.0 2022-03 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
04/03/2023 General II (ES/
EMC)		 19-49 Complete 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.
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
09/17/2018 Materials 8-478 Complete ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
07/06/2020 Dental/
ENT		 4-263 Complete ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
ANSI ADA Standard No. 38-2020 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
07/15/2019 Software/
Informatics		 13-108 Complete IEEE Std 11073-20701-2018 Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/21/2020 Materials 8-551 Complete ASTM F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
12/22/2025 Materials 8-643 Complete ASTM F2820-24 Standard Specification for Polyetherketoneketone (PEKK) Polymers 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
05/29/2023 Dental/
ENT		 4-300 Complete ISO 22674 Third edition 2022-08 Dentistry - Metallic materials for fixed and removable restorations and appliances
ANSI ADA Standard No. 134-2023 Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances
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
05/30/2022 Materials 8-590 Complete ISO TS 17137 Third edition 2021-09 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
09/17/2018 Cardiovascular 3-110 Complete AAMI TIR41:2011/(R)2025 Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
09/17/2018 Materials 8-112 Complete ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
09/17/2018 General Plastic Surgery/
General Hospital		 6-123 Complete ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
07/09/2014 Materials 8-379 Complete ISO 11542-2 First edition 1998-11-15 Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
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 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
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
09/17/2018 InVitro Diagnostics 7-275 Complete CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
09/17/2018 InVitro Diagnostics 7-276 Complete CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 Orthopedic 11-337 Complete ISO 16087 First edition 2013-10-01 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
09/17/2018 Orthopedic 11-339 Complete ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
09/17/2018 Ophthalmic 10-112 Complete ISO 11986 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
08/06/2013 General Plastic Surgery/
General Hospital		 6-147 Complete ASTM D6978-05(2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
01/30/2014 Radiology 12-266 Complete IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
05/26/2025 Radiology 12-377 Complete IEC 62127-03 Edition 2.0 2022-12 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
07/09/2014 Radiology 12-279 Complete IEC 62127-03 Edition 1.1 2013-05 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
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)]
05/29/2023 Materials 8-597 Complete ASTM F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
05/29/2023 Dental/
ENT		 4-301 Complete ISO 21563 Second edition 2021-08 Dentistry - Hydrocolloid impression materials
ANSI ADA Standard No. 128-2022 Hydrocolloid Impression Materials
12/23/2016 Orthopedic 11-312 Complete ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
01/27/2015 Dental/
ENT		 4-136 Complete ASTM F2504-05 (Reapproved 2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
12/23/2016 Software/
Informatics		 13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
12/19/2022 Dental/
ENT		 4-296 Complete ISO 9873 Fourth edition 2019-03 Dentistry - Intra-oral mirrors
ANSI ADA Standard No. 191-2020 Intra-Oral Mirrors
05/29/2023 Dental/
ENT		 4-302 Complete ISO 10477 Fourth edition 2020-10 Dentistry - Polymer-based crown and veneering materials
ANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials
08/20/2012 Cardiovascular 3-103 Complete ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
05/26/2025 Cardiovascular 3-199 Complete ASTM F1841-25 Standard Practice for Assessment of Hemolysis in Blood Pumps
09/17/2018 Anesthesiology 1-140 Complete ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/23/2019 Materials 8-491 Complete ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
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
04/04/2016 Tissue Engineering 15-24 Complete ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
01/14/2019 Dental/
ENT		 4-171 Complete ANSI ASA S3.37-1987 (Reaffirmed 2025) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
12/18/2023 Dental/
ENT		 4-313 Complete ISO 27020 Second edition 2019-06 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2020 Orthodontic Brackets and Tubes
12/23/2024 Dental/
ENT		 4-328 Complete ANSI ADA Standard No. 57-2021 Endodontic Sealing Materials
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/22/2025 Orthopedic 11-439 Complete ASTM F3437-23 Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
07/09/2014 Radiology 12-282 Complete ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
06/07/2021 Sterility 14-562 Complete ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
 
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