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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
03/16/2012 General Plastic Surgery/
General Hospital		 6-177 Complete ASTM E1112-00 (Reapproved 2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
01/30/2014 Radiology 12-228 Complete IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
01/30/2014 Radiology 12-261 Complete ISO IEC 10918-1 First edition 1994-02-15 Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
01/30/2014 Radiology 12-267 Complete IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
04/04/2016 Radiology 12-195 Complete NEMA MS 6-2008 (R2014, R2020) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
07/09/2014 Radiology 12-273 Complete IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
05/29/2024 Anesthesiology 1-175 Complete ISO 18562-3 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
04/04/2016 Materials 8-200 Complete ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
12/23/2016 Materials 8-441 Complete ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
01/15/2013 Sterility 14-213 Complete AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013 Sterility 14-215 Complete AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013 Sterility 14-217 Complete AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
03/16/2012 Anesthesiology 1-72 Complete ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
08/06/2013 Ophthalmic 10-78 Complete ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
12/23/2019 General II (ES/
EMC)		 19-13 Complete IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
09/09/2008 Sterility 14-239 Complete ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
06/07/2018 Neurology 17-15 Complete ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
06/07/2018 General Plastic Surgery/
General Hospital		 6-401 Complete ASTM D7160-16 (Reapproved 2023) Standard Practice for Determination of Expiration Dating for Medical Gloves
05/29/2023 Dental/
ENT		 4-308 Complete 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
05/29/2024 Neurology 17-18 Complete IEEE Std 2010-2023 Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems
05/29/2023 General Plastic Surgery/
General Hospital		 6-488 Complete 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
07/06/2020 InVitro Diagnostics 7-297 Complete ISO TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
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)
12/20/2021 Orthopedic 11-391 Complete ASTM F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
12/19/2022 Biocompatibility 2-297 Complete ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
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
08/06/2013 Dental/
ENT		 4-90 Complete ANSI ASA S3.39:1987 (Reaffirmed 2025) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
01/30/2014 General Plastic Surgery/
General Hospital		 6-117 Complete ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/30/2014 General Plastic Surgery/
General Hospital		 6-303 Complete ISO 10555-5 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
01/30/2014 General Plastic Surgery/
General Hospital		 6-305 Complete ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
01/30/2014 Orthopedic 11-232 Complete ISO 7207-1 Third edition 2007-02-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
09/21/2016 Ophthalmic 10-101 Complete ISO 18189 First edition 2016-06-01 Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
09/17/2018 Radiology 12-318 Complete IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
09/17/2018 Radiology 12-320 Complete IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
09/17/2018 Sterility 14-517 Complete ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
09/17/2018 General II (ES/
EMC)		 19-31 Complete IEEE ANSI C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
09/17/2018 General I (QS/
RM)		 5-42 Complete ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
05/26/2025 General Plastic Surgery/
General Hospital		 6-509 Complete ASTM F3186-24 Standard Specification for Adult Portable Bed Rails and Related Products
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 8-579 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)]
05/30/2022 Sterility 14-577 Complete 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)]
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
01/25/2013 Cardiovascular 3-89 Complete ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-119 Complete IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
09/17/2018 Cardiovascular 3-153 Complete ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
09/17/2018 InVitro Diagnostics 7-284 Complete CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 InVitro Diagnostics 7-277 Complete CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-278 Complete CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
06/07/2018 Biocompatibility 2-249 Complete ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
06/07/2018 Tissue Engineering 15-54 Complete ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
12/21/2020 Materials 8-552 Complete ASTM F3434-20 Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing
12/23/2019 General Plastic Surgery/
General Hospital		 6-424 Complete ASTM D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
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
05/26/2025 ObGyn/
Gastroenterology/
Urology		 9-151 Complete ASTM F1828-22 Standard Specification for Ureteral Stents
08/06/2013 General Plastic Surgery/
General Hospital		 6-179 Complete ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
12/23/2024 Radiology 12-365 Complete IEC 60627 Edition 3.0 2013-07 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
12/19/2022 Dental/
ENT		 4-294 Complete ANSI ADA Standard No. 139-2020 Dental Base Polymers
12/19/2022 Dental/
ENT		 4-295 Complete ANSI ADA Standard No. 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-141 Complete ISO 8637-3 First Edition 2018-07 Extracorporeal systems for blood purification - Part 3: Plasmafilters
12/20/2021 Materials 8-578 Complete ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
09/21/2016 General Plastic Surgery/
General Hospital		 6-381 Complete ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
07/09/2014 Sterility 14-433 Complete ASTM F2227-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
08/14/2015 Software/
Informatics		 13-74 Complete IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
12/23/2016 Anesthesiology 1-119 Complete ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
01/30/2014 Materials 8-157 Complete ISO 9583 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
07/09/2014 Sterility 14-437 Complete ISO ASTM 52701 First edition 2013-11-15 (R2020) Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
04/04/2016 Materials 8-401 Complete ASTM F2118-14 (Reapproved 2020) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
01/14/2019 InVitro Diagnostics 7-178 Complete CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
01/14/2019 InVitro Diagnostics 7-232 Complete CLSI MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
12/21/2020 InVitro Diagnostics 7-305 Complete ISO 17511 Second edition 2020-04 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
07/09/2014 General II (ES/
EMC)		 19-10 Complete UL 1642 5th Edition Lithium Batteries
12/23/2024 Orthopedic 11-410 Complete ASTM F3161-24 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
12/19/2022 General I (QS/
RM)		 5-135 Complete ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
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
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.
08/14/2015 Software/
Informatics		 13-78 Complete INCITS ISO IEC 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
06/27/2016 Sterility 14-481 Complete ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
06/27/2016 Sterility 14-483 Complete ISO ASTM 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
04/04/2016 Tissue Engineering 15-43 Complete ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
06/27/2016 Materials 8-431 Complete ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
04/04/2016 Materials 8-114 Complete ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
08/21/2017 Materials 8-195 Complete ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
08/21/2017 Materials 8-428 Complete ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
08/21/2017 Materials 8-452 Complete ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
12/19/2022 Materials 8-596 Complete ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
12/19/2022 Anesthesiology 1-159 Complete ISO 18778 Second edition 2022-06 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
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 Nanotechnology 18-19 Complete ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
03/18/2009 InVitro Diagnostics 7-71 Complete CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009 InVitro Diagnostics 7-145 Complete CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
09/09/2008 Radiology 12-165 Complete NEMA XR 22-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
05/05/2010 InVitro Diagnostics 7-205 Complete CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
05/05/2010 InVitro Diagnostics 7-207 Complete CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
08/06/2013 Software/
Informatics		 13-62 Complete IEC TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
07/09/2014 Sterility 14-432 Complete ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
12/23/2024 General Plastic Surgery/
General Hospital		 6-504 Complete ASTM F1862/F1862M-24 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
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 Dental/
ENT		 4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
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
 
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