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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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09/17/2018 Orthopedic 11-322 Complete ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
06/27/2016 Radiology 12-294 Complete IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
12/23/2024 Orthopedic 11-418 Complete ASTM F3631-24 Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
12/23/2024 Materials 8-627 Complete ASTM F3604-23 Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion.
12/23/2024 Materials 8-626 Complete ASTM E2948-24 Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete 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
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
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
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
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
07/15/2019 Sterility 14-528 Complete ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
01/14/2019 Dental/
ENT		 4-163 Complete ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
05/29/2023 Radiology 12-351 Complete 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
12/23/2024 Sterility 14-608 Complete AAMI TIR106:2024 Microbiological methods - Understanding and use of product bioburden data
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
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
05/29/2023 Sterility 14-585 Complete AAMI ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
05/29/2024 Software/
Informatics		 13-138 Complete ISO IEEE 11073-10700 First Edition 2024-09 Health informatics - Device interoperability Part 10700: Point-of-care medical device communication - Standard for base requirements for participants in a Service-oriented Device Connectivity (SDC) system
IEEE Std 11073-10700-2022 Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System
12/04/2017 Software/
Informatics		 13-103 Complete IEC TR 80001-2-9 Edition 1.0 2017-01 Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
01/15/2013 Software/
Informatics		 13-34 Complete ANSI AAMI IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1 Edition 1.0 2009-09 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
07/15/2019 Biocompatibility 2-266 Complete ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
12/23/2024 General I (QS/
RM)		 5-143 Complete ISO 14630 Fffth edition 2024-09 Non-active surgical implants -- General requirements
06/07/2021 Orthopedic 11-377 Complete ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis
12/23/2016 Sterility 14-169 Complete ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
03/16/2012 Radiology 12-248 Complete ISO 21254-3 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012 Radiology 12-174 Complete ISO 13697 First edition 2006-05-15 Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
03/16/2012 Radiology 12-175 Complete ISO 24013 First edition 2006-11-15 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
08/20/2012 Software/
Informatics		 13-31 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
08/20/2012 Cardiovascular 3-102 Complete IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/20/2012 Cardiovascular 3-104 Complete ASTM F2914-12 (Reapproved 2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
08/20/2012 General Plastic Surgery/
General Hospital		 6-278 Complete ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
08/06/2013 Orthopedic 11-254 Complete ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
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.
12/23/2024 Anesthesiology 1-189 Complete ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary
09/21/2016 InVitro Diagnostics 7-266 Complete CLSI EP19 2nd Edition (Replaces EP19-R) A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
12/18/2023 Sterility 14-595 Complete ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
08/20/2012 InVitro Diagnostics 7-148 Complete CLSI M28-A2 (Replaces M28-A) Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
03/16/2012 Software/
Informatics		 13-30 Complete CLSI AUTO3-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
03/16/2012 General Plastic Surgery/
General Hospital		 6-268 Complete ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
01/30/2014 Orthopedic 11-274 Complete ISO 18192-2 First edition 2010-06-15 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
03/16/2012 Dental/
ENT		 4-173 Complete ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
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
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
12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
09/17/2018 Orthopedic 11-340 Complete ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
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
12/23/2024 Anesthesiology 1-188 Complete ISO 80601-2-84 Second edition 2023-11 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
12/18/2023 Dental/
ENT		 4-312 Complete ANSI ASA S3.35-2021 American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
04/04/2016 Dental/
ENT		 4-190 Complete ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
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
09/17/2018 Orthopedic 11-336 Complete ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
09/17/2018 Orthopedic 11-338 Complete ISO 11491 First edition 2017-07 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
12/21/2020 Dental/
ENT		 4-264 Complete ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
12/23/2024 InVitro Diagnostics 7-324 Complete CLSI M07 12th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-279 Complete CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
08/21/2017 Dental/
ENT		 4-238 Complete ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
12/18/2023 Dental/
ENT		 4-317 Complete ISO 8325 Third edition 2023-03 Dentistry - Test methods for rotary instruments
01/30/2014 Physical Medicine 16-165 Complete ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
12/21/2020 Dental/
ENT		 4-266 Complete ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
ANSI ADA Standard No. 178-2019 Orthodontic Anchor Screws
12/21/2020 Dental/
ENT		 4-268 Complete ISO 15841 Second edition 2014-08 Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
ANSI ADA Standard No. 32-2017 Orthodontic Wires
07/15/2019 Orthopedic 11-357 Complete ISO 15142-3 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
07/06/2020 Sterility 14-545 Complete ISO ASTM 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
07/06/2020 Sterility 14-549 Complete ASTM F3004-13 (Reapproved 2020) Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
05/29/2023 Physical Medicine 16-234 Complete ISO 7176-14 Third Edition 2022 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
08/14/2015 Physical Medicine 16-194 Complete ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
05/29/2023 Biocompatibility 2-300 Complete ISO 10993-2 Third edition 2022-11 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
09/17/2018 Sterility 14-294 Complete ANSI AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
09/17/2018 Sterility 14-513 Complete ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
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
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)
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)
05/29/2024 Ophthalmic 10-136 Complete IEC 80601-2-58 Edition 3.0 2024-03 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
09/11/2023 Orthopedic 11-401 Complete ISO 21535 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
04/04/2016 Materials 8-399 Complete ASTM F90-14 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
06/27/2016 Materials 8-427 Complete ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
12/23/2016 Physical Medicine 16-199 Complete ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
08/21/2017 Materials 8-458 Complete ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
06/27/2016 General I (QS/
RM)		 5-108 Complete ISO 80369-6 First Edition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
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
01/27/2015 Sterility 14-389 Complete ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
08/06/2013 Software/
Informatics		 13-53 Complete ISO IEEE 11073-10415 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
05/29/2024 Software/
Informatics		 13-136 Complete ISO IEEE 11073-20601 Third Edition 2022-12 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol
08/14/2015 Materials 8-389 Complete ISO 15309 First edition 2013-12-01 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
08/14/2015 Radiology 12-292 Complete IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
06/07/2018 Ophthalmic 10-109 Complete ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
07/09/2014 Radiology 12-194 Complete ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
07/09/2014 Software/
Informatics		 13-15 Complete CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
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
07/09/2014 General I (QS/
RM)		 5-88 Complete ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
12/18/2023 Dental/
ENT		 4-320 Complete ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
10/09/2023 Software/
Informatics		 13-130 Complete ANSI AAMI 2700-2-1:2022 Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
01/27/2015 Sterility 14-242 Complete ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
 
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