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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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08/14/2015 Ophthalmic 10-98 Complete ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
05/26/2025 Radiology 12-368 Complete ISO 13696 Second edition 2022-06 Optics and photonics - Test methods for radiation scattered by optical components
10/04/2004 Radiology 12-116 Complete ISO 13696:2002 Optics and optical instruments -- Test methods for radiation scattered by optical components
05/26/2025 Radiology 12-367 Complete ISO 13695 Second edition 2024-11 Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
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
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-131 Complete ISO 8600-5 Second Edition 2020-10 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
12/21/2020 Sterility 14-551 Complete ISO 14160 Third edition 2020-09 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
01/14/2019 Dental/
ENT		 4-252 Complete ISO 10650 Second edition 2018-08 Dentistry - Powered polymerization activators
ANSI ADA Standard No. 48-2020 Curing Lights (Powered Polymerization Activators)
05/26/2025 Software/
Informatics		 13-145 Complete IEEE Std 11073-10419:2023 Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
05/26/2025 Software/
Informatics		 13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
12/22/2025 Radiology 12-384 Complete ICDM IDMS Version 1.3 May 31 2025 Information Display Measurements Standard
03/16/2012 Anesthesiology 1-73 Complete ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
12/18/2023 Orthopedic 11-408 Complete ASTM F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
01/14/2019 Orthopedic 11-346 Complete ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
12/04/2017 Software/
Informatics		 13-102 Complete IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
12/23/2024 Dental/
ENT		 4-334 Complete ISO 11143 Second edition 2008-07 Dentistry - Amalgam separators
ANSI ADA Standard No. 108-2009, Addendum (R2022) Amalgam Separators
04/04/2016 Software/
Informatics		 13-81 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
08/06/2013 Software/
Informatics		 13-56 Complete ISO IEEE 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
12/20/2021 Orthopedic 11-388 Complete ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/20/2021 Sterility 14-564 Complete USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
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
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
08/21/2017 Dental/
ENT		 4-239 Complete ANSI AAMI CI86:2017/(R)2025 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
07/09/2014 Anesthesiology 1-100 Complete CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
05/26/2025 Neurology 17-20 Complete IEC 60601-2-40 Third edition 2024-12 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
12/18/2023 Anesthesiology 1-166 Complete ISO 11195 Second edition 2018-01 Gas mixers for medical use - Stand-alone gas mixers
12/18/2023 Sterility 14-589 Complete ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
01/14/2019 InVitro Diagnostics 7-286 Complete CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019 Materials 8-489 Complete ASTM F3302-18 Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-68 Complete ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-111 Complete ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
12/18/2023 Sterility 14-590 Complete ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
09/17/2018 Tissue Engineering 15-55 Complete ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
05/29/2024 General Plastic Surgery/
General Hospital		 6-501 Complete ISO 15747 Third edition 2018-09 Plastic containers for intravenous injections
05/29/2024 General Plastic Surgery/
General Hospital		 6-500 Complete IEC 63045 Edition 1.0 2020-05 Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
05/26/2025 Sterility 14-611 Complete ISO 11137-1 Second edition 2025-04 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
12/20/2021 Materials 8-572 Complete ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
04/04/2016 Sterility 14-337 Complete ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
09/09/2008 Sterility 14-191 Complete ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
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
12/18/2023 Materials 8-610 Complete ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
07/09/2014 InVitro Diagnostics 7-213 Complete CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
06/27/2016 General Plastic Surgery/
General Hospital		 6-363 Complete ISO 11810 Second edition 2015-12-15 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
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
12/19/2022 Cardiovascular 3-183 Complete ISO 11658 First edition 2012-05-15 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ANSI AAMI ISO 11658: 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022 Orthopedic 11-394 Complete ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
08/14/2015 General Plastic Surgery/
General Hospital		 6-185 Complete ASTM F881-94 (Reapproved 2022) Standard Specification for Silicone Elastomer Facial Implants
09/09/2008 Sterility 14-240 Complete ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
08/06/2013 Sterility 14-388 Complete ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ANSI AAMI ISO 13408-7:2012 (R2018) Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
06/07/2018 General Plastic Surgery/
General Hospital		 6-404 Complete ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
09/17/2018 Sterility 14-275 Complete ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
12/20/2021 Orthopedic 11-393 Complete ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
03/31/2006 Radiology 12-138 Complete ISO 5799 Second edition 1991-08-01 Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
01/30/2014 General I (QS/
RM)		 5-47 Complete ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
11/08/2005 InVitro Diagnostics 7-113 Complete CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
12/19/2007 Ophthalmic 10-39 Complete ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
01/15/2013 Software/
Informatics		 13-35 Complete ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
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
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)]
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
12/23/2016 Materials 8-368 Complete ASTM F2625-10 (Reapproved 2016) Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
01/30/2014 Sterility 14-395 Complete ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014 Sterility 14-397 Complete AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 Complete AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014 Sterility 14-399 Complete AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014 Sterility 14-400 Complete ASTM F2203-13 (Reapproved 2022) Standard Test Method for Linear Measurement Using Precision Steel Rule
03/14/2011 Radiology 12-221 Complete IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
03/16/2012 Radiology 12-143 Complete ISO 15367-2 First edition 2005-03-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
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
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
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-115 Complete ISO 29943-1 First edition 2017-07. Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports
06/07/2018 Anesthesiology 1-129 Complete ISO 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
06/07/2018 Anesthesiology 1-130 Complete ISO 18082 First edition 2014-06-15 Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
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
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
08/21/2017 Orthopedic 11-175 Complete ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants
08/21/2017 Orthopedic 11-309 Complete ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver Bits
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-264 Complete NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
06/07/2018 Radiology 12-312 Complete IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
06/07/2018 Radiology 12-313 Complete IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
09/17/2018 Sterility 14-512 Complete ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
09/17/2018 Cardiovascular 3-154 Complete ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
 
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