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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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03/16/2012 Radiology 12-134 Complete ISO 11146-1 First edition 2005-01-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
01/14/2019 General Plastic Surgery/
General Hospital		 6-411 Complete ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
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
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-145 Complete 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 Complete ISO 8600-4 Third Edition 2023-01 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
08/21/2017 Materials 8-451 Complete ASTM F2214-16 Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
05/26/2025 Software/
Informatics		 13-143 Complete AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software
01/15/2013 Software/
Informatics		 13-36 Complete AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
05/29/2024 Software/
Informatics		 13-135 Complete ISO IEEE 11073-10407 Second edition 2022-12 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
IEEE Std 11073-10407-2020 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
06/07/2018 Neurology 17-16 Complete IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
05/26/2025 Ophthalmic 10-137 Complete ISO 11979-2 Third edition 2024-10 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
12/22/2025 Orthopedic 11-426 Complete ASTM F2943-25 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
05/26/2025 Cardiovascular 3-198 Complete ISO 25539-3 Second edition 2024-10 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
12/18/2023 Dental/
ENT		 4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
12/18/2023 Materials 8-610 Complete ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-483 Complete ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
12/19/2022 General Plastic Surgery/
General Hospital		 6-483 Complete 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
12/20/2021 InVitro Diagnostics 7-310 Complete ISO 19238 Second edition 2014-02-01 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021 InVitro Diagnostics 7-311 Complete CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
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
12/19/2022 Anesthesiology 1-155 Complete ISO 10079-2 Fourth edition 2022-03 Medical suction equipment - Part 2: Manually powered suction equipment
05/26/2025 Software/
Informatics		 13-148 Complete IEEE Std 11073-10417-2023 Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
05/26/2025 Software/
Informatics		 13-146 Complete IEEE 11073-10103 Second edition 2023 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
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
12/20/2021 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
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 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
12/19/2022 Anesthesiology 1-156 Complete ISO 10079-3 Fourth edition 2022-03 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
01/14/2019 InVitro Diagnostics 7-285 Complete CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
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
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
05/26/2025 General Plastic Surgery/
General Hospital		 6-512 Complete IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION 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
07/15/2019 Anesthesiology 1-143 Complete ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
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 Cardiovascular 3-182 Complete ASTM F3036-21 Standard Guide for Testing Absorbable Stents
12/18/2023 Anesthesiology 1-164 Complete ISO 5361 Fourth edition 2023-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
05/29/2023 Sterility 14-588 Complete AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
12/22/2025 Dental/
ENT		 4-357 Complete ANSI ADA Standard No. 54-1986 (R2024) Double-Pointed, Parenteral, Single Use Needles for Dentistry
01/27/2015 Dental/
ENT		 4-219 Complete ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
01/30/2014 Materials 8-344 Complete ISO 7153-1 Second edition 1991-04-01 Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
01/30/2014 Sterility 14-401 Complete ASTM F2217/F2217M-13 (Reapproved 2023) Standard Practice for Coating/Adhesive Weight Determination
05/30/2022 Materials 8-593 Complete ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 Implants for surgery - Hydroxyapatite - Part 6: Powders
03/18/2009 InVitro Diagnostics 7-192 Complete CLSI MM18-A (Replaces MM18-P) Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
08/20/2012 InVitro Diagnostics 7-197 Complete CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
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
08/06/2013 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)
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
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
12/23/2016 Anesthesiology 1-118 Complete ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/18/2023 Anesthesiology 1-165 Complete ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
05/29/2023 General Plastic Surgery/
General Hospital		 6-490 Complete 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		 6-495 Complete ISO 20698 First Edition 2018-07 Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
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
06/07/2018 Sterility 14-510 Complete ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ANSI AAMI ISO 11137-3:2017/(R)2023 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
09/17/2018 Materials 8-470 Complete ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
12/22/2025 Dental/
ENT		 4-358 Complete ANSI ADA Standard No. 95-2020 Endodontics Instruments - Enlargers
12/22/2025 Dental/
ENT		 4-359 Complete ANSI ADA Standard No. 159-2024 Dentistry - Coiled Springs for Use in Orthodontics
12/22/2025 Dental/
ENT		 4-360 Complete ISO 3630-1 Third edition 2019-08 Dentistry - Endodontic instruments - Part 1: General requirements
ANSI ADA Standard No. 101-2021 Endodontic Instruments - General Requirements
12/22/2025 Dental/
ENT		 4-361 Complete ISO 3630-2 Fourth edition 2023-02 Dentistry - Endodontic instruments - Part 2: Enlargers
05/29/2023 General Plastic Surgery/
General Hospital		 6-493 Complete 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
05/26/2025 Dental/
ENT		 4-343 Complete ANSI ADA Standard No. 105-2024 Elastomeric Auxiliaries for Use in Orthodontics
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
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
09/17/2018 Sterility 14-513 Complete ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
03/16/2012 General Plastic Surgery/
General Hospital		 6-272 Complete ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
08/21/2017 Materials 8-428 Complete ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
12/21/2020 Dental/
ENT		 4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
12/22/2025 General Plastic Surgery/
General Hospital		 6-520 Complete ASTM F3352/F3352M-23b Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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)].
12/18/2023 Sterility 14-596 Complete ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
12/18/2023 Sterility 14-597 Complete AAMI ANSI ST108:2023 Water for the processing of medical devices
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
01/27/2015 General I (QS/
RM)		 5-48 Complete ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
01/27/2015 General I (QS/
RM)		 5-62 Complete ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
04/04/2016 Materials 8-415 Complete ASTM F2778-09 (Reapproved 2020) Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
09/21/2016 General Plastic Surgery/
General Hospital		 6-379 Complete ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
08/14/2015 ObGyn/
Gastroenterology/
Urology		 9-108 Complete ISO 8009 Second edition 2014-11-15 Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
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
01/30/2014 Neurology 17-12 Complete ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
09/17/2018 Dental/
ENT		 4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
04/04/2016 Orthopedic 11-304 Complete ASTM F3107-14 (Reapproved 2023) Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
05/26/2025 Software/
Informatics		 13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
12/22/2025 Radiology 12-385 Complete NEMA PS 3.1 - 3.20 2025d Digital Imaging and Communications in Medicine (DICOM) Set
03/16/2012 Cardiovascular 3-96 Complete ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ANSI AAMI ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
03/08/2004 InVitro Diagnostics 7-86 Complete CLSI C29-A2 (Replaces C29-A) Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004 InVitro Diagnostics 7-87 Complete CLSI C31-A2 (Replaces C31-A) Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004 InVitro Diagnostics 7-88 Complete CLSI C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004 InVitro Diagnostics 7-89 Complete CLSI C39-A (Replaces C39-P) A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004 InVitro Diagnostics 7-105 Complete CLSI H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
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
01/14/2019 Orthopedic 11-272 Complete ASTM F1714-96 (Reapproved 2025) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
12/23/2016 Software/
Informatics		 13-86 Complete ISO IEC 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
 
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