Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
61 to 160 of 1775 Results
 < 
 0.6 
 1.6 
 2.6 
 3.6 
 4.6 
 5.6 
 6.6 
 7.6 
 8.6 
 9.6 
 > 
Results per Page
New Search export reports to excelExport to Excel HelpStandards Search Assistance
Date of
Entry
Sort by Date [Old to new]
Sort by Date [New to old]
Specialty Task
Group Area
Sort by Specialty Task Group Area [A-Z]
Sort by Specialty Task Group Area [Z-A]
Recognition
Number
Sort by Recognition Number [0-9]
Sort by Recognition Number [9-0]
Extent of
Recognition
Sort by Extent of Recognition [A-Z]
Sort by Extent of Recognition [Z-A]
Standards
Developing
Organization

Standard Designation
Number and Date
 

Standard Title
(click for recognition information)
 
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
05/26/2025 Radiology 12-370 Complete ISO 11146-2 Second edition 2021-07 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
05/26/2025 InVitro Diagnostics 7-341 Complete CLSI AUTO03-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition
05/26/2025 InVitro Diagnostics 7-342 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
05/26/2025 InVitro Diagnostics 7-343 Complete CLSI AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
05/26/2025 InVitro Diagnostics 7-345 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
05/26/2025 InVitro Diagnostics 7-337 Complete CLSI AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline
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
06/07/2018 Ophthalmic 10-106 Complete ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
06/07/2018 Ophthalmic 10-107 Complete ISO 18369-4 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
09/17/2018 Materials 8-468 Complete ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
12/23/2019 Materials 8-500 Complete ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
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
03/16/2012 Radiology 12-142 Complete ISO 11146-2 First edition 2005-02-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
12/22/2025 Radiology 12-384 Complete ICDM IDMS Version 1.3 May 31 2025 Information Display Measurements Standard
05/29/2024 Radiology 12-361 Complete ICDM IDMS Version 1.2 May 2023 Information Display Measurements Standard
12/22/2025 Anesthesiology 1-198 Complete ISO 7376 Third edition 2020-08 [Including AMD1:2025] Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements [Including Amendment 1 (2025)]
01/27/2015 Orthopedic 11-283 Complete ASTM F2943-14 (Reapproved 2019) Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
07/06/2020 Tissue Engineering 15-62 Complete ASTM F2602-18 Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
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
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
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
06/27/2016 Materials 8-434 Complete ISO ASTM 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
12/22/2025 Orthopedic 11-434 Complete ASTM F3018-25 Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement
12/22/2025 Orthopedic 11-423 Complete ASTM F2267-24 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
09/17/2018 Materials 8-476 Complete ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
12/23/2024 Materials 8-624 Complete ASTM F2129-24 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-148 Complete ISO CIE 11664-6 Second edition 2022-08 Colorimetry - Part 6: CIEDE2000 colour-difference formula
12/18/2023 Dental/
ENT		 4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
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
08/14/2015 General Plastic Surgery/
General Hospital		 6-353 Complete ASTM F2051-00 (Reapproved 2022) Standard Specification for Implantable Saline Filled Breast Prosthesis
05/30/2022 Materials 8-583 Complete ASTM F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
12/20/2021 Materials 8-566 Complete ASTM F1813-21 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
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
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
05/26/2025 Dental/
ENT		 4-343 Complete ANSI ADA Standard No. 105-2024 Elastomeric Auxiliaries for Use in Orthodontics
12/23/2024 Sterility 14-607 Complete ANSI AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities
05/29/2024 Anesthesiology 1-168 Complete CGA V-7.1:2021 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
03/16/2012 InVitro Diagnostics 7-227 Complete CLSI M53-A (Replaces M53-P) Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
01/30/2014 Sterility 14-405 Complete ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
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
08/14/2015 Radiology 12-289 Complete IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
01/14/2019 Biocompatibility 2-141 Complete ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
09/17/2018 Orthopedic 11-329 Complete ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
12/19/2022 Anesthesiology 1-154 Complete ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
07/26/2016 Biocompatibility 2-227 Complete ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
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
03/16/2012 InVitro Diagnostics 7-165 Complete CLSI H20-A2 (Replaces H20-A) Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
03/16/2012 InVitro Diagnostics 7-166 Complete CLSI GP20-A2 (Replaces GP20-A) Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
03/16/2012 InVitro Diagnostics 7-225 Complete CLSI GP34-A (Replaces GP34-P) Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
08/02/2011 InVitro Diagnostics 7-219 Complete CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
08/02/2011 Ophthalmic 10-65 Complete ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
01/15/2013 General Plastic Surgery/
General Hospital		 6-122 Complete ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
12/18/2023 Materials 8-606 Complete ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
01/27/2015 Sterility 14-141 Complete ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
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)
05/29/2024 Anesthesiology 1-169 Complete CGA V-1:2021 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
01/30/2014 Sterility 14-406 Complete ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
08/14/2015 Ophthalmic 10-99 Complete ISO 4311 First edition 1979-06-01 Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
08/14/2015 Software/
Informatics		 13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
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
09/21/2016 General Plastic Surgery/
General Hospital		 6-380 Complete ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
05/29/2024 Anesthesiology 1-170 Complete CGA C-9:2019 Standard Color Marking of Compressed Gas Containers for Medical Use
07/09/2014 Anesthesiology 1-101 Complete CGA C-9:2013 Standard Color Marking of Compressed Gas Containers for Medical Use
05/29/2024 Anesthesiology 1-171 Complete ISO 5367 Sixth edition 2023-07 Anaesthetic and respiratory equipment - Breathing sets and connectors
08/21/2017 Orthopedic 11-280 Complete ASTM F2624-12 (Reapproved 2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
06/27/2016 Materials 8-426 Complete ASTM F3087-15 (2024) Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016 Materials 8-430 Complete ISO 13356:2015 Third Edition 2015-09-15 Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
06/27/2016 Materials 8-432 Complete ISO ASTM 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
08/21/2017 Biocompatibility 2-248 Complete ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/22/2025 Orthopedic 11-429 Complete ASTM F366-24 Standard Specification for Fixation Pins and Wires
05/29/2024 Software/
Informatics		 13-134 Complete ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
IEEE Std 11073-10404-2020 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
07/06/2020 Software/
Informatics		 13-115 Complete ISO IEC IEEE 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
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 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
05/26/2025 Cardiovascular 3-200 Complete ASTM F2477-24 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
12/21/2020 Dental/
ENT		 4-271 Complete ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
05/29/2024 Sterility 14-602 Complete AAMI TIR12:2020/(R)2023 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
05/29/2023 InVitro Diagnostics 7-316 Complete CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening
04/04/2016 Materials 8-404 Complete ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
09/17/2018 Materials 8-479 Complete ISO 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
06/07/2018 Radiology 12-315 Complete NEMA MS 8-2016 (R2003) Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
 
 < 
 0.6 
 1.6 
 2.6 
 3.6 
 4.6 
 5.6 
 6.6 
 7.6 
 8.6 
 9.6 
 > 
 
-
-