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
-
501 to 600 of 1554 Results
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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)
 
04/04/2016 Orthopedic 11-299 Complete ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
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 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
12/23/2016 Orthopedic 11-311 Complete ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
01/14/2019 Orthopedic 11-347 Complete ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
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
08/14/2015 Orthopedic 11-183 Complete ASTM F1875-98 (Reapproved 2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
09/17/2018 Orthopedic 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-199 Complete ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
09/17/2018 Orthopedic 11-322 Complete ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
09/17/2018 Orthopedic 11-339 Complete ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
12/23/2016 Orthopedic 11-317 Complete ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
04/04/2016 Orthopedic 11-247 Complete ASTM F2789-10 (Reapproved 2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
06/27/2016 Orthopedic 11-307 Complete ASTM F2385-15 (Reapproved 2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
08/21/2017 Orthopedic 11-269 Complete ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
12/23/2016 Orthopedic 11-312 Complete ISO 7206-4 Third edition 2010-06-15 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
12/23/2016 Orthopedic 11-314 Complete ISO 14242-2 Second edition 2016-09-15 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
09/17/2018 Orthopedic 11-341 Complete ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
09/11/2023 Orthopedic 11-400 Complete ISO 21536 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
09/17/2018 Orthopedic 11-335 Complete ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
12/18/2023 Orthopedic 11-404 Complete ASTM F2887-23 Standard Specification for Total Elbow Prostheses
08/21/2017 Orthopedic 11-321 Complete ASTM F2887-17 Standard Specification for Total Elbow Prostheses
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
12/23/2019 Orthopedic 11-360 Complete ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
07/06/2020 Orthopedic 11-369 Complete ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
07/06/2020 Orthopedic 11-367 Complete ISO 14243-3 Second edition 2014-11-01 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/06/2020 Orthopedic 11-368 Complete ASTM F3334-19 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
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
01/14/2019 Orthopedic 11-272 Complete ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
12/23/2019 Orthopedic 11-362 Complete ISO 22622 First edition 2019-07 Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
08/14/2015 Orthopedic 11-290 Complete ISO 8828 Second edition 2014-11-15 Implants for surgery -- Guidance on care and handling of orthopaedic implants
12/19/2022 Orthopedic 11-395 Complete ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
12/19/2022 Orthopedic 11-396 Complete ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022] Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
12/20/2021 Orthopedic 11-388 Complete ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/18/2023 Orthopedic 11-409 Complete ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
07/15/2019 Orthopedic 11-355 Complete ISO 15142-1 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
12/23/2019 Orthopedic 11-361 Complete ISO 14243-5 First edition 2019-05 Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
07/15/2019 Orthopedic 11-349 Complete ISO 14242-3 First edition 2009-03-15 Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
07/09/2014 Orthopedic 11-276 Complete ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
12/18/2023 Orthopedic 11-407 Complete ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
07/06/2020 Orthopedic 11-365 Complete ASTM F1800-19 e1 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
07/06/2020 Orthopedic 11-366 Complete ASTM F2381-19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
07/06/2020 Orthopedic 11-364 Complete ISO 14243-1 Second edition 2009-11-15 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/15/2019 Orthopedic 11-351 Complete ISO 18192-1 Second edition 2011-03-01 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
06/07/2021 Orthopedic 11-383 Complete ASTM F3143-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
12/21/2020 Orthopedic 11-373 Complete ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
06/07/2021 Orthopedic 11-381 Complete ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
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
06/07/2021 Orthopedic 11-384 Complete ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
07/15/2019 Orthopedic 11-353 Complete ISO 18192-3 First edition 2017-06 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
12/21/2020 Orthopedic 11-371 Complete ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
12/21/2020 Orthopedic 11-372 Complete ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
06/07/2021 Orthopedic 11-379 Complete ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
06/07/2021 Orthopedic 11-380 Complete ASTM F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/21/2020 Orthopedic 11-370 Complete ISO 14879-1 Second edition 2020-07 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
06/07/2021 Orthopedic 11-382 Complete ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
07/06/2020 Orthopedic 11-363 Complete ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
06/07/2021 Orthopedic 11-376 Complete ASTM F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
12/19/2022 Orthopedic 11-394 Complete ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
12/20/2021 Orthopedic 11-389 Complete ISO 7206-10 Second edition 2018-08 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
12/18/2023 Orthopedic 11-403 Complete ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
07/15/2019 Orthopedic 11-354 Complete ASTM F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses
12/20/2021 Orthopedic 11-392 Complete ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
12/19/2022 Orthopedic 11-398 Complete ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
01/14/2019 Orthopedic 11-348 Partial ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - General requirements
12/21/2020 Orthopedic 11-330 Partial ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
01/14/2019 Orthopedic 11-184 Partial ISO 8827 First edition 1988-10-15 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
12/19/2022 Orthopedic 11-397 Complete ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/20/2021 Orthopedic 11-390 Complete ISO 23089-2 First edition 2021-05 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
07/15/2019 Orthopedic 11-358 Complete ISO 14242-4 First edition 2018-05 Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
09/17/2018 Orthopedic 11-185 Complete ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
12/21/2020 Orthopedic 11-374 Complete ISO 7207-2 Second edition 2011-07-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
07/15/2019 Orthopedic 11-350 Complete ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
12/21/2020 Orthopedic 11-375 Complete ASTM F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
07/15/2019 Orthopedic 11-356 Complete ISO 15142-2 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
12/21/2020 Ophthalmic 10-120 Complete ISO TR 22979 Second Edition 2017-05 Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
09/17/2018 Ophthalmic 10-57 Complete ANSI Z80.13-2007 (R2022) American National Standard for Ophthalmics - Phakic Intraocular Lenses
12/19/2007 Ophthalmic 10-39 Complete ISO 12865 Second edition 2006-07-01 Ophthalmic instruments - Retinoscopes
12/21/2020 Ophthalmic 10-119 Complete ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
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
07/15/2019 Ophthalmic 10-117 Complete ANSI Z80.37-2017 (R2021) American National Standard for Ophthalmics - Slit-Lamp Microscopes
12/21/2020 Ophthalmic 10-121 Complete ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
01/14/2019 Ophthalmic 10-114 Complete ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019 Ophthalmic 10-115 Complete ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
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
08/14/2015 Ophthalmic 10-97 Complete ISO 13212 Third edition 2014-09-01 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
04/04/2016 Ophthalmic 10-100 Complete ISO 18259 First Edition 2014-10-01 Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
09/17/2018 Ophthalmic 10-111 Complete ISO 11981 Third edition 2017-11 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
12/20/2021 Ophthalmic 10-130 Complete ANSI Z80.36-2021 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
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
03/16/2012 Ophthalmic 10-70 Complete ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes
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
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
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
08/21/2017 Ophthalmic 10-103 Complete ANSI Z80.18-2016 (R2021) American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
06/07/2018 Ophthalmic 10-105 Complete ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
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
 
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
 
-
-