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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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12/23/2024 Orthopedic 11-413 Complete ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws
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 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 11-384 Complete ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
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
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
07/06/2020 Orthopedic 11-363 Complete ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
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
12/23/2024 Orthopedic 11-412 Complete ASTM F3129-24 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
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
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
06/07/2021 Orthopedic 11-382 Complete ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
12/23/2024 Orthopedic 11-411 Complete ASTM F1611-20 (Reapproved 2024) Standard Specification for Intramedullary Reamers
09/17/2018 Orthopedic 11-310 Complete ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers
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 Orthopedic 11-419 Complete ASTM F3690-24 Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance
12/23/2024 Orthopedic 11-410 Complete ASTM F3161-24 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
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
09/17/2018 Orthopedic 11-333 Complete ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
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 11-372 Complete ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
12/23/2024 Orthopedic 11-417 Complete ASTM F3090-24 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
12/23/2024 Orthopedic 11-415 Complete ASTM F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
12/23/2024 Orthopedic 11-416 Complete ASTM F2996-24 Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
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
12/23/2019 Orthopedic 11-360 Complete ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
12/22/2025 Orthopedic 11-437 Complete ASTM F2033-25 Standard Specification for Hip Joint Replacement Bearing Surfaces
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
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
12/22/2025 Orthopedic 11-424 Complete ASTM F983-24 Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
06/07/2021 Orthopedic 11-381 Complete ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
07/06/2020 Orthopedic 11-369 Complete ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
12/22/2025 Orthopedic 11-440 Complete ASTM F3738-25 Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles
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
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 11-355 Complete ISO 15142-1 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
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
08/06/2013 Orthopedic 11-252 Complete ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
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 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
12/22/2025 Orthopedic 11-438 Complete ASTM F2502-24 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/22/2025 Orthopedic 11-436 Complete ISO 7207-2 Third edition 2025-08 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
12/19/2022 Orthopedic 11-398 Complete ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
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
06/27/2016 Orthopedic 11-307 Complete ASTM F2385-15 (Reapproved 2024) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
12/18/2023 Orthopedic 11-403 Complete ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
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
12/19/2022 Orthopedic 11-397 Complete ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/22/2025 Orthopedic 11-439 Complete ASTM F3437-23 Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
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
12/22/2025 Orthopedic 11-426 Complete ASTM F2943-25 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
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
12/22/2025 Orthopedic 11-425 Complete ASTM F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
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)]
12/22/2025 Orthopedic 11-431 Complete ASTM F384-24 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-326 Complete ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018 Orthopedic 11-322 Complete ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
12/19/2022 Orthopedic 11-394 Complete ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular 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
01/14/2019 Orthopedic 11-344 Complete ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
05/26/2025 Orthopedic 11-420 Complete ASTM F2580-24 Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
12/22/2025 Orthopedic 11-432 Complete ASTM F2180-24 Standard Specification for Metallic Implantable Strands and Cables
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
12/20/2021 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)]
12/22/2025 Orthopedic 11-429 Complete ASTM F366-24 Standard Specification for Fixation Pins and Wires
09/17/2018 Orthopedic 11-324 Complete ASTM F366-17 Standard Specification for Fixation Pins and Wires
12/20/2021 Orthopedic 11-388 Complete ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
08/21/2017 Orthopedic 11-269 Complete ASTM F2423-11 (Reapproved 2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
09/17/2018 Orthopedic 11-329 Complete ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
12/23/2016 Orthopedic 11-316 Complete ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/22/2025 Orthopedic 11-428 Complete ASTM F1541-24 Standard Specification and Test Methods for External Skeletal Fixation Devices
12/20/2021 Orthopedic 11-391 Complete ASTM F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
01/14/2019 Orthopedic 11-342 Complete ASTM F732-17 (Reapproved 2025) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
12/20/2021 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
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
05/26/2025 Orthopedic 11-421 Complete ASTM F2077-24 Standard Test Methods for Intervertebral Body Fusion Devices
01/14/2019 Orthopedic 11-347 Complete ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices
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)]
01/14/2019 Orthopedic 11-343 Complete ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
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
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 11-199 Complete ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
07/15/2019 Orthopedic 11-354 Complete ASTM F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses
12/22/2025 Orthopedic 11-427 Complete ASTM F1264-24 Standard Specification and Test Methods for Intramedullary Fixation Devices
04/04/2016 Orthopedic 11-247 Complete ASTM F2789-10 (Reapproved 2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
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
12/22/2025 Orthopedic 11-430 Complete ASTM F564-24 Standard Specification and Test Methods for Metallic Bone Staples
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
12/18/2023 Orthopedic 11-404 Complete ASTM F2887-23 Standard Specification for Total Elbow Prostheses
12/18/2023 Orthopedic 11-405 Complete ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
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
07/06/2020 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
12/18/2023 Orthopedic 11-406 Complete ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
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
 
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