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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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)]
07/15/2019 Orthopedic 11-352 Complete ISO 14242-1 Third edition 2014-10-15 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
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
07/15/2019 Orthopedic 11-354 Complete ASTM F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses
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
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
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
12/23/2019 Orthopedic 11-360 Complete ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
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
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
07/06/2020 Orthopedic 11-363 Complete ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
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)]
07/06/2020 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 11-367 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
07/06/2020 Orthopedic 11-369 Complete ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
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
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
12/21/2020 Orthopedic 11-373 Complete ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
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)]
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
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
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
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 (Reapproved 2025) 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 11-381 Complete ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
06/07/2021 Orthopedic 11-382 Complete ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
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
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
12/20/2021 Orthopedic 11-385 Complete ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
12/20/2021 Orthopedic 11-386 Complete ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
12/20/2021 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
12/20/2021 Orthopedic 11-388 Complete ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
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)]
12/20/2021 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
12/20/2021 Orthopedic 11-391 Complete ASTM F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
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 11-393 Complete ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
12/19/2022 Orthopedic 11-394 Complete ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
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)]
12/19/2022 Orthopedic 11-397 Complete ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/19/2022 Orthopedic 11-398 Complete ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
05/29/2023 Orthopedic 11-399 Complete ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants
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
09/11/2023 Orthopedic 11-401 Complete ISO 21535 Third edition 2023-07 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
12/18/2023 Orthopedic 11-402 Complete ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
12/18/2023 Orthopedic 11-403 Complete ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
12/18/2023 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
12/18/2023 Orthopedic 11-406 Complete ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
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
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
12/18/2023 Orthopedic 11-409 Complete ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
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
12/23/2024 Orthopedic 11-411 Complete ASTM F1611-20 (Reapproved 2024) Standard Specification for Intramedullary Reamers
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
12/23/2024 Orthopedic 11-413 Complete ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws
12/23/2024 Orthopedic 11-414 Complete ASTM F382-24 Standard Specification and Test Method for Metallic Bone Plates
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
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 11-418 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
05/26/2025 Orthopedic 11-420 Complete ASTM F2580-24 Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
05/26/2025 Orthopedic 11-421 Complete ASTM F2077-24 Standard Test Methods for Intervertebral Body Fusion Devices
05/26/2025 Orthopedic 11-422 Complete ASTM F1798-24 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
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
12/22/2025 Orthopedic 11-424 Complete ASTM F983-24 Standard Practice for Permanent Marking of Orthopaedic Implant Components
12/22/2025 Orthopedic 11-425 Complete ASTM F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
12/22/2025 Orthopedic 11-426 Complete ASTM F2943-25 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
12/22/2025 Orthopedic 11-427 Complete ASTM F1264-24 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
12/22/2025 Orthopedic 11-429 Complete ASTM F366-24 Standard Specification for Fixation Pins and Wires
12/22/2025 Orthopedic 11-430 Complete ASTM F564-24 Standard Specification and Test Methods for Metallic Bone Staples
12/22/2025 Orthopedic 11-431 Complete ASTM F384-24 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
12/22/2025 Orthopedic 11-432 Complete ASTM F2180-24 Standard Specification for Metallic Implantable Strands and Cables
12/22/2025 Orthopedic 11-433 Partial ASTM F2028-25a Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
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 11-435 Complete ASTM F3292-25 Standard Practice for Inspection of Spinal Implants Undergoing Testing
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
12/22/2025 Orthopedic 11-437 Complete ASTM F2033-25 Standard Specification for Hip Joint Replacement Bearing Surfaces
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 11-439 Complete ASTM F3437-23 Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
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
05/25/2026 Orthopedic 11-441 Complete ASTM F2789-25 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
05/25/2026 Orthopedic 11-442 Complete ISO 7206-12 Second edition 2025-11 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for press-fit acetabular components
05/25/2026 Orthopedic 11-443 Complete ASTM F2706-25 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
05/25/2026 Orthopedic 11-444 Complete ISO 18192-3 Second edition 2025-11 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses
05/25/2026 Orthopedic 11-445 Complete ASTM F2009-25 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
05/25/2026 Orthopedic 11-446 Complete ASTM F3574-25 Standard Test Methods for Sacroiliac Joint Fusion Devices
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/14/2019 Radiology 12-102 Complete ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
03/16/2012 Radiology 12-105 Complete NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
03/16/2012 Radiology 12-106 Complete ISO 17526 First edition 2003-06-15 Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
03/16/2012 Radiology 12-115 Complete ISO 13695:2004 Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
 
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