ASTM F2722: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops.
Fatigue Test Baseplate/Bearing Fixation
ASTM F2723: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation.
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Fatigue Test
ISO 7206-4: Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of endurance properties of stemmed femoral components.
ISO 7206-6: Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components.
ISO 7206-8: Implants for surgery -- Partial and total hip joint prostheses -- Part 8: Endurance performance of stemmed femoral components with application of torsion.
Many advances have been made in the area of hip replacement devices over the last 50 years, allowing hundreds of thousands of patients to lead normal, active lives. As technology continues to improve, mechanical validation testing remains a critical component to successful product development and improvements.
Orthotek provides mechanical testing for both modular and non-modular hip implant systems. Wear, fatigue, static, and corrosion testing are just a few of the hip replacement testing services we offer.
Femoral Head Test
ISO 7206-9: Implants for surgery - Partial and total hip joint prostheses - Part 9: Determination of resistance to torque of head fixation of stemmed femoral components.
ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads.
ASTM F 2345: Standard test methods for determination of static and cyclic fatigue strength of ceramic modular femoral heads.
Ball Pull-off Test
ASTM F 2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
Hip Geometry
ISO 7206-1: Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions.
ISO 7206-2: Implants for surgery - Partial and total hip joint prostheses: Articulating surfaces made of metallic, ceramic and plastic materials.
ASTM F 1814: Standard Guide for Evaluating Modular Hip and Knee Joint Components.
ASTM F 2033: Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials.
ASTM F 2068: Standard Specification for Femoral Prostheses—Metallic Implants.
ASTM F 2091: Standard Specification for Acetabular Prostheses.
Hip Wear Test
ISO 14242-1: Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests.
ISO 14242-2: Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement.
Insert push-in/out Test
ASTM F 1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device.
Hip Stem Corrosion Test
ASTM F 1875: Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface.
Hip Range of Motion
ISO 21535:
Fatigue Test
ASTM F 2580: Standard test method for evaluation of modular connection of proximally fixed femoral hip prosthesis.
Impingement Test
ASTM F 2582: Standard test method for impingement of acetabular prostheses.
Hip Joint Wear Test
ISO 14242-1: Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests.
ISO 14242-2: Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement.
ISO 14242-3: 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.
Knee Constraint Test
ASTM F 1223: Standard Test Method for Determination of Total Knee Replacement Constraint.
Dislocation Mobile Bearing Test
ASTM F 2724: Standard Test Method for Evaluating Mobile Bearing Knee Dislocation.
ISO 14879: Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays.
ISO 21536: Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants.
ASTM F 1800: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F 2083: Standard Specification for Total Knee Prosthesis
Since the first knee replacement nearly 50 years ago, continuous improvements in design and surgical techniques have led to numerous breakthroughs in technology. Verification testing of these new designs and materials remains as critical as ever to ensuring patient safety throughout the life of the device.
Orthotek offers both total and partial knee replacement testing services. Common tests include fatigue, wear, contact pressure, constraint, and corrosion testing, along with porous coating evaluation and explant failure analysis.
Petella Specification
ASTM F 1672: Standard Specification for Resurfacing Patellar Prosthesis.
Knee Geometry and surfaces
ISO 7207-1: Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions.
ISO 7207-2: Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastic materials.
ISO 21536: Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants.
Knee Wear Test
ISO 14243-1: 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 tests.
ISO 14243-2: Implants for surgery -- Wear of total knee joint prostheses Part 2: Methods of measurement.
ISO 14243-3: 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.
Fatigue Test Under High Flexion
ASTM F2777: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion.
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