Hip Joint Implants
Many advances have been made in the field of hip joint replacement devices over the last 50 years, allowing hundreds of thousands of patients to lead normal and active lives.The technical documentation for hip joint implants requires the verification of device characteristics on the basis of standardized test procedures. Orthotek can conduct these tests with high precesion for both modular and non-modular hip implant systems.
Wear, fatigue and impringement tests on hip joint implants
Test standard overview in the field of hip joint implant
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.
ASTM F3047M: Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations.
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.
ASTM F2580: Standard test method for evaluation of modular connection of proximally fixed femoral hip prosthesis.
Femoral Head Compresion/Tosion/Impact/Pull-off 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.
ISO 7206-13: Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
ISO
11491:Implants
for surgery - Determination of impact resistence of ceramic femoral heads for
hip joint prostheses.
ASTM F2345: Standard
test methods for determination of static and cyclic fatigue strength of ceramic
modular femoral heads.
ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
Femoral Head Compresion/Tosion/Impact/Pull-off 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.
ISO 7206-13: Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
ISO 11491:Implants for surgery - Determination of impact resistence of ceramic femoral heads for hip joint prostheses.
ASTM F2345: Standard test methods for determination of static and cyclic fatigue strength of ceramic modular femoral heads.
ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
Acetabular Device Test
ISO 7206-12: Implants for surgery- Partial and total hip joint prostheses-Part12:Deformation test method for acetabular shells.
ASTM F1820: Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices.
Hip Stem Corrosion Test
ASTM F1875: Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface.
Impingement Test
ASTM F2582: Standard test method for impingement of acetabular prostheses.
Range of Motion Test
ISO 21535:Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants.
Hip Joint Prostheses Requirements
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 F1814: Standard
Guide for Evaluating Modular Hip and Knee Joint Components.
ASTM F2033: Standard
Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing
Surfaces Made of Metallic, Ceramic, and Polymeric Materials.
ASTM F2068: Standard
Specification for Femoral Prostheses—Metallic Implants.
ASTM F2091: Standard
Specification for Acetabular Prostheses.
Other Sections
Test Service Testing Frame&Simulator Finite Element Analysis Scientific Research
Hip lmplants Bone Screw TorsionTester Worst Case Scientific Achievements
Knee lmplants Hip Joint Simulator Complicated Bone Biomechanics Orthotek Technical Journal
Other Joints lmplants Universal Joint Simulator Product Optimizatiom Cooperation Expert
Osteosynthesis Biomaterial Wear Frame Customized Simulation
Failure Analysis Customized Testing Devices