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.



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               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


                Spinal Implants                              Static Frame


                Dental lmplants                              Fatigue Frame


                Failure Analysis                             Customized Testing Devices


                Instruments


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