EndoLab - Implant Testing Services Implant Testing

Hip implants
all procedures accredited

Fatigue Test - ISO 7206-4, ISO 7206-6 and PI-58 (ISO 7206-8)Fatigue Test - ISO 7206-4, ISO 7206-6 and PI-58 (ISO 7206-8) Femoral head torsion test - ISO 7206-13Femoral head torsion test - ISO 7206-13 Femoral Head Compression Test - ISO 7206-10/ ASTM F2345/ PI-14Femoral Head Compression Test - ISO 7206-10/ ASTM F2345/ PI-14 Femoral Head pull-off test - ASTM F 2009Femoral Head pull-off test - ASTM F 2009 Luxation test - PI-3Luxation test - PI-3 Hip surface analysis - ISO 7206-2Hip surface analysis - ISO 7206-2 Hip Wear Test - ISO 14242-1Hip Wear Test - ISO 14242-1 Disassembly Forces of Modular Acetabular Devices - ASTM F1820Disassembly Forces of Modular Acetabular Devices - ASTM F1820 Fretting Corrosion Testing of Modular Implants – Femoral Stem-Head Interface - ASTM F1875Fretting Corrosion Testing of Modular Implants – Femoral Stem-Head Interface - ASTM F1875 Hip Range of Motion – ISO 21535Hip Range of Motion – ISO 21535 Fatigue test - ASTM F 2580Fatigue test - ASTM F 2580 Impingement Test - ASTM F2582Impingement Test - ASTM F2582 Insert Compression Test - PI-11Insert Compression Test - PI-11 Microseparation test - PI-78 (ISO 14242-4)Microseparation test - PI-78 (ISO 14242-4) Third body wear test based on - ISO 14242-1Third body wear test based on - ISO 14242-1 High demand hip wear testing - ASTM F3047MHigh demand hip wear testing - ASTM F3047M Deformation test for acetabular shells - ISO 7206-12Deformation test for acetabular shells - ISO 7206-12 3D Frictional torque measurement of total hip joint prostheses - PI-643D Frictional torque measurement of total hip joint prostheses - PI-64 Guide for assessment of hard-on-hard articulation THR devices - ASTM F3018Guide for assessment of hard-on-hard articulation THR devices - ASTM F3018 Impact Resistance Femoral Heads - ISO 11491Impact Resistance Femoral Heads - ISO 11491 FEA Non-modular Hip Femoral Stem - ASTM F2996FEA Non-modular Hip Femoral Stem - ASTM F2996 Requirements for Femoral Prostheses - Metallic Implants - ASTM F2068Requirements for Femoral Prostheses - Metallic Implants - ASTM F2068 Bearing surface characterization of retrieved hard-on-hard hip prostheses - ...Bearing surface characterization of retrieved hard-on-hard hip prostheses - ASTM F2979 Specific Requirements for Hip-joint Replacement Implants - ISO 21535Specific Requirements for Hip-joint Replacement Implants - ISO 21535 Particular requirements for joint replacement implants - ISO 21534Particular requirements for joint replacement implants - ISO 21534 Fatigue Test of Acetabular Devices - ASTM F3090Fatigue Test of Acetabular Devices - ASTM F3090 Classification and Designation of Dimensions - ISO 7206-1Classification and Designation of Dimensions - ISO 7206-1

Hip Wear Test - ISO 14242-1

Normative References  



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
 


The hip joint simulator developed and built at EndoLab® can test 2x3 specimens simultaneously (plus two soak controls). The specimens are oriented in an anatomically correct position, and the resulting hip joint force is applied via the cup. Consequently, the direction of the force vector is constant relative to the cup and moves relative to the head. All three in-vivo angular displacements are simulated: flexion/extension, abduction/adduction and internal/external rotation.
You can see the simulator moving in this short video.

The specimens are assembled under laminar flow conditions and sealed in capsulated single test chambers to prevent contamination. The test fluid's temperature and fluid level are controlled continuously throughout testing. The wear of the components is determined gravimetrically. If requested, an analysis of the wear debris according to ISO 17853 can be conducted.  


Parameters



Parameters ISO 14242
force curve double-peak according to PAUL
force is fixed relative to cup
force maximum 3.0 kN
frequency 1.0 Hz
cup inclination „L“ according to ISO 14242 -1 30° (corresponds to an in-vivo inclination of 45°)
inclination cup-ball
flexion-extension +25/-18°
abduction-adduction +7/-4°
rotation +2/-11°
test fluid calf serum
temperature 37°C
cycles 5 million
inspection cycles 0.5 million, 1 million, 2 million etc.
 
Implant Testing - Hip Wear Test - ISO 14242-1