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Hip joint prostheses
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Fatigue test ISO 7206-4, 6 and PI-58 (ISO 7206-8) Femoral head torsion test ISO 7206-13 Femoral head compression test PI-14 / ISO 7206-10 Femoral Head pull-off test ASTM F 2009 Luxation test PI-3 Hip surface analysis ISO 7206-2 Hip simulator test ISO 14242-1 Disassembly Forces of Modular Acetabular Devices ASTM F1820 Hip stem corrosion test ASTM F1875 Hip range of motion ISO 21535 Fatigue test ASTM F 2580 Impingement Test ASTM F2582 Insert fatigue test PI-11 Microseparation test PI-78 (ISO 14242-4) Third body wear test based on ISO 14242-1 High demand hip wear testing ASTM F3047M Deformation test for acetabular shells ISO 7206-12 3D Frictional torque measurement of total hip joint prostheses PI-64 Guide for assessment of hard-on-hard articulation THR devices ASTM F3018 Impact resistance femoral heads ISO 11491 FEA non-modular hip femoral stem ASTM F2996 Requirements for Femoral Prostheses – Metallic Implants ASTM F2068 Bearing surface characterization of retrieved hard-on-hard hip prostheses ASTM F2979 Specific requirements for hip-joint replacement implants ISO 21535 Particular requirements for joint replacement implants ISO 21534

Specific requirements for hip-joint replacement implants ISO 21535

Normative References  



ISO 21535: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint implants
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 – Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
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 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads
ISO 14630: Non-active surgical implants - General requirements
ISO 21534: Non-active surgical implants – Joint replacement implants – Particular requirements  


The normative standard provides specific requirements for hip joint replacement implants. Amongst others, test services evaluating the dimensional properties (such as UHMWPE insert thickness, range of motion analysis, articular surface roughness and sphericity) and physical properties (such as wear, femoral stem fatigue and pull-off characteristics of heads) are provided by EndoLab®.

This standard is currently under revision and will provide an updated summary of the tests needed for safety evaluation of hip implants. Additional performance criteria will be provided.

 

Implant Testing - Specific requirements for hip-joint replacement implants ISO 21535


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