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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®.