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Anforderungen an Implantate für den Hüftgelenkersatz ISO 21535

Aktuelle Prüfverfahren  



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 215354: Non-active surgical implants – Joint replacement implants – Particular requirements
 


ISO 21535 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, sphericity) and physical properties (such as wear, femoral stem fatigue, pull-off characteristics of heads) are provided.

EndoLab® and its partner laboratories will provide a full test series according to this test standard.  

Implant Testing - Anforderungen an Implantate für den Hüftgelenkersatz ISO 21535