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Specific requirements for knee-joint replacement implants ISO 21536

Normative References  



ISO 21536: Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint implants
ISO 7207-1: Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification, definitions and designation of dimensions
ISO 14243-1: Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
ISO 14243-2: Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement
ISO 14243-3: Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
ISO 14630: Non-active surgical implants – General requirements
ISO 14879-1: Implants for surgery – Total knee joint prostheses –Part 1: Determination of endurance properties of knee tibial trays
ISO 21534: non-active surgical implants – Joint replacement implants – Particular requirements  


ISO 21536 provides specific requirements for knee joint replacement implants. Amongst others, test services evaluating the dimensional properties (such as UHMWPE insert thickness, articular surface roughness, non-articular surface roughness) and physical properties (such as wear, tibial tray fatigue) are provided.

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

Implant Testing - Specific requirements for knee-joint replacement implants ISO 21536