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  

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

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