ISO 14243-5: Implants for surgery - Wear of total knee prostheses - Part5: Durability performance of the patellofemoral joint - Loading and displacement parameters for testing machines and corresponding environmental conditions for test
Loading and displacement waveforms, which simulate the patellofemoral kinetics and kinematics by combining a squatting sub-cycle with two walking gait sub-cycles, are performed until delamination, cracking, or another identified failure mode occurs.
If the implants do not demonstrate any failure modes by 50 thousand cycles, the test is stopped. At least five polymeric knee joint patellar components are tested. Prior to testing the patellar components are artificially aged according to ASTM F2003.
The EndoLab® knee joint simulator is used for testing. Please download our video to see the simulator moving.