ISO 14243-1 Load-Control Knee Wear Test and ISO 14243-3 Displacement-Control Knee Wear Test
Joint simulator wear testing evaluates the wear performance of TKR prosthesis design and bearing materials under physiological conditions for device optimization and to meet regulatory requirements. Up to 6 TKR implants can be assessed on OIC’s AMTI Knee Simulator. Samples complete 5 million cycles of testing under force-controlled (ISO 14243-1) or displacement-controlled (ISO 14243-3) kinematics. Wear is measured through gravimetric analysis following ISO 14243-2. Typical additions for this test are accelerated aging of polyethylene components (ASTM F2003), wear particle characterization (ASTM F1877), surface roughness characterization, and CMM measurement to evaluate dimensional changes resulting from the test. Adverse condition testing is also commonly performed to evaluate TKR device performance under non-ideal conditions such as increased load, high range of motion, and roughened or pre-damaged articular surfaces.