ISO 14243-3 Implants for Surgery-Total Wear of Knee Joint Prostheses-Displacement Controlled Abrasion Test Machines for Loading and Displacement Parameters and Relevant Environmental Conditions for Testing

ISO 14243-3 describes a test method that specifies the angular motion relative to the flex/elongation between jointed components, the pattern of applied force, the speed and duration of the test, the specimen configuration to be used for the total knee abrasion test, and the test environment.

The kinematics of this part of ISO 14243-3 may not apply to highly constrained knee designs, resulting in damage to joint components in the early stages of testing that may not be representative of clinical service.

The total knee joint prosthesis is mounted in an apparatus that applies cyclic variations of flexion/extension angle, tibial rotation angle, AP displacement, and axial force to the interface between the tibial and femoral components, simulating normal human gait. The tibial component moves relative to the femoral component under the applied flexion/extension role, AP displacement, and axial forces. The applied contact force/displacement actions are axial force, flexion/extension rotation, AP displacement, and tibial rotation. All applied force/displacement actions follow a certain cyclic variation with a fixed relationship between the phases of the actions.

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