BS ISO 14243-3-2004 外科植入物.全部膝关节假肢的磨损.带位移控制和相关试验环境条件的磨损试验机械的负载和位移参数
Implants for surgery - Wear of total knee-joint prostheses - Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
This part of ISO 14243 specifies relative movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control. The kinematics of this part of ISO 14243 may not be applicable to knee designs with a high degree of constraint, which could result in damage to the articulating components in the early stages of the test that would not be representative of clinical service.