标准摘要
[中文适用范围]： ISO 14243 的这一部分描述了一种测试方法，规定了关节部件之间的屈曲/伸展相对角运动、施加力的模式、测试速度和持续时间、用于全膝关节假体磨损测试的样品配置和测试环境在具有轴向负载控制、屈曲/伸展角运动控制、AP位移控制和胫骨旋转控制的磨损测试机中。 ISO 14243 这部分的运动学可能不适用于具有高度约束的膝关节设计，这可能会导致在测试的早期阶段对关节部件造成损坏，而这不能代表临床服务。 [外文原描述]： ISO 14243-3:2014 describes a test method that specifies flexion/extension relative angular 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 14243-3:2014 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.
英文名称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