标准摘要
[中文适用范围]： 本文件规定了关节部件之间的相对角运动、施加力的模式、测试速度和持续时间、样品配置和测试环境，用于在带有负载或负载的磨损测试机中进行全踝关节假体的磨损测试。 位移控制。 注：本文件基于 ISO 14243-1 和 ISO 14243-3 描述的方法，并允许使用与全膝关节置换磨损测试相同的测试设备。 [外文原描述]： This document specifies the 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 ankle-joint prostheses in wear-testing machines with load or displacement control. NOTE This document is based on the method described by ISO 14243‑1 and ISO 14243‑3 and allows for the use of the same test equipment as for total knee replacement wear testing.
英文名称Implants for surgery — Wear of total ankle-joint prostheses — Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test