ISO 14243-3:2004 外科移植-膝关节假体磨损 第3部分:填充控制和相应试验环境条件磨损试验机械填充和取代参数

标准编号:ISO 14243-3:2004

中文名称:外科移植-膝关节假体磨损 第3部分:填充控制和相应试验环境条件磨损试验机械填充和取代参数

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

发布日期:2004-09

标准范围

ISO 14243-3:2004规定了在具有轴向载荷控制、弯曲/伸展角运动控制、AP位移控制和胫骨旋转控制的磨损试验机中,用于全膝关节假体磨损试验的关节部件之间的相对运动、作用力模式、试验速度和持续时间、样品配置和试验环境。ISO 14243-3:2004的运动学可能不适用于具有高度约束的膝关节设计,这可能会在试验的早期阶段导致不代表临床服务的关节部件损坏。

ISO 14243-3:2004 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 ISO 14243-3:2004 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.

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