ISO 14879-1:2020 外科植入物 全膝盖关节假体 第1部分：膝胫骨托耐久性的测定

标准编号：ISO 14879-1:2020

中文名称：外科植入物 全膝盖关节假体 第1部分：膝胫骨托耐久性的测定

英文名称：Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays

发布日期：2020-07

标准范围

本文件规定了一种试验方法，用于在规定的实验室条件下，测定膝关节假体中用于支撑和固定塑料关节表面的胫骨托盘的耐久性。它适用于覆盖胫骨内侧和外侧平台的胫骨托盘。本试验方法不适用于仅由塑料材料制成的胫骨部件。本文件不包括检查和报告试样最终状态的方法；这些可以是测试实验室和提交样本进行测试的各方之间达成协议的主题。注:试验结果与体内性能的相关性尚未确定。

This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia.The test method does not apply to tibial components manufactured solely from plastic materials.This document does not cover methods of examining and reporting the final condition of the test specimen; these can be the subject of agreement between the test laboratory and the parties submitting the specimen for test.NOTE Correlation of test results with in vivo performance has not been established.

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