1.1 本指南涵盖了一个程序，以帮助模块化关节置换植入物的开发人员选择适当的测试和评估，以确定装置的安全性。 1.2 本指南并不试图定义与模块化设备评估相关的所有测试方法。 1.3 本指南中的拆卸测试不包括有意的术中拆卸，但仅用于建议进行必要的测试，以确定意外拆卸负载。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的 ===意义和用途====== 4.1 本指南中建议的测试涵盖了关于模块化髋关节和模块化膝关节组件的许多不同但并非所有可能的研究和关注领域。 4.2 由于无限可能的模块化设计，本指南应作为设备安全测试的指南。在某些情况下，替代试验方法可能有用。研究者仍有责任解决各个模块化设计固有的所有安全问题。 4.3 本文建议的测试应以这样的方式使用，即结果反映模块化的影响（如果有的话）。 4.4 签入的测试 表1 , 表2 或 表3 或在本指南中作为可能考虑的测试指出，可能不适用于每种植入物设计。

1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety. 1.2 This guide does not attempt to define all test methods associated with modular device evaluation. 1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip and modular knee components. 4.2 Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs. 4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any. 4.4 Tests that are checked in Table 1 , Table 2 , or Table 3 or indicated in this guide as a possible test to consider may not be applicable to every implant design.