【国外标准】 Standard Guide for Evaluating Modular Hip and Knee Joint Components

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.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.