1.1本试验方法包括测量单轴静态和疲劳强度，以及脊柱关节融合术植入物组件互连机制的抗松动性。 1.2本试验方法的目的是提供一种机械表征脊柱植入物互连不同设计的方法。最终，各种组件和互连应结合起来进行脊柱植入结构的静态和疲劳测试。由于没有足够的知识来预测使用特定脊柱植入物设计的后果，本测试方法的目的不是解决脊柱植入物结构或子结构的分析，或定义脊柱植入物的性能水平。 1.3本试验方法规定了用于测量脊柱植入物组件互连强度的定义、可能的试验方法本身以及试验结果报告。 1.4以国际单位制表示的值应视为标准值，但角度测量除外，角度测量可按度或弧度报告。 1.5 本标准并非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制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 5.1脊柱植入物通常由几个组件组成，当连接在一起时，形成脊柱植入物结构。脊柱植入结构的设计目的是在关节融合时为脊柱提供一些稳定性。该测试方法概述了不同互连机制的标准化评估，以便于不同设计之间的比较。必须谨慎地进行比较并仔细分析，同时考虑到设计差异可能对负载配置产生的影响。 5.2本试验方法用于量化不同植入物互连设计的静态和疲劳性能。进行机械试验 体外 使用简化的单向荷载和力矩。在模拟体液或生理盐水中进行疲劳试验可能会对互连产生微动、腐蚀或润滑作用，从而影响被测设备的相对性能。因此，测试环境是否为模拟体液、生理盐水（9g NaCl/1000 mL H 2. O） 试验的一个重要特征是有盐滴或干燥，必须准确报告。 5.3脊柱植入结构的负荷 体内 通常情况下，将不同于本试验方法中使用的负载配置。此处获得的结果不能直接用于预测 体内 表演然而，结果可用于在相对机械参数方面比较不同的部件设计。

1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. 1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs. 1.3 This test method sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results. 1.4 The values stated in SI units are to be regarded as standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.5 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 5.1 Spinal implants are generally composed of several components that, when connected together, form a spinal implant construct. Spinal implant constructs are designed to provide some stability to the spine while arthrodesis takes place. This test method outlines standardized evaluations of different interconnection mechanisms to facilitate comparison between different designs. Comparisons must be made cautiously and with careful analysis, taking into account the effects that design differences can have on the loading configurations. 5.2 This test method is used to quantify the static and fatigue properties of different implant interconnection designs. The mechanical tests are conducted in vitro using simplified, unidirectional loads and moments. Fatigue testing in a simulated body fluid or saline may have a fretting, corrosive, or lubricating effect on the interconnection and thereby affect the relative performance of tested devices. Hence, the test environment, whether a simulated body fluid, saline (9g NaCl per 1000 mL H 2 O), with a saline drip, or dry, is an important characteristic of the test and must be reported accurately. 5.3 The loading of spinal implant constructs in vivo will, in general, differ from the loading configurations used in this test method. The results obtained here cannot be used directly to predict in vivo performance. However, the results can be used to compare different component designs in terms of relative mechanical parameters.