1.1这些试验方法涵盖了椎体切除模型中脊柱植入组件静态和疲劳试验的材料和方法。大多数脊柱植入物组件组合的测试材料可能是特定的，这取决于预期的脊柱位置和预期的脊柱应用方法。 1.2这些试验方法旨在为过去、现在和未来脊柱植入物组件之间的机械比较提供基础。它们允许比较不同预期脊柱位置和脊柱应用方法的脊柱植入结构。这些测试方法并不旨在定义性能水平，因为没有足够的知识来预测使用特定设备的后果。 1.3这些试验方法规定了荷载类型和施加荷载方法的指南。定义了三种静载荷类型和一种疲劳试验的方法，用于比较评估脊柱植入组件。 1.4这些试验方法建立了测量位移、确定屈服载荷和评估脊柱植入物组件刚度和强度的指南。 1.5某些脊柱结构可能无法在所有测试配置中进行测试。 1.6以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.7 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====== 脊柱植入物通常由几个组件组成，当这些组件连接在一起时，形成脊柱植入物组件。脊柱植入组件的设计目的是在进行关节融合术时为脊柱提供一些稳定性。这些试验方法概述了用于评估不同脊柱植入物组件的标准材料和方法，从而有助于不同设计之间的比较。 这些测试方法用于量化不同设计的脊柱植入组件的静态和动态机械特性。进行机械试验 体外 使用简化的荷载方案，不要试图模拟脊椎的复杂荷载。 施加在脊柱植入物组件上的载荷 体内 通常，将不同于这些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 表演结果可用于比较不同部件设计的相对机械参数。 在模拟体液或生理盐水中进行疲劳试验可能会导致微动、腐蚀或润滑互连，从而影响被测设备的相对性能。该测试最初应在干燥（室温条件）下进行，以确保一致性。环境的影响可能很大。应考虑在模拟体液、盐水（每1000毫升水9克氯化钠）、盐水滴、水或润滑剂中重复所有或部分这些试验方法。 此类循环测试的最大建议频率应为5 Hz。 纵向构件的位置取决于临床上锚固件紧靠骨结构的位置。铰链销轴与UHMWPE砌块锚固点之间与荷载方向（砌块力矩臂）的垂直距离与锚固类型无关。锚的附着点到UHMWPE块和纵向元件中心之间的距离是螺钉、钩、钢丝、电缆等与杆、板等之间接口设计的函数。

1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies. 1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly. 1.5 Some spinal constructs may not be testable in all test configurations. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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 ====== Spinal implants are generally composed of several components which, when connected together, form a spinal implant assembly. Spinal implant assemblies are designed to provide some stability to the spine while arthrodesis takes place. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies so that comparison between different designs may be facilitated. These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the spine. The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters. Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz. The location of the longitudinal elements is determined by where the anchors are clinically placed against bony structures. The perpendicular distance to the load direction (block moment arm) between the axis of a hinge pin and the anchor's attachment-points to a UHMWPE block is independent of anchor-type. The distance between the anchor's attachment point to the UHMWPE block and the center of the longitudinal element is a function of the interface design between the screw, hook, wire, cable, and so forth, and the rod, plate, and so forth.