1.1本试验方法规定了非生物椎间体融合装置、旨在促进给定脊柱运动节段关节融合的脊柱植入物的轴向压缩沉降试验的材料和方法。 1.2本试验方法旨在为过去、现在和未来非生物椎间融合装置之间的机械比较提供基础。本试验方法允许比较不同预期脊柱位置和椎间盘间隙应用方法的椎间融合器。 本试验方法旨在使用户能够机械地比较椎间融合器，并不旨在提供椎间融合器的性能标准。 1.3本试验方法通过规定荷载类型和施加该荷载的特定方法来描述静态试验方法。本试验旨在对椎间融合器进行比较评估。 1.4制定了测量试块变形和确定椎间融合装置沉降的指南。 1.5 单位 -以国际单位制表示的值应视为标准值，但角度测量除外，角度测量可以用度或弧度表示。 1.6由于一些椎间融合装置需要使用额外的植入物来稳定，因此这些类型的植入物的测试可能不符合制造商的建议用途。 1.7 本标准的使用可能涉及潜在危险设备的操作。 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====== 椎间融合器通常是简单的几何形状器械，通常是多孔或中空的。其功能是支持脊柱前柱，以促进运动节段的关节融合。 该测试方法旨在量化不同设计的椎间融合器的沉降特性，因为这是一种潜在的临床故障模式。进行这些测试 体外 为了简化由椎间融合装置引起的模拟椎体沉降的比较。 施加在椎间融合装置和试块上的静态轴向压缩载荷与所见的复杂载荷不同 体内 因此，该试验方法的结果不能直接用于预测 体内 表演然而，结果可用于比较给定模拟骨密度的不同椎间融合器设计之间不同程度的沉降。 模拟椎体内的位置以及椎间融合装置相对于加载轴的位置将取决于植入物放置的设计和制造商建议。

1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method allows comparison of intervertebral body fusion devices with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices. 1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test is designed to allow for the comparative evaluation of intervertebral body fusion devices. 1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices. 1.5 Units —The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.6 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage. 1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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 ====== Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices. The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo , and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone. The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer’recommendation for implant placement.