1.1 本试验方法规定了非生物椎间体融合装置轴向压缩沉降试验的材料和方法，该装置是为促进给定脊柱运动节段的关节融合术而设计的脊柱植入物。 1.2 该试验方法旨在为过去、现在和未来的非生物椎间体融合器之间的机械比较提供基础。该测试方法旨在使用户能够机械地比较椎间体融合装置，并不旨在提供椎间体融合器的性能标准。 1.3 此测试方法通过指定负载类型和施加此负载的特定方法来描述静态测试方法。该试验方法旨在对椎间体融合器进行比较评估。 1.4 建立了测量试块变形和确定椎间体融合器沉降的指南。 1.5 由于一些椎间体融合器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。 1.6 单位-- 以国际单位制表示的值应被视为标准，但角度测量除外，角度测量可以用度或弧度报告。 1.7 本标准的使用可能涉及潜在危险设备的操作。 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 椎间融合器通常是简单的几何形状的装置，其性质往往是多孔或中空的。它们的功能是支撑脊柱的前柱，以促进运动节段的关节融合术。 5.2 该测试方法旨在量化不同设计的椎间体融合器的沉降特性，因为这是一种潜在的临床失败模式。进行这些测试 体外 以简化由椎间体融合装置引起的模拟椎体沉降的比较。 5.3 施加在椎间体融合器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，该测试方法的结果可能无法直接用于预测 体内 表演然而，对于给定密度的模拟骨骼，该结果可用于比较不同椎间体融合装置设计之间的不同沉降程度。 5.4 模拟椎体内的位置和椎间体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的建议。

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 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 method 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 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. 1.6 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. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 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 ====== 5.1 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. 5.2 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. 5.3 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. 5.4 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's recommendation for implant placement.