1.1本试验方法旨在为椎间盘外运动保护植入物的静态、动态和磨损试验提供试验方法。这些植入物旨在增强脊柱稳定性，而无需去除大量组织，同时允许功能性脊柱单元运动。 1.2使用本试验方法（6.1）中定义的试验介质，使用失重法和尺寸分析来评估磨损，以确定椎间盘外脊柱运动保持程序中使用的部件的磨损。 1.3本试验方法不旨在解决任何潜在的故障模式，因为它与装置固定到其骨界面有关。 1.4本试验方法的目的是在规定条件下进行试验时，就运动学、功能和磨损特性对保留运动的椎间盘外植入物进行比较。 然而，必须认识到，在 体内 条件具有固定参数集的单个实验室模拟可能不具有普遍代表性。 1.5本试验方法不适用于小关节置换装置。 1.6本试验方法规定了使用纯角度旋转来评估保留盘状运动的植入物的机械特性。然而，本试验方法并未规定评估装置在平移过程中的机械特性的方法（例如，前后平移），尽管这种线性运动可能与临床相关。 1.7为了使数据在实验室内和实验室之间具有可复制性和可比性，必须建立统一的程序。本试验方法旨在促进统一的试验方法和额外的数据报告- 保留椎间盘运动的植入物。 1.8在编写本试验方法时，如果没有脊柱、保留运动的椎间盘外植入物的实质性临床检索历史，则无法描绘实际的负荷曲线和模式。因此，本试验方法规定的运动轮廓不一定准确再现发生的运动轮廓 体内 . 相反，该方法为以功能性方式评估植入物设计提供了有用的边界/端点条件。 1.9本试验方法并非性能标准。本测试方法的用户有责任确定被评估设备的安全性和有效性。 1.10以国际单位制表示的数值应视为标准。括号中给出的值仅供参考。 1.11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。 1.12 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====== 该测试方法旨在使用测试介质（见6.1）模拟37℃下的生理环境，量化不同设计的椎间盘外运动保护植入物的静态、动态和磨损特性 ° C、 除尺寸分析外，还使用失重法评估磨损。将植入物置于本试验方法中规定的动态剖面后，确定重量损失。 该信息将使产品制造商或最终用户能够了解特定装置在本试验方法规定的试验条件下的性能。 本试验方法旨在适用于保留椎间盘运动的额外植入物。这些植入物增强了相邻椎体之间的运动/承重特性，从而通过关节或使用顺应性材料完全或部分支持和传输运动。植入物设计中使用陶瓷、金属或聚合物或其组合，本试验方法的目标是能够比较这些设备产生的静态、动态和磨损性能，而不管设备的材料和类型如何。

1.1 This test method is intended to provide test methods for the static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s). 1.2 Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method (6.1). 1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces. 1.4 It is the intent of this test method to enable comparison of motion preserving, extra-discal implants with regard to kinematic, functional, and wear characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single laboratory simulation with a fixed set of parameters may not be universally representative. 1.5 This test method is not intended to address facet arthroplasty devices. 1.6 This test method prescribes the use of pure angular rotations for assessing the mechanical characteristics of extra-discal motion preserving implants. This test method does not, however, prescribe methods for assessing the mechanical characteristics of the device in translation (for example, anterior/posterior translation), though this type of linear motion may be clinically relevant. 1.7 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures are established. This test method is intended to facilitate uniform testing methods and data reporting for extra-discal motion preserving implants. 1.8 Without a substantial clinical retrieval history of spinal, motion preserving extra-discal implants, actual loading profiles and patterns cannot be delineated at the time of the writing of this test method. It therefore follows that the motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo . Rather this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner. 1.9 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to characterize the safety and effectiveness of the device under evaluation. 1.10 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.11 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians. 1.12 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 ====== This test method is designed to quantify the static, dynamic, and wear characteristics of different designs of extra-discal motion preserving implants using testing medium (see 6.1) for simulating the physiologic environment at 37 ° C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method. This test method is intended to be applicable for extra-discal motion preserving implants. These implants augment the motion/load bearing characteristics between adjacent vertebral bodies, and thereby fully or partially support and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combinations thereof are used in implant design, and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.