1.1 本试验方法描述了评估单节段脊柱结构静态和动态特性的方法。 1.2 给出了使用失重法和量纲分析评估磨损的选项。本文所述的方法用于使用本标准中定义的测试介质分析拟用于运动保护的装置( 6.1 ). 1.3 本试验方法不旨在解决任何潜在的故障模式，因为它涉及将设备固定到其骨界面。 1.4 本试验方法的目的是在规定条件下进行试验时，在运动学、功能和磨损特性方面实现单节段椎间盘外脊柱结构。 1.5 本试验方法不适用于小关节置换装置。 1.6 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数据报告。 1.7 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。 1.8 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。 1.9 本标准包括多种试验方法。然而，必须注意的是，用户没有义务使用所有描述的方法进行测试。 相反，用户应该只选择适合特定设备设计的测试方法。在大多数情况下，只需要本文所述测试方法的一个子集。 1.10 以国际单位制表示的数值将被视为标准值，但角度测量除外，角度测量可以以度或弧度报告。本标准不包括其他计量单位。 1.11 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、健康和环境实践，并确定监管限制的适用性。 1.12 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 该测试方法旨在量化单节段脊柱结构不同设计的静态和动态特性。也可以使用测试介质评估允许运动的植入物的磨损（参见 6.1 )用于模拟37岁时的生理环境 °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。 4.2 本试验方法适用于单节段椎间盘外脊柱结构。 三种不同类型的固定装置用于测试单节段椎间盘外脊柱结构，见 图2 , 图4 和 图5 . 另请参见 表1 . 4.3 植入物可以使用多种材料（例如陶瓷、金属、聚合物或其组合）进行设计，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 describes methods to assess the static and dynamic properties of single level spinal constructs. 1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard ( 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 single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions. 1.5 This test method is not intended to address facet arthroplasty devices. 1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting. 1.7 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. 1.8 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. 1.9 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.10 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. No other units of measurement are included in this standard. 1.11 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. 1.12 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 ====== 4.1 This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion 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. 4.2 This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs See Fig. 2 , Fig. 4 , and Fig. 5 . See also Table 1 . 4.3 Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), 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.