1.1 这些测试方法规定了人工椎间盘静态和动态测试的材料和方法。 1.2 这些测试方法旨在为过去、现在和未来的非生物人工椎间盘之间的力学比较提供基础。这些测试方法允许比较具有不同预期脊柱位置（颈椎、胸椎和腰椎）的人工椎间盘以及应用于椎间隙的方法。这些测试方法旨在使用户能够对人工椎间盘进行机械比较，而不是提供人工椎间盘的性能标准。 1.3 这些测试方法通过指定负载类型和施加这些负载的具体方法来描述静态和动态测试。这些测试旨在对人工椎间盘进行比较评估。 1.4 这些测试方法并非旨在解决人工椎间盘的所有临床相关故障模式，其中一些故障模式是特定于设备的。例如，这些测试方法没有解决预期条件下植入物的抗脱落性或植入物耐磨性 体内 荷载和运动。此外，这些试验方法中未涉及对磨损碎屑的生物反应。 1.5 建立了测量位移、确定屈服载荷或力矩以及评估人工椎间盘刚度的要求。 1.6 有些人工椎间盘可能无法在所有测试配置中进行测试。 1.7 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，角度测量可以用度或弧度表示。 1.8 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。 1.9 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====== 5.1 人工椎间盘是替代退化的天然椎间盘的骨科植入物。它们的功能是支持脊柱的前柱，同时允许在手术水平上运动。这些试验方法概述了表征不同人工椎间盘机械性能的材料和方法，以便在不同设计之间进行比较。 5.2 这些测试方法旨在量化不同设计的人工椎间盘的静态和动态特性。进行这些测试 体外 为了分析单个椎间盘置换装置，并在标准模型中比较多个人工椎间盘设计的机械性能。 5.3 施加在人工椎间盘上的载荷可能不同于所见的复杂载荷 体内 因此，这些测试的结果可能无法直接预测 体内 表演然而，研究结果可用于比较不同人工椎间盘的力学性能。 5.4 疲劳试验应在0.9℃下进行 % 37°C下的盐水环境浴，速率为2 Hz或更低。也可以使用其他测试环境，如模拟体液、盐水滴或雾、蒸馏水或其他类型的润滑，并提供充分的理由。 同样，可在充分证明的情况下使用替代试验频率。 5.5 众所周知，材料的失效取决于应力、试验频率、表面处理和环境因素。因此，在确定更改其中一个参数（例如，频率、材料或环境）的影响时，所有其他参数应保持不变，以便于解释结果。特别是，在保持测试环境、植入物材料和加工以及植入物几何形状恒定的情况下，可能需要评估测试频率对器件断裂的影响。

1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs. 1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of artificial intervertebral discs. 1.4 These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods. 1.5 Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs. 1.6 Some artificial intervertebral discs may not be testable in all test configurations. 1.7 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. 1.8 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. 1.9 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 Artificial intervertebral discs are orthopaedic implants that replace degenerated natural intervertebral discs. Their function is to support the anterior column of the spine while allowing motion at the operated level. These test methods outline materials and methods for the characterization of the mechanical performance of different artificial intervertebral discs so that comparisons can be made between different designs. 5.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of artificial intervertebral discs. These tests are conducted in vitro in order to allow for analysis of individual disc replacement devices and comparison of the mechanical performance of multiple artificial intervertebral disc designs in a standard model. 5.3 The loads applied to the artificial intervertebral discs may differ from the complex loading seen in vivo , and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different artificial intervertebral discs. 5.4 Fatigue tests should be conducted in a 0.9 % saline environmental bath at 37°C at a rate of 2 Hz or less. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification. 5.5 It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing one of these parameters (for example, frequency, material, or environment), all others should be kept constant to facilitate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on device fracture while holding the test environment, implant materials and processing, and implant geometry constant.