1.1 这些测试方法涵盖了在椎体切除模型中对枕颈和枕颈胸椎植入物组件进行静态和疲劳测试的材料和方法。枕颈和枕颈胸椎植入物组件的大多数组合的测试材料可能是特定的，这取决于预期的位置和预期的连接方法。 1.2 这些试验方法旨在为过去、现在和未来枕叶之间的机械比较提供基础- 颈椎和枕颈胸椎植入组件。他们可以比较枕颈和枕颈胸椎植入物的构造，以及应用于脊柱的不同方法。这些测试方法并不旨在定义性能水平，因为没有足够的知识来预测使用特定设备的后果。 1.3 这些试验方法规定了荷载类型和施加荷载方法的指南。枕关节比较评估的三种静载荷类型和两种疲劳试验方法- 定义了颈椎和枕颈胸椎植入组件。 1.4 这些测试方法建立了测量位移、确定屈服载荷和评估枕颈或枕颈胸椎植入物组件刚度和强度的指南。 1.5 在所有测试配置中，可能无法测试一些枕颈和一些枕颈胸椎结构。 1.6 以国际单位制表示的数值应视为标准值。 本标准不包括其他计量单位。 1.7 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。 1.8 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 枕颈和枕颈胸椎植入物通常由几个组件组成，当这些组件连接在一起时，形成枕颈胸椎植入物组件或枕颈胸椎植入物组件。枕颈和枕颈胸椎植入组件旨在关节融合过程中为脊柱提供一定的稳定性。这些测试方法概述了评估不同脊柱植入物组件的标准材料和方法，以便于不同设计之间的比较。 5.2 这些测试方法用于量化不同设计的枕颈和枕颈胸椎植入物组件的静态和动态机械特性。进行机械试验 体外 使用简化的载荷方案，不要试图模拟枕颈和枕颈胸椎的复杂载荷。 5.3 施加在脊柱植入物组件上的载荷 体内 通常，将不同于这些试验方法中使用的负载配置。 此处获得的结果不能直接用于预测 体内 表演结果可用于比较不同部件设计的相对机械参数。 5.4 在模拟体液或生理盐水中进行疲劳试验可能会导致微动、腐蚀或润滑互连，从而影响被测设备的相对性能。该测试最初应在干燥（室温条件）下进行，以确保一致性。环境的影响可能很大。 应考虑在模拟体液、盐水（每1000毫升水9克氯化钠）、盐水滴、水或润滑剂中重复所有或部分这些试验方法。此类循环测试的最大建议频率应为5 Hz。 5.5 纵向构件的位置由预期 体内 锚的位置。铰链销轴和锚附着点到聚缩醛块之间与荷载方向的垂直距离与锚无关- 颈部试块的类型，但取决于枕部试块的设计。聚缩醛块和纵向元件中心之间的距离是植入物设计的函数。

1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined. 1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies. 1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs in all test configurations. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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 Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs. 5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the occipital-cervical and occipital-cervical-thoracic spine. 5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters. 5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of the environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz. 5.5 The location of the longitudinal elements is determined by the intended in vivo location of the anchors. The perpendicular distance to the load direction between the axis of a hinge pin and the anchor's attachment points to a polyacetal block is independent of anchor-type for the cervical block, but dependent on the design for the occipital test block. The distance between the polyacetal block and the center of the longitudinal element is a function of the design of the implant.