1.1 本实践为腰椎保留运动的全关节面假体的功能、运动学和磨损测试提供了指导。这些植入物旨在允许运动，并通过替换自然关节面为功能性脊柱单元提供支持。 1.2 本规程无意解决骨-种植体界面或假体组件的静态特性。疲劳特性包括在内，但仅作为小平面载荷下循环磨损试验的副产品，因此在产生应力寿命的典型过程中未得到解决- N） 表征。 1.3 全关节面假体中所用材料的生物相容性在本实践中未涉及。 1.4 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。 1.4.1 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。 1.5 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。 1.6 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 全关节面假体组件- 整个小平面替换可以包括各种形状和配置。其形式可能包括但不限于:球窝关节、具有自由浮动或半浮动的关节- 受约束的第三体、金属承重表面以及弹簧和阻尼机构。此外，它可能具有单边或双边设计。 5.2 脊柱测试仪器: 5.2.1 试验室- 如果是多样本机器，应隔离每个试验室，以防止试样交叉污染。试验室应完全由耐腐蚀材料制成，如丙烯酸塑料或不锈钢，并应可从机器上拆除，以便在试验之间进行彻底清洁。 5.2.2 部件夹紧/固定- 由于试验的目的是表征全关节面假体的磨损和运动功能，因此在试验箱中安装部件的方法不得影响试验期间重量损失或刚度变化评估的准确性。 例如，可以专门制造具有用于接触骨骼的复杂上下表面（例如，烧结珠、羟基磷灰石（HA）涂层、等离子喷涂）的假体，以以不影响磨损模拟的方式修改该表面。 5.2.3 该装置应牢固地（牢固地）连接在骨植入物界面上，与配套测试夹具连接。 5.2.4 高级测试夹具的运动（在 无花果。1和 2. )相对于劣质测试夹具，应将其约束在三维空间中，但规定测试运动/负载方向上的组件除外。 图1 允许在前后定向小关节加载的情况下同时进行侧向弯曲和轴向旋转运动的可能测试装置图 注1: 这种设置需要两个旋转执行器和一个平移执行器。 图2 允许在前后定向小关节加载的情况下同时进行屈伸和侧向弯曲运动的可能测试装置图 注1: 这种设置需要两个旋转执行器和一个平移执行器。 5.2.5 负载和运动: 5.2.5.1 面荷载( f x )最初应用于正向 十、 -轴线。 5.2.5.2 屈曲载荷和运动是正力矩和绕轴旋转 Y -轴线。 5.2.5.3 拉伸载荷和运动是负力矩和绕 Y -轴线。 5.2.5.4 横向弯曲载荷和运动是正力矩和负力矩以及围绕 十、 -轴线。 5.2.5.5 轴向旋转载荷和运动是关于 Z -轴线。 5.2.6 频率- 试验频率应由本规程的用户确定和证明，在没有充分证明的情况下，试验频率不得超过2 Hz，以确保施加的运动（负载）轮廓保持在规定的公差范围内，并且不会显著影响关节面假体的总磨损和功能特性。 看见 X1.6 . 5.2.7 循环计数器- 一个完整的运动是从起始位置到运动范围（或负载控制时的负载）以及返回起始位置（负载）的整个范围。使用自动计数设备对周期进行计数。

1.1 This practice provides guidance for the functional, kinematic, and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets. 1.2 This practice is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating a Stress-Life (S-N) characterization. 1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4.1 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. 1.5 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. 1.6 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 Total Facet Prosthesis Components— The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to: ball-and-socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may have a unilateral or bilateral design. 5.2 Spinal Testing Apparatus: 5.2.1 Test Chambers— In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion-resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests. 5.2.2 Component Clamping/Fixturing— Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation. 5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures. 5.2.4 The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2 ) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads. FIG. 1 Diagrams of Possible Test Apparatus for Allowing Simultaneous Lateral Bending and Axial Rotation Motions with Anterior-Posterior Directed Facet Loading Note 1: This setup would require two rotational actuators and one translational actuator. FIG. 2 Diagrams of Possible Test Apparatus for Allowing Simultaneous Flexion-Extension and Lateral Bending Motions with Anterior-Posterior Directed Facet Loading Note 1: This setup would require two rotational actuators and one translational actuator. 5.2.5 Load and Motion: 5.2.5.1 Facet loads ( f x ) are initially applied in the direction of the positive X -axis. 5.2.5.2 Flexion load and motion are positive moment and rotation about the Y -axis. 5.2.5.3 Extension load and motion are negative moment and rotation about the Y -axis. 5.2.5.4 Lateral bend load and motion are positive and negative moments and rotations about the X -axis. 5.2.5.5 Axial rotation load and motion are positive and negative moments and rotations about the Z -axis. 5.2.6 Frequency— Test frequency shall be determined and justified by the user of this practice, and shall not exceed 2 Hz without adequate justification ensuring that the applied motion (load) profiles remain within specified tolerances and that the total facet prosthesis’s wear and functional characteristics are not significantly affected. See X1.6 . 5.2.7 Cycle Counter— One complete motion is the entire range from starting position through the range of motion (or load when in load control) and returning to the starting position (load). Cycles are to be counted using an automated counting device.