1.1 本标准旨在为用于骨折固定的小型骨金属板的静态测试提供指南。本标准中提到的小骨板将用于远端的最小承载解剖区域，如手指和脚趾，以及颅骨和上表面。下面部/下颌骨、手腕和脚踝固定板通常会更大，并承受大量负荷，不应根据本标准进行评估。 1.2 ASTM规范 功能382 和ISO 9585目前也可用于金属接骨板的测试，因此用户可以选择将这些标准中的任何测试用于小型接骨板。 然而，由于板材尺寸、规格 功能382 并且ISO 9585测试设置和执行难度可以增加用于小骨板的难度。因此，本标准提供了更适合用于小型骨折固定的金属接骨板的替代测试方法。 1.3 本标准并非旨在解决镀层结构或附属部件（例如螺钉和电线）的机械性能问题。 1.4 本标准旨在为小型接骨板的机械比较提供依据。由于在使用这些钢板的身体部位发现了复杂而多变的生物力学，本标准仅用于比较 体外 小型接骨板的机械性能，不用于推断 体内 性能特征。 1.5 本标准通过规定载荷类型和施加这些载荷的具体方法来描述静态试验。评估和表征这些载荷的试验包括:静态扭转、静态悬臂梁弯曲、静态横向弯曲和静态三点弯曲。 1.6 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.7 本标准引用了多项试验。 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。 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）。本标准的使用者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》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 4.1 由于小骨折的种类繁多，用于固定这些骨折的钢板有多种形状和配置。 表1 对每个解剖区域的钢板类型进行分类。平板是最简单的；看见 图2 例如基本平板。许多其他钢板具有适应特定解剖结构的特征，如髁突、复杂（如楔形）、预成型（如跖趾关节（MPJ））、台阶、眼眶、正颌台阶和楔形钢板。 其他钢板，如网格板和毛刺孔板，通常是平的，但设计用于特定的解剖区域，因此它们的设计与传统的直板不同。如果使用一种板材的试验数据证明另一种板材具有机械财产，则应在最终报告中说明这种证明。 4.2 本文所述的大多数测试都集中在“功能单元”上，可以将其描述为由骨折两侧各有一个螺孔的钢板跨越的单线骨折。 如果支柱几何形状是最坏情况的决定因素，则这种配置允许最简单地确定最坏情况下的尺寸。如果最坏情况下的尺寸无法与功能单元/支柱几何结构隔离，可能是由于不规则的螺孔模式或板的形状，可以理解的是，需要修改一些测试，或者可能从测试考虑中删除，以适应板或螺孔的形状。任何测试修改或遗漏应在最终报告中进行描述，并说明与钢板解剖用途、适应症和功能要求相关的基本原理。

1.1 This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load-bearing anatomical areas of the far extremities, such as the fingers and toes, and in the cranium and upper face. Lower face/mandible, wrist, and ankle fixation plates would generally be larger and carry a substantial amount of load and should not be evaluated under this standard. 1.2 ASTM Specification F382 and ISO 9585 are currently available for the testing of metallic bone plates as well, so the user can choose to use any of the tests in these standards for small bone plates. However, due to plate size, Specification F382 and ISO 9585 test setup and execution difficulty can be increased for small bone plates. Thus, this standard offers alternative test methods that are more appropriate for metallic bone plates used in small bone fracture fixation. 1.3 This standard is not intended to address the mechanical performance of the plating construct or accessory components (for example, screws and wires). 1.4 This standard is intended to provide a basis for the mechanical comparison of small bone plates. Due to the complex and varying biomechanics found in the areas of the body where these plates are used, this standard should only be used to compare the in vitro mechanical performance of small bone plates and not used to infer in vivo performance characteristics. 1.5 This standard describes static tests by specifying load types and specific methods of applying these loads. Tests for evaluating and characterizing these loads include the following: static torsion, static cantilever beam bending, static lateral bending, and static three-point bending. 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 Multiple tests are cited 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. 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 ====== 4.1 Due to the variety of small bone fractures, plates used for the fixation of these fractures come in a variety of shapes and configurations. Table 1 categorizes the plate types for each anatomical area. Flat plates are the simplest; see Fig. 2 for an example of a basic flat plate. Many other plates have features to accommodate specific anatomies, such as condylar, complex (such as cuneiform), pre-contoured (such as metatarsophalangeal joint (MPJ)), step, orbital, orthognathic step, and wedge plates. Other plates, such as mesh-based and burr hole plates, are generally flat but are designed to be used in specific anatomical regions, so their designs are not the same as conventional straight plates. If test data is used from one type of plate for justification of the mechanical properties of another type of plate, this justification shall be described in the final report. 4.2 Most of the testing described herein is focused on a “functional unit,” which can be described as a single-line fracture being spanned by a plate with one screw hole on each side of the fracture. This configuration allows for the simplest determination of worst-case size if the strut geometry is the determining factor for the worst case. If a worst-case size cannot be isolated to a functional unit/strut geometry, perhaps due to irregular screw hole patterns or the shape of the plate, it is understandable that some tests would need to be modified, or possibly removed from test consideration, to accommodate the shape of the plate or the screw hole. Any test modifications or omissions shall be described in the final report with a rationale related to the plate’s anatomical use, indications, and functional requirements.