1.1 本试验方法涵盖腰椎间体融合器（IBFD）冲击试验的材料和方法。 1.2 该测试方法旨在为非生物IBFD组件（IBFD和相关插入器工具）之间的机械比较提供基础。该测试方法旨在使用户能够在冲击载荷下比较这些IBFD组件，以模拟用于插入IBFD的手术中外科技术。 1.3 试验方法通过规定冲击能量和施加这些能量的具体方法来描述冲击试验。这些测试旨在对IBFD组件进行比较评估。 1.4 以国际单位制表示的数值应视为标准。本标准中不包括其他测量单位，但角度测量除外，角度测量可能以度或弧度报告。 1.5 本标准并不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。 1.6 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====== 5.1 IBFD可以是单件或多组分设计，本质上可以是多孔或中空的。它们的功能是支撑脊柱的前柱，以促进运动节段的关节融合术。 5.2 术中IBFD组装失败可导致重大临床后果。 4. 本试验方法概述了IBFD组件术中冲击性能的比较表征和评估材料和方法。 5.3 手术过程中施加的冲击力可能变化很大，因此，这些测试的结果可能无法直接预测 体内 表演然而，该结果可用于比较不同IBFD组件的机械性能。测试还可以确定特定IBFD插入器组合中最弱、最有可能失败的点，从而实现设计改进。 5.4 术中临床失败可能是由几个因素引起的，其中一些因素在当前方法中可能无法模拟。 例如，在当前的方法中没有模拟施加到IBFD组件的离轴冲击载荷，但在一些设计中可能会导致术中临床失败。本标准的使用者应考虑将这些因素纳入其评估中。

1.1 This test method covers the materials and methods for impact testing of lumbar intervertebral body fusion devices (IBFD). 1.2 This test method is intended to provide a basis for the mechanical comparison among nonbiologic IBFD assemblies (the IBFD and associated inserter tool). This test method is intended to enable the user to compare these IBFD assemblies under impact loads to simulate the intra-operative surgical technique used to insert the IBFD. 1.3 The test method describes the impact test by specifying impact energies and specific methods for applying these energies. The tests are designed to allow for the comparative evaluation of IBFD assemblies. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of 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 IBFDs can be single-piece or multicomponent designs and can be porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. 5.2 Intra-operative IBFD assembly failures can result in significant clinical consequences. 4 This test method outlines materials and methods for the comparative characterization and evaluation of the intra-operative impact performance of IBFD assemblies. 5.3 The impact forces applied during a surgical procedure may be highly variable 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 IBFD assemblies. The tests may also identify the weakest, most likely to fail points in particular IBFD-inserter combinations, thus enabling design improvements. 5.4 Intra-operative clinical failures may be due to several factors, some of which may not be simulated in the current method. For example, off-axis impact loads applied to the IBFD assembly are not simulated in the current method yet may contribute to intra-operative clinical failures in some designs. The user of this standard should consider incorporating such factors into their evaluations.