1.1 本规程为在测试之前、期间和之后对脊柱植入物进行无损摄影分析提供了指导。本规程的目的是提供记录机械试验过程中发生的植入物特性（例如表面缺陷、裂纹、塑性变形）显著变化的方法。记录这些变化可能有助于理解是否发生了机械故障以及如何发生。 1.2 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。 1.3 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 小组委员会F04.25管辖下的ASTM标准（例如，试验方法 F1717 , F1798 , F2077 , F2267页 , F2346 , F2624 和 F2706 、规范和测试方法 F2193 ，导向装置 F2423 和 F2789 ，实践 F2694 和 F2790 )描述测试方法并规定评估不同类型脊柱植入物的指南（定义见术语 F1582 ). 遵守其中许多标准可能会导致机械故障。然而，在某些情况下，失败可能并不明显。由于这些标准均未讨论、描述或提供设备故障检查方法，因此本规程提供了检查指南，以便最终用户能够有效识别和表征测试零件中的物理变化。 5.2 机械故障和/或设备特性变化的报告是精度和偏差误差的一个来源。不同的表征水平和类型可能会影响数据报告。这种做法可以通过提供有助于有效分析测试零件变化的指导来减少偏差。 5.3 如果在试验中期进行无损评估，则允许继续对试样进行测试，并将试样保存以备试验后检查。检查也可能仅限于在有限许可环境中进行无损评估。

1.1 This practice provides guidance for non-destructive photographic analysis of spinal implants prior to, during, and after testing. The purpose of this practice is to provide methods for documenting notable changes in implant characteristics (e.g., surface defects, cracks, plastic deformation) that have occurred during the course of a mechanical test. Documenting these changes may assist in understanding if mechanical failure has occurred, and how. 1.2 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. 1.3 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 ASTM standards under the jurisdiction of Subcommittee F04.25 (such as, Test Methods F1717 , F1798 , F2077 , F2267 , F2346 , F2624 , and F2706 , Specifications and Test Methods F2193 , Guides F2423 and F2789 , Practices F2694 and F2790 ) describe test methods and prescribe guidelines for evaluating different types of spinal implants (as defined in Terminology F1582 ). Adherence to many of these standards may result in mechanical failure. In some cases, however, the failure may not be obvious. Because none of these standards discuss, describe, or provide methods for inspecting the devices for failure, this practice provides guidelines for inspection such that the end user can effectively identify and characterize physical changes in test parts. 5.2 The reporting of a mechanical failure and/or changes in device characteristics is one source of error in precision and bias. Varying levels and types of characterization have the potential to affect data reporting. This practice may reduce bias by providing guidance that can aid in effectively analyzing changes in test parts. 5.3 Non-destructive evaluation allows continued testing of a specimen if performed mid-test and preserves the specimen for post-test examination. Examination may also be limited to non-destructive evaluation in a limited permission environment.