1.1 本文件提供了在规定条件下测量和报告手术导航和/或机器人定位装置基本静态性能的程序。它们可以在临床使用的子系统（例如，仅跟踪）或完整的计算机辅助手术系统上执行。测试子系统并不意味着整个系统已经过测试。基于本规程测试的功能仅限于系统通过指针在空间中定位点的性能（偏差和精度方面的精度）。空间中的点没有方向；只有多维对象具有方向。因此，对象的方向不在本实践的范围内。然而，在定位点时，指针的不同方向可能会产生错误。 这些错误和指针方向都在本实践的范围内。其目的是提供性能变量的标准化测量，通过该测量，最终用户可以在系统内（例如，使用不同的参考元素或指针）以及不同系统之间（例如，来自不同制造商）进行比较。待评估的参数包括（基于被评估系统的特征）: (1) 相对于坐标系的单点精度。 (2) 指针方向变化引起的跟踪精度灵敏度。 (3) 相对点到点精度。 1.1.1 该方法涵盖了评估系统的所有配置以及测量体积的极端位置。 1.2 本规程定义了一种标准化的报告格式，其中包括用于报告测量值的坐标系的定义，以及统计度量（例如，平均值、RMS和最大误差）。 1.3 以国际单位表示的数值视为标准值。本标准不包括其他测量单位，但角度测量除外，角度测量可以弧度或度数报告。 1.4 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。 1.5 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 本规程的目的是提供可用于评估不同CAS系统准确性的数据。 5.2 手术导航和机器人定位系统的使用越来越普遍。为了就此类系统对给定程序的适用性作出明智的决定，需要在临床应用中评估其准确性能力，并与要求进行比较。由于整个系统的性能受到其子系统性能的限制，因此，初步步骤必须是在受控条件下，客观地描述受控环境中跟踪子系统的精度。 5.3 为了在系统内部和系统之间进行比较，需要一种标准化的测量和报告准确性方法。 坐标系、测量单位、术语和操作条件等参数必须标准化。

1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated): (1) Accuracy of a single point relative to a coordinate system. (2) Sensitivity of tracking accuracy due to changes in pointer orientation. (3) Relative point-to-point accuracy. 1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume. 1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees. 1.4 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. 1.5 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 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems. 5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions. 5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.