1.1 本规程介绍了在规定条件下测量和报告手术导航和/或机器人定位设备基本静态性能（精度、重复性等）的技术。范围涵盖跟踪子系统，仅在本实践中测试系统定位空间中单个点的准确性和重复性。空间中的点没有方向；只有多维对象具有方向。因此，物体的方向不在本实践的范围内。 然而，在定位点时，定位工具的不同方向可能会产生误差。这些错误和定位工具的方向在本实践的范围内。其目的是提供性能变量的标准化测量，最终用户可以通过该测量在不同系统内（例如，不同的固定参考框架或触针工具）和之间（例如，不同的制造商）进行比较。待评估的参数包括（基于待评估系统的特征）: (1) 点相对于坐标系的位置。 (2) 相对点对点精度（线性）。 (3) 单点坐标的重复性。 (4) 对于基于光学的系统，参考框架或工具的可见方向范围。 (5) 该方法涵盖系统中刀具阵列的所有配置。 1.2 本规程中定义的系统仅包括跟踪子系统（光学、磁性、机械等）触针、计算机以及必要的硬件和软件。 因此，本规程包含可在实验室或受控环境中应用于规定模型的测试。 1.3 本规程定义了标准化报告格式，其中包括用于报告测量值和统计测量值（例如，平均值、标准差、最大误差）的坐标系定义。 1.4 该实践将作为特定任务（切割、钻孔、铣削、铰孔、活检针放置等）和外科应用的后续标准的基础。 1.5 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。 1.6 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。 1.7 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，需要用户相信系统提供的数据满足必要的精度要求。为了评估这些系统的潜在用途，并就系统对给定程序的适用性作出明智的决定，需要此类系统的客观性能数据。 虽然最终用户最终希望了解临床应用中系统的精度参数，但第一步必须是在受控条件下描述受控环境中跟踪子系统的数字化精度。 5.3 为了在系统内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的方法。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 practice addresses the techniques of measurement and reporting of basic static performance (accuracy, repeatability, and so forth) of surgical navigation and/or robotic positioning devices under defined conditions. The scope covers the tracking subsystem, testing only in this practice the accuracy and repeatability of the system to locate individual points in space. A point in space has no orientation; only multi-dimensional 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 localization tool can produce errors. These errors and the orientation of the localization tool 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 (for example, different fixed reference frames or stylus tools) and between (for example, different manufacturers) different systems. Parameters to be evaluated include (based upon the features of the system being evaluated): (1) Location of a point relative to a coordinate system. (2) Relative point to point accuracy (linear). (3) Repeatability of coordinates of a single point. (4) For an optically based system, the range of visible orientations of the reference frames or tools. (5) This method covers all configurations of tool arrays in the system. 1.2 The system as defined in this practice includes only the tracking subsystem (optical, magnetic, mechanical, and so forth) stylus, computer, and necessary hardware and software. As such, this practice incorporates tests that can be applied to a prescribed phantom model in a laboratory or controlled setting. 1.3 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, standard deviation, maximum error). 1.4 This practice will serve as the basis for subsequent standards for specific tasks (cutting, drilling, milling, reaming, biopsy needle placement, and so forth) and surgical applications. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization 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 measure, terminology, and operational conditions must be standardized.