1.1 本标准将测量计算机辅助手术（CAS）系统预期临床应用期间用于制骨的设备对环境影响的准确性的影响。本标准中涵盖的环境振动效应将包括来自切割锯（矢状或往复）、毛刺、钻头和冲击载荷的机械振动。还将测量由于拆卸和重新连接或干扰受约束连接而导致的精度变化，该受约束连接在设计上不需要重复参考基座的配准过程。 1.2 应注意的是，一个系统可能需要经历本标准的多次迭代（每个临床应用一次），以记录其在不同临床应用期间的准确性，因为考虑到手术程序从一个程序到下一个程序的可变性，每个程序可能具有不同的外力暴露。 1.3 本标准的所有计量单位均以毫米为单位。 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建立适当的安全、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《国际标准、指南和建议制定原则决定》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比较和评估不同CAS系统准确性的数据。 5.2 CAS系统和机器人跟踪系统的使用越来越普遍，需要用户一定程度的信任，即系统提供的数据符合必要的精度要求。为了评估这些系统的潜在用途，并就系统适用于给定程序做出明智的决定，这些系统的客观性能数据是必要的。虽然最终用户最终希望知道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在受控环境中表征跟踪子系统的数字化精度。 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点精度的方法。坐标系、度量单位、术语和操作条件等参数必须标准化。

1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured. 1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next. 1.3 All units of measure will be reported as millimeters for this standard. 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 comparison and evaluation of the accuracy of different CAS systems. 5.2 The use of CAS systems and robotic tracking 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 point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.