标准摘要
[中文适用范围]： 本国际标准适用于与外部束设备（EBE）一起使用的基于 X 射线的图像引导放射治疗设备的基本安全和基本性能。该特定标准涵盖了用于 IGRT 目的的千伏 (kV) 和兆伏 (MV) X 射线成像设备的安全方面，这些设备与 EBE 具有已知的几何关系。它涵盖了外部束设备和 X 射线成像设备@连接或不直接连接到@但位于与@相同的辐射屏蔽区域@并且专用于@外部束设备@之间的通信和关系的各个方面。该特定标准涉及实时 X-IGRT@在线 X-IGRT 和离线 X-IGRT 设备。它涵盖了降低过度依赖 X-IGRT 外部光束系统 (X-IGRT EBS) 风险的程序。例如，制造商将提供一个交互界面，供用户与系统建议的修正进行交互。如果某个条款或子条款专门适用于 X-IGRT EBE SYSTEMS，则该条款或子条款的内容将如此说明。如果情况并非如此@，则该条款或子条款仅适用于 X-IGRT 设备。此特定标准@包含型式测试和现场测试@，分别适用于制造商和 X-IGRT EBE 系统的一些安装方面，旨在正常使用@由具有特定医疗应用所需技能的操作员在适当许可或有资格人员的授权下操作@用于特定的临床目的@例如固定放射治疗或移动束放射治疗@根据说明书中给出的建议进行维护使用@须由合格人员定期进行质量保证性能和校准检查。注：在本特定标准中，所有提及的安装均指在责任组织场所内的安装 [外文原描述]： IEC 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.
英文名称Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment