IEC 60601-2-68:2014 医用电气设备.第2-68部分:与电子加速器、光离子束治疗设备和放射性核素束治疗设备一起使用的基于X射线的图像引导放射治疗设备的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-68:2014

中文名称：医用电气设备.第2-68部分:与电子加速器、光离子束治疗设备和放射性核素束治疗设备一起使用的基于X射线的图像引导放射治疗设备的基本安全和基本性能的特殊要求

英文名称：Electrical medical 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

发布日期：2014-09-04

标准范围

IEC 60601-2-68:2014适用于与外束设备（EBE）一起使用的基于X射线的图像引导放射治疗（IGRT）设备的基本安全和基本性能。本特殊标准涵盖了IGRT中与EBE具有已知几何关系的千伏和兆伏X射线成像设备的安全方面。它涵盖了EBE和X射线成像设备之间的通信和关系，这些设备与EBE连接或不直接连接，但与EBE位于同一辐射屏蔽区域，且仅用于EBE。本特殊标准涉及实时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 EBE系统风险的程序。例如，制造商将提供一个交互式界面，供用户与系统建议的修正进行交互。

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.

标准预览图