医用电气设备.第2-1部分:1至50MeV范围内医用电子加速器的基本安全性和基本性能用详细要求

[中文适用范围]： 替代：本国际标准适用于用于治疗患者的 1 MeV 至 50 MeV@ 范围内的电子加速器@（以下简称 ME 设备@）的基本安全和基本性能。该特定标准@包括型式测试和现场测试@分别适用于用于人类医疗实践中放射治疗@的电子加速器的制造和一些安装方面，包括可以控制操作参数的选择和显示的那些方面自动由可编程电子子系统 (PESS)@ ?C 在正常条件下和正常使用@下传送具有 ?C 的 X 辐射和/或电子辐射的辐射束。标称能量在 1 MeV 至 50 MeV@- 范围内？ 0@001 Gy 之间的最大吸收剂量率 ?? s?C1 和 1 Gy ??距离辐射源@ 1 m 处的s?C1 ？正常治疗距离 (NTD) 距辐射源@ 0@5 m 至 2 m，且 ?C 旨在为 ?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@？按照使用说明@中给出的建议进行维护？由合格人员定期进行质量保证性能和校准检查。注 1：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。注 2：在本特定标准中，所有提及的吸收剂量均指水中的吸收剂量。 [外文原描述]： IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions: - alignment with the new relevant collateral standards; - new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).