标准摘要
[中文适用范围]: 本国际标准适用于连接交流电源、额定X射线管电压在10 kV至1 MV范围内的治疗用X射线设备的基本安全和关键性能。本标准覆盖远程放射治疗(Teletherapy)和近距离放射治疗(Brachytherapy)。 [外文原描述]: IEC 60601-2-8:2010+A1:2015 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards. This consolidated version consists of the second edition (2010) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV