标准摘要
[中文适用范围]： 本国际标准适用于连接交流电源时标称 X 射线管电压在 10 kV 至 1 MV 范围内的治疗 X 射线设备（以下简称 ME 设备）的基本安全和基本性能。注：本标准涵盖远程治疗和近距离治疗。如果某条款或子条款专门旨在仅适用于 ME 设备或仅适用于 ME 系统，则该条款或子条款的标题和内容将如此说明。如果情况并非如此，则该条款或子条款适用于相关的 ME 设备和 ME 系统。 [外文原描述]： IEC 60601-2-8:2010 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.
英文名称Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV