标准摘要
[中文适用范围]： 本国际标准适用于制造商声明的适合放射引导介入手术的 X 射线设备的基本安全和基本性能，以下简称介入 X 射线设备。其范围尤其不包括： – 放射治疗设备； – 计算机断层扫描设备； – 旨在引入患者体内的配件； – 乳腺X射线照相设备； – 牙科 X 射线设备。 [外文原描述]： IEC 60601-2-43:2010 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration.
英文名称Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures