标准摘要
[中文适用范围]： 替代：本国际标准适用于乳房X线摄影X射线设备和乳房X线立体定向设备@的基本安全和基本性能，以下也称为ME设备。注 1：这包括使用集成数字 X 射线图像接收器或集成存储磷光体子系统的乳房 X 射线照相设备。本文件的范围不包括： ?C 重建断层扫描操作模式； ?C 诊断控制台； ?C 画面归档和通信系统（PACS）； ?C非集成存储荧光阅读器； ?C 硬拷贝相机； ?C 电影@银幕和磁带； ?C计算机辅助检测（CAD）； ?用于进行核心活检的C装置和其他活检仪器； ?C 旨在展示局部造影剂吸收的操作模式（对比增强数字乳房X线照相术）；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@，则该条款或子条款同时适用于 ME 设备和相关的 ME 系统@。注 2：IEC 60601-2-7:1998 和 IEC 60601-2-32 不属于乳房 X 线摄影 X 射线设备和乳房 X 线立体定向设备第三版方案的一部分。 [外文原描述]： IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.
英文名称Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices