标准摘要
[中文适用范围]： 本国际标准适用于乳腺X射线设备的基本安全和基本性能，包括乳腺断层合成设备和乳腺立体定位设备，以下简称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腺X射线设备。 本文件的范围不包括： – 乳腺断层合成以外的重建断层扫描操作模式； – 由IEC 60601-2-44涵盖的CT扫描仪； – 诊断控制台； – 图片存档和通信系统（PACS）； – 非集成存储磷光体阅读器； – 硬拷贝相机； – 胶片、屏幕和暗盒； – 计算机辅助检测（CAD）； – 用于执行核心活检和其他活检仪器的设备； – 用于显示局部对比度介质吸收的操作模式（对比增强数字乳腺摄影）； 如果条款或子条款专门适用于ME设备或ME系统，则该条款或子条款的标题和内容将说明这一点。如果没有说明，则该条款或子条款适用于ME设备和ME系统。 注2：IEC 60601-2-7:1998和IEC 60601-2-32不属于乳腺X射线设备和乳腺立体定位设备的第三版方案。 [外文原描述]： IEC 60601-2-45:2011+A1:2015 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. This consolidated version consists of the third edition (2011) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices