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，包括用于乳腺断层合成的设备和乳腺立体定位设备，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腺X射线设备。 本文件不适用于以下内容： - 除乳腺断层合成之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）； - 非集成存储磷光体读取器； - 硬拷贝相机； - 胶片、屏幕和暗盒； - 计算机辅助检测（CAD）； - 用于进行核心活检和其他活检器械的设备； - 旨在展示局部对比剂吸收的操作模式（对比增强数字乳腺摄影）； 如果某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。如果不是这样，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不是第3版乳腺X射线设备和乳腺立体定位设备方案的一部分。 [外文原描述]： IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 CSV 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