IEC 60601-2-45:2011适用于乳腺X射线摄影设备和乳腺立体定向设备的基本安全和基本性能。IEC 60601-2-45:2011阐述了乳腺X射线摄影设备的系统级，该设备由X射线发生器、相关设备和附件组成。尽可能地解决组件功能问题。本特定标准中规定的最低安全要求被认为是为乳房X射线摄影设备的操作提供了实际的安全程度。与本第2-45部分的前一版一样，本第三版包括了乳腺X光检查用高压发生器的要求。第三版取消并取代了2001年出版的第二版。本版为技术修订版。 本文件与IEC 60601-1（2005）第三版和IEC 60601-1-3（2010）保持一致。对乳腺X射线摄影设备的当前技术进行了进一步修改。

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.