医用电气设备 第2-45部分：乳腺X射线摄影设备和乳腺摄影立体定位器安全的特殊要求

[中文适用范围]： 补充：本专用标准包含为乳房X线照相术和乳房X线立体定向设备设计的X射线设备的安全要求。 X 射线发生器及其子组件的安全要求构成本标准的组成部分。 [外文原描述]： The object of this standard is 1. to formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment; 2. to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. It is the bilingual version of the english version published in 2001.