IEC 60601-2-45 Ed. 2.0 b:2001

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.