This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT, including equipment for MAMMOGRAPHIC TOMOSYNTHESIS, and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT.
IEC 60601-2-45 Ed. 3.2 b:2022
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Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices CONSOLIDATED EDITION