Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (Edition 3.1; Consolidated Reprint)
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. NOTE 1 This includes MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or integrated storage phosphor subsystems. Excluded from the scope of this document are: ?C reconstructive tomography other than MAMMOGRAPHIC TOMOSYNTHESIS; ?C CT SCANNERS covered by IEC 60601-2-44; ?C diagnostic consoles; ?C picture archiving and communication systems (PACS); ?Cnon-integrated storage phosphor readers; ?C hard copy cameras; ?C films@ screens and cassettes; ?C computer aided detection (CAD); ?C devices for performing core biopsy and other biopsy instruments; ?C modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography); If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as relevant. NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rd edition scheme for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.