IEC 60601-2-45 Medical Electrical Equipment - Special Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Equipment

The purpose of this standard is to 1. formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and conditions of use of such equipment; 2. to identify specific requirements to ensure safety and to identify methods for demonstrating compliance with those requirements.

Outside the scope of this standard:

• Reconstructive tomography other than mammographic tomosynthesis;
• CT scanners under IEC 60601-2-44;
• diagnostic consoles;
• Picture archiving and communication systems (PACS);
• Non-integrated storage phosphor readers;
• Hard copy cameras;
• Films, screens and cassettes;
• computer aided detection (CAD);
• Devices for performing core biopsy and other biopsy instruments;
• modes of operation for demonstrating local contrast agent uptake (contrast-enhanced digital mammography);

If an article or subclause is specifically intended to apply to ME EQUIPMENT only or ME SYSTEMS only, the title and content of that article or subclause shall indicate so. If this is not the case, the item or subclause applies to both ME EQUIPMENT and, accordingly, ME SYSTEMS.

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