Appareils électromédicaux - Partie 2-45 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils de mammographie à rayonnement X et des appareils mammographiques stéréotaxiques

Scope

Replacement:

This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT 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:

- reconstructive tomography modes of operation;

- 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 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.