EVS-EN 60601-2-54:2009+A1:2015

Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and
RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used
for interventional applications and refers to applicable requirements in this particular
standard.
ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption
densitometry, computed tomography, mammography or dental applications are excluded from
the scope of this International Standard. The scope of this International Standard also
excludes radiotherapy simulators.
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 Taking into account economic and social factors, the scope of this particular standard includes
ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with
DIRECT RADIOSCOPY are prohibited.