BS EN 60601-2-54:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
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.
BS EN 60601-2-54:2009 history
2019BS EN 60601-2-54:2009+A2:2019 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2015BS EN 60601-2-54:2009+A1:2015 Medical electrical equipment-Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2010BS EN 60601-2-28:2010 Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
1993BS EN 60601-2-28:1993 Medical electrical equipment - Particular requirements for safety - Specification for X-ray source assemblies and X-ray tube assemblies for medical diagnosis