UNE EN IEC 60601-2-54:2024
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Endorsed by Asociación Española de Normalización in November of 2024.)
Equipos electromédicos. Parte 2-54: Requisitos particulares para la seguridad básica y características de funcionamiento esencial de los equipos de rayos X para radiografía y radioscopia. (Ratificada por la Asociación Española de Normalización en noviembre de 2024.)
| Standard number: | UNE EN IEC 60601-2-54:2024 |
| Pages: | 89 |
| Released: | 2024-11-01 |
| Status: | Standard |
UNE EN IEC 60601-2-54:2024
201.1.1 Scope 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 INDIRECT 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 or radiotherapy 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. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ME EQUIPMENT and ME SYSTEMS for RADIOGRAPHY and RADIOSCOPY.
