prEN IEC 60601-2-54:2026

Replacement:
This document 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 document.
ME EQUIPMENT and ME SYSTEMS intended solely to be used for bone or tissue absorption densitometry, computed tomography, CBCT, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators.
Although CBCT systems without radiographic or radioscopic imaging modes (i.e. standalone CBCT systems) are excluded from the scope of this standard, certain clauses related to the CBCT MODE OF OPERATION of this standard can be relevant.
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.