DIN EN IEC 60601-2-54:2025-05

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. This document 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. Therefore, X-ray equipment specified for direct radioscopy no longer belongs to the scope of this document. The standard differs from DIN EN 60601-2-54 (VDE 0750-2-54):2020-03 as follows: The purpose of these Particular Requirements is to establish particular requirements for the basic safety and essential performance of ME EQUIPMENT and ME SYSTEMS intended for radiography and radioscopy. A new subclause devotes particular attention to examination protocols that distinguish between adult and pediatric applications; this applies in particular to X-ray equipment without an automatic control system.