DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 60601-2-54
; VDE 0750-2-54:2025-05
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2022); German version EN IEC 60601-2-54:2024
Medizinische elektrische Geräte - Teil 2-54: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für Radiographie und Radioskopie (IEC 60601-2-54:2022); Deutsche Fassung EN IEC 60601-2-54:2024
Overview
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.
Document: references other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
