EN 60601-2-54

Medical electrical equipment — Part 2-54: 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 medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The new edition of DIN EN 60601-2-43 (currently a draft) will contain requirements for the safety of X-ray equipment intended for interventional applications. The latter refers to DIN EN 60601-2-54, provided that it concerns requirements for interventional applications. X-ray equipment for – bone or tissue absorption densitometry, – computed tomography, – mammography and – dental applications are excluded from the scope of this standard. The standard is also not applicable to therapy simulators. Within its specific scope, this standard replaces requirements indicated in the standards – DIN EN 60601-2-7: “Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators”, – DIN EN 60601-2-28: “Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies” as far as beam limiting devices are concerned, and DIN EN 60601-2-32: “Particular requirements for the safety of associated equipment of X-ray equipment”. Particular requirements for radiographic and fluoroscopic systems included in the collateral standard DIN EN 60601-1-3 have been extracted and moved into this particular standard. At DIN, the German Institute for Standardization, the responsible Committee is NA 080-00-16 GA Joint Committee NAR/DKE “Bildgebende Systeme” (“Imaging systems”), collaborating with Deutsche Röntgengesellschaft (German Radiological Society) and Deutsche Gesellschaft für Nuklearmedizin e. V. (DGN) (German Society of Nuclear Medicine), Deutsche Gesellschaft für Medizinische Physik e. V. (DGMP) (German Society for Medical Physics) and Deutsche Gesellschaft für Radioonkologie (DEGRO) e. V. (German Society for Radio Oncology).