DIN EN IEC 60601-2-43 Berichtigung 1
; VDE 0750-2-43 Berichtigung 1:2024-07
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2022); German version EN IEC 60601-2-43:2023; Corrigendum 1
Medizinische elektrische Geräte - Teil 2-43: Besondere Festlegungen für die Sicherheit und wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für interventionelle Verfahren (IEC 60601-2-43:2022); Deutsche Fassung EN IEC 60601-2-43:2023; Berichtigung 1
Overview
X-ray equipment for fluoroscopy-guided interventional procedures can expose patients and operators to higher levels of radiation than the doses normally encountered. This can result in the occurrence of deterministic damage if the procedures involve the irradiation of localized areas of the patient with considerable amounts of radiation. Another consequence can be a high contribution to the overall stochastic RISK of radiation-induced cancer and so on for the patient. A further consequence is the need for device functions to be available with minimal periods of loss of critical functions. The types of interventional procedures considered here are well established in the clinical field, for example in: - invasive cardiology, - interventional radiology, - interventional neuroradiology.
Document: references other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
