Medical electrical equipment — Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
This part of the standard series applies to X-ray equipment which has been declared suitable by the manufacturer for radioscopically guided interventional procedures and which is hereinafter referred to as interventional X-ray equipment. Due to this, this standard contains additional requirements for X-ray equipment which are not contained in DIN EN 60601-2-54. The interventional procedures considered in this standard are fully established in clinical areas, for example in – invasive cardiology, – interventional radiology, – interventional neuroradiology. These procedures also comprise many applications which are currently being developed and created in a wide range of medical and surgical specialties. The standard does not apply to: – radiotherapy equipment; – computed tomography equipment; – accessory intended for introduction into the patient; – mammography X-ray equipment; – dental X-ray equipment. Specifications for radiation protection which were formerly included in standard DIN EN 60601-1-3 were adopted into this standard and adapted to the state of the art. The Committee responsible for this standard is national Joint Committee NA 080-00-16 GA Joint Working Committee NAR/DKE “Bildgebende Systeme” (“Imaging systems”) of the Radiology Standards Committee (NAR) at DIN, the German Institute for Standardization e. V., collaborating with the Deutsche Röntgengesellschaft (German Radiological Society) and the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.