Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
This standard describes particular requirements for basic safety and essential performance of X-ray tube assemblies for medical diagnosis. The standard also contains requirements for components of X-ray tube assemblies, such as X-ray tube housings, stators, ventilators, as well requirements for more complex units, such as X-ray generators or X-ray source assemblies, if they have an influence on the X-ray equipment. The second edition of this particular standard has been prepared to adjust it to IEC 60601-1:2005 (3. edition). Due to new technologies, technical changes have also been incorporated. The responsible Committee is national Joint Working Committee NA 080-00-16 GA “Bildgebende Systeme” (“Imaging systems”) of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE (www.dke.de) and of the Radiology Standards Committee (NAR) of DIN, the German Institute for Standardization e. V., collaborating with Deutsche Röntgengesellschaft (German Radiological Society).