Medical electrical equipment. Pt. 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2017); German version EN IEC 60601-2-28:2019

The International Standard was prepared in IEC/TC 62/SC 62B "Diagnostic imaging equipment" with German participation of the joint committee NAR-DKE NA 080-00-016 GA "Imaging systems". This standard applies to X-ray sources for medical diagnostics. It also includes specifications for components of the X-ray tube such as housing, stator and fan as well as specifications for more complex units such as the X-ray generator or the diaphragm system, insofar as they have an influence on the X-ray tube. The third edition of this standard has been prepared to align with the basic standard IEC 60601-1:2005 (3rd edition), Amendment 1:2012. Due to new technologies, technical changes have also been incorporated. This standard supersedes DIN EN 60601-2-28:2010-11; VDE 0750-2-28:2010-11. Compared to DIN EN 60601-2-28 (VDE 0750-2-28):2010-11, the following changes have been made: a) adaptation to the basic standard IEC 60601-1:2005 (3rd edition), Amendment 1:2012; b) incorporation of technical changes due to new technologies; c) editorial revision.