DIN EN 60601-2-45:2017-01

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE CHARACTERISTICS of X-RAY EQUIPMENT designed for mammography and of MAMMOGRAPHIC STEREOTACTIC DEVICES. The standard does not cover, among other things, biopsy facilities. These Special Specifications amend and supplement the basic standard DIN EN 60601-1 (VDE 0750-1):2007-07. The first amendment has been incorporated into this standard. The first amendment to the third edition of these Special Specifications has been prepared to provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT based on IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:201X (4th edition) and IEC 60601-1-3:2008 + A1:2013. These Special Specifications address the system level of MAMMOGRAPHIC X-RAY EQUIPMENT and they introduce devices for MAMMOGRAPHIC THOMOSYNTHESIS. Working Committee NA 080-00-16 GA Joint Working Committee NAR/DKE "Bildgebende Systeme" ("Imaging systems") at DIN-Normenausschuss Radiologie (NAR) (DIN Standards Committee Radiology) at DIN, the German Institute for Standardization e. V. in collaboration with Deutsche Röntgengesellschaft (German Radiological Society) and in cooperation with Deutsche Gesellschaft für Medizinische Physik (German Society for Medical Physics), Deutsche Gesellschaft für Nuklearmedizin (DGN) (German Society of Nuclear Medicine) and Deutsche Gesellschaft für Radioonkologie (German Society for Radio Oncology) and the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE is responsible for this standard.