DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-2-45
; VDE 0750-2-45:2017-01
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011 + A1:2015); Deutsche Fassung EN 60601-2-45:2011 + A1:2015
Medizinische elektrische Geräte - Teil 2-45: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgen-Mammographiegeräten und mammographischen Stereotaxie-Einrichtungen (IEC 60601-2-45:2011 + A1:2015); Deutsche Fassung EN 60601-2-45:2011 + A1:2015
Overview
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.
Document: references other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
