DIN Standards Committee for Organizational Processes
DIN EN 60601-2-45
; VDE 0750-2-45:2025-12
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 + A2:2022); German version EN 60601-2-45:2011 + A1:2015 + A2:2024
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 + A2:2022); Deutsche Fassung EN 60601-2-45:2011 + A1:2015 + A2:2024
Overview
The third edition of these particular requirements has been prepared in order to establish a complete set of safety requirements for mammographic X-ray equipment based on IEC 60601-1:2005 (third edition) and its supplementary standards. The minimum safety requirements specified in in these particular requirements are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. The following are excluded from the scope of this document: - reconstructive tomography other than A1 mammographic tomosynthesis; A1 CT scanners, covered by IEC 60601-2-44; - diagnostic consoles; - picture archiving and communication systems (PACS); - non-integrated imaging plate reader; - image documentation systems; - films, slides, and cassettes; - computer-aided detection (CAD); - devices for performing punch biopsies or other biopsy instruments; - operating modes for displaying local contrast medium image (contrast-enhanced digital mammography). The standard differs from DIN EN 60601-2-45 (VDE 0750-2-45):2017-01 as follows: a) adaptation of terms and references; b) adaptations in Clause 201.7 Markings; c) updates and additional explanations in Annex AA. The specifications in this document apply to the system level of mammographic X-ray equipment that consist of a combination of an X-ray generator, associated application equipment, and accessories. Component functions are dealt with to the extent required.
Document: references other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
