Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
This International Standard applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. The standard does not cover biopsy devices, amongst others. These particular requirements amend and supplement basic standard DIN EN 60601-1 (VDE 0750-1):2007-07. Like the previous edition, the standard also contains requirements for high-voltage generators for mammography. Due to this, standard DIN EN 60601-2-7 “Medical electrical equipment – Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators” is excluded from the scope of this standard. With respect to the previous edition of the standard, requirements for device-related radio protection from standard DIN EN 60601-1-3:1995-02 have been adopted. Furthermore, modality-specific requirements of the standards DIN EN 60601-2-28:1995-12 “Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis” and DIN EN 60601-2-32:1995-11 “Medical electrical equipment – Part 2: Particular requirements for the safety of associated equipment of X-ray equipment” have been replaced in this standard. The committee responsible for this standard is NA 080-00-16 GA NAR/DKE Joint Committee “Bildgebende Systeme” (“Imaging systems”) of the Radiology Standards Committee (NAR) at DIN, the German Institute of Standardization e. V., collaborating with the Deutsche Röntgengesellschaft (German Radiological Society) and in cooperation with the Deutsche Gesellschaft für Medizinische Physik (German Society for Medical Physics), the Deutsche Gesellschaft für Nuklearmedizin (German Society of Nuclear Medicine) and the Deutsche Gesellschaft für Radioonkologie (German Society for Radio Oncology) of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.