DIN Standards Committee Health Technologies
DIN EN 60601-2-44
; VDE 0750-2-44:2017-03
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009 + Cor.:2010 + A1:2012 + A2:2016); German version EN 60601-2-44:2009 + A11:2011 + A1:2012 + A2:2016
Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die Computertomographie (IEC 60601-2-44:2009 + Cor.:2010 + A1:2012 + A2:2016); Deutsche Fassung EN 60601-2-44:2009 + A11:2011 + A1:2012 + A2:2016
Overview
This standard applies to the basic safety and essential performance of CT scanners. The scope is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly (single vessel X-ray generators). For the latter reason the standard DIN EN 60601-2-7 may not be applied to CT scanners. Particular requirements amend and supplement DIN EN 60601-1 (VDE 0750-1):2007-07. The second amendment to DIN EN 60601-1 (VDE 0750-1):2007-07 is mainly concerned with editorial corrections and the implementation of the latest publications of the general specifications and supplementary standards. Joint Working Committee NA 080-00-16 GA "Bildgebende Systeme" ("Imaging systems") of DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE (www.dke.de) and DIN Standards Committee Radiology (NAR) in collaboration with Deutsche Röntgengesellschaft (German Radiological Society) is responsible for this docment.
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
