DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-2-1
; VDE 0750-2-1:2016-08
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (IEC 60601-2-1:2009 + A1:2014); German version EN 60601-2-1:2015
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektronenbeschleunigern im Bereich von 1 MeV bis 50 MeV (IEC 60601-2-1:2009 + A1:2014); Deutsche Fassung EN 60601-2-1:2015
Overview
This standard amends and supplements DIN EN 60601-1 (VDE 0750-1):2013-12. The standard applies to the basic safety and essential performance of electron accelerators in the range of 1 MeV to 50 MeV for the treatment of patients. This standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy. No attempt is made to define requirements for their optimum operation. The purpose of this standard is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment; it places limits on the degradation of equipment functions beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the equipment. DIN EN 60976 and IEC/TR 60977 are closely related to this standard. The standard DIN EN 60976 specifies test methods and reporting formats for performance tests for electron accelerators for use in radiation therapy with the aim of providing uniform methods for conducting such tests. The technical report IEC/TR 60977 proposes performance values measured by test methods specified in DIN EN 60976 that may be achievable with current technology. The committee responsible for this standard is NA 080-00-15 GA Gemeinschaftsausschuss NAR/DKE "Strahlentherapie" (Joint Committee NAR/DKE "Radiotherapy") of the Radiology Standards Committee (NAR) at DIN in collaboration with Deutsche Röntgengesellschaft (German Radiological Society) and the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE and in collaboration with Deutsche Gesellschaft für Nuklearmedizin e. V. (DGN) (German Society of Nuclear Medicine), Deutsche Gesellschaft für Medizinische Physik e. V. (DGMP) (German Society for Medical Physics) and Deutsche Gesellschaft für Radioonkologie e. V. (DEGRO) (German Society for Radio Oncology).
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
