DIN EN 60601-2-8
; VDE 0750-2-8:2016-08
Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010 + A1:2015); German version EN 60601-2-8:2015 + A1:2016
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV (IEC 60601-2-8:2010 + A1:2015); Deutsche Fassung EN 60601-2-8:2015 + A1:2016
Overview
The International Standard has been prepared in IEC TC/SC 62C "Equipment for radiotherapy, nuclear medicine and radiation dosimetry" with the German collaboration of NA 080-00-15 GA Gemeinschaftsausschuss NAR/DKE "Strahlentherapie" (Joint Committee NAR/DKE "Radiotherapy"). This standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is a supplementary standard to IEC 60601-1:2005 and applies to therapy X-ray equipment in the range of 10 kV to 1 MV. This standard specifies requirements to be met by manufacturers in the design and construction of therapy X-ray equipment. Subclause 201.10.1 provides tolerance limits beyond which interlocks prevent, interrupt, or terminate irradiation to avoid an unsafe condition. Subclause 201.10.1 does not attempt to specify optimum performance requirements. The purpose of this clause is to designate those design features that are considered essential to the safe operation of such equipment at this time. It sets limits on the degradation of the performance of the equipment where a fault condition may be assumed, such as failure of a component, and in which case an interlock will then prevent further operation of the equipment. 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
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
