DIN Standards Committee Health Technologies
DIN EN 60601-2-11
; VDE 0750-2-11:2016-04
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment (IEC 60601-2-11:2013); German version EN 60601-2-11:2015
Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die Strahlensicherheit von Gammabestrahlungseinrichtungen (IEC 60601-2-11:2013); Deutsche Fassung EN 60601-2-11:2015
Overview
This standard describes the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. The standard modifies and amends DIN EN 60601-1 (VDE 0750-1):2007-07. This standard establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. The committee responsible for this standard is NA 080-00-15 GA NAR/DKE Gemeinschaftsausschuss "Strahlentherapie" (NAR/DKE Joint Committee "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
