DIN Standards Committee Health Technologies
DIN EN 60601-2-18
; VDE 0750-2-18:2016-10
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18:2009); German version EN 60601-2-18:2015
Medizinische elektrische Geräte - Teil 2-18: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten (IEC 60601-2-18:2009); Deutsche Fassung EN 60601-2-18:2015
Overview
This standard applies to the basic safety and essential performance characteristics of endoscopic devices together with their interconnection conditions and interface conditions. These particular requirements amend und supplement DIN EN 60601-1 (VDE 0750-1):2007-07. These particular requirements have been adapted to the new structure of DIN EN 60601-1:2007-07. In addition, the essential performance characteristics have been specified for endoscopes: An extension of the requirements has been added by adding energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard. References to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices have been defined instead of continuing to specify different tests. The responsible committee is DKE/UK 812.4 "Elektrooptische Geräte" ("Electro-optical equipment") of the DKE (Deutsche Kommission Elektrotechnik Elektronik Informationstechnik) at DIN und VDE.
