DIN Standards Committee Heating and Ventilation Technology and their Safety
DIN EN 60601-2-36
; VDE 0750-2-36:2015-11
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:2014); German version EN 60601-2-36:2015
Medizinische elektrische Geräte - Teil 2-36: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur extrakorporal induzierten Lithotripsie (IEC 60601-2-36:2014); Deutsche Fassung EN 60601-2-36:2015
Overview
This product standard from the standard series DIN EN 606060-1 (VDE 0750-1) describes the safety requirements for equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses(for example, fragmentation of kidney and gall stones). The applicability of this particular standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are described in other applicable standards. The responsible committee is DKE/UK 812.2 "Therapie, Chirurgie" ("Therapy, surgery") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
