DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-2-26
; VDE 0750-2-26:2016-02
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 60601-2-26:2012); German version EN 60601-2-26:2015
Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC 60601-2-26:2012); Deutsche Fassung EN 60601-2-26:2015
Overview
These particular requirements apply to the safety and essential performance characteristics of EEG devices. This standard is applicable to EEG devices used in a clinical environment (for example, hospital, physician's office, etcetera). This standard does not cover requirements for other equipment used in electroencephalography such as: a) phono-photic stimulators; b) electroencephalographic telemetry; c) EEG data storage and retrieval; d) EEG devices particularly intended for monitoring during electro-convulsive therapy; e) ambulatory electroencephalographic recorders. These particular requirements amend and supplement IEC 60601-1 (third edition 2005): "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", hereinafter referred to as general requirements. The committee responsible is Subcommittee DKE/UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
