DIN EN 60601-2-26:2016-02

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.