DIN EN IEC 80601-2-26
; VDE 0750-2-26:2025-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 80601-2-26:2019 + COR1:2021 + AMD1:2024); German version EN IEC 80601-2-26:2020 + AC:2021 + A1:2024
Medizinische elektrische Geräte - Teil 2-26: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC 80601-2-26:2019 + COR1:2021 + AMD1:2024); Deutsche Fassung EN IEC 80601-2-26:2020 + AC:2021 + A1:2024
Overview
This part of the International Standard IEC 80601 is applicable to the basic safety, including the essential performance characteristics, of electroencephalographs, hereinafter also referred to as ME devices or ME systems. This document applies to electroencephalographs intended for use in professional healthcare facilities, in emergency settings, or for medical care in a home environment. The purpose of this document is to adapt these particular requirements to edition 3.2 of the general requirements and to new editions of supplementary standards and their amendments through technical changes. None with regard to electroencephalographs as described in the scope of these Particular Requirements. The standard differs from DIN EN IEC 80601-2-26 (VDE 0750-2-26):2022-04 and DIN EN IEC 80601-2-26 Corrigendum 1 (VDE 0750-2-26 Corrigendum 1):2022-06 as follows: a) Figure 202.101 has been changed from IEC 60601-2-26:2012 to IEC 80601-2-26:2019. In particular, R4 has been added so that R3 and R4 form an attenuator for the output signal of the sine wave generator (G).
