DIN EN IEC 60601-2-40
; VDE 0750-2-40:2025-12
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (IEC 60601-2-40:2024); German version EN IEC 60601-2-40:2025
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale (IEC 60601-2-40:2024); Deutsche Fassung EN IEC 60601-2-40:2025
Overview
These particular requirements apply for the basic safety and essential performance of electromyographs and evoked response equipment. These particular requirements specify physical safety and operational requirements for patients and operators with regard to electromyographs and evoked response equipment. Equipment intended for transcutaneous electrical stimulation of nerves and muscles are excluded. DIN EN 60601-2-10 (VDE 0750-2-10) applies to this equipment. The standard differs from DIN EN 60601-2-40 (VDE 0750-2-40):2019-04 as follows: a) update of the reference to the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020; b) added requirements for constant voltage stimulators; c) clarified requirements for visual stimulators.
