DIN EN 60601-2-25
; VDE 0750-2-25:2016-08
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (IEC 60601-2-25:2011); German version EN 60601-2-25:2015
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographen (IEC 60601-2-25:2011); Deutsche Fassung EN 60601-2-25:2015
Overview
This product standard from the DIN EN 606060-1 (VDE 0750-1) series of standards describes the safety requirements for electrocardiographs, recording and interpreting single-channel and multichannel electrocardiographs, for producing extractable electrocardiograms for diagnostic purposes. They are also applicable to vector cardiographs and devices for stress testing. Minimum safety requirements are included. Specific requirements for use in ambulances for phonocardiographs, cardiographic monitors, polygraphs, telemetry, special examinations (for example, HIS bundle electrocardiographs), and so on, are not covered. Also excluded are medical electrical devices with microelectrodes applied directly in the fibres of the heart muscle. The contents of the standards DIN EN 60601-2-25 (VDE 0750-2-25):2001-04 and DIN EN 60601-2-51 (VDE 0750-2-51):2004-02 were combined in this standard and, at the same time, adapted to the structure and philosophy (basic safety and essential performance characteristics) of DIN EN 60601-1 (VDE 0750-1):2007-07. Furthermore, adaptation to the requirements for electromagnetic compatibility according to DIN EN 60601-1-2 (VDE 0750-1-2):2008-02 was carried out. 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.
