DIN Standards Committee Health Technologies
DIN EN 60601-2-47
; VDE 0750-2-47:2016-02
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems (IEC 60601-2-47:2012); German version EN 60601-2-47:2015
Medizinische elektrische Geräte - Teil 2-47: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von ambulanten elektrokardiographischen Systemen (IEC 60601-2-47:2012); Deutsche Fassung EN 60601-2-47:2015
Overview
This standard applies to the safety and essential performance of ambulatory electrocardiographic equipment/systems used in medical treatment and an adaptation to the DIN EN 60601-1 family including the supplementary standards. Electrocardiographic equipment are: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The responsible committee is Subcommittee DKE/UK 812.1 "Diagnostik" ("Diagnostics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
