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Standard [CURRENT]

DIN EN 60601-2-47:2016-02

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

German title
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
Publication date
2016-02
Original language
German
Pages
73

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Publication date
2016-02
Original language
German
Pages
73

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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.

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