(IEC 60601-2-47:2012); German version EN 60601-2-47:2015
Class/Status:
Standard,
valid
Released: 2016-02
VDE Art. No.: 0700924
This standard specifies the basic safety and essential performances for ambulatory electrocardiographic systems (medical electrical equipment). Within the scope of this standard are systems of the following types:
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. The type of storage media used is irrelevant with regard to this standard;
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
This standard amends DIN EN 60601-1 (VDE 0750-1):2007-07.
Replacement for:
DIN EN 60601-2-47 VDE 0750-2-47:2002-11
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Prinz, Thorsten (Hrsg.)
Entwicklung und Herstellung medizinischer SoftwareNormen in der MedizintechnikVDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich |
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