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DIN EN 60601-2-47 VDE 0750-2-47:2016-02

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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

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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.

Author VDE
Editor VDE
Document type Standard
Format Paper
ICS 11.040.55 : Diagnostic equipment
Number of pages 73
Replace DIN EN 60601-2-47 (2002-11)
Cross references EN 60601-2-47 (2015-05), IDT
Weight(kg.) 0.2241
Year 2016
Document history DIN EN 60601-2-47 (2016-02)
Country Germany
Keyword DIN EN 60601;DIN EN 60601-2;EN 60601;EN 60601-2;EN 60601-2-47;60601