Abstract

This particular standard applies to basic safety and essential performance of ECG-equipment and accessories (including ecg electrodes, trunk cables, and lead wires). Additional specific requirements apply to the ECG-equipment based on the intended use claimed by the manufacturer for equipment intended for ECG-patient monitoring, diagnostic, or ambulatory use. This particular standard applies to ECG-equipment for use in professional healthcare facilities as well as in emergency medical service environments and home healthcare environments.

Begin

2019-01-31

Planned document number

DIN EN IEC 80601-2-86

Project number

02228748

Responsible national committee

DKE/GUK 812.1 - Diagnostik und Brain Computer Interfaces  

draft standard

Medical electrical equipment - Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires (IEC 62D/1628/CD:2018); Text in German and English
2019-06
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previous edition(s)

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
2016-02

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Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011 + Cor.:2012); German version EN 60601-2-27:2014
2015-04

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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
2016-08

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