Development and Validation of a Device for Mechanical Bend Test in Cardiac Defibrillators Electrodes Cables in Accordance with ABNT NBR IEC 60601-2-4:2014

摘要

The reliability and safety in electromedical equipment identified by certification tests mainly depend on the use of measuring instruments and appropriate testing devices. According to the subclause 201.15.4.101 of the Technical Standard ABNT NBR IEC 60601-2-4:2014, cardiac defibrillators cables and electrodes must be tested to mechanical bend endurance using a suitable electromechanical device. The present article describes the development and validation of a device to be employed in a Tests Laboratory accredited by CGCRE/INMETRO to perform this conformity test.