The EN 60601-2-4 standard published by the International Electrotechnical Commission (IEC) describes the basic safety and performance characteristics and test methods of cardiac defibrillators. Heart defibrillators are medical devices used to return the heart's abnormal beat back to a normal heart rhythm. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-2-4 Electrical medical equipment - Part 2-4: Specific features for the basic safety and important performance of heart defibrillators.
This specific standard describes the requirements for the safety of cardiac defibrillator devices, a medical equipment. These implantable devices are small battery-powered devices placed in the chest to monitor heart rhythm and detect irregular heartbeats. This device uses one or more wires attached to the heart to make an electric shock to correct an abnormal heart rhythm.
The EN 60601-2-4 standard covers remote control defibrillators, external transcutaneous pacemakers, and cardiac monitors. Of these, cardiac monitors are addressed in TS EN 60601-2-27 Electrical medical equipment - Part 2-27: Specific features for the required performance and safety of electrocardiographic monitoring equipment. In addition, cardiac monitors using ECG monitoring electrodes are not covered by this standard unless they are used exclusively for AED rhythm recognition detection or beat detection for synchronized cardioversion.
Defibrillation waveform technology is developing and the effectiveness of waveforms is changing. The choice of a particular waveform, including waveform, delivered energy, efficiency, and safety, is specifically excluded from the scope of this standard.
Our organization also provides businesses with basic safety and performance testing services for cardiac defibrillators according to EN 60601-2-4, as part of our laboratory services.
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