The IEC 60601-2-4 standard, prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), describes the basic safety and basic performance criteria of cardiac defibrillators (devices that allow the heart to return to normal heart rhythm). . This standard has been published in our country by the Turkish Standards Institute 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.
Electrical devices called defibrillators are used to return the abnormal beat of the heart to normal heart rhythm. When the electrical energy is shocked with this device, the heart is stimulated from the outside and contracts. This medical equipment is also used in the treatment of heart rhythm disorders. There are also small-sized portable devices that are capable of analyzing the heart rhythm, providing circulation when necessary and applying electroshock, which returns the heart to a normal rhythm.
Defibrillators are considered among high risk medical equipment. In order to prevent malfunction of this device during its use, testing and calibration measurements must be made every six months according to international standards. There are various warning indicators on the device.
Briefly, shockable rhythm is defined with defibrillator devices, the complex rhythm is corrected, the patient's condition is monitored and the patient's electrocardiogram is seen.
The following standards referred to during the implementation of the 60601-2-4 standard are indispensable: IEC 60601-1-2 (medical electrical equipment, general requirements for basic safety and basic performance, electromagnetic compatibility), IEC 61000-4-2, Electromagnetic compatibility, electrostatic discharge immunity test) and ISO 15223-1 (medical device labels, labeling and symbols to be used).
Tests in accordance with IEC 60601-2-4 standard are also carried out by our organization within the scope of medical device tests.
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