Ensuring Reliable ECG Performance through Comprehensive Safety Testing

Electrocardiography (ECG) devices play a vital role in modern healthcare by monitoring and recording the electrical activity of the heart. Their applications range from diagnostic examinations to continuous patient monitoring and ambulatory recording. Reliable operation of these devices is essential for providing healthcare professionals with accurate and meaningful information.

Consequently, testing ECG equipment goes beyond basic electrical safety checks. Depending on their intended use, devices must meet specific requirements set out in applicable standards. These include aspects such as protection against electrical hazards, the performance of ECG signal acquisition, and immunity to electrical interference that may occur during medical procedures.

As a testing laboratory, SIQ Ljubljana conducts testing of ECG equipment in accordance with internationally recognized standards from the IEC 60601 series. These include IEC 60601-2-25 for electrocardiographs, IEC 60601-2-27 for electrocardiographic monitoring equipment, and IEC 60601-2-47 for ambulatory electrocardiographic systems. Together with the general requirements of IEC 60601-1, these standards address specific safety characteristics and essential performance requirements relevant to different types of ECG equipment.

By combining expertise in medical electrical equipment with comprehensive testing capabilities, SIQ Ljubljana supports manufacturers at every stage – from product development (pre-compliance testing) and design verification to conformity assessment (full testing). Testing against the applicable IEC 60601 requirements enables manufacturers to demonstrate compliance with internationally recognized safety and essential performance requirements and helps ensure that ECG devices are ready for reliable use in their intended clinical or home environments.

More information:
Urban Kraševec
E-mail: urban.krasevec@siq.si
Tel.: +386 1 4778 377