A Practical Guide to ECG Device Performance Testing According to International Standards

The primary objective of this paper was to present a complete procedure, including a tester schematic, to test the compliance of any electrocardiographic (ECG) device or its elements, such as the analog front-end (AFE), with the International Electrotechnical Commission (IEC) standards. The paper highlights the importance of designing ECG devices in compliance with the standards, an issue often overlooked in academic research at a lower technology readiness level, and provides detailed guidance on the testing procedure. A measurement system designed to evaluate the performance of ECG devices in accordance with three IEC standards (60601-2-25, 60601-2-27, and 60601-2-47) is presented. A review of standard measurement procedures was conducted using a device equipped with the ADS1298 AFE. The measurements demonstrating the ADS1298’s compliance with the IEC 60601-2-25 ECG standard were performed using the ECG Tester TEST, manufactured by the Łukasiewicz Research Network–Krakow Institute of Technology, Biomedical Engineering Center.