Study of a Statistical Risk-Analysis Tool for Evaluating Interference Impact on an ECG Signal

The latest European Union regulations mandate a risk-based approach to electromagnetic compatibility (EMC). In this context, this study addresses challenges in assessing medical devices’ risk over diverse electromagnetic environments and extended service periods. Combining an ECG signal with waveforms representing various interferences, it explores a novel concept for statistically evaluating interference impact on cyclic biosignals, such as the electrocardiogram (ECG), akin to statistical eye diagrams. The tool offers utility for risk analysis and EMC debugging as it extends insight beyond basic statistical parameters, such as mean or standard deviation, by visualizing the distribution of the total signal for each sample on a unit interval.