How to Assess EMI-Risk Acceptability Criteria in Medical Device EMC Risk Management

Electromagnetic-interference (EMI) risks are among the potential causes of failure in all electronic equipment. Therefore, it is crucial to define EMI-risk acceptability criteria (EMI-RAC) at the beginning of the electromagnetic-compatibility (EMC) risk management process to decide the acceptable risk levels to be achieved. However, defining these criteria is complex due to their dependence on various factors, such as regulations, standards, state-of-the-art (SOTA) practices, reference databases, and expert judgment. Therefore, this letter discusses how to distinguish acceptable, tolerable, and unacceptable risk boundaries and regions that define EMI-RAC. This letter provides practical guidelines for manufacturers through simple anecdotal examples where the business objectives are systematically transformed into technical acceptability criteria and eventually into verifiable EMC testing performance criteria. It also illustrates how manufacturers can represent criteria and balance risk reduction in medical device design to manage EMI risks. This is achieved in relation to risk-benefit analysis and SOTA solutions while avoiding field failures and damage to reputation.