EMC evaluation in radiation-emitting medical devices: regulatory limits and an integrated safety approach

INTRODUCTION: Electromagnetic compatibility (EMC) is a fundamental safety requirement for medical devices, ensuring both the limitation of electromagnetic emissions and adequate immunity to external electromagnetic disturbances. AREAS COVERED: Within the European regulatory framework, EMC is addressed in the Regulation 2017/745 (MDR), which requires manufacturers to minimize radiation emissions, prevent interference with other devices, and provide appropriate information in the instructions for use. The main technical reference standard for EMC is IEC 60,601-1-2, which defines test methods and limits for electromagnetic emissions and immunity. However, this standard evaluates radiated emissions only above 30 MHz, creating a regulatory gap for devices operating at lower frequencies. Moreover, it does not address the assessment of unintended or spurious emissions below this threshold. EXPERT OPINION: To address these limitations, additional standards and guidelines must be considered. IEC 62,311 provides methodologies for assessing human exposure to electromagnetic fields across the frequency range 0 Hz-300 GHz, while exposure limits can be derived from the ICNIRP guidelines and the European Directive 2013/35/EU. By combining EMC testing according to IEC 60,601-1-2 with exposure assessment based on IEC 62,311 and comparison with ICNIRP limits, manufacturers can demonstrate full regulatory compliance in terms of EMC.