EMC testing ensures that the electronic or electrical device does not emit many radiated or conducted emissions while still functioning as intended in other electromagnetic environments. For medical devices, EMC testing determines the product’s basic safety and reveals whether or not the intended
performance and outcome are occurring. EMC testing also gauges a medical device’s ability to function as it should in the electromagnetic environment it is in without a strong, adverse reaction. These requirements are similar to the functional safety assessment of EM disturbances in other areas of the
medical device industry.
Regulatory bodies across the globe have enacted standards and limitations on the levels of emissions that electronic and electrical products can generate. Although a few exemptions exist, EMC immunity testing is often mandated for those who design, manufacture, or import electronic products – specifically concerning medical devices. There are two standards for testing, IEC 60601, which includes a section regarding EMC testing, while AIM 7351731 takes a more in-depth approach by layering RFID protection compliance testing on existing EMC testing.
TÜV SÜD’s EMC facilities offer accredited testing to the AIM 7351731 standard and are among the few facilities to provide this service in the US.