Development of a standard reference object for monitoring quality and reproducibility in dB/dt-heating tests for medical devices

The intent of this study is to introduce and characterize a standard reference object for gradient-induced dB/dt heating studies. Key attributes of a standard reference object would be simplicity, sensitivity (large response to exposure conditions), and reproducibility. Various geometries, materials, and exposure conditions were studied, and the results indicate the temperature rise of a simple copper annulus can be used to verify all components of a dB/dt exposure and measurement system are functioning prior to a device test. The thermal response of a 5-cm diameter copper annulus was characterized as a function of frequency and dB/dt-amplitude, both in air and in tissue-mimicking gel.