Concept for the testing of automated functions in therapeutic medical devices Konzept für die Prüfung von autonomen Funktionen von therapeutischen Medizingeräten

In this paper, a testing for highly automated function (HAF) is adapted from the automotive industry to therapeutic medical devices. It contains different steps to achieve a safety argumentation: First, scenarios of interest (SoI) based on a systematic generalization of failure mode and effect analysis (FMEA) are identified, then the concrete scenarios are generated using design of experiment (DoE). These scenarios are simulated virtually and physically and are then evaluated. The procedure is explained with the use of examples.