For patient safety, it is important that a medical device can safely and reliably perform its intended purpose. The challenge in medical technology is that medical devices are heterogeneous systems and thus no widely applicable standard concepts for functional safety exist in medical technology. This is also reflected in the regulatory landscape, with its rather generally applicable standards. Patient safety is currently achieved by performing continuous risk management with an acceptable level of residual risk. Functional safety and its design concepts, as applied in other industries, have so far found little application in the field of medical technology. In this paper, the automotive safety concept "EGAS" is analyzed with regard to its applicability for medical devices. Based on the investigated example of a medical ventilator, important parallels were found between the automotive and the medical device sector, indicating the possibility of successfully applying the EGAS safety concept to medical devices.

Aspiration catheters play an important role in mechanical thrombectomy in interventional neuroradiology as they provide support for stent retrievers or are increasingly used separately for contact aspiration. To evaluate the performance of different aspiration catheters in terms of suction force, most current studies rely on manual measurement methods or the suction force is not measured close to the aspiration catheter tip. Moreover, there is currently no standardized method that records measurements digitally and with high temporal resolution. To overcome these challenges, we propose a new test bench that simulates a dedicated aspiration scenario and takes measurements close to the aspiration catheter tip. To meet the requirements, a simplified vascular phantom, a pressure sensor and a simplified clot model were implemented in the prototype. To demonstrate the applicability of the prototype, two commonly used aspiration catheters were evaluated. The obtained measurements show that it is possible to perform standardized comparisons between aspiration catheters from different manufacturers as well as different aspiration pumps and aspiration tubings and their combinations. The developed prototype overcomes the still widely used manual and semimanual and thus error prone measurement methods for the evaluation of vacuum based thrombectomy systems.