Influence of different test gases in a non-destructive 100% quality control system for medical devices

摘要

The purpose of this research is to evaluate the detectability of defect membranes in intravenous (IV) infusion filter systems. The device under test (DUT) protects critical ill patients and has a high priority for the risk management of intensive care units. The developed quality control system stands out from other filter integrity methods because no method located on this topic represents such a simple, reliable, fast and non-destructive technique, examined without liquid. The invented method works as a pressure driven test and uses gas to identify defects. Previous studies have demonstrated the capability of detecting various types of errors. In this paper the influence of different test gases on the detectability of smallest defects is presented.