SAFETY TESTING FOR A PLASMA-BASED DISINFECTION DEVICE FOR DENTISTRY

Abstract

The driving force behind this work is the compliance of a dental disinfection device with the regulatory standard DIN EN 60601-1, which is mandatory for all medical electrical devices in the European Union and the United States. The project was motivated by the challenges faced by companies in complying with these regulations, as few certified regulatory bodies exist to assess the compliance of devices. To evaluate compliance with the necessary standards, various safety tests were conducted, including mechanical resistance, electrical insulation, and maximum temperature tests. Furthermore, the technology employed by the device, namely plasma, was described, and an overview of the current regulations for medical device manufacturers was provided. The experiments also allowed for the characterization of technical specifications, including the IP rating, of the device's footswitch. Insulation testing, for example, is of great importance as it directly contributes to reducing the risk of electric shock to both patients and operators. Therefore, the tests performed in this work directly save lives. The results of this investigation demonstrate that the device meets the regulatory standards, indicating its compliance with the necessary requirements here addressed. This research contributes to the advancement of compliance research in the field of medical electrical devices and offers valuable insights to enterprises navigating the complex regulatory landscape for market approval.