The aim of the project is to develop a technical-methodical approach that supports the approval and certification process as well as the risk management of networked medical devices in integrated operating theatres and thus also enables small and medium-sized companies in the medical technology sector to access the market.
For this purpose, a test platform including suitable protocols, test scenarios and test fields as well as corresponding approval strategies will be developed which is able to test the networking of medical devices and software components in various simulated scenarios and to validate them with regard to various parameters. The networking is based on the now approved IEEE 11073 SDC standard family (SDC for short). SDC stands for service-oriented device connectivity. Due to the intensive work of the colleagues from OR.NET e.V. and the participating colleagues from the MoVE consortium (AP 12), the IEEE 11073-20701 standard has also been adopted since September 2018 and is now being prepared for publication. The first partial standard IEEE 11073-20702 was already declared an ISO standard at the end of 2018. This is also to be expected for the other partial standards in the coming period.
Fritz Stephan GmbH
HEBU Medical GmbH
steute Schaltgeräte GmbH & Co.KG
Aachen University Hospital, Medical Technology Section
University of Leipzig, ICCAS
University of Lübeck, IMI
University of Lübeck, ISP
University of Rostock, IMD
University Transfer Clinic Lübeck (UTK)
RWTH University of Aachen, meditec