The project ROTESS (risk-based testing of safety critical systems) was launched in July 2009 and lasted until end of 2010. It was supported by the Fraunhofer research program Challenge with two participating Fraunhofer institutes, namely IESE and FOKUS (Competence Center MOTION).

In the joint project, IESE and FOKUS will work on concepts and case studies for risk-based testing of medical systems. Like in many other technical domains, medical systems become more and more software intensive electronic systems. A number of national and international standards place strong safety requirements on such systems, like ISO 14971 and ISO 13485. The goal of the project was to provide testing concepts for risk management of electronic systems in the medical domain. Both partners brought their long experience in the field of testing into the research work. Workshops and show cases were planned to attract the medical industry and to establish long term co-operations.

Our approach was a model-based and risk-oriented approach. The starting point was the formalization of safety requirements resulted from hazard analysis e.g. FMEA or FTA using Behavior Tree, a formal requirement modeling language. This language will be extended to populate risk, which is in general characterized by probability and severity of hazard occurrence, in the behavior trees. The requirement modeling will be refined after transformed into the UML. UML profiles like U2TP or QoS-Profile can be used to describe testing related details, in order to facilitate risk-oriented test generation and test execution.