Abstract
Medical devices, especially when operated in the surgery room, are safety critical systems, as the patient’s life may depend on them. As such, there are high legal requirements to meet by the manufacturers of such devices. One of the typical requirements is that whenever medical devices are interconnected, the whole setup has to be approved by the corresponding legal body. For economical reasons, however, it is desirable to interconnect devices from different manufacturers in an individual fashion for each surgery room. Then however no integration test has been carried out a priori and thus the whole setup could not have been approved. In other words such economical demands impose challenges both on the technical as well as the legal situation. In this contribution, we report on these challenges as well as on first ideas to address them.
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Leucker, M. (2014). Challenges for the Dynamic Interconnection of Medical Devices. In: Margaria, T., Steffen, B. (eds) Leveraging Applications of Formal Methods, Verification and Validation. Specialized Techniques and Applications. ISoLA 2014. Lecture Notes in Computer Science, vol 8803. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-45231-8_29
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DOI: https://doi.org/10.1007/978-3-662-45231-8_29
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