One focus of the working group is on the development of methods and tools for manufacturers and operators for the modular approval and commissioning of openly networkable medical devices in the OR on the basis of the IEEE 11073 SDC communication standard.
The open dynamic networking of devices from different manufacturers with their hardware and software components represents a completely new situation as well as an essential legal issue with regard to approval capability. The main focus here is on risk management (EN ISO 14971), risk analysis (technical and MMI-centric) and the method of validating software components that communicate via a network. The task is to find a technically feasible and legally unambiguously clarified modular overall architecture which, on the one hand, enables manufacturers to obtain approval as a medical device (including test procedures with regard to conformity and interoperability) and, on the other hand, provides operators with procedures for checking the combinability of medical devices prior to (initial) commissioning.
The aim of this working group is to consider the problem of the modular approval of subsystems with open interfaces as components of integrated total OPs. Within the framework of risk management as part of the conformity assessment procedure, manufacturers must be enabled to include the risk analyses of the individual components in a modular overall risk assessment in flexible integration via open interfaces. For this purpose, tools and standards will be developed to support the new approval process for modular systems. A main objective of the working group is to develop test environments and laboratories together with independent test houses, which enable a verification of medical devices and their SDC interfaces regarding conformity and interoperability as well as regarding validation.