Mechanical and electrical design standards of medical devices

The construction of the iToBoS machine is a great challenge for the ATMO-2ES team at Bosch.

There are various regulations that apply to the construction of medical equipment, such as IEC60601-1 (“General requirements for basic safety and essential performance”), the standard EN ISO 14941 (“Medical devices – Application of risk Management to medical devices”) or Regulation 2017/745 of the European Parliament for medical devices. 

The objective of the iToBoS project is the construction of prototypes with a level of technological maturity TRL7 (Technology readiness level 7). But what levels of technological maturity exist? It is a scale that goes from TRL1 to TRL9, and in this case TRL7 is about carrying out a prototyped demonstration of the system in an operational environment, without being complete, validated and not yet in a state of being susceptible to be manufactured and marketed. This, applied to the case of iToBoS, means the construction of the intelligent scanner demonstrating its functionality, and that it is tested with real patients in a medical room, but without necessarily having to comply with all the regulations, validations and standards that may affect (although the objective is to get as close as possible to all these regulations in order for the prototype to be as close as possible to a final product).