The present document contains requirements to demonstrate that Medical Body Area Network System (MBANS)
“…shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid
harmful interference” (article 3.2 of the Directive 2014/53/EU) [i.3]. The present document does not necessarily include
all the requirements which may be required by a user, nor does it necessarily represent the optimum performance
achievable.
The types of devices that can belong to MBANSs are on-body and off-body medical sensors, patient monitoring devices
and medical actuators covered by the Medical Device Directive (Directive 93/42/EEC [i.5]).