scope:

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]).

The present document applies to the following MBANS applications which are considered to operate indoor:

• MBANS operating in the healthcare facility.

• MBANS operating in the patient's home.

The present document contains the following basic technical characteristics of MBANS radio equipment which are also addressed in annex 2 of CEPT/ERC/REC 70-03 [i.2]:

• Healthcare facility MBANS with 1 mW maximum e.i.r.p. and not more than 10 % duty cycle over a maximum emission bandwidth of 3 MHz.

• Patient's home MBANS with 10 mW maximum e.i.r.p. and not more than 2 % duty cycle over a maximum emission bandwidth of 3 MHz.