本文件包含证明医疗身体区域网络系统（MBANS）“的构造应确保其有效使用并支持有效使用无线电频谱，以避免有害干扰”（指令2014/53/EU第3.2条）[i.3]。本文件不一定包括用户可能需要的所有要求，也不一定代表可实现的最佳性能。可属于MBANS的设备类型包括医疗设备指令（指令93/42/EEC[i.5]）涵盖的体上和体外医疗传感器、患者监测设备和医疗执行器。本文件适用于以下被视为在室内操作的MBA应用:在医疗设施中操作的MBA。在患者家中工作的MBA。本文件包含以下MBANS无线电设备的基本技术特性，这些特性也在CEPT/ERC/REC 70的附件2中进行了阐述- 03[i.2]:医疗设施MBAN，最大e.i.r.p.为1 mW，最大发射带宽为3 MHz，占空比不超过10%。患者家中的MBAN，最大e.i.r.p.为10 mW，最大发射带宽为3 MHz，占空比不超过2%。

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.