ETSI - EN 301 559
Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the 2 483,5 MHz to 2 500 MHz range; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
|Publication Date:||1 October 2016|
The present document covers, for Low Power Active Medical Implants (LP-AMI) using the band bands 2 483,5 MHz to 2 500 MHz, and associated Peripherals (LP-AMI-P) used in an Active Medical Implant Communications System (AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential between AMICS operating in the band or between AMICS and other primary or secondary users of the band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.5] radio parts contained therein (referred to herein as LP-AMI and LP-AMI-P for associated peripheral devices) are regulated under the Directive 2014/53/EU [i.1].
The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are EU wide harmonised for the SRD category "active medical implant devices" according to Commission Implementing Decision 2013/752/EU [i.13] with the following usage restrictions:
- "This set of usage conditions is only available to active implantable medical devices. Peripheral master units are for indoor use only."
The present document contains the technical characteristics for LP-AMI and associated peripherals LP-AMI-P radio equipment which is also addressed by CEPT/ERC/REC 70-03 [i.3] annex 12 sub-band e) to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.
The present document applies to LP-AMI and LP-AMI_P operating in the band 2 483,5 MHz to 2 500 MHz:
• for telecommand and telemetry between LP-AMI and LP-AMI-P;
• for telecommand and telemetry between LP-AMI to another LP-AMI;
• with or without an integral antenna; and/or
• with an antenna connection provided only for the purpose of connecting a dedicated antenna.
The present document contains required characteristics considered necessary for the radio devices used in AMICS to meet in order to efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and delivering therapies to individuals with various illnesses. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between AMICS operating in the band or between an AMICS and the primary users of the band.
The present document is a specific product standard applicable to low power transmitters that are part of a system used in the AMICS operating in spectrum within the frequency band 2 483,5 MHz to 2 500 MHz.
The present document contains requirements to demonstrate that Low Power Active Medical Implants (LP-AMI) "…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.1]. 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