ETSI - EN 301 559-1
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 1: Technical characteristics and test methods
|Publication Date:||1 June 2012|
The present document covers, for Low Power Active Medical Implants (LP-AMI), 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. Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.7]: radio parts contained therein (referred to herein as LP-AMI, and LP-AMI-P for associated peripheral devices) are regulated under the Directive 1999/5/EC [i.1] (R&TTE Directive).
It is intended that the present document applies to operation in the band 2 483,5 MHz to 2 500 MHz that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands.
The present document contains the technical characteristics for LP-AMI and associated peripherals radio equipment which is also addressed by CEPT/ERC/REC 70-03 [i.2] and annex 12 band f 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.
It applies to LP-AMI and associated peripherals operating in the band 2 483,5 MHz to 2 500 MHz:
• for telecommand and telemetry to/from an LP-AMI in a patient's body to LP-AMI-P or between these equipments;
• for telecommand and telemetry to/from an LP-AMI to another LP-AMI within the human body;
• with or without an integral antenna; and/or
• with an antenna connection provided only for the purpose of connecting an external dedicated antenna.
The present document covers requirements for radiated emissions above 30 MHz.