scope:

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. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.3] 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 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.

In addition to the present document, other ENs that specify technical requirements in respect of essential requirements under other parts of article 3 of the R&TTE Directive [i.1] will apply to equipment within the scope of the present document.