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. 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).