ÖNORM EN 301839-1 V 1.1.1

The present document covers, for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS), the required characteristics considered necessary to efficiently use the available spectrum and protect the public. ULP-AMI equipment and accessories in the MICS service is a unique new technology, available world wide in the medical field, that will provide high speed communications capability between individuals with implanted devices and medical practitioners engaged in utilizing these implants for the purposes of diagnosing and delivering therapy to individuals with various illnesses. The specifications contained in the present document were developed to insure 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 (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and the primary users of the band. Equipment in the MICS service consists of active medical implants that communicate only to other active medical implants or to external programmer/control transmitters. The present document is a specific product standard applicable to active medical implants operating in the frequency band, 402 MHz to 405 MHz, and other radio devices that are considered to be accessories to active medical implants as described in Directive 90/385/EEC [6]. It is intended that the present document applies to operation in the band 402 MHz to 405 MHz only and 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 ULP-AMI radio equipment and is referencing CEPT/E (...abbreviated)