SSH EN 301 839-1 V1.3.1:2009

Çështjet e pajtueshmërisë Elektromagnetike dhe të spektrit të Radios (ERM); Pajisje me Rreze të Shkurtër (SRD); Implantet Mjekësore Aktive me Fuqi Ultra të Ulët (ULP-AMI) dhe pajisjet Periferike (ULP-AMI-P) që punojnë në diapazonin e frekuencave nga 402 MHz deri në 405 MHz; Pjesa 1: Karakteristikat teknike dhe metodat e provës

Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1: Technical characteristics and test methods

Scope

The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals
(ULP-AMI-P) used in a Medical Implant Communications Service (MICS), the required characteristics considered
necessary to efficiently use the available spectrum and serve the interests of implant users. 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 (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.
Also included in the present document is the capability of Low Duty Cycle/Low Power Access in the 403,5 MHz to
403,8 MHz frequency band.
An AIMD is regulated under the AIMD Directive 90/385/EEC [i.10]: radio parts contained therein (referred to herein as
ULP-AMI and ULP-AMI-P for 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 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 which is also addressed by
CEPT/ERC/REC 70-03 [i.2] and annex 12 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 ULP-AMI devices and accessories operating in the band 402 MHz to 405 MHz:
• for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or
• for telecommand and telemetry to/from an AIMD to another AIMD 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 25 MHz.