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ÖNORM EN 302195-1 V 1.1.1:2004-05
Electromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories - Part 1: Technical characteristics and test methods
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Разработчик:
Зарубежные/ON
ICS:
11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы
Описание
The present document applies to Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers
operating in the range from 9 kHz to 315 kHz and any associated radio apparatus transmitting in the frequency range of
9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital
modulation techniques such as, but not limited to, FSK or pulse position modulation. Analogue voice modulation is not
within the scope of the present document.
The present document contains the technical characteristics and test methods for radio equipment and is referenced in
CEPT/ERC Recommendation 70-03 [2], annex 12 band(b).
The present document does not necessarily include all the characteristics which may be required by a user, nor does it
necessarily represent the optimum performance achievable. It is a product standard which may be completely or
partially superseded by specific standards covering specific applications.
The present document applies to ULP-AMI transceivers conforming to the following:
inductive loop systems;
with an antenna connection and/or with an integral antenna;
for use as telecommunications and telecommand transmission to/from active medical implants.
ULP-AMI equipment has an inherent safety of human life implication, manufacturers and users are cautioned to pay
particular attention to the potential for interference from other systems operating in the same or adjacent bands.
The present document covers physician operated programmer/controllers transmitters (typically fixed stations), patient
operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations).
All types of digital modulation for radio devices are covered by the present document.
The radio equipment, covered by the classification SRD is divided into several power classes based on maximum
radiated field strength or output p (...abbreviated)
Ключевые слова:
Telekommunikation, Fernmeldetechnik, Nachrichtentechnik, Kommunikationstechnologie, Informationsverarbeitung, elektromagnetische Verträglichkeit, EMV, ERM, Funksystem, Funkausrüstung, Funkausstattung, Gesundheit, SRD, Implantat, medizinisch, Medizintechnik, Prüfung, ULP-AMI