ETSI - EN 302 195-1
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 and Accessories; Part 1: Technical characteristics and test mehtods
|Publication Date:||1 January 2004|
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/ECC Recommendation 70-03 , 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 It is a product standard which may be completely or partially superseded by specific standards covering specific applications.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
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 power (see table 1). The power class designation is based on CEPT/ERC Recommendation 70-03  and ERC Decisions.