ETSI - EN 302 195-2
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 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
|Publication Date:||1 March 2004|
The present document applies to Ultra Low Power Active Medical Implants (ULP-AMI) transmitters and receivers:
- transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m;
- receivers operating in the range from 9 kHz to 315 kHz.
The present document applies to ULP-AMI devices:
- either with a Radio Frequency (RF) output connection and dedicated antenna, or with an integral antenna;
- for telecommand, telemetry etc. applications;
- for all types of digital modulation;
- with or without speech.
The present document covers fixed stations (physician
All types of digital modulation for implanted radio devices and associated accessories are covered by the present document.
The power class designation is based on CEPT/ERC Recommendation 70-03 .
The present document is intended to cover the provisions of article 3.2 of Directive 1999/5/EC (R&TTE Directive)  article 3.2, which states that "... radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference".
In addition to the present document, other ENs that specify technical requirements in respect of essential requirements under other parts of article 3 of the R&TTE Directive  may apply to equipment within the scope of the present document.