ČSN ETSI EN 302195-V2.1.1 (875119)

The category - similar standards:

Implants for surgery, prosthetics and orthoticsReceiving and transmitting equipment

Annotation of standard text ČSN ETSI EN 302195-V2.1.1 (875119):

V2.1.1

The present document applies to ULP-AMI equipment operating in the frequency range from 9 kHz to 315 kHz and any associated Peripherals (ULP-AMI-P) transmitters and receivers operating 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 applies to ULP-AMI/ULP/AMI-P transmitters and receivers:

• - transmitters operating in range from 9 kHz to 315 kHz with power levels ranging up to 30 dBuA/m at 10m;
• - 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.

The present document covers ULP-AMI-P fixed stations (physician programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the implanted patient).

The present document contains the technical requirements for characteristics of ULP-AMI/ULP-AMI-P radio equipment which are aligned with annex 12 Sub-band (a) of CEPT/ERC Recommendation 70-03 [i.1].

The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP AMI) and Peripherals (ULP AMI P) operating in the frequency range 9 kHz to 315 kHz "shall be so con-structed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.2]. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable