scope:

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 programmer/controllers), mobile stations (patient programmers, handheld or otherwise) and portable stations (implanted devices providing medical benefit to the implanted patient). All types of digital modulation for implanted radio devices and associated accessories are covered by the present document.