scope:

The present document applies to the following radio equipment types:

• Ultra Low Power Active Medical Implants (ULP-AMI).

• Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-P).

These radio equipment types are capable of operating in all or any part of the frequency bands in table 1

The present document contains the technical characteristics for ULP-AMI and ULP-AMI-P radio equipment which is also addressed by ERC/DEC (01)17 [i.1]. It applies to ULP-AMI devices and accessories ULP-AMP-P operating in the frequency band 402 MHz to 405 MHz:

• for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or

• for telecommand and telemetry to/from an AIMD to another AIMD within the human body.

The present document contains requirements to demonstrate that Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS) "… shall be so constructed 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.