SSH EN 302 195 V2.1.1:2016

Pajisje me Rreze të Shkurtër (SRD); Implantet Mjekësore Aktive me Fuqi Ultra të Ulët (ULP-AMI) dhe aksesorët (ULP-AMI-P) që punojnë në diapazonin e frekuencave nga 9 kHz deri në 315 kHz Standard i harmonizuar që mbulon kërkesat thelbësore të artikullit 3.2 të Direktivës 2014/53EU

Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU

Scope

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 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.