SSH EN 301 839 V2.1.1:2016

Implantet Mjekësore Aktive me Fuqi Ultra të Ulët (ULP-AMI) dhe pajisjet Periferike (ULP-AMI-P) që punojnë në diapazonin e frekuencave nga 402 MHz deri në 405 MHz; Standard i harmonizuar që mbulon kërkesat thelbësore të artikullit 3.2 të Direktivës 2014/53/EU

Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU

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.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) operating frequency bands
Transmit Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P)
402 MHz to 405 MHz
Receive Ultra Low Power Active Medical Implants
(ULP-AMI) and Peripherals (ULP-AMI-P)
402 MHz to 405 MHz
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.