ČSN ETSI EN 302 510 V2.1.1   (875138) Zařízení krátkého dosahu (SRD) - Aktivní zdravotnické membránové implantáty velmi nízkého výkonu (ULP-AMI-M) a periferní zařízení (ULP-AMI-M-P) provozované v kmitočtovém rozsahu 30 MHz až 37,5 MHz - Harmonizovaná norma pokrývající základní požadavky článk

Anotace textu normy ČSN ETSI EN 302 510 V2.1.1   (875138)

The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane Implant Peripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a Medical Implant Communications System in the frequency band 30 MHz to 37,5 MHz.

The present document contains the technical requirements for characteristics of ULP-AMI-M and ULP-AMI-M-P radio equipment which are aligned with annex 12 Sub-band (d) of CEPT/ERC Recommendation 70-03 [i.6].

The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category ´active medical implant devices´ according to 2013/752/EU [i.10] with the following usage restrictions:

- ´This set of usage conditions is only available to ultra-low power medical membrane implants for blood pressure measurements within the definition of active implantable medical devices in Directive 90/385/EEC.´

The present document contains requirements to demonstrate that Ultra Low Power Active Medical Membrane Implants and peripherals used in a medical membrane implant communications system ´. 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.1]). It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.