ČSN ETSI EN 302510-V2.1.1 (875138)

Kategorie - ähnliche Normen:

Implants for surgery, prosthetics and orthoticsReceiving and transmitting equipment

Die Annotation des Normtextes ČSN ETSI EN 302510-V2.1.1 (875138):

V2.1.1

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