Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Dir...
1Key Takeaways
The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane ImplantPeripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a MedicalImplant Communications System in the frequency band 30 MHz to 37,5 MHz.Table 1: Ultra Low Power Acti…
2Scope / Description
The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane ImplantPeripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a MedicalImplant Communications System in the frequency band 30 MHz to 37,5 MHz.Table 1: Ultra Low Power Active Medical Membrane Implants andPeripherals operating in the frequency band 30 MHz to 37,5 MHzUltra Low Power Active Medical Membrane Implantsand Peripherals service frequency bandsTransmitters Ultra Low Power Active MedicalMembrane Implants and peripherals 30 MHz to 37,5 MHzReceivers Ultra Low Power Active MedicalMembrane Implants and peripherals 30 MHz to 37,5 MHzThe present document contains the technical requirements for characteristics of ULP-AMI-M and ULP-AMI-M-P radioequipment 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 bloodpressure 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 Implantsand peripherals used in a medical membrane implant communications system " shall be so constructed that it botheffectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 ofthe 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.