ANNEX 12: ACTIVE MEDICAL IMPLANTS AND THEIR ASSOCIATED PERIPHERALS

Scope of annex
This annex covers frequency bands and regulatory as well as informative parameters recommended for Active Medical Implants and their associated peripherals.

Frequency Band Power / Magnetic Field Spectrum access and mitigation requirements Modulation /occupied bandwidth ECC/ERC Deliverable Notes
a 9kHz  -  315kHz
 30 dBµA/m at 10 m ≤ 10% duty cycle Not specified For Ultra Low Power Active Medical Implants (ULP-AMI) using inductive loop techniques for telemetry purposes
e 315kHz  -  600kHz
 -5 dBµA/m at 10 m ≤ 10% duty cycle Not specified For animal implants. The frequency band is also identified in Annex 9.
f 12500kHz  -  20000kHz
 -7 dBµA/m at 10 m per 10 kHz ≤ 10% duty cycle Not specified For Ultra Low Power active Animal Implants Devices (ULP-AID), limited to indoor use only. The frequency band is also identified in Annex 9.
b 30MHz  -  37.5MHz
 1 mW e.r.p. ≤ 10% duty cycle Not specified For Ultra Low Power Medical Membrane Implants (ULP-MMI) for blood pressure measurements
d 401MHz  -  406MHz
 * * * ERC/DEC/(01)17 For Ultra Low Power Active Medical Implant (ULP-AMI) communication systems. * See detailed requirements in the related ERC Decision
c 2483.5MHz  -  2500MHz
 10 dBm e.i.r.p. LBT+AFA and ≤ 10% duty cycle. The equipment shall implement a spectrum access mechanism as described in the applicable harmonised standard or an equivalent spectrum access mechanism ≤ 1 MHz For Low Power Active Medical Implants (LP-AMI), covered by the applicable harmonised standard. Individual transmitters may combine adjacent channels on a dynamic basis for increased bandwidth higher than 1 MHz. Peripheral units are for indoor use only. The frequency band is also identified in Annex 2.

Additional Information

Harmonised Standards
EN 302 195 Sub-band a) EN 302 536 Sub-band e) EN 300 330 Sub-band f) EN 302 510 Sub-band b) EN 301 839 and EN 302 537 Sub-band d) EN 301 559 Sub-band c)

Technical parameters also referred to in the harmonised standard
Sub-band f): The transmission mask of ULP-AID is defined as follows: 3 dB bandwidth 300 kHz, 10 dB bandwidth 800 kHz, 20 dB bandwidth 2 MHz.

Frequency issues
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