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 / maximum occupied bandwidth ECC/ERC Deliverable Notes
a 9kHz  -  315kHz
30 dBµA/m at 10m ≤ 10% duty cycle Not specified The application is for Ultra Low Power Active Medical Implant systems using inductive loop techniques for telemetry purposes
b 315kHz  -  600kHz
-5 dBµA/m at 10m ≤ 10% duty cycle Not specified The application is for animal implantable devices
c 12500kHz  -  20000kHz
-7 dBµA/m at 10m ≤ 10% duty cycle Not specified The application is for ULP active animal implantable devices (ULP-AID), limited to indoor only applications. The maximum field strength is specified in a bandwidth of 10 kHz. The transmission mask of ULP-AID is defined as follows: 3dB bandwidth 300 kHz, 10dB bandwidth 800 kHz, 20dB bandwidth 2 MHz. The frequency band is also identified in Annex 9
d 30MHz  -  37.5MHz
1 mW e.r.p. ≤ 10% duty cycle Not specified The application is for Ultra Low Power medical membrane implants for blood pressure measurements.
e 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 and associated peripherals, 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 b) EN 300 330 Sub-band c) EN 302 510 Sub-band d) EN 301 559 Sub-band e)

Technical parameters also referred to in the harmonised standard
No information

Frequency issues