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 | ETSI ENs | Notes | |
|---|---|---|---|---|---|---|---|
| a | 9kHz - 315kHz |
30 dBµA/m at 10 m | ≤ 10% duty cycle | Not specified | EN 302 195 | 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 | EN 302 536 | 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 | EN 300 330 | 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 | EN 302 510 | For Ultra Low Power Medical Membrane Implants (ULP-MMI) for blood pressure measurements | |
| g | 42MHz - 56MHz |
0.01 mW e.r.p. | No requirements | 14 MHz | EN 300 422 | For cochlear implant systems | |
| d1 | 401MHz - 402MHz |
* | * | * | ERC/DEC/(01)17 | EN 302 537 | For Ultra Low Power Active Medical Implant (ULP-AMI) communication systems. * See detailed requirements in the related ERC Decision |
| d2 | 402MHz - 405MHz |
* | * | * | ERC/DEC/(01)17 | EN 301 839 | For Ultra Low Power Active Medical Implant (ULP-AMI) communication systems. * See detailed requirements in the related ERC Decision |
| d3 | 405MHz - 406MHz |
* | * | * | ERC/DEC/(01)17 | EN 302 537 | 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 ≤ 10% duty cycle for peripherals | ≤ 1 MHz | EN 301 559 | For Low Power Active Medical Implants (LP-AMI). The whole frequency band may also be used dynamically as a single channel to maintain a communications session. Peripheral units are for indoor use only. The frequency band is also identified in Annexes 12 and 13. | |
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
Sub-band g):
The specific subset of ETSI EN 300 422 for Cochlear Implants is in development.