On November 29, 2017, the Telecom Regulator ENACOM released Resolution 4665-E/2017 which specifies the minimum necessary conditions that the medical devices must comply with for an effective and efficient use of the radio-electric spectrum.
This new Resolution enters in effect on January 1st, 2018 (30 days after its publication)
Resolution highlights:
1. The frequency bands from 9 to 315 kHz and from 30 to 37.5 MHz are being allocated for the Radio Communication System for Medical Use (SRMED), with secondary category, having to comply with the conditions established in the Annex “Definitions and Technical Parameters of the SRMED, registered in the Annex IF-2017- 25768526- APN-DNPYC#ENACOM.
2. It establishes that the equipment models reached hereby must be registered in the Registration of Telecommunication Activities and Materials (RAMATEL).
3. The passive implantable medical devices, which require for their operation to be energized by a reading device, will be exempt from the registration in RAMATEL.
4. Until one Accredited Laboratory has been authorized to carry out tests based on the standard approved, a Declaration of Conformity will be accepted conditionally, as indicated in the Annex “Declaration of Conformity” registered in the Official Document IF-2017-25768786-APN-DNPYC#ENACOM.
5. The applicants who have registered equipment under the conditions established within a period of 180 consecutive days as of the first laboratory’s approval, the reports of tests issued by an accredited laboratory, for its definitive homologation. The inscriptions that do not adapt in time and form to this situation, will expire automatically.
6. It is established that up to 30 consecutive days after the publication of the present document, interested parties may request the registration or renewal in RAMATEL of medical devices operating in the frequency bands of 9 to 315 kHz and 30 to 37.5 MHz, in accordance with the provisions of ENACOM Resolution No. 6038/2016.
Technical Parameters include:
Maximum level of Electric Field Strength:
9 to 315 kHz: 30 dBµA/m @ 10 m at OATS
30 to 37,5 MHz: 150,000 µV/m @ 3 m at OATS
401 to 406 kHz: 18,260 μV / m @ 3 m at OATS
Emission Bandwidth by Frequency Range:
9 – 315 kHz: No limit.
30 – 37,5 MHz: No limit.
401 – 402 MHz: 100 kHz.
402 – 405 MHz: 300 kHz.
405 – 406 MHz: 100 kHz.
Allowed Device Types:
9 – 315 kHz: Implantable and programmers.
30 – 37,5 MHz: Implantable and readers.
401 – 402 MHz: Implantable, programmers and used in the body.
402 – 405 MHz: Implantable, and programmers.
405 – 406 MHz: Implantable, programmers and used in the body.
Protection against interference exclusively for the band 401 to 406 MHz. It must incorporate a control system for access to the environment in order to minimize the possibilities of interference, in accordance with the technical standard of homologation.
Please refer to PDF attached to view full Resolution from ENACOM (Spanish).