On August 12th, 2020 ENACOM published the resolution No 863 for Medical Devices, also ENACOM issued a new standard named ENACOM-Q2-60.15 V19.1.

The principal objective of is new resolution is:

1. Allocate the frequency bands for the Radiocommunication System for Medical Use (SRMED), with a secondary category.

2. Provide that, for the use of the indicated bands.

3. Approve the Technical Standard for homologation for the devices of the Radiocommunication System for Medical use (SRMED).

4.Establish that the models of equipment reached by the present, must be registered in RAMATEL.

5.Establish that passive implantable medical devices, which require for their operation to be energized by a reader device, will be exempt from registration in the RAMATEL.

Important:

• Devices already registered under old standard of medical devices have 180 days since habilitation of the first laboratory allowed to perform these tests.

• Medical devices using frequencies within 9-315 kHz or 30-37,5 MHz are allowed to be renewed or registered under Low Power Standard for 30 days since new resolution is published. But once laboratories are adapted to test, devices must be retested.

Maximum allowed output power per band:

• Band 9 - 315 kHz: 30 dBμA/m @ 10m in EPZA

• Band 30 - 37.5 MHz: 150 000 μV/m @ 3 m in EPZA

• Band 401-406 MHz: 18,260 μV/m @ 3 m in EPZA

• Band 430-440 MHz: 1,480 μV/m @ 3 m en EPZA (new)

At the moment, there is no lab accredited to test under this standard, neither under the previous standard. For that reason, ENACOM allows manufacturers to approve these devices using a Declaration of Conformity including: Manufacturer name and address, Product description (brand, model, specification and other details), reference to compliance to ENACOM-Q2-60.15 V19.1 standard, date and signatory name/surname/position.

Once one lab get the accreditation to test under this standard, the DoC option will be removed.

Sources in Spanish:

https://www.boletinoficial.gob.ar/detalleAviso/primera/233527/20200812

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