New ENACOM Resolution and Standard for Medical Devices in Argentina: SRMED II

 

The new ENACOM Resolution 4665-E/2017 has been released!

Keypoints:

  • Allocates the frequency bands from 9 to 315 kHz and 30 to 37,5 MHz for the Radiocommunications System for Medical Use (SRMED II)
  • New Technical Testing Standard for Radiocommunications System for Medical Use

From the moment that the first laboratory is recognized for testing the new standard, applicants will have 180 days to perform the tests over their already-approved products. Meanwhile, it will be possible to submit a Declaration of Conformity avoiding testing.

For a copy of the new resolution, or for questions concerning this update, please contact info@americascompliance.com

Resolution ENACOM 4479-E/2017 for Medical Devices

ENACOM has released new 4479-E/2017 regulation that specifies the minimum necessary conditions medical devices must comply with for an effective and efficient use of the radio-electric spectrum. This new regulation will be in effect by September 2017.

Key points from the new resolution:

  • Current attributions of frequency bands from 401 to 406 MHz for low powered devices (established by Resolution 67/2012 and its Amendments) will be no longer in effect.
  • Frequency bands from 401 to 406 MHz will be allocated for the Radio communications System for Medical Use (SRMED).

SRMED are considered as radio communications systems consisting solely of electronic devices implanted or used in the human body and its respective “programming”, for medical purposes.

 

Technical Specifications:

Band structure

  • Bandwidth: 401 – 406 MHz
  • Channeling: Not required.

Transmission Characteristics:

  • Maximum level of Electric Field Strength: 18,260 μV/m @ 3 m in OATS.

Emission Bandwidth for Frequency Range

  • 401 – 402 MHz: 100 kHz.
  • 402 – 405 MHz: 300 kHz.
  • 405 – 406 MHz: 100 kHz.

Device types allowed

  • 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.

This standard may apply to various types of Medical Devices that make use of the radio electric spectrum, including:

  • Implantable pacemakers.
  • Implantable defibrillators.
  • Nerve stimulation.
  • Insulin Meters.
  • Insulin pumps.

If you have any questions, feel free to contact us at info@americascompliance.com