Mandatory testing of medical devices

Argentina
Argentina
, 2021-09-14
The Argentinian authority ENACOM released Resolución 1248/2021, in which one lab has been accredited to test the ENACOM-Q2-60.15 Medical Devices standard.

This means local testing will be mandatory from March 1, 2022.

Maximum allowed output power per band:

  • Band 9 - 315 kHz: 30 dB μA/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

Until March 1, 2022 manufacturers are allowed to approve their medical devices with a DoC including: Manufacturer name and address, Product description (brand, model, specification and other details), reference to compliance to ENACOM-Q2-60.15 standard, date and signatory name/surname/position.

Sources:

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