ENACOM has released Resolution 863 (replaces 465-E/2017) with the new technical standard ENACOM-Q2-60.15 V19.1 for approval of medical devices in Argentina.
Highlights of Resolution 863:
– 430~440 MHz band allocation for wireless endoscope medical capsules and related receivers
– Exemption from testing and registration of active implantable medical devices that must be powered by a reader device for operation
Currently assigned frequencies and associated field strengths:
– 9-315 kHz: 30 dBμA/m @ 10m in EPZA
– 30-37.5 MHz: 150,000 μV/m @ 3 m in EPZA
– 401-406 MHz: 18,260 μV/m @ 3 m in EPZA
– 430-440 MHz: 1,480 μV/m @ 3 m en EPZA
With respect to the technical standard ENACOM-Q2-60.15 V19.1, there is currently no accredited laboratory, so no local testing is required. Manufacturers are currently using Declaration of Conformity to demonstrate compliance with standards and testing will be mandatory if an accredited local laboratory is designated.