As leaders in MRI safety, Healtis is actively involved in the evolution of the normative standards surrounding the MRI safety and compatibility testing of both passive and active medical devices.
As such, we wanted to inform you of a recent change in the critical ASTM F2182 standard ‘Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging’ . As of this month, this standard has been updated to edition 19e2.
If you currently have a MR conditional product on the market, this change may affect your device. Contact us today to see how your old test report compares to the new requirements of the current edition of the regulatory standard and what actions you may need to take.