MR safety tests
MR safety tests are necessary to indicate whether there are any hazards to the patient resulting from exposure to the MR environment, and if so, under which conditions these hazards remain within tolerable limits. These conditions include include the MR field strength B0, the spatial gradient, dB/dt (time rate of change of the magnetic field), radio frequency (RF) fields, specific absorption rate (SAR) and optionally additional conditions like specific configurations of the device or implant.
In the list on the right several MR safety tests according to ASTM and ISO/TS 10974 are specified. These include tests regarding the interactions of the implant or device with the static magnetic field, the radio frequency (RF) field and the gradient field.
The results of the conducted MR safety and compatibility tests are summed up in the optional MR labeling draft, which can be used as a basis for the categorization as MR Safe, MR Unsafe or MR Conditional in the manufacturer's Instructions For Use (IFU).