[Test methods to determine magnetic resonance (MR) safety and MR image compatibility of implants/devices]

In the present article, interactions associated with magnetic resonance (MR) procedures and MR test procedures for implants/devices are examined.

Since 2012, many interactions of items with MR procedures have been physically described and translated into standardized ASTM and ISO testing procedures. Despite the standardized procedures, the determination of the test method to use is an important decision. The MR user is also responsible for the transfer and interpretation of the individual technical parameters despite the MR Conditional labelling and therefore relatively unambiguous instruction. This includes the total MR examination duration, which often has no clinical practical duration, but is derived from the 15 min of the ASTM radiofrequency (RF) heating test.

There has been an increasing standardization of the test methods as well as the MR labeling requirements and the advantageous transfer of the parameters to suitable input masks on the MR systems.

The current use of standardized MR test methods and MR marking represents the best possible state of the art from the point of view of the approval of medical devices as well as from a liability point of view for the manufacturers of implants-and for MR users in clinical practice. However, off-label decisions (i.e., deviations from the manufacturer's official MR marking) in everyday clinical practice can be medically justified.