FDA SAFETY STANDARDS

We’ve got you covered for safety!
Cardinal Medical is proud to be among the leaders of the MRI industry working to adhere to the new American Society of Testing and Materials (ASTM) International Standards for MRI Device Marking. These new standards are aimed at eliminating the confusion of the Food and Drug Administration’s (FDA) previous terms “MR Safe” and “MR Compatible.” We encourage our customers to request an email copy of the test results. There are now three terms applicable to MRI Device Marking for safety:

MR SAFE as defined by the ASTM International document is applied to an item that poses no known hazards in all MR environments. MR SAFE items would include nonconducting, nonmagnetic items such as a plastic Petri dish. The document further states that an item may be determined to be MR SAFE by providing a scientifically based rationale rather than test data. Unlike the previous FDA’s definition of MR Safe, the new MR SAFE may only be applied if the item is 100% safe, without exception, regardless of MR system field strength or any environmental or extenuating circumstances. The universal icon to be used for all MR SAFE products is a green square with white capital letters “MR”, or, a white square with green border and green capital letters “MR”. Items marked with the green MR SAFE icon may be taken into, used, or placed anywhere within any MR environment without risk or potential harm.
MR CONDITIONAL is defined by the ASTM International as an item that has been demonstrated to pose no known hazards in a specified MR environment with specifiedconditions of use. Conditions that may be used to define the specified MR environment include field strength, spatial gradient, RF fields, specific absorption rate (SAR) as well as the potential for additional conditions such as operational conditions for a device. The MR CONDITIONIAL label is used to alert the user that there are certain limitations to the usability of the item, or the testing that was performed. As an example, an item may have been tested for a 1.5-Tesla system, but not a 3-Tesla. Items bearing the MR CONDITIONAL icon should include additional information on the label, as to what the conditionality of use is, such as a gauss-line restriction or SAR level limitation. The icon designated for MR CONDITIONAL marking is a yellow equilateral triangle with a black border and black capital letters “MR” inside.
MR UNSAFE as defined by the ASTM International is any item that is a known threat or poses ahazard in all MR environments. An example of an MR UNSAFE item would be a pair of ferromagnetic scissors, or any item constructed of ferrous metals. The MR UNSAFE icon consists of a white circle with red border and diagonal strike through and the capital black letters “MR” inside.