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If a device is to be labeled MR Safe, the following information should be provided:
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Data demonstrating that when the device is introduced or used in the MRI environment (i.e. the MRI scan room) it does not pose an increased safety risk to the patient or other personnel,
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a scientifically-based rationale for why data are not necessary to prove the safety of the device in the MR environment (for example, a passive device made entirely of a polymer known to be nonreactive in strong magnetic fields).
If a device is to be labeled MR Compatible, the following information should be provided:
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Data demonstrating that when the device is introduced or used in the MRI environment, it is MR safe that it performs its intended function without performance degradation, and that it does not adversely affect the function of the MRI scanner (e.g. no significant image artifacts or noise). Any image artifact or noise due to the medical device should be quantified (e.g., % volume affected, signal to noise ratio),
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a scientifically-based rationale for why data are not necessary to prove the compatibility of the device in the MRI environment.
Test Conditions:
The static magnetic field strength ( Gauss (G) or Tesla (T)) to which the device was tested and demonstrated to be MRI 'safe', 'compatible', or 'intended for use in' should be related to typical machine ratings (e.g. 0.5 T, 1.5 T, 2.0 T, and shielded or unshielded magnet, etc).
The same conditions should be used for the spatial gradient ( field strength per unit distance (i.e., G/cm)) in which the device was tested and demonstrated to be 'safe', 'compatible', or 'intended for use in'.
Also the RF transmitter power used during testing of the device, should be related to this typical machine ratings. | |
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| • View the DATABASE results for 'MR Compatibility' (4).
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| • View the NEWS results for 'MR Compatibility' (2).
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| | Further Reading: | | Basics:
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News & More:
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