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AAMI Technical Information Report Gives Guidance to AIMD Designers Regarding MRI Compatibility

AAMI Guidance Implantable Device Compatibility with MRI

A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans.

ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform manufacturers about device behavior and patient risks so that MR-conditional AIMDs can be designed and labeled appropriately.  The introduction to the TIR explains:

Test methods described in this Technical Specification are primarily designed and intended as bench-top tests using equipment and techniques to simulate the fields (B0 static, gradient, and RF) found in MR 1.5 T scanners. Although, in a few cases, clinical scanner tests are implied, in all others, the AIMD manufacturer assumes the burden for development and validation of clinical scanner-based test methods.  Furthermore, the test signals and parameters specifically described within this Technical Specification for bench-top testing are not being encouraged or recommended for use on clinical scanners and to do so might result in scanner damage.

 
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