We have recently expanded our capabilities to include MRI safety evaluation of electrically active devices to our scope of accreditation.
MED Institute is accredited to ISO/IEC 17025:2017, BSI certified to ISO 13485:2016, and BSI audited to ISO 14155:2011 by Perry Johnson Laboratory Accreditation (PJLA). Our multi-disciplinary team has most recently added ISO/TS 10974:2018 to our scope of PJLA accredited test methods. ISO/TS 10974 is a test specification used for assessing the safety of magnetic resonance imaging for patients with an active implantable medical device (AIMD).
An “active medical device” refers to an electrically active device that is surgically or medically introduced into the human body that remains in place after the procedure. AIMDs require an internal or external power supply such as a battery or other electrical source and may contain accessories including but not limited to lead wires, battery packs, or controllers.
Examples of AIMDs:
AIMDs can be complex and present a higher risk classification as they are designed to remain implanted for extended periods of time and rely on a power source to function. Electrically active devices could be hazardous in the MRI environment because of the interactions with the static magnetic field, gradient fields, and RF fields of an MRI system. One of the unique concerns of introducing an AIMD into the MRI environment is the potential for device malfunction. Exposure to these various electromagnetic fields may interfere with the electronic components and cause device failure such as a performance degradation, loss of function, or unintentional responses.
We have a considerable history developing and gaining approval on Class III and unique Class II implants. We can help evaluate your AIMD for MRI safety and provide labeling for your device. We can test for magnetically induced force and torque, radiofrequency induced heating, gradient induced heating, gradient induced vibration, B0 malfunction, RF-induced malfunction, gradient induced malfunction, and combined fields testing for your active device.
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