The problem we are addressing is easy enough to understand: many people need permanently or semipermanently implanted medical devices (e.g. pacemakers), and many of these people will need an MR scan at some point in their lives.
The MR environment is especially challenging for medical devices for several reasons.
The electromagnetic environment is both highly complex and extreme. Static magnetic fields thousands of times stronger than Earth’s magnetic field are present. Spatial gradients of the static magnetic fields result in massive forces and torques on even slightly magnetic materials and objects.
Strong time-varying (kHz, or “audio frequency”) gradient fields result in heating of conductive devices, electromagnetic interference, and kHz mechanical vibrations and torques.
Finally, the radiofrequency (RF) electric and magnetic fields are much more intense than anything humans or devices are normally exposed to. Exposure to RF fields primarily results in significant device heating. RF electromagnetic interference can also be a problem in control and communication circuits.
We support and guide clients through all stages of device testing:
- initial evaluation and assessment;
- planning and protocol development;
- computer simulations as required;
- technical execution;
- regulatory submission and review (ongoing, any jurisdiction worldwide);
- sustained engineering, ongoing review of product modifications and evolution.
We also offer customized educational and training courses (at any level) for MRI safety and physics. Contact us for more information or to discuss your individual needs.
We provide qualified testing to all of the following test standards and guidance documents:
ASTM F2182-19 – “Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging”.
ASTM F2052-21 – “Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment”.
ASTM F2213-17 – “Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment”.
ASTM F2119-07 – “Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants”.
ASTM F2503-20 – “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”
ISO/TS 10974:2018(E) – “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device”.
IEC 60601-2-33 Ed. 3.2 B:2015 – “Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis”
FDA Guidance Document: “Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices”, Guidance for Industry and Food and Drug Administration Staff, Center for Devices and Radiological Health, US Food and Drug Administration, 22 March 2016.