MRI Compatibility & Safety Testing

BDC Laboratories offers ISO/IEC 17025:2017 Accredited MRI compatibility testing of passive medical devices, as well as numerical modeling in support of testing programs when appropriate. With participation in the ASTM standard committee for MRI assessment, BDC’s technical experts possess a unique insight into the various aspect of this challenging evaluation. In addition to continuing to support the worldwide cardiac and endovascular communities with MRI safety testing, BDC is also able to provide MRI safety testing for orthopedic, spinal, dental and other passive implant technologies. Numerical simulation and modeling provide direction and insight to a test article’s response within an MRI field while the physical testing provides confirmation and the measured response of the test article.

BDC’s MRI compatibility and safety testing programs meet all the requirements of the published standards as listed below. In addition to executing MRI studies to a pre-defined assessment strategy, the BDC team is well versed in developing a comprehensive evaluation strategy when one does not already exist.

Testing Services

ASTM Standards

  • F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • F2119: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
  • F2213: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

FDA Guidance

  • Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
  • Assessment of Radiofrequency – Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices