MRI Compatibility & Safety TestingBDC Laboratories now provides MRI compatibility testing of passive medical devices in response to continued requests by our customers and the industry. With this expansion, we are able to better serve the need for professional, accurate, comprehensive and timely support in the determination of MRI safety and compatibility of passive devices. Through our offering of both numerical modeling & physical testing, in addition to continuing to support the worldwide cardiac and endovascular communities with this service, BDC will be able to also provide MRI testing for orthopedic, spinal and other passive implant types. 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 Labs MRI compatibility and safety testing programs meet the published guidance documents listed below.
- 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
- 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
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Medical Device Testing
Comprehensive stent and stent graft testing programs are available based on ISO 25539, including durability, and the FDA’s Guidance Document 1545. Read more »
Comprehensive vascular graft and A/V access graft testing programs are available based on ISO 7198 in its entirety. Read more »
BDC Labs offers comprehensive testing programs based on ISO 10555 and ISO 11070 in their entity, as well as the FDA Guidance Document 824. In addition, BDC offers dialysis catheter testing, including recirculation quantification. Read more »
Heart valve durability and hydrodynamic testing activities are available based on the ISO 5840 guidance document. Read more »
Fully validated Coating Integrity & Particulate Testing capability for stents, catheters and guidewires per ASTM 2743 and FDA Guidance Documents. Read more »