Heart Valve TestingBDC Laboratories principals actively participate in the AAMI/ISO Cardiac Valve Prosthesis Committee responsible for the ISO 5840 valve standard. Leveraging on our intimate knowledge of cardiovascular fluid dynamics, heart valve testing requirements and regulatory landscape, our team can provide a unique resource for your heart valve hydrodynamic testing and durability testing needs for both surgical and transcatheter heart valves. Moreover, as experts in testing of endovascular stents, the BDC team can meet the testing requirements of transcatheter heart valve frames and structures.
Our heart valve testing capabilities, per the published guidance documents are listed below. In addition to these outlined tests, BDC Labs excels in developing custom test methods specific to novel and unique technologies.
- Pulsatile Hydrodynamic Evaluation
- Accelerated Wear Durability
- Component / Structural Fatigue Assessment (stent frame & commissures)
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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 »
Fully validated Coating Integrity & Particulate Testing capability for stents, catheters and guidewires per ASTM 2743 and FDA Guidance Documents. Read more »
MRI compatibility testing and numerical modeling per ASTM standards’ requirements for passive medical devices. Read more »