Stent & Stent
Graft Testing
BDC Laboratories are active members of AAMI, ISO, and ASTM International Standards Committees. The principals at BDC Labs have a unique understanding of stent testing and verification guidelines recognized by the FDA and European Notified Bodies. Dr. Steven Weinberg and Dr. Craig Weinberg participate as active members of the ISO 25539 Standard Workgroup which covers Endovascular Prostheses (Part 1) and Vascular Stents (Part 2). In addition, Dr. Craig Weinberg participates in the ASTM Endovascular Prosthesis Standards Committee that is continuously working toward establishing testing methods aimed at Stent Testing and Stent Graft Testing.
BDC Labs can be your complete stent and stent graft testing solution. With capabilities that include establishing of testing plans, developing and validating testing protocols, and finally, executing nearly all of the tests outlined in the ISO 25539-1 and -2 standards, as well as the FDA 1545 guidance document. All testing can be executed under Good Laboratory Practices (GLP) and audited through our established quality assurance program. For tests that exceed the focus of our laboratory, our group has trusted associates that can complete the testing while BDC Laboratories personnel oversee all activities.
Durability Testing
BDC Laboratories can execute and monitor your stent durability or stent graft durability test program. We have full capabilities to execute testing per ASTM F2477 test method for vascular stents under Good Laboratory Practices (GLP). Testing can be accomplished at our facility with either BDC Labs radial durability test systems or other testers purchased and brought to BDC Laboratories. With our highly technical engineering staff, we also have the ability to design and construct custom tests for your unique stent or stent graft needs. In addition to radial fatigue testing, BDC Labs is capable and experienced in testing stents and stent grafts in other modes, either independent or combined.
- Tension / Compression Fatigue
- Bending Fatigue
- Torsion Fatigue
- Radial Fatigue
- Straight, Bifurcated, Angulated, and Aortic Arch configurations
Acute Bench Testing
BDC Labs’ testing services, per the published stent and stent graft guidance documents (FDA Guidance Document 1545, ISO 25539, and ASTM documents), are extensive and can be reviewed by following the Stent Testing Standards link below. In addition to these standards tests, BDC Labs excels in developing custom test methods specific to novel technologies that do not fit into these predefined classifications. All testing activities can be executed per Good Laboratory Practices (GLP) and audited with our established quality assurance program.
Read more: Stent Testing Standards »