Vascular Graft Testing

Dr. Steven Weinberg, BDC Laboratories’ founder and one of our principals, was co-chair of the US AAMI committee responsible for drafting the ISO 7198 guidance document. Currently, both BDC Laboratories’ principals continue to be active in the AAAMI/ISO committee for Tubular Vascular Prostheses, and the vascular graft community at-large. Our expertise and experience encompass a vast array of graft technologies including: textile, biological, ePTFE, polyurethane, and arterial-venous (A/V) access grafts.

Based on our extensive knowledge of testing and evaluating vascular grafts, BDC Labs can offer a complete testing solution. Our group is capable of establishing the testing plan, developing and validating the testing protocols, and executing all the tests outlined in the ISO 7198 test standard. Finally, all testing activities can be executed under Good Laboratory Practices (GLP) and audited by our quality assurance group.

Services

In addition to the tests outlined in ISO 7198 (see table below), BDC Laboratories can support unique test activities that may be required for your technology, such as radial fatigue evaluation and monofilament adhesion determination. Leverage BDC Labs principals’ vast experience and expertise in development of your FMEA and/or Hazard Analysis in establishing your specific testing program.