Vascular Graft Testing

BDC Laboratories’ technical experts are active in the AAMI/ISO 7198 Standard Workgroup (WG3) committee for Tubular Vascular Prostheses, as well as have many years experience in the industry. Our expertise and experience encompass a vast array of vascular 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 solutions as presented below. Our group is capable of supporting all aspects of the vascular graft evaluation, including developing the testing strategy, establishing protocols, validating methods, performing data analyses and providing regulatory quality final reports. Moreover, all test programs can be executed at a level consistent with the data’s application to optimize efficiency in time and cost, ranging from abbreviated early stage development studies to final, formal regulatory submission studies.

ISO Standards

  • Visual Inspection
  • Integral Water Permeability / Leakage
  • Longitudinal Tensile Strength
  • Usable Length
  • Wall Thickness
  • Dynamic Compliance
  • Porosity
  • Water Entry Pressure (WEP)
  • Burst Strength
  • Relaxed Inner Diameter
  • Suture Retention Strength
  • Water Permeability
  • Circumferential Tensile Strength
  • Burst Strength after Repeated Puncture
  • Pressurized Inner Diameter
  • Kink Diameter / Radius