Vascular Graft Testing

BDC Laboratories’ principals are active in the AAMI/ISO 7198 Standard Workgroup (WG3) committee for Tubular Vascular Prostheses, and the vascular graft community at-large. 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 establishing the testing plan, developing and validating the testing protocols, and executing all the tests outlined in the ISO 7198 test standard.

Testing Services

  • 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
ISO 17025 Accreditation

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Medical Device Testing

Stent Graft 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 »

Catheter Testing

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 Testing

Heart valve durability and hydrodynamic testing activities are available based on the ISO 5840 guidance document. Read more »

Coating & Particulate Testing

Fully validated Coating Integrity & Particulate Testing capability for stents, catheters and guidewires per ASTM 2743 and FDA Guidance Documents. Read more »

General Testing Services

With our extensive experience in functional evaluation of medical devices, BDC Laboratories excels in testing on all types of devices and technologies. Our team can create custom test programs, fixtures, and equipment for any technology. Read more »