Endovascular Testing Programs

Our comprehensive internal capabilities, per the published stent and stent graft guidance documents, are presented in the table to the right. In addition to these outlined tests, BDC Laboratories excels in developing custom test methods specific to novel and unique technologies. Please contact us so we can discuss your specific endovascular device testing requirements and build a personal program that meets your goals.

Internal Capabilities

ISO 25539-1 & -2

Implant

  • Dimensional Verification
  • Diameter to Balloon Inflation Pressure
  • Length to Diameter Relationship
  • Recoil
  • Dimensional Verification
  • Diameter to Balloon Inflation Pressure
  • Length to Diameter
  • Recoil
  • Integral Water Permeability
  • Water Entry Pressure
  • Fabric Water Permeability
  • Burst/Circumferential Strength
  • Crush Resistance (Flat Plate & Radial)
  • Flex/Kink
  • Local Compression
  • Longitudinal Tensile Strength
  • Migration Resistance
  • Modular Pull Strength
  • Radial Force
  • Strength After Repeated Puncture
  • Graft to Stent Attachment Strength
  • Fatigue Durability
  • Dislodgement Force
  • Dogboning
  • Profile Effect/Flaring
  • Stent-Free Surface Area

ISO 25539-1 & -2

Endovascular System

  • Dimensional Verification
  • Profile/Diameter
  • Hemostasis
  • Simulated Use
  • Force to Deploy

Delivery System

  • Balloon Inflation / Deflation Time
  • Balloon Rated Burst Pressure
  • Balloon Volume to Burst
  • Balloon Rated Fatigue
  • Tensile Bond Strength
  • Torsional Bond Strength
  • Tubing Longitudinal Tensile Strength

ASTM Standards

  • F2477: Radial Durability
  • F2079: Stent Recoil
  • F2081: Dimensional Attributes
  • F2394: Stent Securement

FDA Guidance 1545

  • Dimensional Verification
  • Percent Surface Area
  • Foreshortening
  • Recoil
  • Stent Integrity
  • Radial Stiffness / Radial Strength
  • Mechanical Properties
  • Durability Testing
  • Crush Resistance
  • Kink Resistance
  • Delivery, Deployment, Retraction
  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Stent Diameter vs. Balloon Pressure
  • Catheter Bond Strength
  • Crossing Profile
  • Balloon Inflation / Deflation Time
  • Stent Securement