Stent & Stent Graft Testing

The BDC Laboratories’ team are active members of AAMI/ISO 25539 Standard Workgroup (WG3) which covers Endovascular Prostheses (Part 1), Vascular Stents (Part 2) and Vena Cava Filters (Part 3). In addition the team participates in the ASTM Endovascular Prosthesis Standards Committee that is continuously working toward establishing testing methods aimed at Stent Testing and Stent Graft Testing.

Our comprehensive internal testing capabilities, per the published stent and stent graft guidance documents, are presented below. In addition to these outlined tests, BDC Labs excels in developing custom test methods specific to novel and unique technologies.

Testing Services

Implant
  • Dimensional Verification
  • Diameter to Balloon Inflation Pressure
  • Length to Diameter Relationship
  • 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
  • Magnetic Resonance Imaging (MRI) Safety
  • Radial Force
  • Strength After Repeated Puncture
  • Graft to Stent Attachment Strength
  • Radial Durability
  • Bending Durability
  • Axial Durability
  • Torsional Durability
  • Dislodgement Force
  • Dogboning
  • Profile Effect/Flaring
  • Stent-Free Surface Area
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
  • F2477: In vitro Pulsatile Durability Testing of Vascular Stents
  • F2942: In vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
  • F2743: Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
  • F2079: Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
  • F2081: Characterization and Presentation of the Dimensional Attributes of Vascular Stents
  • F2394: Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
  • F3067: Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
  • F2052: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • F2119: Evaluation of MR Image Artifacts from Passive Implants
  • F2182: Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging (MRI)
  • F2213: Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • F2503: Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • Dimensional Verification
  • Percent Surface Area
  • Foreshortening
  • Recoil
  • Stent Integrity
  • Radial Stiffness / Radial Strength
  • Mechanical Properties
  • Durability Testing
  • Particulate Evaluation
  • Magnetic Resonance Imaging (MRI) Safety and Compatibility
  • 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
ISO 17025 Accreditation

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Medical Device Testing

Vascular Graft Testing

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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 »