Catheter Testing

BDC Laboratories provides complete solutions for all types of catheter testing and guidewire testing. Our experience includes testing: CVC catheters (central venous), PICC catheters (peripherally inserted central catheters), PTCA catheters (percutaneous transluminal coronary angioplasty), dialysis catheters, guide catheters, and delivery catheters. Our team has extensive experience performing all tests outlined in the ISO 10555 and ISO 11070 standards documents, as well as the FDA 824 guidance document as listed below.

Dialysis Catheter Recirculation

BDC Labs has established a testing apparatus and methodology to quantify the percent of recirculation between the arterial and venous lumens of a dialysis catheter. The recirculation test apparatus can accommodate the catheter deployed within a transparent silicone model including the right atrium, SVC and IVC or a rigid model. A glycerin-water solution to simulate the viscosity of blood can be utilized and if requested, qualitative flow visualization can be performed to highlight the fluid dynamics at the tip of the catheter during the test conditions.

Testing Services

  • Surface Inspection
  • Corrosion Resistance
  • Peak Tensile Force
  • Liquid Leakage Under Pressure
  • Air Leakage During Aspiration
  • Determination of Catheter Flowrate
  • Burst Pressure
  • Power Injection for Flowrate and Pressure
  • Surface Inspection
  • Corrosion Resistance
  • Strength of Union of Needle to Hub
  • Force At Break
  • Leakage From Sheath Introducer
  • Leakage Through Hemostasis Valve
  • Guidewire Fracture Test
  • Guidewire Flexing Test
  • Safety Wire to Coil Strength
  • Core Wire to Coil Strength
  • Strength of Union Hub to Dilator
  • Dimensional Verification
  • Pressure vs. Flow Characterization
  • Catheter Body Tensile Strength
  • Catheter Stiffness
  • Body to Hub Tensile Strength
  • Tip Attachment Strength
  • Catheter Elongation
  • Leakage At Hub
  • Catheter Burst Pressure
  • Catheter Flexural Fatigue
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 »

Vascular Graft Testing

Comprehensive vascular graft and A/V access graft testing programs are available based on ISO 7198 in its entirety. 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 »

MRI Compatibility Testing

MRI compatibility testing and numerical modeling per ASTM standards’ requirements for passive medical devices. 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 »