Catheter & Dilator Guidance Documents
Our internal capabilities, per the published catheter, catheter introducers, and dilator guidance documents are listed to the right. In addition to these standard tests, BDC Labs is also capable of developing custom test methods specific to novel designs that do not fit in these descriptions. Please contact us so we can discuss your specific testing requirements and build a personal program that meets your goals.
Internal Capabilities
Multi-lumen dialysis catheters draw and return blood to the cardiovascular system in close proximity. A result of this characteristic is a tendency for recirculation between the arterial and venous catheter lumens. Therefore, cleaned blood returning to the patient will mix with blood being drawn and decrease the efficiency of the treatment. BDC Labs has a proven testing method to determine and quantify the percent recirculation that will occur at different dialysis catheter flow rates and cardiac output.
FDA Guidance 824
- 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 10555-1
- Surface Inspection
- Corrosion Resistance
- Tensile Bond Strength At Break
- Torsional Bond Strength At Break
- Freedom From Liquid Leakage
- Freedom From Air Leakage
- Hemostasis Valve
ISO 11070
- Surface Inspection
- Corrosion Resistance
- Strength of Union of Needle to Hub
- Force At Break
- Leakage From Sheath Introducer
- Leakage Through Hemostasis Valve
- Guide Wire Fracture Test
- Guide Wire Flexing Test
- Safety Wire to Coil Strength
- Core Wire to Coil Strength
- Strength of Union Hub to Dilator

