We have vast experience in testing & designing of: CVC catheters (central venous), PICC catheters (peripherally inserted central catheters), PTCA catheters (percutaneous transluminal coronary angioplasty), and dialysis catheters.
Medzus is able to provide design validation studies for catheters to all parts of the standard. Medzus will gladly develop a customized comprehensive testing program to meet your company’s regulatory requirements.
Surface Inspection
Corrosion Resistance
Peak Tensile Force
Liquid Leakage Under Pressure
Air Leakage During Aspiration
Determination of Catheter Flow rate
Burst Pressure
Power Injection for Flow rate and Pressure
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 10555-2: Angiographic Catheter Testing
ISO 10555-3: Central Venous Catheter Testing
ISO 10555-4: Balloon Dilation Catheter Testing
ISO 10555-5: Peripheral Intravascular Catheter Testing
Balloon Rated Burst Pressure (RBP)
Balloon Diameter to Inflation Pressure
Balloon Deflation Time
Balloon Fatigue
Safety Wire to Coil Strength
Core Wire to Coil Strength
Strength of Union Hub to Dilator