Catheter Testing

BDC Laboratories provides complete solutions for the testing and evaluation of all types of catheters. Our experience includes testing: CVC catheters (central venous catheters), PICC catheters (peripherally inserted central catheters), PTCA catheters (percutaneous transluminal coronary angioplasty), DCB catheters (drug coated balloon catheters), dialysis catheters, guide catheters and delivery catheters. In addition to the catheter testing outlined in the ISO 10555 series, ASTM standards and FDA guidance documents, BDC’s capabilities also includes the associated luer lock connector performance testing outlined in ISO 80369, as listed below.

BDC Labs is capable of supporting all aspects of catheter evaluation as presented below, including developing the testing strategy, establishing protocols, validating methods, performing data analyses and providing regulatory quality final reports. Moreover, all test programs can be executed at a level consistent with the data’s application to optimize efficiency in time and cost, ranging from abbreviated early stage development studies to final, formal regulatory submission studies.