Catheter Testing
BDC Laboratories provides complete solutions for testing and evaluating of all types of catheters, including central venous catheters (CVC catheters), peripherally inserted central catheters (PICC catheters), percutaneous transluminal coronary angioplasty (PTCA catheters), drug-coated balloon catheters (DCB catheters), dialysis catheters, guide catheters, and delivery catheters.
In addition to performing catheter testing as outlined in the ISO 10555 series, ASTM standards, and FDA guidance documents, BDC Laboratories also conducts performance testing for associated luer lock connectors as outlined in ISO 80369.
Service Highlights
Standards-Driven Excellence
BDC Laboratories’ catheter evaluation capabilities, per the published guidance documents, appear below.
Complete Testing Solution
Our team supports all aspects of evaluation, including developing the testing strategy, establishing protocols, performing data analyses, and providing regulatory quality final reports.
Scalable Test Program
We execute all test programs according to the data’s application, ranging from abbreviated early-stage development studies to final, formal regulatory submission studies.
Relevant Standards
ISO Standards
ISO 10555-1, 10555-2, 10555-3,10555-4, 10555-5, 10555-6
- Surface Inspection
- Corrosion Resistance
- Peak Tensile Force
- Freedom from Leakage – Liquid Leakage
- Freedom from Leakage – Air Aspiration
- Hubs
- Flowrate
- Power Injection
- Catheter Burst Pressure
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Deflation Time
- Balloon Diameter to Inflation Pressure
- Flushing Volume
- Needle Point
- Needle Hub
- Strength of Needle Union & Needle Tube
- Needle Penetration & Withdrawal Force
- Magnetic Resonance Imaging (MRI) Compatibility
ISO 80369-7, 80369-20
- Air leakage during aspiration
- Leakage by Pressure Decay
- Positive Pressure Liquid Leakage
- Sub-Atmospheric Pressure Air Leakage
- Stress Cracking
- Resistance to Separation from Axial Load
- Resistance to Separation from Unscrewing
- Resistance to Overriding
- Disconnection by Unscrewing
- Modification to Generate Variable Data
ASTM Standards
- F3320: Standard Guide for Coating Characterization of Drug Coated Balloons
FDA Guidance
PTCA Catheters
- Dimensional Verification
- Balloon Preparation, Deployment & Retraction
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance (Diameter vs. Pressure)
- Balloon Inflation & Deflation Time
- Catheter Bond Strength
- Tip Pull Test
- Flexibility and Kink Test
- Torque Strength
- Coating Integrity
- Particulate Evaluation
- Catheter Body Burst Pressure
- Contrast Media Flow Rate
Hemodialysis Catheters
- Dimensional Verification
- Pressure versus Flow Rate
- Recirculation Rate
- Priming Volume
- Tensile Strength
- Air Leakage
- Liquid Leakage
- Repeated Clamping Extension Tubes
Testing Backed by ISO/IEC 17025 Accreditation
At BDC Laboratories, quality is central to everything we do. We maintain ISO/IEC 17025:2017 accreditation and comply with relevant portions of 21 CFR Part 58 (Good Laboratory Practices), among other U.S. and international governing standards. With a comprehensive quality management system, we ensure service and product integrity with a focus on regulatory compliance and continuous improvement.
Why BDC?
Built Around Your Goals
From first conversation to final report, we collaborate with your team to design and execute accredited testing programs aligned with your device goals and regulatory requirements.
Regulatory-Ready, On Time
With ISO/IEC 17025:2017 accreditation and 40+ years of industry experience, we deliver precise, regulatory-ready results on timelines that keep your project moving.
Reliable, Responsive Partnership
You’ll work with project managers who stay engaged throughout the process. They’re available for questions, quick to respond, and focused on keeping your program on track.
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Connect with an Expert at BDC
Provide a few details about your project, and a BDC Laboratories team member will respond within 2 business days to advise on next steps.