Implanted blood access devices are the cornerstone of long-term hemodialysis treatment, providing reliable vascular access for repeated procedures. To ensure patient safety and device reliability, these devices must demonstrate structural and functional integrity under demanding clinical conditions. Integrity testing verifies that the device can withstand mechanical stresses, pressure cycles, and repeated use without leakage, fracture, or performance degradation.
At our laboratory, we perform Integrity Testing in full compliance with ISO 18193, the international standard governing implanted blood access devices for hemodialysis. This rigorous evaluation ensures every device is validated against globally recognized benchmarks for safety and performance.
- Leakage & Pressure Resistance:
Evaluation of device sealing and lumen integrity under physiologically relevant pressures. - Mechanical Strength:
Assessment of tensile, torsional, and fatigue resistance to confirm durability during repeated cannulation. - Functional Reliability:
Verification of connectors, ports, and valve mechanisms to ensure consistent performance. - Regulatory Documentation:
Comprehensive reporting aligned with ISO 18193 requirements to support CE and global approvals.
- Patient Safety:
Reliable integrity prevents complications such as blood leakage, infection risk, or device failure. - Performance Assurance:
Testing confirms devices maintain structural stability and functional reliability throughout their intended lifespan. - Design Optimization:
Data-driven insights guide improvements in materials, geometry, and manufacturing processes. - Accelerated Market Access:
Compliance with ISO 18193 streamlines regulatory pathways and builds confidence with clinicians and stakeholders.
By combining advanced test systems, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the integrity of their implanted blood access devices. Partnering with us means confidence in compliance, innovation, and patient protection.