The global medical consumable industry is raising higher thresholds for raw material safety and stability in 2026, especially for long-term indwelling medical devices such as PICC catheters. Unlike ordinary industrial TPU materials, PICC-grade TPU pellets need to pass multiple rigorous biological and physical tests to adapt to long-term venous indwelling scenarios, and have gradually formed an independent segmented material standard in the high-end medical market.
Industry inspection data shows that qualified PICC catheter TPU materials must fully comply with ISO 10993 biological evaluation standards and USP Class VI medical grade certification. Strict indicators such as cell cytotoxicity, skin sensitization, hemolysis rate and residual extractables need to be controlled within ultra-low ranges. This is the core reason why general-purpose TPU cannot replace medical-specific formulas in vascular intervention devices.
In clinical application feedback, traditional PVC and ordinary silicone catheters have obvious shortcomings. PVC materials contain plasticizer precipitation risks, while silicone tubes are too soft and prone to tube collapse during insertion. In contrast, customized polyether-based medical TPU pellets maintain balanced hardness and flexibility. The tensile strength is stable, and the tube body will not kink or deform during long-term indwelling. Meanwhile, the material has excellent hydrolysis resistance, effectively avoiding performance attenuation caused by long-term contact with blood and body fluids within 3–6 months of clinical use.
With the continuous tightening of medical device supervision in various countries, downstream catheter manufacturers are gradually eliminating non-standard general materials and turning to stable batch medical-grade TPU suppliers. As a professional manufacturer focusing on medical special polymer raw materials, we strictly control formula purity, residual monomers and volatile substances of PICC-specific TPU pellets. Each batch is equipped with complete biological test reports and batch traceability files, meeting the mass production and registration filing requirements of high-end PICC catheter manufacturers.