Disposable infusion sets are Class III medical devices, conforming to GB 8368-1998 standard, and are primarily used to establish intravenous infusion access. The product consists of an intravenous needle, needle cap, infusion tubing, medication filter, flow regulator, drip chamber, stopper puncture device, and air filter; some models are equipped with injection ports or medication dispensing ports. Their production must comply with the "Standardized Management of Sterile Medical Devices Production," and a quality tracking and disposal system must be established for their distribution and use.
Based on function, they are categorized into standard, precision filtration, fine-tuning, burette, drip bottle, and light-protected types. Precision filtration infusion sets use nuclear pore membranes to filter 5μm particles and are suitable for children and critically ill patients. Use must follow gravity infusion principles, and the operating temperature range is 10–40℃. Reuse or opening damaged packaging is strictly prohibited. Common adverse events include leakage, blockage, and chills/fever, which must be reported through the National Medical Device Adverse Event Monitoring System.
