Abstract:Objective To prepare the sterile hydrophilic lubricating silicone catheter with good bio-safety and adapting to the
clinical needs. Methods The silicone catheter was coated with a thermocuring hydrophilic lubricating coating. After packaging and
sterilization, the sterile hydrophilic lubricating silicone catheter was prepared. The sterile hydrophilic lubricating silicone catheter and
blank silicone catheter were analyzed by infrared spectroscopy, scanning electron microscope and contact angle tester. Tribological
properties of sterile hydrophilic lubricating silicone catheter were tested by reference to YY/T 1536-2017. According to the test
methods of GB/T 16886.5-2017 and GB/T 16886.10-2017, the bio-safety of sterile hydrophilic lubricating silicone catheter was
evaluated. The contact angle data was analyzed statistically by one-way ANOVA method. Results The friction force (<0.10 N) and
contact angle of the sterile hydrophilic lubricating silicone catheter were greatly reduced, the coating retained comparatively low
friction force after 200 times test before and after soaked by artificial urine (<0.30 N). Meanwhile, the sterile hydrophilic lubricating
silicone catheter had good bio-safety. Conclusion The surface of silicone catheter can be modified by hydrophilic lubricating coating
to prepare sterile hydrophilic silicone catheter.