USP Class VI, ISO 10993 biocompatibility evaluation, and ISO 13485:2016 quality system certification, manufactured at an FDA-registered facility
DONGGUAN, China, June 16, 2026 /PRNewswire/ — Dongguan Ruixiang Precision Silicone Products Co., Ltd. (Ruixiang Silicone) has released a platinum-cured medical-grade silicone tubing series manufactured at an FDA-registered facility and carrying USP Class VI certification, ISO 10993 biocompatibility evaluation, and ISO 13485:2016 quality management system certification. The product is intended for use as fluid transfer components in extracorporeal cardiac assist systems, micro-infusion systems, and hemodialysis equipment, where tubing comes into direct contact with drug solutions or extracorporeal circulation pathways.
The release addresses a material problem that has persisted in conventional peroxide-cured silicone tubing. During peroxide vulcanization, the decomposition of peroxide initiators generates residual byproducts within the crosslinked matrix. When post-cure processing fails to remove these residuals completely, they gradually migrate out of the tubing matrix and into any fluid in contact with it. In drug delivery contexts, this leaching introduces contaminants into fluids in contact with the tubing. Over time, the same residuals cause the visible yellowing and surface blooming that indicate a peroxide-cured tube is no longer serviceable. Ruixiang Silicone’s platinum-catalyzed addition cure process generates no such residual byproducts. The reaction proceeds through direct addition chemistry, in which vinyl and hydride siloxane groups combine to form new carbon-silicon bonds without releasing any small-molecule byproducts. Because no residuals are produced in the first place, no high-temperature post-cure cycle is required. For medical device manufacturers evaluating peroxide cure versus platinum cure silicone tubing for regulated applications, this distinction directly affects material qualification documentation requirements.
The practical result is tubing that remains colorless and transparent through extended storage and repeated autoclave sterilization. The optical clarity of the tubing also enables visual inspection of fluid lines during operation.
Dimensional Tolerances and Process
In peristaltic pump applications, wall distribution inconsistency translates directly to flow rate error over thousands of operating hours. Ruixiang Silicone holds inner and outer diameter tolerances to ±0.02 mm using a vertical extrusion process, where gravity-assisted material flow supports consistent wall distribution across the tube cross-section. The minimum processable inner diameter is 0.14 mm with a wall thickness floor of 0.1 mm. These specifications bring the product into range for micro-catheter assembly and precision infusion device manufacturing.
