What are the production standards for medical silicone tubes

2020/7/14 9:56:52

Medical silicone tubes are mainly used in drainage tubes, blood transfusion tubes, various catheters, silicone blood vessels, silicone blood vessels, peristaltic pump silicone tubes (biopharmaceuticals) and other industries. Because silica gel has better chemical stability and biocompatibility than other materials, medical silicone tube is non-toxic, odorless, physiologically inert, resistant to biological aging, and has little response to human tissues. The foreign body reaction does not cause inflammation to the surrounding tissues, so it is more and more widely used in health care. This is particularly demanding on product quality.
Medical silicone tubes are made of high-quality silicone raw materials and advanced mechanical extrusion. It should be certified by EU ROHS and US FDA and comply with Chinese national standards.

LFGB European Standard for the Production of Medical Silicone Tubes: Five items tested
1. Cell
2. Sensitization
3. Skin irritation
4. Toxicity
5. Blood compatible hemolysis
Medical device tubes have high transparency, no odor, excellent aging resistance, high tear resistance, excellent resilience, not easy to deform, weak acid and alkali resistance, high and low temperature resistance, etc., can be used from -50 degrees to 250 degrees, Special requirements can reach 300 degrees, which is not available in other materials. Medical silicone tubes also have great requirements on the production environment. The production workshop should be kept clean and dust-free for a long time, and the mechanical equipment must also be cleaned and inspected regularly to produce higher-quality medical silicone tubes.