Medical Grade Silicone: How to define it?

We may already be quite familiar with the common silicone products in daily life, and we all know that the characteristics of silicone are safe and non-toxic. Even so, why should we distinguish different grades according to the safety and application of the product? For example, medical-grade silicone is widely used in Medical respirators, various infusion tubes, stomach, nasal and urinary catheters, etc., and even general silicone products such as earplugs have also been upgraded to medical-grade silicone as a marketing highlight. After all, how is medical grade silicone defined and how is it widely used?

Medical silicone is used in various products in various forms, such as liquid silicone oil, gel silicone jelly, foamed silicone sponge, and elastic silicone in solid form. Their common points must have good biocompatibility, no irritation to human tissue, no toxicity, no allergic reaction, so as to ensure that there is no problem of body rejection. The above conditions are required to have relevant test reports as certification. Also because of the relatively harsh conditions, it is mainly used in medical devices and implants above the second grade.

When the medical-grade silicone meets the standards defined by the application industry, it can further obtain FDA(Food and Drug Administration) or LFGB certification(food contact materials) according to market demand to endorse the product. The difference between LFGB and FDA is the different way of the testing method. Silicone products that pass either one of these tests are safe for human use. In terms of pricing,  products in LFGB standard will be more expensive than FDA standard,  and LFGB is more comprehensive and more strict than FDA. So, FDA is more widely used.

Medical grade silicone is resistant to high temperature, about -60°C~+270°C, and does not change much when exposed to moisture, water, or temperature. So it has high elasticity. This is a very important feature in the machining process, that is, focusing on tightness and ductility.

Medical grade silicone can withstand repeated disinfection and sterilization conditions, so the physiological stability is relatively high, which is a basic requirement for the application of medical devices.

There are countless medical devices made of silicone, which are widely classified as silicone respirators, silicone infusion tubes, orthodontic braces, injection needle plugs, silicone patches for wound/scar treatment, and silicone components for medical testing equipment such as silicone dust boots. , Silicone waterproof ring, silicone buttons, and other non-invasive devices.

When silicone implants last inside of the human body anywhere from 24 hours to 30 days belonging short-term/temporary implants. For example silicone Internal nasal splints, Endorectal Coil, Nasogastric catheters, organ drainage catheters, enemas, etc.

When silicone implants last inside of the human body for more than 30 days belonging long-term/permanent implants. Such as cardiac pacemakers, cardiac stents, breast silicone implants, artificial nose molds, silicone septal buttons, silicone contraceptive rings, etc.

GSUN focuses on the OEM production of medical and food grade silicone rubber products, and constantly strives to improve the product quality system and expand production capacity to meet the huge and immediate needs of customers. , skin sensitization, cell epidermis) and other related food medical certification testing standards, and third-party testing can be carried out according to customer needs.