Production and Common Applications of Medical Silicone

We may be very familiar with everyday silicone products that are known for their safety and non-toxicity. So why differentiate between different grades based on the safety and application of the product? For example, medical grade silicone is widely used in medical breathing masks, various infusion tubes, stomach, nasal and urinary catheters, etc. Even general silicone products such as earplugs are being upgraded to medical grade silicone as a marketing point. What exactly is medical grade silicone, how is it defined, and how is it widely used?

Medical silicone is used in various forms in various products

Such as liquid silicone oil, gelatinous silicone jelly, foam silicone sponge, and solid elastic silicone body. They must all have good biocompatibility, non-irritating, non-toxic, and non-allergic to human tissues to ensure that there is no organism rejection. The above conditions require relevant test reports as certification. Due to the relatively strict conditions, they are mainly used in medical devices and implants above level 2.

When medical silicone rubber meets the standards defined by the application industry, it can further obtain certification based on market demand for product endorsement. Although the testing standards vary greatly, as long as the product passes one of the above certifications, it can strengthen the compliance of the product with medical, human or food contact. However, since the testing standards of LFGB are not only more stringent than FDA, but also more expensive, FDA certification applications are more widespread.

Characteristics of medical silicone

Wide range of applicable temperature

Medical silicone has high temperature resistance, about -60°C ~ +270°C, and has small changes when dampened by water or exposed to higher temperatures. Therefore, it has high elasticity, which is quite an important feature in processing processes related to sealing and elongation.

Excellent antibacterial function

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

High radiation resistance

Medical devices often require sterilization, and there are many methods, including ozone, high-intensity pulse light, microwave sound waves, and ultraviolet light. The characteristics of medical silicone rubber such as ozone resistance, UV resistance, and radiation resistance are quite in line with the standards of this field.

Application of medical silicone

Medical parts

Silicone-made medical devices are numerous, widely classified into silicone breathing masks, silicone infusion tubes, corrective braces, injection needle plugs, silicone patches for wound/scars, silicone components for medical testing instruments such as silicone dust covers, silicone waterproof rings, silicone keys, and other non-invasive devices.

Temporary implants

If medical silicone rubber implants stay in the body for 24 hours to 30 days or less, they belong to short-term/temporary implants, such as silicone nasal splints, invasive nuclear magnetic resonance aids, nasal-gastric catheters, organ drainage catheters, irrigation devices, etc.

Permanent implants

If medical silicone rubber implants remain in the body for more than 30 days (inclusive), they belong to long-term/permanent implants, such as cardiac pacemakers, heart stents, breast silicone implants, artificial nasal models, nasal septum surgery implants, and silicone contraceptive rings.