Medical Grade Silicone: Definition, Applications, and Benefits

We may already be quite familiar with silicone products commonly seen in daily life, and it is well known that silicone is a safe and non-toxic material. However, why is it still necessary to distinguish different grades of silicone based on product safety and application? 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 increasingly adopted medical-grade silicone as the industry standard. So, what exactly defines medical-grade silicone, and how has it become so widely utilized across industries?

〈Extended Reading：What You Should Know About Silicone Rubber〉

What is Medical-grade silicone rubber？

Medical-grade silicone is utilized in a wide range of products and exists in various forms, such as liquid silicone oil, gel silicone jelly, foamed silicone sponge, and solid elastic silicone. What these materials have in common is their excellent biocompatibility — they cause no irritation to human tissue, are non-toxic, and do not trigger allergic reactions, thereby preventing any risk of bodily rejection. Compliance with these conditions must be verified through relevant biocompatibility test reports and certifications. Due to these stringent requirements, medical-grade silicone is primarily used in Class II and Class III medical devices and implants.

〈Extended Reading：Applications of Liquid Silicone Rubber in Medical Devices〉

What is medical-grade silicone raw material?

Medical-grade silicone raw material is primarily based on high-purity polydimethylsiloxane (PDMS), an organosilicon polymer composed of silicon, oxygen, carbon, and hydrogen. It features excellent biocompatibility and chemical stability. To meet medical application requirements, the raw material is refined in a cleanroom environment, with a platinum catalyst added to ensure non-toxicity. It undergoes rigorous screening to remove trace impurities, achieving nearly 100% purity. These materials must comply with international standards such as ISO 10993 and USP Class VI, passing tests for cytotoxicity, hemolysis, and skin irritation to ensure they do not cause rejection or allergic reactions in the human body. Medical-grade silicone raw materials come in various forms, including liquid silicone rubber (LSR), solid silicone rubber (HCR), and gel-like silicone, and are widely used in the manufacture of medical products such as respiratory masks, implants, and catheters.

FDA Approved Medical-grade silicone rubber

When medical-grade silicone meets the standards defined by its respective application industry, it can further obtain FDA or LFGB certification according to market needs to strengthen the product’s credibility. The FDA (Food and Drug Administration) is the regulatory authority in the United States, while LFGB refers to the German Food, Tobacco Products, Cosmetics and Other Commodities Act. Although the two certifications differ significantly in their testing standards, products that pass either one demonstrate compliance for medical, human contact, or food-contact applications. However, since LFGB testing is generally more stringent and costly compared to FDA, FDA certification tends to be more widely adopted in the industry.

Differences Between Food-Grade Silicone and Medical-Grade Silicone

Although both food-grade silicone and medical-grade silicone are safe and non-toxic silicone materials, they have significant differences due to their application scenarios and standard requirements. Food-grade silicone is primarily used in products that come into contact with food and must comply with food contact safety standards (such as the U.S. FDA or Germany’s LFGB) to ensure it is non-toxic, odorless, and does not release harmful substances. The testing focuses on safety for short-term contact.

Medical-grade silicone, on the other hand, is used in medical devices and implants and must pass more stringent biocompatibility tests (such as ISO 10993 or USP Class VI) to ensure it is non-irritating, non-cytotoxic, and suitable for long-term implantation in the human body. Medical-grade silicone has higher purity, a more rigorous manufacturing process, and higher costs, whereas food-grade silicone standards are relatively less strict, and the price is lower.

〈Extended Reading：How to Distinguish Food Grade Silicone and Regular Silicone? 〉

Comparison Table of Food-Grade Silicone and Medical-Grade Silicone

The feature of Medical-grade silicone rubber

Temperature resistance range

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, ensuring that medical equipment, such as sealing components in surgical instruments, can maintain functionality even in extreme environments.

〈Extended Reading：High-Temperature Silicone: Characteristics, Applications, and Buying Guide〉

Excellent antibacterial function

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. The antibacterial properties of medical-grade silicone stem from its high purity and chemical inertness, effectively preventing bacterial adhesion and reducing the risk of cross-infection.

〈Extended Reading：Is Silicone Toxic? A Comprehensive Analysis of Silicone Safety〉

High radiation resistance

Medical devices often need to be sterilized, and there are many methods, including ozone, high-intensity pulsed light, microwave sound waves, and ultraviolet rays, etc. The characteristics of medical silicone rubber, such as ozone resistance, ultraviolet resistance, and radiation resistance, are quite suitable. standard in this field. This property of medical-grade silicone enables medical devices to withstand multiple sterilization methods without being damaged or degraded during the disinfection process.

Application of Medical-grade silicone rubber

Medical parts

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. The soft and non-toxic properties of these medical-grade silicone components enhance patient comfort and safety during use.

Silicone Implants(temporary)

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. These applications primarily leverage the excellent biocompatibility of medical-grade silicone to assist with short-term needs during diagnostic or therapeutic processes.

Silicone Implants(permanent)

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. These long-term medical-grade silicone implants must undergo the most stringent biocompatibility testing to ensure they do not trigger rejection reactions or release harmful substances while remaining in the body for extended periods.

Conclusion

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.If you are looking for a professional medical-grade silicone manufacturer, please feel free to contact us for consultation, and our dedicated team will provide you with expert service.