Medical Grade Silicone

Medical Grade Silicone is present in more items than we may realize. Let’s delve deeper into this versatile material, which is utilized in a wide range of products including medical equipment, cosmetic tools, reusable sandwich bags, cooking utensils, and even electronic devices.

Despite encountering silicone frequently, including in many environmentally-friendly products, people often question its safety for both human health and the environment at large. However, medical-grade silicone is known for its biocompatibility and non-immunogenic nature. This means that it does not trigger adverse immunological responses when used on the skin or inside the body, ensuring it is safe for use in various applications.

What Is Medical Grade Silicone?

Many companies employ the term “medical grade silicone,” which generally encompasses two distinct meanings:

Medical-long-term implantable material: This technical phrase refers to a material intended for use as part of an implantable device that can remain within the body for an extended period. Due to its exceptional purity, it is typically too costly for food-grade applications.

Medical grade: More precisely known as medical-healthcare grade or Class VI silicone, this type is extensively tested for biocompatibility. It serves as our preferred material for a wide range of products, including menstrual cups, baby bottle nipples, scuba mouthpieces, water pipes, as well as items that come into contact with food and skin.

Both medical-healthcare grade (Class VI) and medical-long-term implantable materials are deemed safe for food contact. It’s important to note that both grades are predominantly comprised of liquid silicone rubber (LSR), which is injection molded to yield clean and consistent parts.

What is medical-grade silicone made of?

When broken down into its fundamental components, silicone consists of silicon dioxide (a combination of silicon and oxygen) with the addition of hydrogen, extra oxygen atoms, and possibly carbon. It is interesting to note that the name “silicone” is derived from its significant composition of silicon dioxide.

Silicon dioxide is a mineral that can be found in various natural sources such as sand, soil, granite, rocks, and concrete. It is incredibly abundant, accounting for more than a quarter of the Earth’s crust. Over the centuries, silicon dioxide has been utilized for numerous purposes, including the production of glass. In more recent times, it has been refined into silicone, which was invented in the 1930s.

Medical-grade silicone is manufactured with a high level of chemical stability. This ensures that the material does not react with its surroundings, making it safe for use inside and on the human body. For silicone to be classified as “medical” or “medical grade,” it must adhere to these rigorous and specific production standards.