Medical-grade silicone is used across a range of medical products and devices to sustain patient life and improve comfort and safety during medical treatments. It is designed to be non-toxic and highly biocompatible, making it a preferred material in the larger medical industry. Learn more about medical-grade silicone and its unique properties in this brief guide.
What Is Medical-Grade Silicone?
Medical-grade silicone is a rubber material composed of silicon dioxide (silicon and oxygen) and other elements. Silicon dioxide is found naturally in plants, water, and the earth. Its more refined form, silicone, was invented in the 1930s to protect electrical equipment.
The production process for medical-grade silicone involves breaking silicon down into its smallest components and combining it with hydrogen, oxygen, and carbon. This ultimately creates a highly chemically stable form of silicone that is non-reactive to its surroundings. To be classified as medical or medical grade, the material must also pass vigorous testing in line with USP and ISO standards.
Properties of Medical-Grade Silicone
Medical-grade silicone presents an array of properties that differentiate it from other types and make it safe for use in the medical field.
- Biocompatibility. Medical-grade silicone is tested and approved by the FDA for biocompatibility. This makes it suitable for use in implants, medical devices, and various medical equipment.
- Purity. The unique production process for medical silicone eliminates any toxic elements. This high level of purity ensures the safety and effectiveness of medical devices.
- Durability and Flexibility. Medical-grade silicone’s high quality, flexibility, and durability enable it to withstand multiple uses and severe conditions. These properties make it suitable for applications that require positive engagement and movement (e.g. tubing, implantation, and wearable medical devices).
- Temperature Resistance. Medical-grade silicone does not degrade when exposed to extreme temperatures, making it ideal for sterilization processes and extremely high- or low-temperature environments.
- Chemical Resistance. Medical-grade silicone withstands all types of chemicals, including acids, bases, and solvents. As a result, it doesn’t degrade after prolonged contact with bodily fluids.
Using Medical-Grade Silicone In Healthcare Settings
The unique properties of medical-grade silicone make it the best choice for a variety of healthcare applications. Medical-grade silicone’s biocompatibility, flexibility, and strength make it ideal for use in catheters, tubes, and O-rings. The absence of toxins and hypoallergenic nature guarantees the patient’s safety and the device’s longevity.
Its durability and fluid/chemical resistance also make it crucial for use in other medical equipment like syringes. Silicone syringe sleeves provide enough grip to handle the syringe. At the same time, they protect sterility, since the user does not need to touch the syringe directly.
Medical-grade silicone’s ability to produce a secure seal and maintain contact with human skin without adverse reactions makes it suitable for use in masks for respiratory therapy and anesthesia patients. The masks produce a seal that enhances the flow of oxygen or anesthetic gases toward the patient’s respiratory system while ensuring sores don’t form from contact.
Medical-Grade Silicone at RD Rubber
Medical-grade silicone is a crucial component of many health and life-sustaining devices. RD Rubber Technology Corp. is a custom component manufacturer with extensive experience serving the healthcare industry. We offer a variety of high-quality, medical-grade rubber and silicone parts for medical applications. Our teams work closely with our customers’ technical teams to achieve optimal material and manufacturing standards for the pharmaceutical, biopharmaceutical, and medical device sectors.
Contact us for more information about our products and capabilities.