Not all extruded silicone rubber is the same, and in high-stakes industries, even small differences can have a major impact. From use in critical equipment to applications inside the human body, silicone must deliver on performance, safety, and reliability. As demand increases, silicone manufacturers continue to develop specialized formulations to meet the needs of complex applications.
A key advancement is the use of silicone tubes in medicine, where purity, biocompatibility, and strict regulatory compliance are non-negotiable. This makes it important for engineers, designers, and procurement teams to understand the clear distinction between medical-grade silicone and industrial-grade silicone.
In this blog, we’ll explore how these two types differ, their primary applications, and how to select the right option for your product.
What Is Medical-Grade Silicone?
Medical-grade silicone is a high-purity, specially engineered silicone designed for use in medical, pharmaceutical, and life science applications. It is valued for its biocompatibility, chemical stability, and ability to withstand sterilization processes such as autoclaving, gamma radiation, and ethylene oxide exposure.
These unique properties make it suitable for components that have direct or prolonged contact with human tissue, fluids, or medication.
Medical detectable silicone must meet strict regulatory standards to ensure safety and performance. It complies with FDA requirements and undergoes testing under ISO 10993 guidelines for cytotoxicity, sensitization, and irritation.
At Elastostar Rubber Corporation, all medical silicone products are tested in accordance with USP Class VI standards, passing Sections 87 and 88 to confirm they are non-toxic and non-carcinogenic.
Common Applications of Medical-Grade Silicone
Medical silicone tube for respiratory, IV, and catheter systems
Medical silicone rubber used in seals, membranes, and plungers
Custom-molded medical silicone products for surgical and diagnostic use
Precision medical device silicone components for implants or wearable technology
Medical-grade silicone gaskets for sealing sensitive healthcare equipment
From implants to external devices, medical-grade silicone strips and components enhance safety, cleanliness, and performance in critical healthcare applications.
What Is Regular/Industrial-Grade Silicone?
Industrial-grade silicone is a versatile and durable material engineered for non-medical applications where strength, resistance, and performance are required. Unlike medical-grade silicone, it is not tested for biocompatibility or intended for prolonged human contact.
This type of silicone delivers excellent resistance to heat, weathering, ozone, and chemicals, making it ideal for tough environments and long-term industrial use.
It is widely used in automotive, aerospace, construction, electronics, and lighting industries. Industrial-grade silicone maintains flexibility under stress, performs across extreme temperature ranges, and is cost-effective for large-scale manufacturing needs.
Common Applications of Industrial-Grade Silicone
Sealing and insulation solutions from a trusted rubber product manufacturer
Custom-molded industrial silicone components for machinery and heavy equipment
Weather-resistant silicone rubber strips for panels, doors, and enclosures
Durable gasket seal rubber for engines, HVAC systems, and household appliances
For demanding commercial and technical applications, industrial-grade silicone products provide strength, reliability, and long-lasting performance where medical certifications are not required.
Key Differences Between Medical-Grade and Regular Silicone
Understanding the differences between medical-grade silicone and industrial-grade silicone is important when safety, compliance, and performance are critical. Below are the five main areas where these materials vary.
1. Purity and Composition
Medical-grade sanitary gaskets are made with ultra-high purity silicone, free from harmful fillers or additives, making them safe for direct human contact. In contrast, industrial-grade silicone may include fillers that improve strength or reduce costs but are not suitable for use with the body.
2. Biocompatibility
Medical-grade silicone is certified safe for use with human tissue, fluids, and implants. It meets strict standards such as ISO 10993 and USP Class VI. Industrial-grade silicone, however, is not tested for biocompatibility and should not be used for medical or surgical applications.
3. Curing Methods
Platinum-cured silicone, commonly used in medical applications, is ultra-pure, stable, and low in extractables. Peroxide-cured silicone, often used in industrial applications, is more cost-effective but can leave behind trace by-products that are unsuitable for medical use.
Read More – Advantages of Platinum-Cured Silicone Tubing
4. Resistance to Sterilization
Medical-grade silicone gasket material can be sterilized multiple times through autoclaving, gamma radiation, or ethylene oxide (ETO) without losing performance. Industrial silicone does not guarantee the same level of stability after repeated sterilization.
5. Long-Term Use and Durability
Both medical-grade and industrial-grade silicone are durable, but their purposes differ. Medical-grade silicone is engineered for long-term safety when in contact with the human body, while industrial-grade silicone is designed for mechanical strength and environmental durability.
Food-grade silicone tubing is also ultra-clean, body-safe, and certified for applications in medical devices and implants. Industrial silicone, while strong and flexible, is not designed for biological safety.
Applications of Medical-Grade vs. Industrial-Grade Silicone
The selection between medical-grade silicone and industrial-grade silicone depends on the specific application, focusing on safety for human use in healthcare or durability in demanding industrial environments. Each grade is designed to meet unique performance standards and regulatory requirements.
1. Medical Applications of Medical-Grade Silicone
Medical grade silicone tubing and components are widely used in healthcare because of their purity, flexibility, and proven biocompatibility. In both implantable and external devices, this material ensures safety and compliance.
Key medical applications include:
Medical grade silicone tubing for respiratory systems, IV lines, and catheters
Leak-proof medical silicone seals in surgical and diagnostic devices
Long-lasting medical silicone gaskets for pumps and lab equipment
Advanced silicone medical devices such as wearable health monitors, infusion systems, and implantable tools
Medical-grade silicone withstands sterilization and prolonged contact with bodily fluids without degrading, making it a reliable choice in clinical environments.
2. Industrial Applications of Industrial-Grade Silicone
Industrial-grade silicone is formulated for performance in harsh and demanding conditions. While not suited for medical use, it offers outstanding resistance to heat, chemicals, and mechanical stress.
Common industrial applications include:
Extruded profiles like silicone and rubber cords for sealing, insulation, and vibration control
Heavy-duty hoses and silicone rubber pipe for fluid handling in processing and manufacturing systems
Custom-molded components, including custom silicone rings, for automotive, lighting, and electrical assemblies
Industrial-grade silicone provides durability under fluctuating temperatures, chemical exposure, and high-pressure environments, making it indispensable across industries.
Is Medical-Grade Silicone Safer Than Industrial-Grade Silicone?
Yes, medical-grade silicone is much safer for applications involving the human body. Its specialized formulation, rigorous testing, and compliance with international health standards make it the preferred choice for medical and healthcare products.
1. Low Allergenicity and Biocompatibility
Medical-grade silicone gasket seals are designed to be hypoallergenic, nontoxic, and nonreactive. Even with extended use, they do not cause irritation or trigger an immune response. This makes them ideal for implants, wearable medical devices, and components that come into contact with human tissue or fluids.
2. Safe for Long-Term Internal Use
Unlike industrial-grade silicone, which is not tested for biological safety, medical silicone is subjected to strict biocompatibility testing (ISO 10993, USP Class VI). This ensures it is safe for long-term exposure inside the body, from intravenous devices to soft tissue implants.
3. Formulated for Sensitive Applications
White rubber strips are often used in medical sealant formulations, ensuring reliable adhesion and secure bonding in surgical procedures, wound care, and medical device assembly. These materials must maintain stability without releasing harmful by-products—something industrial-grade silicone cannot guarantee.
In summary, both silicone types are durable and versatile, but only medical-grade silicone is certified and trusted for body-contact and healthcare applications.
How to Choose the Right Silicone for Your Application
Selecting the right silicone—medical-grade or industrial-grade—depends on the specific requirements of your application. Using the wrong grade can lead to compliance issues, reduced performance, or safety risks.
1. Understand the Operating Environment
Evaluate the conditions your product will face. Medical-grade silicone is necessary for applications involving human tissue, pharmaceuticals, or sterile environments. Industrial-grade silicone, on the other hand, is often more cost-effective and suitable for automotive, mechanical, or outdoor applications.
2. Consider Performance Requirements
Silicone is valued for its resistance to heat, chemicals, and aging. For high-heat environments, such as sterilization processes or engines, high-temperature silicone is recommended to ensure flexibility and long-term durability.
3. Address Custom Design Needs
For specialized applications, customization is key. Leading suppliers can provide:
Custom gasket designs for complex shapes
High-performance silicone gasket material for pressure sealing
Durable silicone o-rings for repeated movement
Fluorosilicone sealing rings for leak-proof protection in fluids or gases
Custom solutions are critical for designs involving tight tolerances, unique geometries, or multi-functional components.
4. Ensure Regulatory Compliance
Always confirm that the silicone meets FDA, ISO, and USP standards for medical or food-grade applications. Industrial-grade silicone does not always meet these requirements, and using it in sensitive applications could result in safety or compliance issues.
Why Elastostar Rubber Corporation Is Your Trusted Partner for Medical and Industrial Silicone Products
Elastostar Rubber Corporation is a certified silicone product manufacturer with 100% U.S.-based production. We specialize in delivering high-quality, custom silicone solutions for both medical and industrial applications—on time and to exact specifications.
Medical Silicone Contract Manufacturing Experts
As leaders in medical silicone contract manufacturing, Elastostar produces FDA- and ISO-compliant components for tubing, seals, and medical devices. Our focus on safety, biocompatibility, and precision ensures every part meets the highest standards for healthcare applications.
Industrial Rubber Extrusion Manufacturers in the USA
In addition to medical-grade solutions, Elastostar is a trusted name among rubber extrusion manufacturers in the USA. We design and produce durable, high-performance industrial silicone parts, including seals, gaskets, and custom profiles, built to withstand demanding environments.
What We Offer
At Elastostar, we provide complete support throughout every stage of your project:
Reverse engineering, design assistance, and prototyping.
Smooth transition from prototype to production runs.
Customized solutions from trusted custom silicone manufacturers.
Industry-leading short lead times for faster delivery.
Why Choose Elastostar Rubber Corporation
By combining quality, speed, and technical expertise, Elastostar helps you bring reliable silicone solutions to market with confidence. From medical tubing to industrial gaskets, our products are engineered to perform.
Contact Elastostar Rubber Corporation today to discuss your project needs.
Conclusion
Knowing the difference between medical-grade and industrial-grade silicone is key to selecting the right material. Medical-grade silicone is designed for safety, purity, and biocompatibility in medical devices, tubing, and implants.
Industrial-grade silicone, while not intended for body contact, delivers durability and flexibility for seals, gaskets, and machinery components. By understanding their properties, curing methods, and application differences, you can choose the right solution for performance and compliance.
