Not all extruded silicone rubber is created equal; in high-stakes industries, the difference can be everything. Whether used in critical equipment or inside the human body, silicone must meet the demands of performance, safety, and reliability. Silicone manufacturers develop specialized formulations for increasingly complex applications as the market grows.
One of the most significant advancements is using silicone tubes in medicine, where purity, biocompatibility, and regulatory compliance are non-negotiable. Understanding the distinction between medical-grade and industrial-grade silicone is important for engineers, designers, and procurement teams.
In this blog, we’ll explain how these two types differ, where each is used, and how to choose the right one for your product.
What Is Medical-Grade Silicone?
Medical-grade silicone is a specially formulated, high-purity silicone designed for medical, pharmaceutical, and life science applications. It is known for its exceptional biocompatibility, chemical stability, and ability to handle sterilization methods such as autoclaving, gamma radiation, and ethylene oxide exposure.
These properties are for components that require direct or prolonged contact with human tissue, fluids, or medication.
Metal detactable silicone must meet strict regulatory standards for safety and performance. It complies with FDA regulations and is tested under ISO 10993 guidelines for cytotoxicity, sensitization, and irritation.
At Elastostar Rubber Corporation, all of our medical silicones are tested according to USP Class VI. They pass USP Class VI Sections 88 and 87, confirming their non-toxic and non-carcinogenic nature.
Common Applications Include
- Medical silicone tube for respiratory, IV, and catheter systems.
- Medical silicone rubber is used in seals, membranes, and plungers.
- Custom-molded medical silicone products for surgical or diagnostic use.
- Precision medical device silicone components for implants or wearable tech.
- High-performance medical-grade silicone gaskets for sealing medical equipment.
Whether internally or externally, medical-grade strips improve safety, cleanliness, and performance in critical healthcare applications.
Read More– Medical-Grade Silicone: Meaning & Applications
What Is Regular/Industrial-Grade Silicone?
Industrial-grade silicone is a versatile, durable material designed for non-medical applications where performance and environmental resistance are key. Unlike high-temperature silicone, it is not tested for biocompatibility or direct contact with the human body.
However, it offers excellent resistance to heat, weathering, ozone, and many chemicals, making it suitable for heavy-duty, high-performance environments.
This grade of silicone is widely used in automotive, aerospace, construction, lighting, and electronics industries. It maintains flexibility under stress, performs reliably across extreme temperature ranges, and is cost-effective for large-scale manufacturing.
Common Applications Include
- Sealing and insulation solutions from a rubber product manufacturer
- Custom-molded industrial silicone components for machinery and equipment
- Weather-resistant silicone rubber strips for doors, panels, and enclosures
- Durable gasket seal rubber used in engines, HVAC systems, and appliances
For demanding commercial and technical applications, industrial-grade silicone products provide strength, longevity, and performance where regulatory medical standards are not required.
Key Differences Between Medical-Grade and Regular Silicone
Understanding the differences between medical-grade and industrial-grade silicone is important when performance, safety, and compliance are at stake.
Below are the five major areas where these materials differ.
1. Purity and Composition
Sanitary gaskets are manufactured with extremely high purity and are free from harmful additives or fillers, ensuring safety for human use. However, industrial-grade silicone may contain fillers that improve strength or reduce cost but are unsuitable for contact with the body.
2. Biocompatibility
It is certified safe for human tissue, fluids, and implants. It passes international standards such as ISO 10993 and USP Class VI. Industrial-grade silicone, such as surgical silicone, is not tested for biocompatibility and is unsafe for medical or surgical use.
3. Curing Methods
- Platinum-cured silicone (used in medical applications) is ultra-pure, stable, and low in extractables.
- Peroxide-cured silicone (used in industrial applications) is cost-effective but may leave behind trace by-products unsuitable for medical use.
Read More– Advantages Of Platinum Cured Silicone Tubing
4. Resistance to Sterilization
Silicone gasket material can be sterilized multiple times using methods like autoclaving, gamma radiation, or ethylene oxide (ETO) without degrading. Industrial silicone is not guaranteed to maintain performance after sterilization.
5. Long-Term Use and Durability
Both grades are durable, but medical-grade silicone is designed for long-term contact with the body. Industrial-grade silicone, while strong, is optimized for mechanical or environmental durability, not biological safety.
Food tubing is ultra-clean, body-safe, and certified for medical devices and implants. Industrial silicone is strong and flexible, but it is not made for use with the human body.
Choosing the right type depends on where and how the silicone will be used.
| No. | Feature | Medical-Grade Silicone | Industrial-Grade Silicone |
| 1 | Purity | Ultra-pure, free of fillers | May contain fillers or additives |
| 2 | Biocompatibility | Safe for human contact; passes ISO & USP tests | Not suitable for medical or human use |
| 3 | Curing Method | Peroxide-cured silicone | Gaskets, seals, machinery parts, and insulation |
| 4 | Sterilization Resistance | Handles autoclave, gamma, and ETO methods | Limited sterilization capability |
| 5 | Durability | Long-term body-safe durability | Durable for industrial and mechanical use |
| 6 | Common Use | Surgical silicone, medical tubing, implants | Gaskets, seals, machinery parts, insulation |
Applications of Medical-Grade vs. Industrial-Grade Silicone
The choice between medical-grade and industrial-grade silicone is driven by the application’s specific needs, whether safety for human use or mechanical durability in demanding environments.
Each grade is formulated for distinct performance standards and regulatory requirements.
1. Medical Applications of Medical-Grade Silicone
Medical-grade silicone is trusted in healthcare settings due to its purity, flexibility, and biocompatibility. It is extensively used in implantable and external medical devices where safety and compliance are critical.
Common applications include:
- Medical grade silicone tubing for respiratory systems, IV lines, and catheters
- Leak-proof medical silicone seals used in surgical and diagnostic devices
- Long-lasting medical silicone gaskets in lab equipment and pumps
- Advanced silicone medical devices, including wearable health monitors, infusion systems, and implantable tools
These components must handle sterilization and prolonged exposure to bodily fluids without degrading, making medical-grade silicone essential in clinical environments.
2. Industrial Applications of Industrial-Grade Silicone
Industrial-grade silicone is engineered for high performance in harsh environments. While unsuitable for medical use, it excels in applications requiring heat resistance, elasticity, and chemical stability.
Typical industrial uses include:
- Extruded profiles include silicone and rubber cords for sealing, insulation, and vibration control.
- Durable hoses and silicone rubber pipe for fluid handling in manufacturing and processing systems.
- Custom-molded components like custom silicone rings are used in automotive, lighting, and electrical assemblies.
This grade of silicone is ideal for applications that demand durability under pressure, exposure to chemicals, or fluctuating temperatures.
Is Medical-Grade Silicone Safer Than Industrial-Grade Silicone?
Yes, medical silicone is significantly safer for applications involving the human body. Its formulation, testing, and compliance with international health standards make it the preferred material for medical and healthcare-related products.
1. Low Allergenicity and Biocompatibility
Silicone gasket seals are engineered to be hypoallergenic, nontoxic, and nonreactive. Even with prolonged contact, they do not cause skin irritation or an immune response. Thus, they are ideal for implants, wearable devices, and other components that interface with human tissue or fluids.
2. Safe for Long-Term Internal Use
Unlike industrial-grade silicone, which is not tested for biological safety, medical-grade silicone undergoes strict biocompatibility testing (ISO 10993, USP Class VI). It is safe for long-term exposure inside the human body, from soft tissue implants to intravenous devices.
3. Formulated for Sensitive Applications
White rubber strips are commonly used in medical sealant formulations, ensuring strong adhesion and safe bonding in surgical settings, wound care, and device assembly. These sealants must maintain their integrity without releasing harmful by-products, something industrial silicones cannot guarantee.
In summary, while both silicone types are durable and high-performing, only medical-grade silicone is trusted and certified for use in critical, body-contact applications.
Read More – Why Medical Grade Silicone Tubing Is the Best Choice For Healthcare Tubing?
How to Choose the Right Silicone for Your Application?
Selecting the appropriate type of silicone, medical-grade or industrial-grade, depends on your application’s specific demands. Choosing the wrong grade can lead to compliance issues, product failure, or safety risks.
1. Understand the Operating Environment
Start by evaluating the conditions your product will face. Medical-grade silicone is essential if the application involves contact with human tissue, pharmaceuticals, or sterile environments. Industrial-grade silicone may be more cost-effective and suitable for mechanical, automotive, or outdoor use.
2. Consider Performance Requirements
Silicone is valued for its resistance to temperature, chemicals, and aging. Materials like high-temperature silicone are required to maintain flexibility and durability in high-heat environments, such as engines or sterilization processes.
3. Address Custom Design Needs
If your product requires a customised solution, look for suppliers who can provide:
- Custom gasket designs for non-standard shapes
- High-performance silicone gasket material for sealing under pressure
- Durable and flexible silicone o-ring solutions for repeated movement
- Specialized fluorosilicone sealing rings for leak-proof performance in fluids or gases
Customization is significant when your design involves complex geometries, specific tolerances, or multi-functional components.
4. Ensure Regulatory Compliance
Always verify that the silicone complies with FDA, ISO, and USP standards for medical or food-grade applications. Not all silicones meet these requirements, and using the wrong type could lead to regulatory or safety concerns.
Choosing the proper silicone balances performance, safety, and compliance. Considering the operating environment, functional requirements, and certification needs, you can ensure your application performs reliably and safely under real-world conditions.
Why Elastostar Rubber Corporation Is Your Trusted Partner for Medical and Industrial Silicone Products?
At Elastostar, we are proud to be a certified silicone product manufacturer with 100% U.S.-based production. We deliver high-quality, custom silicone solutions for medical and industrial applications on time and to exact specifications.
As medical silicone contract manufacturing experts, we produce safe, FDA- and ISO-compliant components for tubing, seals, and devices. Our industrial capabilities as rubber extrusion manufacturers in the USA allow us to deliver durable, high-performance parts for demanding environments.
What do we offer?
- Complete support with reverse engineering, design assistance, and prototyping.
- Smooth scale-up from prototype to production run.
- Customised solutions from trusted custom silicone manufacturers.
- The shortest lead times in the industry.
At Elastostar Rubber Corporation, we combine quality, speed, and technical expertise to help you build confidently. Contact us today to discuss your project needs.
Recommended Reads
- Top Advantages of Platinum Cured Silicone Tubing
- What Is the Difference Between Aluminum and Silicone LED Channels?
- Why FDA-Approved Silicone Rubber Is Preferred for Food Industry Gaskets & Seals
Conclusion
Understanding the difference between medical-grade and industrial-grade silicone is essential for selecting the right material. Medical-grade silicone is designed for safety, purity, and biocompatibility for medical devices, tubing, and implants.
While unsuitable for body contact, industrial-grade silicone offers durability and flexibility for applications like seals, gaskets, and machinery components. This blog covered their properties, curing methods, application differences, and how to choose based on performance and compliance needs.
FAQs
1. What is the difference between medical-grade silicone and regular silicone?
Medical-grade silicone is highly purified, biocompatible, and safe for contact with the human body. It is used in medical devices, implants, and tubing. Regular or industrial-grade silicone is designed for mechanical use and may contain fillers unsuitable for medical or biological applications.
2. Is medical-grade silicone FDA-approved?
Yes, medical-grade silicone must meet FDA standards and often complies with additional certifications such as ISO 10993 and USP Class VI to ensure its safety for medical and healthcare use.
3. Can you use regular silicone in medical devices?
No, regular silicone is not tested or certified for human contact. It may contain additives or residues that could pose health risks, making it unsuitable for use in medical devices.
4. Is surgical silicone safe for implants?
Yes, surgical silicone used in implants is rigorously tested for long-term biocompatibility, non-toxicity, and stability within the human body. It must also meet strict regulatory standards before being used in surgical applications.
5. Where can I buy custom medical-grade silicone products in the USA?
You can purchase custom medical-grade silicone components directly from certified U.S.-based manufacturers like Elastostar Rubber Corporation. These companies offer custom extrusion, molding, and fast-turnaround solutions for medical and industrial needs. Contact us to discuss your requirements or request a quote customised to your application.
6. Is medical-grade silicone better than industrial silicone for food contact?
Yes, medical-grade silicone is often safer for food contact because of its high purity and lack of toxic additives. However, food-grade silicone is also available and appropriate for food applications.
