When I first supplied silicone tubing to a medical equipment manufacturer, I was impressed by how precise the requirements were — every surface had to be smooth, sterile, and biocompatible. That was when I realized why silicone rubber has become indispensable in the medical field.
Silicone rubber is widely used in medical applications because it is biocompatible, chemically stable, heat-resistant, flexible, and easy to sterilize, making it ideal for devices that contact the human body.
In modern medicine, silicone has replaced many traditional materials because it performs reliably under extreme temperatures and repeated sterilization cycles — without leaching harmful substances.
What makes silicone rubber biocompatible?
When a material touches the human body, it must not cause irritation, toxicity, or allergic reactions. This is where silicone outperforms almost every other rubber.
Biocompatibility means silicone rubber can safely contact human tissue and fluids without triggering immune or toxic responses.
Medical-grade silicone, made from ultra-pure raw materials, passes international tests such as USP Class VI1 and ISO 109932 for cytotoxicity and sensitization. It is non-reactive with blood, mucus, or skin.
Key Biocompatibility3 Properties
| Property | Description | Medical Relevance |
|---|---|---|
| Non-toxic4 | Free from BPA, phthalates, latex | Prevents allergic reactions |
| Non-carcinogenic5 | Chemically inert | Safe for long-term implants |
| Non-irritant | Skin-friendly | Suitable for wearable devices |
| Sterilizable6 | Withstands steam, ETO, gamma | Ensures hygiene and safety |
At Julong Rubber, we use high-consistency silicone rubber (HCR) and liquid silicone rubber (LSR) compounds that meet medical-grade purity. These materials maintain their softness and clarity even after dozens of autoclave cycles.
How does silicone rubber maintain hygiene and sterilization?
In hospitals, every material must endure repeated sterilization — steam, radiation, or chemical exposure. Silicone rubber passes this test easily.
Silicone rubber maintains stability during high-temperature sterilization and does not degrade, melt, or release harmful residues.
Its molecular structure — alternating silicon and oxygen atoms — gives it strong resistance to oxidation and hydrolysis. Unlike PVC7 or polyurethane, silicone doesn’t yellow, crack, or harden with time.
Sterilization Methods Compatible with Silicone
| Method | Temperature | Duration | Silicone Performance |
|---|---|---|---|
| Autoclave Steam | 121–134°C | 15–30 minutes | Excellent |
| Ethylene Oxide (EtO) | Low temp gas | 8–12 hours | Excellent |
| Gamma Radiation | — | — | Excellent |
| Dry Heat | up to 180°C | — | Excellent |
For reusable devices like breathing masks or catheters, this stability is critical. Silicone’s structure remains unchanged even after 500 sterilization cycles — something no organic rubber can match.
Why is flexibility so important in medical silicone parts?
Flexibility8 determines comfort and function. When a tube bends without collapsing, or a gasket seals while staying soft, the patient benefits.
Silicone rubber stays elastic over a wide temperature range (−60°C to +230°C), providing both comfort and functional stability in medical devices.
This property allows silicone to perform in both cold storage and high-heat sterilization. Even thin-wall tubing doesn’t kink or lose shape under pressure.
Flexibility Performance at a Glance
| Property | Typical Value | Benefit |
|---|---|---|
| Elongation at Break9 | 400–800% | Easy handling and bending |
| Shore A Hardness Range10 | 10–80 | Custom softness levels |
| Tear Strength11 | >20 kN/m | Prevents rupture |
| Compression Set12 | <25% | Long-term shape retention |
We often customize the hardness of silicone to match the application — softer (30–40 ShA) for tubing and seals, firmer (60–70 ShA) for pumps and connectors. This flexibility ensures both performance and comfort.
What medical devices use silicone rubber?
Silicone’s purity, stability, and softness make it a material of choice for everything from implants to diagnostic tools.
Silicone rubber is used in catheters, tubing, gaskets, seals, respiratory masks, syringes, prosthetics, and medical sensors.
Common Silicone Medical Applications
| Device Type | Example | Silicone Role |
|---|---|---|
| Fluid Transfer13 | IV tubing, peristaltic pump hoses | Non-toxic fluid path |
| Respiratory | Oxygen masks, ventilator tubing | Soft, hypoallergenic contact |
| Implantable14 | Breast implants, pacemaker seals | Biocompatible and stable |
| Diagnostic Equipment | O-rings, seals, sampling gaskets | Leak-free sealing |
| Wearable Devices | Heart-rate sensor straps | Skin-safe and elastic |
In one case, a client in the Netherlands used our translucent LSR seals in a portable medical analyzer. After 12 months of use, they reported zero leakage and unchanged elasticity — proof of silicone’s reliability.
How does silicone rubber compare with other medical elastomers?
Many materials compete in the medical field, such as TPE, PVC, and polyurethane. Yet, silicone remains unmatched in safety and stability.
Compared to other elastomers, silicone rubber offers the best combination of temperature tolerance, sterilization resistance, and biocompatibility.
Comparison Table: Silicone vs Other Medical Materials
| Property | Silicone Rubber | PVC7 | TPE15 | Polyurethane (PU)16 |
|---|---|---|---|---|
| Temperature Range (°C) | −60 to +230 | −10 to +60 | −40 to +120 | −40 to +80 |
| Biocompatibility3 | Excellent | Moderate (may contain plasticizers) | Good | Good |
| Sterilization Resistance17 | Excellent | Poor | Fair | Fair |
| Flexibility | Excellent | Good | Excellent | Excellent |
| Transparency18 | High | High | High | Moderate |
| Cost | Moderate | Low | Moderate | High |
PVC is cheap but contains plasticizers that can leach into fluids. PU is strong but less stable under heat. Silicone combines the strengths of all — flexibility, cleanliness, and safety — with minimal downsides.
Why do hospitals prefer silicone over other materials?
Hospitals need reliable, sterile, and reusable materials. Silicone rubber meets all three requirements, reducing maintenance costs and infection risks.
Hospitals prefer silicone rubber because it ensures patient safety, simplifies sterilization routines, and provides long-term durability without contamination.
From disposable tubing to implantable devices, silicone’s performance remains stable even after long-term use. It complies with FDA 21 CFR 177.260019, ISO 10993, and USP Class VI, which are global standards for medical materials.
At Julong Rubber, we supply both solid and liquid silicone components to European and Asian medical manufacturers who rely on our consistent purity, controlled molding, and full traceability.
Conclusion
Silicone rubber is trusted in the medical world because it’s clean, stable, flexible, and safe. From surgical devices to wearable sensors, it quietly supports human health every day.
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Understanding USP Class VI certification helps ensure the safety and biocompatibility of medical devices. ↩
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Exploring ISO 10993 will provide insights into the safety assessments for medical materials. ↩
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Understanding biocompatibility is essential for ensuring patient safety in medical applications. ↩ ↩
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Learn why non-toxic materials are crucial for preventing allergic reactions in patients. ↩
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Discover the significance of using non-carcinogenic materials for long-term patient safety. ↩
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Understanding sterilization methods ensures the hygiene and safety of medical devices. ↩
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Exploring this resource will reveal why silicone is preferred over PVC in medical settings, highlighting safety and performance benefits. ↩ ↩
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Flexibility in medical devices enhances patient comfort and functionality. ↩
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Learn how elongation at break affects the performance and handling of silicone products. ↩
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Understanding Shore A Hardness Range is crucial for selecting the right silicone for medical devices, ensuring comfort and performance. ↩
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Understanding tear strength is crucial for ensuring the durability and reliability of medical devices, preventing failures during use. ↩
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Understanding compression set helps in evaluating the long-term shape retention of silicone. ↩
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Explore how silicone is used in fluid transfer to ensure non-toxic and safe pathways. ↩
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Discover why silicone is preferred for implantable devices due to its biocompatibility. ↩
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Explore this resource to understand how TPE compares to silicone, especially in terms of flexibility and biocompatibility. ↩
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Explore this resource to understand how PU compares to silicone and its role in medical devices, enhancing your knowledge of material choices. ↩
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Comparing sterilization resistance helps in selecting the best materials for medical devices. ↩
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Understanding transparency in silicone can reveal its importance in medical applications, ensuring safety and performance. ↩
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Understanding FDA regulations ensures compliance and safety in medical device manufacturing. ↩
