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China ISO13485 Medical-Grade Silicone Tube Factory - Reliable Suppliers for High-Purity Silicone Tubing
Key Features & Advantages
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◎ Superior Biocompatibility & Certification: Complies with ISO13485 (Biological Evaluation of Medical Devices) standards. Undergoes rigorous testing to ensure it does not cause cytotoxicity, sensitization, or irritation.
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◎ Excellent Physical & Temperature Resistance: Operates stably from -60℃ to 220℃. Highly transparent, flexible, and resistant to repeated kinking and aging.
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◎ Stable Chemical & Electrical Properties: Resistant to a wide range of bodily fluids, pharmaceuticals, and disinfectants. Excellent electrical insulation performance.
Product Specifications & Parameters
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◎ Material: High-purity platinum-cured silicone rubber.
◎ Standard Color: High transparency (custom colors available upon request).
◎ Inner Diameter Range: Various sizes from small to large bore, customizable per drawings.
◎ Process: Produced via batch process for high transparency and tear resistance.
Characteristics
| Item | Parameter | |||
|---|---|---|---|---|
| (Shore A)(Hardness) | 40A±5A | 50A±5A | 60A±5A | 70A±5A |
| MPa(Kg/cm2) Tensile strength | ≧8.0 | ≧7.0 | ≧7.0 | ≧8.0 |
| Elongation | ≧500% | ≧500% | ≧400% | ≧300% |
| kN/m(kg f/cm) Tear strength | ≧ 18 | ≧25 | ≧25 | ≧40 |
| Ω·m(Ω·cm) Physical resistivity | ≧2×1014 | ≧2×1014 | ≧2×1014 | ≧2×1014 |
| KV/mm Dielectric strength | ≧20 | ≧20 | ≧20 | ≧20 |
| Use temperature range | -50～+200 | -50～+200 | -50～+200 | -50～+200 |
| Aging condition 200°C | No cracking at 4h | No cracking at 4h | No cracking at 4h | No cracking at 4h |
| Breakdown strength | 20kv/mm | 20kv/mm | 20kv/mm | 20kv/mm |
| Ozone resistance | flawless | flawless | flawless | flawless |
Main Purpose
Primary Application Fields
◎ Automotive Industry: Fuel lines, brake lines, turbocharger hoses, coolant systems, and air intake systems.
◎ Industrial Machinery: Hydraulic and pneumatic systems, chemical transfer lines, food processing equipment (e.g., beverage filling lines), and pharmaceutical machinery.
◎ Aerospace & Defense: Aircraft fuel systems, hydraulic lines, and environmental control systems.
◎ Renewable Energy: Solar thermal systems, wind turbine cooling systems, and geothermal applications.
◎ Heavy Equipment & Mining: Excavator hydraulic hoses, mining slurry transfer lines, and dust extraction systems.
Usage Precautions & Maintenance
◎ Installation & Connection: Use medical-grade clamps or quick-connect fittings. Avoid over-stretching or twisting.
◎ Cleaning & Sterilization: Supports autoclaving (steam sterilization), gamma irradiation, and ethylene oxide sterilization. Can be cleaned with water, alcohol, or medical-grade detergents.
◎ Storage Conditions: Store in a cool, dry, ventilated place away from direct sunlight and sharp objects.
◎ Compatibility Testing: Conduct compatibility tests before use with strong acids, alkalis, or solvents.
Product Specification Sheet
| Specifications | Wall thickness Standard 0.5-0.9 |
Wall thickness Standard 1.0-1.9 |
Wall thickness Standard 2.0-2.9 |
Wall thickness Standard 3.0-3.9 |
Wall thickness Standard 4.0-5.0 |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | |
| Φ0.4 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | - | - | - | - | - | - |
| Φ0.5 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | - | - | - | - | - | - |
| Φ0.6 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | - | - | - | - | - | - |
| Φ0.7 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | - | - | - | - | - | - |
| Φ0.8 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | - | - | - | - | - | - |
| Φ 1.0 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | - | - |
| Φ 1.2 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | - | - |
| Φ 1.5 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | - | - |
| Φ2.0 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | ±0.2 | ±0.25 |
| Φ2.5 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | ±0.2 | ±0.25 |
| Φ3.0 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.2 | ±0.25 |
| Φ3.5 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.2 | ±0.25 |
| Φ4.0 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.2 | ±0.25 |
| Φ4.5 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.2 | ±0.25 |
| Φ5.0 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.2 | ±0.25 |
| Φ5.5 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.2 | ±0.25 |
| Φ6.0 | ±0.15 | ±0.1 | ±0.15 | ±0.15 | ±0.15 | ±0.25 | ±0.2 | ±0.25 | ±0.25 | ±0.25 |
| Φ6.5 | ±0.15 | ±0.1 | ±0.15 | ±0.15 | ±0.15 | ±0.25 | ±0.2 | ±0.25 | ±0.25 | ±0.25 |
| Φ7.0 | ±0.15 | ±0.1 | ±0.15 | ±0.15 | ±0.15 | ±0.25 | ±0.2 | ±0.25 | ±0.25 | ±0.25 |
| Φ7.5 | ±0.15 | ±0.1 | ±0.15 | ±0.15 | ±0.15 | ±0.25 | ±0.2 | ±0.25 | ±0.25 | ±0.25 |
| Φ8.0 | ±0.2 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | ±0.25 | ±0.2 | ±0.25 | ±0.25 | ±0.3 |
| Φ8.5 | ±0.2 | ±0.1 | ±0.2 | ±0.15 | ±0.2 | ±0.25 | ±0.2 | ±0.3 | ±0.25 | ±0.3 |
| Φ9.0 | ±0.2 | ±0.1 | ±0.2 | ±0.15 | ±0.2 | ±0.25 | ±0.2 | ±0.3 | ±0.25 | ±0.3 |
| Φ9.5 | ±0.2 | ±0.1 | ±0.2 | ±0.15 | ±0.2 | ±0.25 | ±0.2 | ±0.3 | ±0.25 | ±0.3 |
| Φ 10.0 | ±0.2 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.3 | ±0.25 | ±0.3 | ±0.25 | ±0.3 |
| Φ 11.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ 12.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ 13.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ 14.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ 15.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ 16.0 | ±0.4 | ±0.15 | ±0.4 | ±0.25 | ±0.4 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ 17.0 | ±0.4 | ±0.15 | ±0.4 | ±0.25 | ±0.4 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ 18.0 | ±0.4 | ±0.15 | ±0.4 | ±0.25 | ±0.4 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ 19.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ20.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.5 | ±0.35 | ±0.5 | ±0.35 |
| Specifications | Wall thickness Standard 0.5-0.9 |
Wall thickness Standard 1.0-1.9 |
Wall thickness Standard 2.0-2.9 |
Wall thickness Standard 3.0-3.9 |
Wall thickness Standard 4.0-5.0 |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | Internal diameter tolerance | Wall thickness tolerance | |
| Φ21.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.5 | ±0.35 | ±0.5 | ±0.35 |
| Φ22.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.5 | ±0.35 | ±0.5 | ±0.35 |
| Φ23.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.5 | ±0.35 | ±0.5 | ±0.35 |
| Φ24.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.5 | ±0.35 | ±0.5 | ±0.35 |
| Φ25.0 | ±0.5 | ±0.15 | ±0.5 | ±0.25 | ±0.5 | ±0.35 | ±0.3 | ±0.4 | ±0.5 | ±0.45 |
| Φ26-30 | ±0.8 | ±0.2 | ±0.8 | ±0.25 | ±0.8 | ±0.4 | ±0.8 | ±0.4 | ±0.8 | ±0.45 |
| Φ31-35 | ± 1.5 | ±0.2 | ± 1.5 | ±0.25 | ± 1.5 | ±0.4 | ± 1.5 | ±0.5 | ± 1.5 | ±0.45 |
| Φ36-40 | ± 1.5 | ±0.2 | ± 1.5 | ±0.25 | ± 1.5 | ±0.4 | ± 1.5 | ±0.5 | ± 1.5 | ±0.45 |
| Φ41-45 | ± 1.8 | ±0.2 | ± 1.8 | ±0.25 | ± 1.8 | ±0.4 | ± 1.8 | ±0.5 | ± 1.8 | ±0.45 |
| Φ46-50 | ± 1.8 | ±0.2 | ± 1.8 | ±0.25 | ± 1.8 | ±0.4 | ± 1.8 | ±0.5 | ± 1.8 | ±0.45 |
| Φ51-55 | ±2.5 | ±0.25 | ±2.5 | ±0.3 | ±2.5 | ±0.5 | ±2.5 | ±0.5 | ±2.5 | ±0.45 |
| Φ56-60 | ±3.0 | ±0.3 | ±3.0 | ±0.5 | ± 13.0 | ±0.5 | ±3.0 | ±0.5 | ||
| Φ61-65 | ±4.0 | ±0.3 | ±4.0 | ±0.5 | ±4.0 | ±0.5 | ±4.0 | ±0.5 | ||
| Φ66-70 | ±5.0 | ±0.4 | ±5.0 | ±0.5 | ±5.0 | ±0.5 | ±5.0 | ±0.5 | ||
| Φ71-75 | ±6.0 | ±0.4 | ±6.0 | ±0.5 | ±6.0 | ±0.55 | ±6.0 | ±0.6 | ||
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Frequently Asked Questions
Q1: What certifications does this platinum-cured silicone tubing comply with?
Our silicone tubing complies with ISO 13485 standards for the biological evaluation of medical devices. It undergoes rigorous testing to confirm it does not cause cytotoxicity, sensitization, or skin irritation, making it suitable for medical and food-grade applications.
Q2: What is the operating temperature range of the silicone tubing?
The silicone tubing operates stably across a wide temperature range of -60℃ to 220℃. It maintains its physical properties and flexibility at both extreme low and high temperatures, making it ideal for demanding industrial and automotive environments.
Q3: Can the inner diameter and wall thickness be customized?
Yes. We offer a wide range of inner diameters from Φ0.4mm up to Φ75mm and various wall thickness options. All specifications can be fully customized according to customer drawings and requirements. Please contact us with your exact dimensions for a tailored quote.
Q4: How should the silicone tubing be cleaned and sterilized?
The tubing supports multiple sterilization methods including autoclaving (steam sterilization), gamma irradiation, and ethylene oxide sterilization. For routine cleaning, water, alcohol, or medical-grade detergents are all suitable. Avoid prolonged contact with strong acids, alkalis, or solvents without prior compatibility testing.
Q5: What industries is this silicone tubing suitable for?
This silicone tubing is widely used across multiple industries including automotive (fuel and brake lines), industrial machinery (hydraulic systems), aerospace & defense (aircraft fuel systems), renewable energy (solar thermal systems), pharmaceutical manufacturing, food processing, and heavy equipment & mining applications.
Q6: What hardness grades are available, and how does hardness affect performance?
The tubing is available in four Shore A hardness grades: 40A, 50A, 60A, and 70A. Softer grades (40A–50A) offer greater flexibility and higher elongation (up to ≧500%), while harder grades (60A–70A) provide higher tear strength (up to ≧40 kN/m) and are better suited for high-pressure or abrasion-resistant applications.