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China ISO13485 Medical-Grade Silicone Tube Factory - Top Suppliers for Biocompatible Silicone Solutions
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
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(kgf/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 |
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| ID tolerance | Wall tolerance | ID tolerance | Wall tolerance | ID tolerance | Wall tolerance | ID tolerance | Wall tolerance | ID tolerance | Wall 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 | - | - | - | - | - | - |
| Φ1.0 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | - | - |
| Φ1.2 | ±0.1 | ±0.1 | ±0.1 | ±0.15 | ±0.1 | ±0.2 | ±0.1 | ±0.2 | - | - |
| Φ1.5 | ±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 |
| Φ10.0 | ±0.2 | ±0.1 | ±0.2 | ±0.2 | ±0.2 | ±0.3 | ±0.25 | ±0.3 | ±0.25 | ±0.3 |
| Φ11.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ12.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ13.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ14.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ15.0 | ±0.3 | ±0.15 | ±0.3 | ±0.2 | ±0.3 | ±0.3 | ±0.3 | ±0.35 | ±0.3 | ±0.35 |
| Φ16.0 | ±0.4 | ±0.15 | ±0.4 | ±0.25 | ±0.4 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ17.0 | ±0.4 | ±0.15 | ±0.4 | ±0.25 | ±0.4 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ18.0 | ±0.4 | ±0.15 | ±0.4 | ±0.25 | ±0.4 | ±0.35 | ±0.45 | ±0.35 | ±0.45 | ±0.35 |
| Φ19.0 | ±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 |
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| ID tolerance | Wall tolerance | ID tolerance | Wall tolerance | ID tolerance | Wall tolerance | ID tolerance | Wall tolerance | ID tolerance | Wall 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
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QWhat certifications does this platinum-cured silicone tubing comply with?This silicone tubing complies with ISO13485 (Biological Evaluation of Medical Devices) standards. It undergoes rigorous testing to confirm it does not cause cytotoxicity, sensitization, or irritation, making it suitable for medical and food-grade applications.
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QWhat is the operating temperature range of this silicone tubing?The tubing operates stably from -60℃ to 220℃, offering excellent performance in both extreme cold and high-heat environments. It is also resistant to aging and repeated kinking over extended use.
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QCan the inner diameter and wall thickness be customized?Yes. The tubing is available in a wide range of inner diameters and wall thicknesses, all customizable according to customer drawings or specific requirements. Please refer to the product specification sheet for standard tolerance values.
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QWhich sterilization methods are compatible with this tubing?This silicone tubing supports autoclaving (steam sterilization), gamma irradiation, and ethylene oxide (EO) sterilization. It can also be cleaned using water, alcohol, or medical-grade detergents without degrading its physical properties.
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QWhat industries and applications is this silicone tubing suitable for?This tubing is suitable for a wide range of industries including automotive (fuel and coolant lines), industrial machinery (hydraulic and pneumatic systems), aerospace and defense (fuel systems and hydraulic lines), renewable energy (solar thermal, wind turbine cooling), pharmaceutical machinery, food processing, and heavy equipment such as mining and excavation.
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QHow should this silicone tubing be stored and maintained?Store the tubing in a cool, dry, well-ventilated place, away from direct sunlight and sharp objects. Before use with strong acids, alkalis, or solvents, conduct compatibility testing to ensure material integrity. Avoid over-stretching or twisting during installation.