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China ISO13485 Medical-Grade Silicone Tube Factory - Trusted Suppliers for Safe, Biocompatible Solutions
Key Features & Advantages
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◎ Superior Biocompatibility & CertificationComplies 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 ResistanceOperates stably from -60℃ to 220℃. Highly transparent, flexible, and resistant to repeated kinking and aging.
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◎ Stable Chemical & Electrical PropertiesResistant 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
Specification Sheet 01
Specification Sheet 02
| 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 Tol. | WT Tol. | ID Tol. | WT Tol. | ID Tol. | WT Tol. | ID Tol. | WT Tol. | ID Tol. | WT Tol. | |
| 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 Tol. | WT Tol. | ID Tol. | WT Tol. | ID Tol. | WT Tol. | ID Tol. | WT Tol. | ID Tol. | WT Tol. | |
| 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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What certifications does this platinum-cured silicone tubing comply with?This silicone tubing complies with ISO 13485 (Biological Evaluation of Medical Devices) standards. It undergoes rigorous biocompatibility testing to confirm it does not cause cytotoxicity, sensitization, or irritation, making it suitable for medical and food-grade applications.
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What is the operating temperature range of this silicone tubing?The tubing operates stably across a wide temperature range of -60℃ to 220℃ (-76°F to 428°F), making it suitable for extreme cold and high-heat industrial, automotive, and medical environments.
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Can the inner diameter and wall thickness be customized?Yes. The tubing is available in a wide range of inner diameters from Φ0.4mm up to Φ75mm, with multiple wall thickness options. All dimensions can be customized according to your drawings or specific application requirements.
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What sterilization methods are compatible with this tubing?This silicone tubing supports multiple sterilization methods including autoclaving (steam sterilization at high pressure), gamma irradiation, and ethylene oxide (EtO) sterilization. It can also be cleaned with water, alcohol, or medical-grade detergents.
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Is this silicone tubing resistant to chemicals and bodily fluids?Yes. The tubing exhibits excellent resistance to a wide range of bodily fluids, pharmaceuticals, and disinfectants. However, compatibility testing is recommended before use with strong acids, alkalis, or organic solvents to ensure suitability for your specific application.
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What are the main industries this silicone tubing is used in?This tubing is widely used across the automotive industry (fuel lines, coolant systems), industrial machinery (hydraulic systems, food processing), aerospace & defense (aircraft fuel systems), renewable energy (solar thermal, wind turbines), and heavy equipment & mining (hydraulic hoses, slurry transfer lines).