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China ISO13485 Medical-Grade Silicone Tube Suppliers | High-Purity Factory Products for Medical Applications
Key Features & Advantages
- ◎ 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.
- ◎ Excellent Physical & Temperature Resistance Operates stably from -60℃ to 220℃. Highly transparent, flexible, and resistant to repeated kinking and aging.
- ◎ 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 | 40A±5A | 50A±5A | 60A±5A | 70A±5A |
|---|---|---|---|---|
| (Shore A) Hardness | 40A±5A | 50A±5A | 60A±5A | 70A±5A |
| MPa Tensile Strength | ≧8.0 | ≧7.0 | ≧7.0 | ≧8.0 |
| Elongation | ≧500% | ≧500% | ≧400% | ≧300% |
| kN/m Tear Strength | ≧18 | ≧25 | ≧25 | ≧40 |
| Ω·m 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| ID Tolerance | WT Tolerance | ID Tolerance | WT Tolerance | ID Tolerance | WT Tolerance | ID Tolerance | WT Tolerance | ID Tolerance | WT 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| ID Tolerance | WT Tolerance | ID Tolerance | WT Tolerance | ID Tolerance | WT Tolerance | ID Tolerance | WT Tolerance | ID Tolerance | WT 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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What is platinum-cured silicone rubber, and why is it preferred for medical applications? +Platinum-cured silicone rubber uses a platinum catalyst during the vulcanization process, resulting in an extremely pure material with no by-products. This makes it highly biocompatible, non-toxic, and compliant with ISO13485 medical device standards. It does not cause cytotoxicity, sensitization, or irritation, making it the preferred choice for tubing used in medical devices, pharmaceutical equipment, and food contact applications.
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What temperature range can this silicone tubing withstand? +This silicone tubing operates stably from -60℃ to 220℃ (with standard use range of -50℃ to +200℃). It maintains its flexibility, transparency, and mechanical properties across this wide temperature range, making it suitable for both cryogenic and high-temperature industrial and medical environments.
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What sterilization methods are compatible with this silicone tubing? +The tubing supports multiple sterilization methods including autoclaving (steam sterilization at high pressure and temperature), gamma irradiation, and ethylene oxide (EtO) sterilization. It can also be cleaned with water, isopropyl alcohol, or medical-grade detergents without degrading the material's properties.
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Can the silicone tubing be customized in size or color? +Yes. The standard color is high transparency, but custom colors are available upon request. Inner diameter and wall thickness can be customized per customer drawings, covering a wide range from small micro-bore sizes (Φ0.4mm) to large bore sizes (Φ75mm+). Various hardness grades from 40A to 70A Shore A are also available.
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How should the silicone tubing be stored to maintain its performance? +Store the tubing in a cool, dry, and well-ventilated environment away from direct sunlight, heat sources, and sharp objects. Avoid contact with strong acids, alkalis, or organic solvents during storage. Proper storage conditions help preserve the tubing's transparency, flexibility, and mechanical integrity over time.
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Is this silicone tubing suitable for use with chemicals and pharmaceutical fluids? +Yes. The tubing demonstrates excellent chemical resistance against a wide range of bodily fluids, pharmaceutical solutions, and common disinfectants. However, it is recommended to conduct compatibility testing before use with strong acids, strong alkalis, or specific solvents to ensure full suitability for your application. Its stable electrical insulation properties also make it suitable for use in electrical and electronic environments.