Medical Silicone Tubing
Extruded VMQ silicone medical tubing (hose) manufactured in an ISO 8 cleanroom. FDA, EC 1935/2004, USP VI, and ISO 10993 approved. High biocompatibility, flexibility, and thermal resistance. Manufacturing under ISO 9001 and ISO 13485.
Process Principle
Medical silicone hose (tubing) is produced via extrusion in an ISO 8 cleanroom with particle control, ensuring total purity and biocompatibility. Manufactured in extruded VMQ silicone for maximum flexibility and biocompatibility.
Materials and Formulations
Extruded VMQ silicone with hardnesses from 40 to 70 Shore A. Medical, pharmaceutical, or food-grade formulations with platinum catalysis. Compliant with FDA 21 CFR 177.2600, USP Class VI, and ISO 10993.
Dimensions and Finishes
Inner diameters from 0.3 to 25 mm. Wall thicknesses controlled under ISO 3302-1 E1/E2. Smooth, transparent, or colored surfaces. Option for clean cutting or sterilization testing.
Production Environments
Manufacturing in a certified ISO 8 cleanroom under ISO 9001 and ISO 13485, with process validation and complete batch traceability.
Product Gallery
Key Technical Data
Typical values obtained according to series datasheets and indicated standards. May vary based on hardness, formulation, and raw material. Final validation is the customer's responsibility.
| Property | Typical Values | Standard |
|---|---|---|
| Hardness (Shore A) | 20 – 90 | ISO 7619-1 |
| Tensile Strength | 6 – 12 MPa | ISO 37 |
| Elongation at Break | 200 – 600 % | ISO 37 |
| Tear Resistance | 15 – 30 kN/m | ISO 34-1 |
| Density | 1,11 – 1,20 g/cm³ | ISO 2781 |
| Working Temperature | –60…+250 °C | — |
| Tolerances | Extrusión E1–E3 · Longitudes L2–L3 | ISO 3302-1/-2 |
Certifications and Regulatory Compliance in Silicone Extrusion
Every extrusion process is backed by international certifications that guarantee traceability, safety, and regulatory conformity in highly demanding sectors.
Main Certifications
- ISO 9001:2015 – Quality Management
- ISO 13485:2016 – Medical Devices
- EN 9100 – Aerospace
- GMP – Good Manufacturing Practices
- Validated ISO 8 Cleanroom (550 m², ISO 14644-1 to -7)
Regulatory Compliance
- FDA 21 CFR 177.2600 – Food Contact
- EC 1935/2004 – Materials in Contact with Food
- EN 45545-2 – Railway Fire Protection
- UL94 – Material Flammability
- ISO 10993 and USP Class VI – Medical and Pharmaceutical Biocompatibility
- REACH (1907/2006) and RoHS (2015/863) – Chemical and Electrical Substances
Main Application Sectors
Key Applications
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Medical fluid or vacuum equipment
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Peristaltic pumping or liquid transfer
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Suction, drainage, or irrigation systems
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Diagnostic and laboratory devices
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Bioengineering and sensor applications
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High-flow infusion lines for ICU
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Ventilation tubes for neonates (high purity)
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Components for enteral and parenteral feeding pumps
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Blood circulation hoses in dialysis machines
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Tubes for Foley catheters and urinary drainage systems
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Connection lines in invasive pressure monitors
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Pipework in anaesthesia machines and ventilators
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Gas sampling tubes for patient analysis
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Flexible components for endoscopes (internal protection)
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Tubes for cell culture medium transfer (Cleanroom)
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Chemotherapy drug administration lines
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Coaxial tubes for surgical irrigation and aspiration
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Flexible connections in medical cryotherapy equipment
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Hoses for peristaltic antibiotic dosing pumps
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Radiopaque tubes for X-ray visibility (diagnostic)
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Suction lines for surgical aspirators
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Pipework for portable insulin delivery devices
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Components for aspiration biopsy kits
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Tubes for gas lines in neonatal incubators
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Hoses for reagent transfer in automated analysers
Manufacturing and Delivery Options
- Materials: extruded VMQ silicone
- Hardness: 40–70 Shore A
- Formulations: Medical-grade, Pharmaceutical-grade, Food-grade
- Colors: Transparent, white, blue, or medical RAL
- Production: ISO 8 Cleanroom
- Delivery: Cut, sterilized, or spooled tubing
- Esterilización: compatible con autoclave y EtO
Recommended Related Products
Product Selection Matrix
| Customer Requirement | Recommended Solution |
|---|---|
| Biocompatible medical tubing | Medical Tubing |
| Standard industrial tubing | Industrial Tubing |
| Reinforced multilayer tubing | Reinforced Hoses/Tubing |
| Special technical tubing | Specialty Tubing |
| Tubos especiales OEM | Specialty Tubing |
Technical Conclusion and Recommendations
The medical silicone tubing from ProSilicones64 offers certified biocompatibility, purity, and precision.
Manufactured under ISO 9001 and ISO 13485 in an ISO 8 cleanroom with validated formulations (FDA, USP VI, ISO 10993).
A European benchmark in medical silicone extrusion for devices, laboratories, and sanitary OEMs.
La referencia para dispositivos médicos y farmacéuticos.
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