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China ISO13485 Medical-grade Silicone Tube factory
Silicone Tube

China ISO13485 Medical-grade Silicone Tube factory

Product Introduction‌‌

This medical-grade silicone tube is strictly made from high-purity platinum-cured silicone rubber, specifically designed for medical and pharmaceutical applications.

It meets stringent international standards for biocompatibility and safety, ensuring it is non-toxic, odorless, and chemically inert when in direct contact with human tissue, bodily fluids, or pharmaceuticals.

    ‌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

    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

    app-img1

    ‌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.

    app-img2

    ‌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 

    ns

     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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