Medical Rubber

Elkem Silicones Silbione® medical grade HCRs are ideal for making products that contribute to healthcare and patient wellbeing.

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​Elkem Silicones: safe and efficient silicone rubber products for medical applications

Fluid management in medical devices plays a critical role in healthcare and patient wellbeing. Silicones are often used to make medical tubes, catheters and valves because of their inherent characteristics: biocompatibility (absence of hemolysis and of tissue and bacterial adhesion), chemical inertness, purity, transparency, high-performance physical properties and stability across a wide range of environmental conditions.

The Elkem Silicones Silbione® 71000 series of medical grade HCRs (High Consistency Rubbers) are silicone master batches that enable efficient industrial processing to manufacture high-performance products for end users and patients. The Silbione® brand is not only a guarantee of product performance, but is backed with a full-service offer. This offer includes the supply of documentation and certification for critical applications, to facilitate industrial operations, comply with regulatory requirements and satisfy customer demand. All of this guarantees that your material is manufactured in appropriated conditions with reinforced control.

Silbione® products offer optimal performance features:

  • Excellent processing characteristics (especially well adapted to rubber extrusion), featuring short curing times
  • Full compliance with stringent national and international regulations
  • Formulations to ensure products are fit for human use
    • Harmless due to the inorganic Si-O-Si chain
    • High levels of transparency for ease of use (visual control)
    • Absence of nitrosamines either in the elastomer or in the initial compound
    • Excellent mechanical characteristics for improving performance
  • Outstanding physical and chemical stability
    • Wide temperature range (-50 °C + 200 °C)
    • High resistance to thermal aging and oxidizing agents (oxygen, ozone, UV)
    • Excellent behavior after sterilization (steam, gamma ray & EtO)
    • Good resiliency properties
    • Transparency for visual control through final product

Elkem Silicones has implemented manufacturing and quality control practices to ensure that its range of medical-grade HCRs are made to satisfy user needs and comply with the specific requirements of each application.

These include:

  • Absence of cross-contamination
  • High levels of filtration
  • Specific assay protocols and processes
  • ISO 9001 certified quality control
  • Testing for skin contact applications carried out in accordance with EC Directive 93/42, for medical devices
    • Cytotoxicity
    • Skin irritation
    • Sensitization.

 

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Medical Rubber

 

 

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Silbione silicone brand logo.https://silicones.elkem.com/EN/Our_offer/Our_Brands/Pages/Silbione.aspx

 

 

 

 

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