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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.
Elkem (Bluestar Silicones) SILBIONE® LSR 4365 Liquid Silicone Rubber
Categories: Polymer; Thermoset; Silicone; Silicone Rubber; Liquid Silicone Rubber (LSR)

Material Notes: Description: SILBIONER High Performance – High Durometer LSRs are two-component platinumcatalyzed silicone elastomers designed for liquid injection molding healthcare and medical devices, including applications of less than 30-day implantation in the human body. Available in 30 to 70 durometer Shore A, Bluestar Silicones’ SILBIONER High Performance – High Durometer LSRs offer the distinctive advantages of easy processing and easy release combined with high performance physical properties. Designed specifically for healthcare applications, SILBIONER High Performance – High Durometer LSRs meet or exceed testing requirements of United States Pharmacopoeia (USP) Class VI. Biocompatibility testing addresses the categories of evaluation for cytotoxicity, skin sensitization and skin irritation specified in ISO 10993 for skin contact or device use of less than 30-day implantation.

Applications: The easy processing and high performance physical properties of the SILBIONE R LSRs make them suitable for a broad range of applications including:

  • Fabrication of healthcare and medical devices, including skin contact or less than 30-day implantation
  • Skin contact parts like masks and goggles
  • Infant care products
  • Overmolding (Silbione® LSR 60)
Features:
  • Easy processing
  • Excellent mold release for shorter cycle times
  • Superior clarity
  • High performance physicals – high tear and elongation
  • Rapid cure at elevated temperatures
  • Can be post-cured, but post cure is not necessary to achieve desired physicals

Information provided by Bluestar Silicones

Vendors:
Available Properties
  • Specific Gravity, TP 013
  • Storage Temperature
  • Hardness, Shore A, ASTM D2240, Press Cured, 5 min, 177°C
  • Tensile Strength, ASTM D412, Press Cured, 5 min, 177°C
  • Elongation at Break, ASTM D412, Press Cured, 5 min, 177°C
  • 100% Modulus, ASTM D412, Press Cured, 5 min, 177°C
  • Tear Strength, ASTM D624, Die B, Press Cured, 5 min, 177°C
  • Extrusion Rate, TP 001
  • Shelf Life
  • USP Class VI
  
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Category Notes
Plastic

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USP Class VI adhesives
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