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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 4325 Liquid Silicone Rubber
Categories: Polymer; Thermoset; Silicone; Silicone Rubber; Liquid Silicone Rubber (LSR)

Material Notes: Description: SILBIONE® Liquid Silicone Rubbers (LSRs) are two-component platinum-catalyzed 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 01 to 25 durometer Shore A, Bluestar Silicones’ SILBIONE® LSRs offer the distinctive advantages of easy processing and easy release combined with high performance physical properties. Designed specifically for healthcare applications, SILBIONE® 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 device use of less than 30 days duration. See Table 2.

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

  • Fabrication of healthcare and medical devices, including less than 30 day implantation
  • Skin contact parts like liners
  • Balloons
  • Orthopedic Insoles and cushioning applications
  • Prosthetic liners
  • Rollers
Features:
  • Easy processing and convenient 1:1 mix ratio
  • Excellent mold release for shorter cycle times
  • Superior clarity
  • High performance physicals – high tear and elongation; can be molded into thin-walled parts
  • Rebound resilience characteristics – cushioning and non-tacky
  • Rapid cure at elevated temperatures
  • Can be post-cured, but post cure is not necessary to achieve desired physicals
  • Easily pigmented
  • Soft, skin-like feel when molded

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
  • Hardness, Shore A, ASTM D2240, 2 hr post cure @ 200°C
  • Hardness, Shore A, ASTM D2240, 4 hr post cure @ 200°C
  • Tensile Strength, ASTM D412, 4 hr post cure @ 200°C
  • Tensile Strength, ASTM D412, Press Cured, 5 min, 177°C
  • Tensile Strength, ASTM D412, 2 hr post cure @ 200°C
  • Elongation at Break, ASTM D412, 4 hr post cure @ 200°C
  • Elongation at Break, ASTM D412, 2 hr post cure @ 200°C
  • Elongation at Break, ASTM D412, Press Cured, 5 min, 177°C
  • 100% Modulus, ASTM D412, Press Cured, 5 min, 177°C
  • 100% Modulus, ASTM D412, 2 hr post cure @ 200°C
  • 100% Modulus, ASTM D412, 4 hr post cure @ 200°C
  • Tear Strength, ASTM D624, Die B, Press Cured, 5 min, 177°C
  • Tear Strength, ASTM D624, Die B, 2 hr post cure @ 200°C
  • Tear Strength, ASTM D624, Die B, 4 hr post cure @ 200°C
  • Extrusion Rate, TP 031
  • Shelf Life
  • USP Class VI
  
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Plastic

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USP Class VI adhesives
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