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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 4305 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

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Physical PropertiesMetricEnglishComments
Specific Gravity 1.07 g/cc1.07 g/ccTP 013
Viscosity 60000 cP60000 cPTP 005
Storage Temperature 5.00 - 32.0 °C41.0 - 89.6 °F
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 3.03.02 hr post cure @ 200°C; ASTM D2240
 3.03.04 hr post cure @ 200°C; ASTM D2240
 5.05.0Press Cured, 5 min, 177°C; ASTM D2240
Hardness, Shore OO 4545Press Cured, 5 min, 177°C; ASTM D2240
 47474 hr post cure @ 200°C; ASTM D2240
 49492 hr post cure @ 200°C; ASTM D2240
Tensile Strength 2.45 MPa355 psi4 hr post cure @ 200°C; ASTM D412
 2.48 MPa360 psi2 hr post cure @ 200°C; ASTM D412
 3.10 MPa450 psiPress Cured, 5 min, 177°C; ASTM D412
Elongation at Break 980 %980 %2 hr post cure @ 200°C; ASTM D412
 988 %988 %4 hr post cure @ 200°C; ASTM D412
 1100 %1100 %Press Cured, 5 min, 177°C; ASTM D412
100% Modulus  0.103 MPa
@Strain 100 %
15.0 psi
@Strain 100 %
Press Cured, 5 min, 177°C; ASTM D412
 0.110 MPa
@Strain 100 %
16.0 psi
@Strain 100 %
2 hr post cure @ 200°C; ASTM D412
 0.110 MPa
@Strain 100 %
16.0 psi
@Strain 100 %
4 hr post cure @ 200°C; ASTM D412
Tear Strength 9.82 kN/m56.0 pli4 hr post cure @ 200°C; ASTM D624, Die B
 9.99 kN/m57.0 pli2 hr post cure @ 200°C; ASTM D624, Die B
 10.5 kN/m60.0 pliPress Cured, 5 min, 177°C; ASTM D624, Die B
 
Processing PropertiesMetricEnglishComments
Shelf Life 12.0 Month12.0 Month
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes
 
Descriptive Properties
AppearanceTP 038

Some of the values displayed above may have been converted from their original units and/or rounded in order to display the information in a consistent format. Users requiring more precise data for scientific or engineering calculations can click on the property value to see the original value as well as raw conversions to equivalent units. We advise that you only use the original value or one of its raw conversions in your calculations to minimize rounding error. We also ask that you refer to MatWeb's terms of use regarding this information. Click here to view all the property values for this datasheet as they were originally entered into MatWeb.

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PBLUST066 / 191042

USP Class VI adhesives

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