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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.

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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

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.12 g/ccTP 013
Storage Temperature 5.00 - 32.0 °C
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 23Press Cured, 5 min, 177°C; ASTM D2240
 252 hr post cure @ 200°C; ASTM D2240
 264 hr post cure @ 200°C; ASTM D2240
Tensile Strength 1185 psi4 hr post cure @ 200°C; ASTM D412
 1198 psiPress Cured, 5 min, 177°C; ASTM D412
 1250 psi2 hr post cure @ 200°C; ASTM D412
Elongation at Break 870 %4 hr post cure @ 200°C; ASTM D412
 927 %2 hr post cure @ 200°C; ASTM D412
 950 %Press Cured, 5 min, 177°C; ASTM D412
100% Modulus 0.0540 ksi
@Strain 100 %
Press Cured, 5 min, 177°C; ASTM D412
 0.0690 ksi
@Strain 100 %
2 hr post cure @ 200°C; ASTM D412
 0.0720 ksi
@Strain 100 %
4 hr post cure @ 200°C; ASTM D412
Tear Strength 168 pliPress Cured, 5 min, 177°C; ASTM D624, Die B
 200 pli2 hr post cure @ 200°C; ASTM D624, Die B
 200 pli4 hr post cure @ 200°C; ASTM D624, Die B
 
Processing PropertiesOriginal ValueComments
Extrusion Rate 130 g/minTP 031
Shelf Life 12.0 Month
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
AppearanceTP 038
Resiliency (%)41ASTM D2632

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 go back to viewing the property data in MatWeb's normal format.

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PBLUST068 / 191044

USP Class VI adhesives

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