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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 4360 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

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.12 g/ccTP 013
Viscosity 700000 cP
@Shear Rate 10 1/s
 2.00e+6 cP
@Shear Rate 1 1/s
Storage Temperature 5.00 - 32.0 °C
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 60Press Cured, 5 min, 177°C; ASTM D2240
 614 hr post cure @ 200°C; ASTM D2240
Tensile Strength 1225 psiPress Cured, 5 min, 177°C; ASTM D412
 1250 psi4 hr post cure @ 200°C; ASTM D412
Elongation at Break 430 %4 hr post cure @ 200°C; ASTM D412
 450 %Press Cured, 5 min, 177°C; ASTM D412
100% Modulus 0.380 ksi
@Strain 100 %
Press Cured, 5 min, 177°C; ASTM D412
 0.400 ksi
@Strain 100 %
4 hr post cure @ 200°C; ASTM D412
Tear Strength 230 pliPress Cured, 5 min, 177°C; ASTM D624, Die B
 235 pli4 hr post cure @ 200°C; ASTM D624, Die B
Compression Set 25 %4 hr post cure @ 200°C; ASTM D395B
 50 %Press Cured, 5 min, 177°C; ASTM D395B
 
Processing PropertiesOriginal ValueComments
Extrusion Rate 95.0 g/minTP 001
Shelf Life 12.0 Month
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
AppearanceTP 038
Resiliency (%)604 hr post cure @ 200°C, ASTM D2632
 63Press Cured, 5 min, 177°C, ASTM D2632

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PBLUST076 / 191052

USP Class VI adhesives

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