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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 4370 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 PropertiesMetricEnglishComments
Specific Gravity 1.14 g/cc1.14 g/ccTP 013
Storage Temperature 5.00 - 32.0 °C41.0 - 89.6 °F
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 6868Press Cured, 5 min, 177°C; ASTM D2240
 70704 hr post cure @ 200°C; ASTM D2240
Tensile Strength 8.27 MPa1200 psi4 hr post cure @ 200°C; ASTM D412
 8.62 MPa1250 psiPress Cured, 5 min, 177°C; ASTM D412
Elongation at Break 400 %400 %4 hr post cure @ 200°C; ASTM D412
 440 %440 %Press Cured, 5 min, 177°C; ASTM D412
100% Modulus  3.72 MPa
@Strain 100 %
540 psi
@Strain 100 %
Press Cured, 5 min, 177°C; ASTM D412
 4.00 MPa
@Strain 100 %
580 psi
@Strain 100 %
4 hr post cure @ 200°C; ASTM D412
Tear Strength 35.1 kN/m200 pli4 hr post cure @ 200°C; ASTM D624, Die B
 40.3 kN/m230 pliPress Cured, 5 min, 177°C; ASTM D624, Die B
Compression Set 40 %40 %Press Cured, 5 min, 177°C; ASTM D395-98, Method B
 
Processing PropertiesMetricEnglishComments
Extrusion Rate 70.0 g/min70.0 g/minTP 001
Shelf Life 12.0 Month12.0 Month
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes
 
Descriptive Properties
AppearanceTP 038
Resiliency (%)604 hr post cure @ 200°C, ASTM D2632
 63Press Cured, 5 min, 177°C, ASTM 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 view all the property values for this datasheet as they were originally entered into MatWeb.

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PBLUST079 / 191055

USP Class VI adhesives

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