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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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Wacker Silpuran® 2120 A/B Silicone Adhesive
Categories: Polymer; Thermoset; Silicone

Material Notes: Product description: 2-part, addition-curing silicone composition curing to a soft, tacky silicone adhesive.

Properties: SILPURAN® 2120 A/B has good adhesive properties that can be adjusted to suit the relevant requirements.

Special features:

  • highly biocompatible
  • no by-products from curing process
  • pourable
  • two-part, 1 : 1 mixing ratio
  • good adhesion
  • high transparency
Application: SILPURAN® 2120 A/B can be used as a skin adhesive and for silicone sheets in medical applications. Bio certification SILPURAN® 2120 A/B was tested and certified according to ISO 10993-1 and USP Class VI for biocompatibility. The following studies were performed on vulcanisates of SILPURAN® 2120 A/B according to ISO 10993-1:
  • cytotoxicity
  • sensitization
The following studies were performed on vulcanisates of SILPURAN® 2120 A/B according to USP Class VI:
  • acute systemic toxicity
  • intracutaneous toxicity
  • implantation test
SILPURAN® 2120 A/B is suitable for use in the manufacturing of medical devices according to the Wacker Health Care Guideline.

Information provided by Wacker Chemie AG.

Vendors: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
 
Physical PropertiesOriginal ValueComments
Density 0.970 g/ccComponent A; ISO 2811
 0.970 g/ccComponent B; ISO 2811
Viscosity 30500 cPComponent B; DIN EN ISO 3219
 31000 cPComponent A; DIN EN ISO 3219
 
Mechanical PropertiesOriginal ValueComments
Penetration 120[mm/10], hollow cone of 62.5 g, 60 s, test sample 170 g, curing time 60 min at 120 °C; DIN ISO 2137
 
Processing PropertiesOriginal ValueComments
Pot Life 20.0 min
Gel Time 2.00 min
@Temperature 70.0 °C
DIN 16945
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
ColorcolorlessCatalyzed A+B
 colorlessComponent A
 colorlessComponent B

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PWACK9474 / 205003

USP Class VI adhesives

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