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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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ExxonMobil Santoprene® 181-57W180 Thermoplastic Elastomer  (discontinued **)
Categories: Polymer; Thermoplastic; Elastomer, TPE; Thermoplastic Vulcanizate Elastomer (TPV)

Material Notes: A soft, black, specialty thermoplastic vulcanizate (TPV) in the thermoplastic elastomer (TPE) family. It has USP Class VI Certificate of Compliance for biocompatibility, MEM elution cytotoxicity to L-929 mouse fibroblast cells, 72 hour exposure to rubber extracts and USP physiochemical test for elastomer closures, heavy metals such as lead. This grade of Santoprene TPV is shear-dependent and can be processed on conventional thermoplastics equipment for injection molding or extrusion. It is polyolefin based and completely recyclable.

Key Features:

  • Based on a series of biocompatibility tests conducted on representative grades, this grade should meet the USP (U.S. Pharmacopeia) Class VI requirements for plastics.
  • Additionally some ISO 10993 tests have been conducted.
  • Each medical grade undergoes annual testing for cytotoxicity and heavy metals.
  • Drug master file maintained with the FDA.
  • EU and China RoHS compliant.
Applications:
  • Medical – Soft Touch Grips, USP Class VI Seals and Gaskets
Uses:
  • Medical/Healthcare Applications
Availability: Africa & Middle East, Europe, North America, Asia Pacific, Latin America and South America

Information provided by ExxonMobil Chemical

Key Words: EU 2003/11/EC; RoHS Compliant; USP Class VI
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
Specific Gravity 0.940 g/ccASTM D792
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 612 mm, 15 sec; ISO 868
Tensile Strength at Break 677 psiAcross Flow; ASTM D412
Tensile Stress at Strain 290 psi
@Strain 100 %
Across Flow; ASTM D412
Elongation at Break 330 %Across Flow; ASTM D412
 
Processing PropertiesOriginal ValueComments
Processing Temperature 175 - 230 °C
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
ColorBlack
FormPellets

**
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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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