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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.
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:
Available Properties
  • Specific Gravity, ASTM D792
  • Hardness, Shore A, ISO 868, 2 mm, 15 sec
  • Tensile Strength at Break, ASTM D412, Across Flow
  • Tensile Stress at Strain, ASTM D412, Across Flow
  • Elongation at Break, ASTM D412, Across Flow
  • Processing Temperature
  • USP Class VI
  
Property Data

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Manufacturer Notes:
Exxon Chemical

Category Notes
Plastic
Thermoplastic Elastomer

**
Materials flagged as discontinued () are no longer part of the manufacturer’s standard product line according to our latest information. These materials may be available by special order, in distribution inventory, or reinstated as an active product. Data sheets from materials that are no longer available remain in MatWeb to assist users in finding replacement materials.

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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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