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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® 8281-55MED Thermoplastic Elastomer
Categories: Polymer; Thermoplastic; Elastomer, TPE; Thermoplastic Vulcanizate Elastomer (TPV)

Material Notes: A soft, colorable, specialty, non-hygroscopic thermoplastic vulcanizate (TPV) in the thermoplastic elastomer (TPE) family. USP Class VI Certificates of Compliance exist for representative samples of our medical grades. Prior to release, each medical grade lot undergoes a Cytotoxicity study using the ISO elution method and a Physico-Chemical - Elastomeric Closures test for heavy metals such as lead. This grade of Santoprene 8000 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
Processing Method: Injection Molding and Multi Injection Molding

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 PropertiesMetricEnglishComments
Specific Gravity 0.920 g/cc0.920 g/ccASTM D792
Maximum Moisture Content 0.0800.080
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 59592 mm, 15 sec; ISO 868
Tensile Strength at Break 4.60 MPa667 psiAcross Flow; ASTM D412
Tensile Stress at Strain 1.60 MPa
@Strain 100 %
232 psi
@Strain 100 %
Across Flow; ASTM D412
Elongation at Break 430 %430 %Across Flow; ASTM D412
Tear Strength 5.01 kN/m28.6 pli212°F, Die C; ASTM D624
 14.0 kN/m79.9 pli73°C, Die C; ASTM D624
Compression Set 14 %
@Temperature 22.8 °C,
Time 605000 sec
14 %
@Temperature 73.0 °F,
Time 168 hour
ASTM D395
 
Processing PropertiesMetricEnglishComments
Processing Temperature 175 - 230 °C347 - 446 °F
Rear Barrel Temperature 177 - 191 °C351 - 376 °F
Middle Barrel Temperature 179 - 193 °C354 - 379 °F
Front Barrel Temperature 185 - 199 °C365 - 390 °F
Nozzle Temperature 185 - 210 °C365 - 410 °F
Melt Temperature 143 - 216 °C289 - 421 °F
Mold Temperature 23.9 - 51.7 °C75.0 - 125 °F
Back Pressure 0.345 - 0.689 MPa50.0 - 99.9 psi
Clamp Pressure 41.0 - 69.0 MPa5950 - 10000 psi
Vent Depth 0.00254 cm0.00100 in
Cushion 0.317 - 0.635 cm0.125 - 0.250 in
Screw Speed 100 - 200 rpm100 - 200 rpm
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes
 
Descriptive Properties
ColorNatural Color
FormPellets
Injection RateFast
Max Regrind20%
Screw Compression Ratio2:1 - 2.5:1
Screw L/D Ratio16:1 - 20:1

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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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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