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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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Master Bond EP46HT-2Med Two Component Heat Resistant Biocompatible Epoxy System
Categories: Polymer; Adhesive; Thermoset; Epoxy; Epoxy Adhesive; Epoxy, High Temperature

Material Notes: Key Features:
  • Serviceable from -100°F to +550°F
  • Glass transition temperature (Tg) >220°C
  • Superior durability
  • Meets USP Class VI requirements
  • Resists sterilization including repeated autoclaving
  • High bond strength to similar and dissimilar substrates
Product Description: Master Bond EP46HT-2Med is a two component epoxy system for high performance bonding, sealing, coating and potting. It has been tested and qualified as a Class VI formulation, meaning it meets the biocompatibility requirements of that widely recognized test. EP46HT-2Med is 100% reactive and formulated to cure rapidly at elevated temperatures of 250-300°F. The optimum cure is 3-4 hours at 250-300°F followed by 2-3 hours at 350-400°F. EP46HT-2Med has magnificent resistance to repeated sterilization by autoclaving, radiation or chemicals. The mix ratio is 100 to 30 by weight and once cured EP46HT-2Med has prime mechanical and physical properties. It bonds well to a variety of substrates including metals, composites, ceramics, glass, rubbers and many plastics. It should be noted that it also resists other hostile chemicals including acids, bases and many solvents. It has an attractive electrical insulation profile. The service temperature range is -100°F to +550°F. The color of Part A is clear and Part B is brown. EP46HT-2Med is used in medical device applications where resistance to repeated sterilization and biocompatibility are paramount.

Product Advantages:

  • Very long working life at room temperature
  • Passes USP Class VI testing for biocompatibility
  • Capable of resisting repeated sterilization by steam, chemicals and radiation
  • Top tier electrical insulator
  • Good flow properties
  • Lower exotherm, suitable for potting
  • Exceptional adhesive properties

Information provided by Master Bond Inc.

Vendors: Master Bond is a leading manufacturer of adhesives, sealants, coatings and potting compounds. Master Bond’s vast product line consists of over 3,000 epoxy, polyurethane, silicone, cyanoacrylate and latex adhesives that vary in viscosity, cure speed, strength, chemical resistance, electrical properties, etc. Our custom adhesives offer design flexibility and provide excellent bonding performance. Visit www.masterbond.com.

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Physical PropertiesOriginal ValueComments
Viscosity 50 - 350 cPPart B
 12000 - 20000 cPmixed
 60000 - 110000 cPPart A
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore D >= 75
Tensile Strength >= 10000 psi
Tensile Modulus 400000 - 450000 psi
Compressive Strength 20000 psi
Adhesive Bond Strength >= 2000 psiTensile lap, Aluminum to Aluminum
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity >= 1.00e+14 ohm-cm
Dielectric Strength 450 V/mil
@Thickness 3.17 mm
 
Thermal PropertiesOriginal ValueComments
CTE, linear 30.0 - 35.0 µm/m-°C
Maximum Service Temperature, Air 550 °F
Minimum Service Temperature, Air -100 °F
Glass Transition Temp, Tg >= 220 °C
 
Processing PropertiesOriginal ValueComments
Cure Time 2.00 - 3.00 hourPost cure for optimum properties at 350-400°F
 3.00 - 4.00 hour
@Temperature 121 - 149 °C
Working Life >= 1440 minAfter mixing, 100 g batch
Shelf Life 6.00 Month
@Temperature <=23.9 °C
in original, unopened containers
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
Mixing Ratio100:30 by weightParts A to B

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PMASTM888 / 185481

USP Class VI adhesives

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