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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 EP21LV3/5MED Two Part Epoxy
Categories: Polymer; Thermoset; Epoxy

Material Notes: Key Features:
  • Convenient handling
  • Passes USP Class VI testing for biocompatibility
  • Meets criteria for indirect food contact
  • Fine physical strength profile
Product Description: Master Bond EP21LV3/5Med is a special two component epoxy system that combines toughness and compliance with USP Class VI specifications. It is a lower viscosity epoxy that can be used for bonding, sealing, coating and encapsulation. This system has a forgiving 60 to 100 mix ratio by weight and a relatively long working life at room temperature. It cures readily at room temperature or more rapidly at elevated temperature. At ambient temperatures, it cures in about 2-3 days, and at 200°F, in about 3 hours. To optimize properties, an overnight cure at room temperature followed by 3-4 hours at 150-200°F, is recommended. EP21LV3/5Med bonds well to a wide variety of substrates including metals, composites, glass and ceramics as well as many rubbers and plastics. Its toughness makes it particularly useful for bonding dissimilar substrates. It also allows it to resist rigorous thermal cycling that more typical rigid epoxies. Some other attractive features include low shrinkage upon curing along with good resistance to many chemicals including water, cleaning agents, and most significantly, cold steriliants, ethylene oxide (EtO) and radiation. The system is compatible with indirect food contact as per the FDA standard 175.105. It is serviceable over the wide temperature range of -80°F to +250°F. Its potent electrical insulation properties combined with its good flow, also allow it to be used for potting and encapsulation. The color of Part A is clear and Part B is amber clear. EP21LV3/5Med is used primarily for disposable and reusable medical devices, especially in applications where a toughened, forgiving epoxy is better suited to handle requirements than more rigid type systems.

Product Advantages:

  • Easy to mix and dispense
  • Excellent toughness, less stiff than most epoxies
  • Excels in withstanding thermal cycling
  • Resists most types of sterilization
  • Biocompatible as per USP Class VI requirements

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 10000 - 14000 cPPart A
 10000 - 14000 cPMixed
 11000 - 15000 cPPart B
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore D 60 - 70
Tensile Strength 5000 - 6000 psi
Tensile Modulus 200000 - 250000 psi
Adhesive Bond Strength 2000 - 2200 psiTensile lap, Aluminum to Aluminum
Peel Strength 10.0 - 15.0 pli
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity >= 1.00e+14 ohm-cm
Dielectric Constant 3.15
@Frequency 60 Hz
 
Thermal PropertiesOriginal ValueComments
CTE, linear 60.0 - 70.0 µm/m-°C
Maximum Service Temperature, Air 250 °F
Minimum Service Temperature, Air -80.0 °F
 
Processing PropertiesOriginal ValueComments
Cure Time 2.00 - 3.00 hour
@Temperature 23.9 °C
 3.00 hour
@Temperature 93.3 °C
Working Life 60.0 - 90.0 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
Cure ScheduleOvernight at 75°Fplus 3-4 hours at 150-200°F, Optimum cure
Mixing Ratio60:100 by weightParts A to B

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PMASTM826 / 185419

USP Class VI adhesives

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