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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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Tra-Con Tra-Bond FDA2 Food and Drug Application Epoxy Adhesive
Categories: Polymer; Adhesive; Thermoset; Epoxy

Material Notes: TRA-BOND FDA-2 is a medium viscosity epoxy resin system specifically developed for medical device applications. It has been tested in accordance with USP biological reactivity tests, in vivo and received Class VI approval. This two-part amber adhesive is easily mixed, used and cured at room temperature for bonding, laminating and repair applications by manufacturers of food preparation, processing and packaging equipment, and by manufacturers of catheters, hearing aids, dental products and other biomedical instruments and devices. TRA-BOND FDA-2 is an effective electrical insulator, and it provides low permeability to gases and vapors, and good resistance to water, weather, galvanic action, to petroleum solvents, lubricants, and fuels, to mild acids and alkalis, and to many other organic and inorganic compounds.

Information provided by Tra-Con Inc.

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.12 g/ccMixed
Solids Content 100 %Reactive Solids Content
Viscosity 14000 cP
@Temperature 25.0 °C
After mixing
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore D 80
Elongation at Yield 9.0 %
Adhesive Bond Strength 1800 psiLap shear, alum to alum
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity 1.20e+14 ohm-cm
Dielectric Constant 3.4
@Frequency 1000 Hz
Dielectric Strength 420 V/mil
Dissipation Factor 0.020
@Frequency 1000 Hz
 
Thermal PropertiesOriginal ValueComments
CTE, linear 53.0 µm/m-°C
@Temperature 20.0 °C
Maximum Service Temperature, Air 145 °C
Minimum Service Temperature, Air -70.0 °C
Glass Transition Temp, Tg 54.0 °CUltimate Tg
 
Processing PropertiesOriginal ValueComments
Cure Time 1.00 - 4.00 hour
@Temperature 65.0 °C
 24.0 hour
@Temperature 25.0 °C
Pot Life 45 min
 
Compliance PropertiesOriginal ValueComments
FDA Yes
USP Class VI Yes
 
Descriptive Properties
Color Amber
Mix Ratio, parts by weight100/100Resin/Hardener
Working Life hours 3

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PTRAC259 / 71187

USP Class VI adhesives

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