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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.

Epoxy Technology EPO-TEK® 353ND High Temperature Epoxy
Categories: Polymer; Thermoset; Epoxy; Epoxy, High Temperature

Material Notes: Product Description: EPO-TEK® 353ND is a two component, high temperature epoxy designed for semiconductor, hybrid, fiber optic, and medical applications. It is one of the most popular EPO-TEK® brand products, and is known throughout the world for its performance and reliability. Also available in a single component frozen syringe.

Advantages & Application Notes:

  • Reasonable pot-life that allows for low temperature curing to be realized. It has an amber color change upon cure.
  • Passes NASA low outgassing standard ASTM E595 with proper cure
  • Semiconductor suggested applications: wafer-wafer bonding of CSP; fabrication of MEMs devices; flip chip underfill.
  • Hybrid suggested applications: providing near hermetic seals and UHV seals in sensor devices, resisting high temperature packaging
    • Down-Hole petrochemical fiber optic sensors, resisting >200°C field conditions
  • Fiber optic adhesive designed to meet Telecordia 1221 - suggested applications:
    • Sealing fiber into ferrules, transmitting light in the optical pathway from 800- 1550 nm range
    • Fiber component packaging; adhesive for active alignment of optics, environmental seal of opto-package, V-groove arrays
  • Medical suggested applications:
    • Potting fiber optic bundles into ferrules for light guides and endoscopes; capable of resisting several sterilization techniques including ETO, gamma, ION beam, H202 plasma, and >200 autoclave steam cycles; excellent adhesion to surfaces including SST, diamond, titanium, brass, ceramics, glass and most plastics.
    • Adhesive for catheter devices including stents and guide wires.
    • Certified to USP Class VI and ISO 10993 biocompatibility standards for medical implants.
    • Compatible with CIDEX® OPA sterilization.
  • Electronics Assembly suggested applications:
    • Used as dielectric layer in the fabrication of capacitors; laminating PZT ferroelectrics found in ultrasound or ink-jetting devices
    • Impregnating and insulating copper coil windings in motors and inductor coils. Bonding ferrite cores and magnets.
    • Structural grade epoxy found in hard-disk drive devices; bonding of SST metals, kapton, and magnets

Information Provided by Epoxy Technology

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Physical PropertiesMetricEnglishComments
Specific Gravity 1.02 g/cc1.02 g/ccPart B
 1.18 g/cc1.18 g/ccFrozen Syringe
 1.20 g/cc1.20 g/ccPart A
Viscosity 3000 - 5000 cP
@Temperature 23.0 °C
3000 - 5000 cP
@Temperature 73.4 °F
50 rpm
 
Chemical PropertiesMetricEnglishComments
Ionic Impurities - K (Potassium) 5.0 ppm5.0 ppm
Ionic Impurities - Cl (Chloride) 329 ppm329 ppm
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore D 8585
Tensile Modulus 3.56 GPa517 ksiStorage
Shear Strength >= 13.8 MPa>= 2000 psiLap
 >= 35.2 MPa>= 5100 psiDie
 
Electrical PropertiesMetricEnglishComments
Volume Resistivity >= 1.80e+13 ohm-cm>= 1.80e+13 ohm-cm
Dielectric Constant 3.17
@Frequency 1000 Hz
3.17
@Frequency 1000 Hz
Dissipation Factor 0.0050
@Frequency 1000 Hz
0.0050
@Frequency 1000 Hz
 
Thermal PropertiesMetricEnglishComments
CTE, linear 54.0 µm/m-°C30.0 µin/in-°FBelow Tg
 206 µm/m-°C114 µin/in-°FAbove Tg
Maximum Service Temperature, Air 250 °C482 °FContinuous
 350 °C662 °FIntermittent
Minimum Service Temperature, Air -55.0 °C-67.0 °FContinuous
 -55.0 °C-67.0 °FIntermittent
Glass Transition Temp, Tg >= 90.0 °C>= 194 °FDynamic Cure 20—200°C /ISO 25 Min; Ramp 10—200°C @ 20°C/Min
Decomposition Temperature 412 °C774 °FDegradation Temperature
 
Optical PropertiesMetricEnglishComments
Refractive Index 1.5694
@Wavelength 589 nm
1.5694
@Wavelength 589 nm
uncured
Transmission, Visible  <= 80 %
@Wavelength 550 nm
<= 80 %
@Wavelength 550 nm
Spectral
 <= 95 %
@Wavelength 800 - 1000 nm
<= 95 %
@Wavelength 800 - 1000 nm
Spectral
 <= 98 %
@Wavelength 1100 - 1600 nm
<= 98 %
@Wavelength 1100 - 1600 nm
Spectral
 
Processing PropertiesMetricEnglishComments
Cure Time  1.00 min
@Temperature 150 °C
0.0167 hour
@Temperature 302 °F
Minimum Bond Line
 5.00 min
@Temperature 120 °C
0.0833 hour
@Temperature 248 °F
Minimum Bond Line
 10.0 min
@Temperature 100 °C
0.167 hour
@Temperature 212 °F
Minimum Bond Line
 30.0 min
@Temperature 80.0 °C
0.500 hour
@Temperature 176 °F
Minimum Bond Line
Pot Life 120 min120 min
 <= 120 min<= 120 minFrozen Syringe
Shelf Life 12.0 Month
@Temperature 25.0 °C
12.0 Month
@Temperature 77.0 °F
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes
 
Descriptive Properties
ColorAmberGardner <18, Part B
 ClearGardner <5, Part A
ConsistencyPourable liquid
Ionic Impurities NH4409 ppm
Mix Ratio by Weight10:1
Number of ComponentsTwo
Weight Loss0.22%200°C
 0.39%250°C
 0.87%300°C

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PPOXYT122 / 141161

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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