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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.

Mitsubishi Chemical Advanced Materials Duratron® U1000 LSG PEI Polyetherimide, unfilled, extruded, Biocompatibility tested (ASTM Product Data Sheet)  (Unverified Data**)
Categories: Polymer; Thermoplastic; Polyetherimide (PEI); Polyetherimide (PEI), Extrusion Grade

Material Notes: Duratron® U1000 (Formerly Ultem® 1000) polyetherimide is an amorphous, high-performance polymer with exceptional flame and heat resistance. It performs continuously to 340°F (171°C), making it ideal for high strength/high heat applications, and those requiring consistent dielectric properties over a wide frequency range. It is hydrolysis resistant, highly resistant to acidic solutions and capable of withstanding multiple autoclaving cycles.

Duratron® U1000 is USP Class VI compliant. Duratron® U1000 commonly is machined into parts for reusable medical devices, analytical instrumentation, electrical/electronic insulators and a variety of structural components requiring high strength and rigidity at elevated temperatures.

Quadrant Engineering Plastic Products is now Mitsubishi Chemical Advanced Materials.

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Physical PropertiesMetricEnglishComments
Specific Gravity 1.28 g/cc1.28 g/ccASTM D792
Water Absorption 0.25 %0.25 %Immersion, 24hr; ASTM D570(2)
Water Absorption at Saturation 1.25 %1.25 %Immersion; ASTM D570(2)
 
Mechanical PropertiesMetricEnglishComments
Hardness, Rockwell M 112112ASTM D785
Hardness, Rockwell R 125125ASTM D785
Hardness, Shore D 8686ASTM D2240
Tensile Strength 117 MPa17000 psiASTM D638
Tensile Strength at 150°C (300°F) 86.2 MPa12500 psiASTM D638
Tensile Strength at 65°C (150°F) 103 MPa15000 psiASTM D638
Elongation at Break 60 %60 %ASTM D638
Tensile Modulus 3.45 GPa500 ksiASTM D638
Flexural Strength 138 MPa20000 psiASTM D790
Flexural Modulus 3.45 GPa500 ksiASTM D790
Compressive Strength 152 MPa22000 psi10% Def.; ASTM D695
Compressive Modulus 3.31 GPa480 ksiASTM D695
Shear Strength 103 MPa15000 psiASTM D732
Izod Impact, Notched 0.267 J/cm0.500 ft-lb/inASTM D256 Type A
Coefficient of Friction, Dynamic 0.420.42Dry vs. Steel; QTM55007
K (wear) Factor 5840 x 10-8 mm³/N-M2900 x 10-10 in³-min/ft-lb-hrQTM 55010
Limiting Pressure Velocity 0.06568 MPa-m/sec1875 psi-ft/min4:1 safety factor; QTM 55007
 
Electrical PropertiesMetricEnglishComments
Surface Resistivity per Square >= 1.00e+13 ohm>= 1.00e+13 ohmEOS/ESD S11.11
Dielectric Constant 3.15
@Frequency 1e+6 Hz
3.15
@Frequency 1e+6 Hz
ASTM D150
Dielectric Strength 32.7 kV/mm830 kV/inShort Term; ASTM D149
Dissipation Factor 0.0013
@Frequency 1e+6 Hz
0.0013
@Frequency 1e+6 Hz
ASTM D150
 
Thermal PropertiesMetricEnglishComments
CTE, linear 55.8 µm/m-°C
@Temperature -40.0 - 149 °C
31.0 µin/in-°F
@Temperature -40.0 - 300 °F
ASTM E831
Thermal Conductivity 0.177 W/m-K1.23 BTU-in/hr-ft²-°FASTM F433
Maximum Service Temperature, Air 171 °C340 °FLong Term
Deflection Temperature at 1.8 MPa (264 psi) 204 °C400 °FASTM D648
Glass Transition Temp, Tg 210 °C410 °FASTM D3418
Flammability, UL94 V-0
@Thickness 3.17 mm
V-0
@Thickness 0.125 in
Estimated Rating
 
Compliance PropertiesMetricEnglishComments
3A-Dairy NoNo
Canada AG NoNo
FDA YesYes
NSF YesYesSTD 51, Natural Only
USDA YesYes
USP Class VI YesYes
 
Chemical Resistance PropertiesMetricEnglishComments
Acids, Strong (pH 1-3) UnacceptableUnacceptable
Acids, Weak AcceptableAcceptable
Alcohols AcceptableAcceptable
Alkalies, Strong (pH 11-14) UnacceptableUnacceptable
Alkalies, Weak AcceptableAcceptable
Chlorinated Solvents UnacceptableUnacceptable
Conductive / Static Dissipative NoNo
Continuous Sunlight AcceptableAcceptable
Hot Water / Steam AcceptableAcceptable
Hydrocarbons - Aliphatic LimitedLimited
Hydrocarbons - Aromatic UnacceptableUnacceptable
Inorganic Salt Solutions AcceptableAcceptable
Ketones, Esters UnacceptableUnacceptable
 
Descriptive Properties
ColorNatural and black
Machinability31-10, 1=Easier to Machine

**
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P1SM501 / 129701

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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