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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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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 PropertiesOriginal ValueComments
Specific Gravity 1.28 g/ccASTM D792
Water Absorption 0.25 %Immersion, 24hr; ASTM D570(2)
Water Absorption at Saturation 1.25 %Immersion; ASTM D570(2)
 
Mechanical PropertiesOriginal ValueComments
Hardness, Rockwell M 112ASTM D785
Hardness, Rockwell R 125ASTM D785
Hardness, Shore D 86ASTM D2240
Tensile Strength 17000 psiASTM D638
Tensile Strength at 150°C (300°F) 12500 psiASTM D638
Tensile Strength at 65°C (150°F) 15000 psiASTM D638
Elongation at Break 60 %ASTM D638
Tensile Modulus 500 ksiASTM D638
Flexural Strength 20000 psiASTM D790
Flexural Modulus 500 ksiASTM D790
Compressive Strength 22000 psi10% Def.; ASTM D695
Compressive Modulus 480000 psiASTM D695
Shear Strength 15000 psiASTM D732
Izod Impact, Notched 0.500 ft-lb/inASTM D256 Type A
Coefficient of Friction, Dynamic 0.42Dry vs. Steel; QTM55007
K (wear) Factor 2900 x 10-10 in³-min/ft-lb-hrQTM 55010
Limiting Pressure Velocity 1875 psi-ft/min4:1 safety factor; QTM 55007
 
Electrical PropertiesOriginal ValueComments
Surface Resistivity per Square >= 1.00e+13 ohmEOS/ESD S11.11
Dielectric Constant 3.15
@Frequency 1e+6 Hz		ASTM D150
Dielectric Strength 830 V/milShort Term; ASTM D149
Dissipation Factor 0.0013
@Frequency 1e+6 Hz		ASTM D150
 
Thermal PropertiesOriginal ValueComments
CTE, linear 31.0 µin/in-°F
@Temperature -40.0 - 149 °C		ASTM E831
Thermal Conductivity 1.23 BTU-in/hr-ft²-°FASTM F433
Maximum Service Temperature, Air 340 °FLong Term
Deflection Temperature at 1.8 MPa (264 psi) 400 °FASTM D648
Glass Transition Temp, Tg 410 °FASTM D3418
Flammability, UL94 V-0
@Thickness 3.17 mm		Estimated Rating
 
Compliance PropertiesOriginal ValueComments
3A-Dairy No
Canada AG No
FDA Yes
NSF YesSTD 51, Natural Only
USDA Yes
USP Class VI Yes
 
Chemical Resistance PropertiesOriginal ValueComments
Acids, Strong (pH 1-3) Unacceptable
Acids, Weak Acceptable
Alcohols Acceptable
Alkalies, Strong (pH 11-14) Unacceptable
Alkalies, Weak Acceptable
Chlorinated Solvents Unacceptable
Conductive / Static Dissipative No
Continuous Sunlight Acceptable
Hot Water / Steam Acceptable
Hydrocarbons - Aliphatic Limited
Hydrocarbons - Aromatic Unacceptable
Inorganic Salt Solutions Acceptable
Ketones, Esters Unacceptable
 
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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