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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.

SABIC ULTEM™ HU2100 PEI (Americas)  (Unverified Data**)
Categories: Polymer; Thermoplastic; Polyetherimide (PEI)

Material Notes: 10% Glass fiber filled, standard flow Polyetherimide (Tg 217C). US FDA and European Food Contact approved. For medical devices and pharmaceutical applications. Healthcare management of change, biocompatible (ISO 10993 or USP Class VI); food contact compliant; Steam, Gamma, EtO, and E-beam sterilizable.

Information provided by SABIC

Vendors: Ensinger TECAPEI™ shapes combine Ultem® PEI polymer with Ensinger's proprietary extrusion techniques for exceptional reliability, consistency, dimensional stability, and high temperature mechanical performance. FDA, USP Class VI and NSF compliant.

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Physical PropertiesMetricEnglishComments
Specific Gravity 1.34 g/cc1.34 g/ccASTM D792
Density 1.34 g/cc0.0484 lb/in³ISO 1183
Water Absorption 1.0 %1.0 %23°C/sat; ISO 62
Moisture Absorption 0.600 %0.600 %23°C / 50% RH; ISO 62
Linear Mold Shrinkage, Flow 0.0050 - 0.0060 cm/cm
@Thickness 3.20 mm
0.0050 - 0.0060 in/in
@Thickness 0.126 in
SABIC method
Melt Flow  5.0 g/10 min
@Load 3.80 kg,
Temperature 200 °C
5.0 g/10 min
@Load 8.38 lb,
Temperature 392 °F
ASTM D1238
 9.0 g/10 min
@Load 5.00 kg,
Temperature 360 °C
9.0 g/10 min
@Load 11.0 lb,
Temperature 680 °F
cm³/10 min; ISO 1133
 
Mechanical PropertiesMetricEnglishComments
Tensile Strength at Break 115 MPa16700 psi5 mm/min; ISO 527
 115 MPa16700 psi5 mm/min; ASTM D638
Tensile Strength, Yield 114 MPa16500 psi5 mm/min; ASTM D638
 115 MPa16700 psi5 mm/min; ISO 527
Elongation at Break 4.0 %4.0 %5 mm/min; ISO 527
 6.0 %6.0 %5 mm/min; ASTM D638
Elongation at Yield 4.0 %4.0 %5 mm/min; ISO 527
 6.0 %6.0 %5 mm/min; ASTM D638
Tensile Modulus 4.50 GPa653 ksi1mm/min; ISO 527
 4.68 GPa679 ksi5 mm/min; ASTM D638
Flexural Strength 185 MPa26800 psi2 mm/min; break; ISO 178
Flexural Yield Strength 160 MPa23200 psi1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 4.50 GPa653 ksi2 mm/min; ISO 178
 5.50 GPa798 ksi1.3 mm/min, 50 mm span; ASTM D790
Izod Impact, Notched 0.530 J/cm0.993 ft-lb/inASTM D256
 0.530 J/cm
@Temperature -30.0 °C
0.993 ft-lb/in
@Temperature -22.0 °F
ASTM D256
Izod Impact, Unnotched (ISO) 30.0 kJ/m²14.3 ft-lb/in²80*10*4; ISO 180/1U
 30.0 kJ/m²
@Temperature -30.0 °C
14.3 ft-lb/in²
@Temperature -22.0 °F
80*10*4; ISO 180/1U
Charpy Impact, Notched 0.700 J/cm²3.33 ft-lb/in²Edgew 80*10*4 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 10.0 J7.38 ft-lbASTM D3763
 
Electrical PropertiesMetricEnglishComments
Dielectric Strength 15.0 kV/mm
@Thickness 3.20 mm
381 kV/in
@Thickness 0.126 in
in oil; IEC 60243-1
Arc Resistance 60 - 120 sec60 - 120 secASTM D495
Comparative Tracking Index 100 - 175 V100 - 175 VUL 746A
 150 V150 VIEC 60112
Hot Wire Ignition, HWI  30 - 60 sec
@Thickness >=1.50 mm
30 - 60 sec
@Thickness >=0.0591 in
UL 746A
 60 - 120 sec
@Thickness >=3.00 mm
60 - 120 sec
@Thickness >=0.118 in
UL 746A
High Amp Arc Ignition, HAI  0.00 - 15 arcs
@Thickness >=3.00 mm
0.00 - 15 arcs
@Thickness >=0.118 in
UL 746A
 30 - 60 arcs
@Thickness >=1.50 mm
30 - 60 arcs
@Thickness >=0.0591 in
UL 746A
High Voltage Arc-Tracking Rate, HVTR 25.4 - 80.0 mm/min1.00 - 3.15 in/minUL 746A
 
Thermal PropertiesMetricEnglishComments
CTE, linear, Parallel to Flow  26.0 µm/m-°C
@Temperature 23.0 - 150 °C
14.4 µin/in-°F
@Temperature 73.4 - 302 °F
ISO 11359-2
 32.4 µm/m-°C
@Temperature -40.0 - 40.0 °C
18.0 µin/in-°F
@Temperature -40.0 - 104 °F
ASTM E831
CTE, linear, Transverse to Flow  60.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
33.3 µin/in-°F
@Temperature -40.0 - 104 °F
ASTM E831
 60.0 µm/m-°C
@Temperature 23.0 - 150 °C
33.3 µin/in-°F
@Temperature 73.4 - 302 °F
ISO 11359-2
Deflection Temperature at 1.8 MPa (264 psi) 205 °C401 °F1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 205 °C
@Thickness 3.20 mm
401 °F
@Thickness 0.126 in
unannealed; ASTM D648
Vicat Softening Point 212 °C414 °FRate B/50; ISO 306
 217 °C423 °FRate B/120; ISO 306
 223 °C433 °FRate B/50; ASTM D1525
UL RTI, Electrical 170 °C338 °FUL 746B
UL RTI, Mechanical with Impact 170 °C338 °FUL 746B
UL RTI, Mechanical without Impact 170 °C338 °FUL 746B
Flammability, UL94  V-0
@Thickness >=0.410 mm
V-0
@Thickness >=0.0161 in
UL 94
 5VA
@Thickness >=1.90 mm
5VA
@Thickness >=0.0748 in
UL 94
 
Processing PropertiesMetricEnglishComments
Processing Temperature 80.0 - 120 °C176 - 248 °FHopper Temperature
Nozzle Temperature 350 - 405 °C662 - 761 °FInjection Molding
Zone 1 340 - 395 °C644 - 743 °F
Zone 2 350 - 405 °C662 - 761 °F
Zone 3 360 - 415 °C680 - 779 °F
Melt Temperature 370 - 410 °C698 - 770 °F
Mold Temperature 140 - 180 °C284 - 356 °F
Drying Temperature 150 °C302 °FInjection Molding
Dry Time 4.00 - 6.00 hour4.00 - 6.00 hourInjection Molding
Moisture Content 0.020 %0.020 %
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes

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PSABI14802 / 248269

USP Class VI adhesives

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