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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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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 PropertiesOriginal ValueComments
Specific Gravity 1.34 g/ccASTM D792
Density 1.34 g/ccISO 1183
Water Absorption 1.0 %23°C/sat; ISO 62
Moisture Absorption 0.600 %23°C / 50% RH; ISO 62
Linear Mold Shrinkage, Flow 0.0050 - 0.0060 cm/cm
@Thickness 3.20 mm
SABIC method
Melt Flow 5.0 g/10 min
@Load 3.80 kg,
Temperature 200 °C
ASTM D1238
 9.0 g/10 min
@Load 5.00 kg,
Temperature 360 °C
cm³/10 min; ISO 1133
 
Mechanical PropertiesOriginal ValueComments
Tensile Strength at Break 115 MPa5 mm/min; ISO 527
 115 MPa5 mm/min; ASTM D638
Tensile Strength, Yield 114 MPa5 mm/min; ASTM D638
 115 MPa5 mm/min; ISO 527
Elongation at Break 4.0 %5 mm/min; ISO 527
 6.0 %5 mm/min; ASTM D638
Elongation at Yield 4.0 %5 mm/min; ISO 527
 6.0 %5 mm/min; ASTM D638
Tensile Modulus 4500 MPa1mm/min; ISO 527
 4680 MPa5 mm/min; ASTM D638
Flexural Strength 185 MPa2 mm/min; break; ISO 178
Flexural Yield Strength 160 MPa1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 4500 MPa2 mm/min; ISO 178
 5500 MPa1.3 mm/min, 50 mm span; ASTM D790
Izod Impact, Notched 53.0 J/mASTM D256
 53.0 J/m
@Temperature -30.0 °C
ASTM D256
Izod Impact, Unnotched (ISO) 30.0 kJ/m²80*10*4; ISO 180/1U
 30.0 kJ/m²
@Temperature -30.0 °C
80*10*4; ISO 180/1U
Charpy Impact, Notched 7.00 kJ/m²Edgew 80*10*4 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 10.0 JASTM D3763
 
Electrical PropertiesOriginal ValueComments
Dielectric Strength 15.0 kV/mm
@Thickness 3.20 mm
in oil; IEC 60243-1
Arc Resistance 60 - 120 secASTM D495
Comparative Tracking Index 100 - 175 VUL 746A
 150 VIEC 60112
Hot Wire Ignition, HWI 30 - 60 sec
@Thickness >=1.50 mm
UL 746A
 60 - 120 sec
@Thickness >=3.00 mm
UL 746A
High Amp Arc Ignition, HAI 0.00 - 15 arcs
@Thickness >=3.00 mm
UL 746A
 30 - 60 arcs
@Thickness >=1.50 mm
UL 746A
High Voltage Arc-Tracking Rate, HVTR 25.4 - 80.0 mm/minUL 746A
 
Thermal PropertiesOriginal ValueComments
CTE, linear, Parallel to Flow 26.0 µm/m-°C
@Temperature 23.0 - 150 °C
ISO 11359-2
 32.4 µm/m-°C
@Temperature -40.0 - 40.0 °C
ASTM E831
CTE, linear, Transverse to Flow 60.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ASTM E831
 60.0 µm/m-°C
@Temperature 23.0 - 150 °C
ISO 11359-2
Deflection Temperature at 1.8 MPa (264 psi) 205 °C1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 205 °C
@Thickness 3.20 mm
unannealed; ASTM D648
Vicat Softening Point 212 °CRate B/50; ISO 306
 217 °CRate B/120; ISO 306
 223 °CRate B/50; ASTM D1525
UL RTI, Electrical 170 °CUL 746B
UL RTI, Mechanical with Impact 170 °CUL 746B
UL RTI, Mechanical without Impact 170 °CUL 746B
Flammability, UL94 V-0
@Thickness >=0.410 mm
UL 94
 5VA
@Thickness >=1.90 mm
UL 94
 
Processing PropertiesOriginal ValueComments
Processing Temperature 80.0 - 120 °CHopper Temperature
Nozzle Temperature 350 - 405 °CInjection Molding
Zone 1 340 - 395 °C
Zone 2 350 - 405 °C
Zone 3 360 - 415 °C
Melt Temperature 370 - 410 °C
Mold Temperature 140 - 180 °C
Drying Temperature 150 °CInjection Molding
Dry Time 4.00 - 6.00 hourInjection Molding
Moisture Content 0.020 %
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes

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PSABI14802 / 248269

USP Class VI adhesives

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