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USP Class VI adhesives

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SABIC LEXAN™ Healthcare HPS2 PC (Americas)
Categories: Polymer; Thermoplastic; Polycarbonate (PC); Polycarbonate, Gamma Radiation Resistant

Material Notes: LEXAN HPS2 is a high flow polycarbonate (PC) with an MVR (300°C/1.2kg) of 16. This is a biocompatible (ISO10993 or USP Class VI) grade for medical devices and pharmaceutical applications. It is gamma and e-beam sterilizable, contains mold release and adheres to our healthcare management of change policy.

Information provided by SABIC

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.20 g/ccASTM D792
 1.20 g/ccASTM D792
Density 1.19 g/ccASTM D792
Water Absorption 0.15 %24 hours; ASTM D570
Moisture Absorption at Equilibrium 0.35 %ASTM D570
 0.58 %
@Temperature 100 °C
ASTM D570
Linear Mold Shrinkage, Flow 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
SABIC method
Melt Flow 16 g/10 min
@Load 1.20 kg,
Temperature 300 °C
cm³/10 min; ISO 1133
 17.5 g/10 min
@Load 1.20 kg,
Temperature 300 °C
ASTM D1238
 
Mechanical PropertiesOriginal ValueComments
Hardness, Rockwell M 70ASTM D785
Hardness, Rockwell R 118ASTM D785
Tensile Strength at Break 65.0 MPa50 mm/min; ISO 527
 68.0 MPa50 mm/min; ASTM D638
Tensile Strength, Yield 62.0 MPa50 mm/min; ASTM D638
 63.0 MPa50 mm/min; ISO 527
Elongation at Break 100 %50 mm/min; ISO 527
 125 %50 mm/min; ASTM D638
Elongation at Yield 6.0 %50 mm/min; ISO 527
 7.0 %50 mm/min; ASTM D638
Tensile Modulus 2350 MPa1mm/min; ISO 527
 2370 MPa50 mm/min; ASTM D638
Flexural Yield Strength 90.0 MPa2 mm/min; ISO 178
 96.0 MPa1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 2130 MPa1.3 mm/min, 50 mm span; ASTM D790
 2300 MPa2 mm/min; ISO 178
Izod Impact, Notched 106.8 - 694.2 J/mcolors; ASTM D256
 694 J/mnatural, tints; ASTM D256
Izod Impact, Unnotched 3204 J/mASTM D4812
Izod Impact, Notched (ISO) 12.0 kJ/m²80*10*4; ISO 180/1A
Izod Impact, Unnotched (ISO) NB80*10*4; ISO 180/1U
 NB
@Temperature -30.0 °C
80*10*4; ISO 180/1U
Charpy Impact Unnotched NBEdgew 80*10*4 sp=62mm; ISO 179/1eU
 NB
@Temperature -30.0 °C
Edgew 80*10*4 sp=62mm; ISO 179/1eU
Charpy Impact, Notched 10.0 kJ/m²Edgew 80*10*4 sp=62mm; ISO 179/1eA
 35.0 kJ/m²ISO 179/2C
Tensile Impact Strength 472 kJ/m²ASTM D1822
Dart Drop, Total Energy 62.0 Jpeak; ASTM D3763
Falling Dart Impact 169 JASTM D3029
Taber Abrasion, mg/1000 Cycles 10CS-17, 1 kg; ASTM D1044
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity >= 1.00e+15 ohm-cmIEC 60093
 >= 1.00e+17 ohm-cmASTM D257
Surface Resistance >= 1.00e+15 ohmROA; IEC 60093
Dielectric Constant 2.7
@Frequency 50.0 - 60.0 Hz
IEC 60250
 2.7
@Frequency 1e+6 Hz
IEC 60250
 2.96
@Frequency 1e+6 Hz
ASTM D150
 3.17
@Frequency 50.0 - 60.0 Hz
ASTM D150
Dielectric Strength 14.9 kV/mm
@Thickness 3.20 mm
in air; ASTM D149
 17.0 kV/mm
@Thickness 3.20 mm
in oil; IEC 60243-1
Dissipation Factor 0.00090
@Frequency 50.0 - 60.0 Hz
ASTM D150
 0.0010
@Frequency 50.0 - 60.0 Hz
IEC 60250
 0.010
@Frequency 1e+6 Hz
ASTM D150
 0.010
@Frequency 1e+6 Hz
IEC 60250
 
Thermal PropertiesOriginal ValueComments
CTE, linear, Parallel to Flow 68.4 µm/m-°C
@Temperature -40.0 - 95.0 °C
ASTM E831
 70.0 µm/m-°C
@Temperature 23.0 - 80.0 °C
ISO 11359-2
Specific Heat Capacity 1.25 J/g-°CASTM C 351
Thermal Conductivity 0.190 W/m-KASTM C177
 0.200 W/m-KISO 8302
Hot Ball Pressure Test 125 °CIEC 60695-10-2
Deflection Temperature at 0.46 MPa (66 psi) 133 °CEdgew 120*10*4 sp=100mm; ISO 75/Be
 137 °C
@Thickness 6.40 mm
unannealed; ASTM D648
Deflection Temperature at 1.8 MPa (264 psi) 122 °C1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 129 °C
@Thickness 6.40 mm
unannealed; ASTM D648
Vicat Softening Point 140 °CRate B/50; ISO 306
 141 °CRate B/120; ISO 306
Oxygen Index 25 %ISO 4589
 
Optical PropertiesOriginal ValueComments
Refractive Index 1.586ASTM D542
Haze 1.0 %
@Thickness 2.54 mm
ASTM D1003
Transmission, Visible 88 %
@Thickness 2.54 mm
ASTM D1003
 
Processing PropertiesOriginal ValueComments
Nozzle Temperature 275 - 300 °CInjection Molding
Zone 1 260 - 280 °C
Zone 2 270 - 295 °C
Zone 3 280 - 305 °C
Melt Temperature 280 - 305 °C
Mold Temperature 70.0 - 95.0 °C
Drying Temperature 120 °CInjection Molding
Dry Time 3.00 - 4.00 hourInjection Molding
 48.0 hourCumulative; Injection Molding
Moisture Content 0.020 %
Back Pressure 0.300 - 0.700 MPa
Shot Size 40 - 60 %
Vent Depth 0.00250 - 0.00760 cm
Screw Speed 40 - 70 rpm
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes

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PSABI10686 / 244153

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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