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USP Class VI adhesives

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 PropertiesMetricEnglishComments
Specific Gravity 1.20 g/cc1.20 g/ccASTM D792
 1.20 g/cc1.20 g/ccASTM D792
Density 1.19 g/cc0.0430 lb/in³ASTM D792
Water Absorption 0.15 %0.15 %24 hours; ASTM D570
Moisture Absorption at Equilibrium 0.35 %0.35 %ASTM D570
 0.58 %
@Temperature 100 °C
0.58 %
@Temperature 212 °F
ASTM D570
Linear Mold Shrinkage, Flow 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
0.0050 - 0.0070 in/in
@Thickness 0.126 in
SABIC method
Melt Flow  16 g/10 min
@Load 1.20 kg,
Temperature 300 °C
16 g/10 min
@Load 2.65 lb,
Temperature 572 °F
cm³/10 min; ISO 1133
 17.5 g/10 min
@Load 1.20 kg,
Temperature 300 °C
17.5 g/10 min
@Load 2.65 lb,
Temperature 572 °F
ASTM D1238
 
Mechanical PropertiesMetricEnglishComments
Hardness, Rockwell M 7070ASTM D785
Hardness, Rockwell R 118118ASTM D785
Tensile Strength at Break 65.0 MPa9430 psi50 mm/min; ISO 527
 68.0 MPa9860 psi50 mm/min; ASTM D638
Tensile Strength, Yield 62.0 MPa8990 psi50 mm/min; ASTM D638
 63.0 MPa9140 psi50 mm/min; ISO 527
Elongation at Break 100 %100 %50 mm/min; ISO 527
 125 %125 %50 mm/min; ASTM D638
Elongation at Yield 6.0 %6.0 %50 mm/min; ISO 527
 7.0 %7.0 %50 mm/min; ASTM D638
Tensile Modulus 2.35 GPa341 ksi1mm/min; ISO 527
 2.37 GPa344 ksi50 mm/min; ASTM D638
Flexural Yield Strength 90.0 MPa13100 psi2 mm/min; ISO 178
 96.0 MPa13900 psi1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 2.13 GPa309 ksi1.3 mm/min, 50 mm span; ASTM D790
 2.30 GPa334 ksi2 mm/min; ISO 178
Izod Impact, Notched 1.068 - 6.942 J/cm2.001 - 13.01 ft-lb/incolors; ASTM D256
 6.94 J/cm13.0 ft-lb/innatural, tints; ASTM D256
Izod Impact, Unnotched 32.04 J/cm60.02 ft-lb/inASTM D4812
Izod Impact, Notched (ISO) 12.0 kJ/m²5.71 ft-lb/in²80*10*4; ISO 180/1A
Izod Impact, Unnotched (ISO) NBNB80*10*4; ISO 180/1U
 NB
@Temperature -30.0 °C
NB
@Temperature -22.0 °F
80*10*4; ISO 180/1U
Charpy Impact Unnotched NBNBEdgew 80*10*4 sp=62mm; ISO 179/1eU
 NB
@Temperature -30.0 °C
NB
@Temperature -22.0 °F
Edgew 80*10*4 sp=62mm; ISO 179/1eU
Charpy Impact, Notched 1.00 J/cm²4.76 ft-lb/in²Edgew 80*10*4 sp=62mm; ISO 179/1eA
 3.50 J/cm²16.7 ft-lb/in²ISO 179/2C
Tensile Impact Strength 472 kJ/m²225 ft-lb/in²ASTM D1822
Dart Drop, Total Energy 62.0 J45.7 ft-lbpeak; ASTM D3763
Falling Dart Impact 169 J125 ft-lbASTM D3029
Taber Abrasion, mg/1000 Cycles 1010CS-17, 1 kg; ASTM D1044
 
Electrical PropertiesMetricEnglishComments
Volume Resistivity >= 1.00e+15 ohm-cm>= 1.00e+15 ohm-cmIEC 60093
 >= 1.00e+17 ohm-cm>= 1.00e+17 ohm-cmASTM D257
Surface Resistance >= 1.00e+15 ohm>= 1.00e+15 ohmROA; IEC 60093
Dielectric Constant  2.7
@Frequency 50.0 - 60.0 Hz
2.7
@Frequency 50.0 - 60.0 Hz
IEC 60250
 2.7
@Frequency 1e+6 Hz
2.7
@Frequency 1e+6 Hz
IEC 60250
 2.96
@Frequency 1e+6 Hz
2.96
@Frequency 1e+6 Hz
ASTM D150
 3.17
@Frequency 50.0 - 60.0 Hz
3.17
@Frequency 50.0 - 60.0 Hz
ASTM D150
Dielectric Strength  14.9 kV/mm
@Thickness 3.20 mm
378 kV/in
@Thickness 0.126 in
in air; ASTM D149
 17.0 kV/mm
@Thickness 3.20 mm
432 kV/in
@Thickness 0.126 in
in oil; IEC 60243-1
Dissipation Factor  0.00090
@Frequency 50.0 - 60.0 Hz
0.00090
@Frequency 50.0 - 60.0 Hz
ASTM D150
 0.0010
@Frequency 50.0 - 60.0 Hz
0.0010
@Frequency 50.0 - 60.0 Hz
IEC 60250
 0.010
@Frequency 1e+6 Hz
0.010
@Frequency 1e+6 Hz
ASTM D150
 0.010
@Frequency 1e+6 Hz
0.010
@Frequency 1e+6 Hz
IEC 60250
 
Thermal PropertiesMetricEnglishComments
CTE, linear, Parallel to Flow  68.4 µm/m-°C
@Temperature -40.0 - 95.0 °C
38.0 µin/in-°F
@Temperature -40.0 - 203 °F
ASTM E831
 70.0 µm/m-°C
@Temperature 23.0 - 80.0 °C
38.9 µin/in-°F
@Temperature 73.4 - 176 °F
ISO 11359-2
Specific Heat Capacity 1.25 J/g-°C0.299 BTU/lb-°FASTM C 351
Thermal Conductivity 0.190 W/m-K1.32 BTU-in/hr-ft²-°FASTM C177
 0.200 W/m-K1.39 BTU-in/hr-ft²-°FISO 8302
Hot Ball Pressure Test 125 °C257 °FIEC 60695-10-2
Deflection Temperature at 0.46 MPa (66 psi) 133 °C271 °FEdgew 120*10*4 sp=100mm; ISO 75/Be
 137 °C
@Thickness 6.40 mm
279 °F
@Thickness 0.252 in
unannealed; ASTM D648
Deflection Temperature at 1.8 MPa (264 psi) 122 °C252 °F1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 129 °C
@Thickness 6.40 mm
264 °F
@Thickness 0.252 in
unannealed; ASTM D648
Vicat Softening Point 140 °C284 °FRate B/50; ISO 306
 141 °C286 °FRate B/120; ISO 306
Oxygen Index 25 %25 %ISO 4589
 
Optical PropertiesMetricEnglishComments
Refractive Index 1.5861.586ASTM D542
Haze 1.0 %
@Thickness 2.54 mm
1.0 %
@Thickness 0.100 in
ASTM D1003
Transmission, Visible 88 %
@Thickness 2.54 mm
88 %
@Thickness 0.100 in
ASTM D1003
 
Processing PropertiesMetricEnglishComments
Nozzle Temperature 275 - 300 °C527 - 572 °FInjection Molding
Zone 1 260 - 280 °C500 - 536 °F
Zone 2 270 - 295 °C518 - 563 °F
Zone 3 280 - 305 °C536 - 581 °F
Melt Temperature 280 - 305 °C536 - 581 °F
Mold Temperature 70.0 - 95.0 °C158 - 203 °F
Drying Temperature 120 °C248 °FInjection Molding
Dry Time 3.00 - 4.00 hour3.00 - 4.00 hourInjection Molding
 48.0 hour48.0 hourCumulative; Injection Molding
Moisture Content 0.020 %0.020 %
Back Pressure 0.300 - 0.700 MPa43.5 - 102 psi
Shot Size 40 - 60 %40 - 60 %
Vent Depth 0.00250 - 0.00760 cm0.000984 - 0.00299 in
Screw Speed 40 - 70 rpm40 - 70 rpm
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes

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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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