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USP Class VI adhesives

SABIC LEXAN™ Healthcare HP4REU PC (Europe)
Categories: Polymer; Thermoplastic; Polycarbonate (PC)

Material Notes: LEXAN HP4REU is a medium flow polycarbonate (PC) with an MVR (300°C/1.2kg) of 9. This is a biocompatible (ISO10993 or USP Class VI) grade for medical devices and pharmaceutical applications. It is EtO and steam sterilizable, contains mold release and adheres to our healthcare management of change policy. Available only in Europe.

Information provided by SABIC

Vendors: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
 
Physical PropertiesMetricEnglishComments
Specific Gravity 1.20 g/cc1.20 g/ccASTM D792
Density 1.20 g/cc0.0434 lb/in³ISO 1183
Water Absorption 0.35 %0.35 %23°C/sat; ISO 62
Moisture Absorption 0.150 %0.150 %23°C / 50% RH; ISO 62
Linear Mold Shrinkage, Flow 0.0050 - 0.0070 cm/cm0.0050 - 0.0070 in/inSABIC method
 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
0.0050 - 0.0070 in/in
@Thickness 0.126 in
SABIC method
Melt Flow  9.0 g/10 min
@Load 1.20 kg,
Temperature 300 °C
9.0 g/10 min
@Load 2.65 lb,
Temperature 572 °F
cm³/10 min; ISO 1133
 10 g/10 min
@Load 1.20 kg,
Temperature 300 °C
10 g/10 min
@Load 2.65 lb,
Temperature 572 °F
ASTM D1238
 
Mechanical PropertiesMetricEnglishComments
Ball Indentation Hardness 95.0 MPa13800 psiISO 2039-1
Tensile Strength at Break 68.0 MPa9860 psi50 mm/min; ASTM D638
 70.0 MPa10200 psi50 mm/min; ISO 527
Tensile Strength, Yield 62.0 MPa8990 psi50 mm/min; ASTM D638
 63.0 MPa9140 psi50 mm/min; ISO 527
Elongation at Break 120 %120 %50 mm/min; ISO 527
 130 %130 %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 2.30 GPa334 ksi2 mm/min; ISO 178
 2.34 GPa339 ksi1.3 mm/min, 50 mm span; ASTM D790
Izod Impact, Notched 8.01 J/cm15.0 ft-lb/inASTM D256
 1.00 J/cm
@Temperature -30.0 °C
1.87 ft-lb/in
@Temperature -22.0 °F
ASTM D256
Izod Impact, Notched (ISO) 70.0 kJ/m²33.3 ft-lb/in²80*10*3; ISO 180/1A
 10.0 kJ/m²
@Temperature -30.0 °C
4.76 ft-lb/in²
@Temperature -22.0 °F
80*10*3; ISO 180/1A
Izod Impact, Unnotched (ISO) NBNB80*10*3; ISO 180/1U
 NB
@Temperature -30.0 °C
NB
@Temperature -22.0 °F
80*10*3; ISO 180/1U
Charpy Impact Unnotched NBNBEdgew 80*10*3 sp=62mm; ISO 179/1eU
 NB
@Temperature -30.0 °C
NB
@Temperature -22.0 °F
Edgew 80*10*3 sp=62mm; ISO 179/1eU
Charpy Impact, Notched 3.50 J/cm²16.7 ft-lb/in²ISO 179/2C
 7.50 J/cm²35.7 ft-lb/in²Edgew 80*10*3 sp=62mm; ISO 179/1eA
 1.50 J/cm²
@Temperature -30.0 °C
7.14 ft-lb/in²
@Temperature -22.0 °F
Edgew 80*10*3 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 63.0 J46.5 ft-lbASTM D3763
Taber Abrasion, mg/1000 Cycles 1010CS-17, 1 kg; SABIC method
 
Electrical PropertiesMetricEnglishComments
Volume Resistivity >= 1.00e+15 ohm-cm>= 1.00e+15 ohm-cmIEC 60093
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
Dielectric Strength 17.0 kV/mm
@Thickness 3.20 mm
432 kV/in
@Thickness 0.126 in
in oil; IEC 60243-1
Dissipation Factor  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
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
CTE, linear, Transverse 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 -40.0 - 40.0 °C
38.9 µin/in-°F
@Temperature -40.0 - 104 °F
ISO 11359-2
Thermal Conductivity 0.200 W/m-K1.39 BTU-in/hr-ft²-°FISO 8302
Hot Ball Pressure Test 125 °C257 °FIEC 60695-10-2
 140 °C284 °FIEC 60695-10-2
Deflection Temperature at 0.46 MPa (66 psi) 138 °C280 °FEdgew 120*10*4 sp=100mm; ISO 75/Be
Deflection Temperature at 1.8 MPa (264 psi) 127 °C261 °F1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 132 °C
@Thickness 3.20 mm
270 °F
@Thickness 0.126 in
unannealed; ASTM D648
Vicat Softening Point 141 °C286 °FRate B/50; ASTM D1525
 143 °C289 °FRate B/50; ISO 306
 145 °C293 °FRate B/120; ISO 306
UL RTI, Electrical 130 °C266 °FUL 746B
UL RTI, Mechanical with Impact 125 °C257 °FUL 746B
UL RTI, Mechanical without Impact 125 °C257 °FUL 746B
Flammability, UL94  HB
@Thickness 3.00 mm
HB
@Thickness 0.118 in
UL 94
 HB
@Thickness 1.50 mm
HB
@Thickness 0.0591 in
UL 94
Oxygen Index 25 %25 %ISO 4589
Glow Wire Test 850 °C
@Thickness 1.00 mm
1560 °F
@Thickness 0.0394 in
IEC 60695-2-12
 
Optical PropertiesMetricEnglishComments
Refractive Index 1.5861.586ISO 489
Haze <= 0.80 %
@Thickness 2.54 mm
<= 0.80 %
@Thickness 0.100 in
ASTM D1003
Transmission, Visible 88 %
@Thickness 2.54 mm
88 %
@Thickness 0.100 in
ASTM D1003
 
Processing PropertiesMetricEnglishComments
Processing Temperature 60.0 - 80.0 °C140 - 176 °FHopper Temperature
Nozzle Temperature 270 - 290 °C518 - 554 °FInjection Molding
Zone 1 260 - 280 °C500 - 536 °F
Zone 2 270 - 290 °C518 - 554 °F
Zone 3 280 - 310 °C536 - 590 °F
Melt Temperature 280 - 310 °C536 - 590 °F
Mold Temperature 80.0 - 110 °C176 - 230 °F
Drying Temperature 120 °C248 °FInjection Molding
Dry Time 2.00 - 4.00 hour2.00 - 4.00 hourInjection Molding
Moisture Content 0.020 %0.020 %
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes

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PSABI10680 / 244147

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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