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USP Class VI adhesives

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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 PropertiesOriginal ValueComments
Specific Gravity 1.20 g/ccASTM D792
Density 1.20 g/ccISO 1183
Water Absorption 0.35 %23°C/sat; ISO 62
Moisture Absorption 0.150 %23°C / 50% RH; ISO 62
Linear Mold Shrinkage, Flow 0.0050 - 0.0070 cm/cmSABIC method
 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
SABIC method
Melt Flow 9.0 g/10 min
@Load 1.20 kg,
Temperature 300 °C
cm³/10 min; ISO 1133
 10 g/10 min
@Load 1.20 kg,
Temperature 300 °C
ASTM D1238
 
Mechanical PropertiesOriginal ValueComments
Ball Indentation Hardness 95.0 MPaISO 2039-1
Tensile Strength at Break 68.0 MPa50 mm/min; ASTM D638
 70.0 MPa50 mm/min; ISO 527
Tensile Strength, Yield 62.0 MPa50 mm/min; ASTM D638
 63.0 MPa50 mm/min; ISO 527
Elongation at Break 120 %50 mm/min; ISO 527
 130 %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 2300 MPa2 mm/min; ISO 178
 2340 MPa1.3 mm/min, 50 mm span; ASTM D790
Izod Impact, Notched 801 J/mASTM D256
 100 J/m
@Temperature -30.0 °C
ASTM D256
Izod Impact, Notched (ISO) 70.0 kJ/m²80*10*3; ISO 180/1A
 10.0 kJ/m²
@Temperature -30.0 °C
80*10*3; ISO 180/1A
Izod Impact, Unnotched (ISO) NB80*10*3; ISO 180/1U
 NB
@Temperature -30.0 °C
80*10*3; ISO 180/1U
Charpy Impact Unnotched NBEdgew 80*10*3 sp=62mm; ISO 179/1eU
 NB
@Temperature -30.0 °C
Edgew 80*10*3 sp=62mm; ISO 179/1eU
Charpy Impact, Notched 35.0 kJ/m²ISO 179/2C
 75.0 kJ/m²Edgew 80*10*3 sp=62mm; ISO 179/1eA
 15.0 kJ/m²
@Temperature -30.0 °C
Edgew 80*10*3 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 63.0 JASTM D3763
Taber Abrasion, mg/1000 Cycles 10CS-17, 1 kg; SABIC method
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity >= 1.00e+15 ohm-cmIEC 60093
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
Dielectric Strength 17.0 kV/mm
@Thickness 3.20 mm
in oil; IEC 60243-1
Dissipation Factor 0.0010
@Frequency 50.0 - 60.0 Hz
IEC 60250
 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
CTE, linear, Transverse to Flow 68.4 µm/m-°C
@Temperature -40.0 - 95.0 °C
ASTM E831
 70.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ISO 11359-2
Thermal Conductivity 0.200 W/m-KISO 8302
Hot Ball Pressure Test 125 °CIEC 60695-10-2
 140 °CIEC 60695-10-2
Deflection Temperature at 0.46 MPa (66 psi) 138 °CEdgew 120*10*4 sp=100mm; ISO 75/Be
Deflection Temperature at 1.8 MPa (264 psi) 127 °C1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 132 °C
@Thickness 3.20 mm
unannealed; ASTM D648
Vicat Softening Point 141 °CRate B/50; ASTM D1525
 143 °CRate B/50; ISO 306
 145 °CRate B/120; ISO 306
UL RTI, Electrical 130 °CUL 746B
UL RTI, Mechanical with Impact 125 °CUL 746B
UL RTI, Mechanical without Impact 125 °CUL 746B
Flammability, UL94 HB
@Thickness 3.00 mm
UL 94
 HB
@Thickness 1.50 mm
UL 94
Oxygen Index 25 %ISO 4589
Glow Wire Test 850 °C
@Thickness 1.00 mm
IEC 60695-2-12
 
Optical PropertiesOriginal ValueComments
Refractive Index 1.586ISO 489
Haze <= 0.80 %
@Thickness 2.54 mm
ASTM D1003
Transmission, Visible 88 %
@Thickness 2.54 mm
ASTM D1003
 
Processing PropertiesOriginal ValueComments
Processing Temperature 60.0 - 80.0 °CHopper Temperature
Nozzle Temperature 270 - 290 °CInjection Molding
Zone 1 260 - 280 °C
Zone 2 270 - 290 °C
Zone 3 280 - 310 °C
Melt Temperature 280 - 310 °C
Mold Temperature 80.0 - 110 °C
Drying Temperature 120 °CInjection Molding
Dry Time 2.00 - 4.00 hourInjection Molding
Moisture Content 0.020 %
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes

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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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