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USP Class VI adhesives

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SABIC LEXAN™ Healthcare HPS4 PC (Europe)
Categories: Polymer; Thermoplastic; Polycarbonate (PC); Polycarbonate, Gamma Radiation Resistant

Material Notes: Medium flow polycarbonate. For medical devices and pharmaceutical applications. Healthcare management of change, biocompatible (ISO10993 or USP Class VI).EtO, steam, e-beam, and gamma sterilizable. Contains mold release.

Information provided by SABIC

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.19 g/ccASTM D792
Density 1.19 g/ccISO 1183
Water Absorption 0.14 %24 hours; ASTM D570
 0.26 %23°C/sat; ISO 62
Moisture Absorption 0.100 %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
Linear Mold Shrinkage, Transverse 0.0050 - 0.0070 cm/cm
@Thickness 3.20 mm
SABIC method
Melt Flow 10 g/10 min
@Load 1.20 kg,
Temperature 300 °C
cm³/10 min; ISO 1133
 10.5 g/10 min
@Load 1.20 kg,
Temperature 300 °C
ASTM D1238
 
Mechanical PropertiesOriginal ValueComments
Tensile Strength at Break 73.0 MPa50 mm/min; ISO 527
 74.0 MPa50 mm/min; ASTM D638
Tensile Strength, Yield 61.0 MPa50 mm/min; ISO 527
 62.0 MPa50 mm/min; ASTM D638
Elongation at Break 128 %50 mm/min; ISO 527
 140 %50 mm/min; ASTM D638
Elongation at Yield 6.0 %50 mm/min; ISO 527
 6.5 %50 mm/min; ASTM D638
Tensile Modulus 2300 MPa50 mm/min; ASTM D638
 2390 MPa1mm/min; ISO 527
Flexural Yield Strength 93.0 MPa2 mm/min; ISO 178
 100 MPa1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 2250 MPa2 mm/min; ISO 178
 2400 MPa1.3 mm/min, 50 mm span; ASTM D790
Izod Impact, Notched 840 J/mASTM D256
 220 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 70.0 kJ/m²Edgew 80*10*3 sp=62mm; ISO 179/1eA
 82.0 kJ/m²ISO 179/2C
 15.0 kJ/m²
@Temperature -30.0 °C
Edgew 80*10*3 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 88.0 JASTM D3763
 
Thermal PropertiesOriginal ValueComments
CTE, linear, Parallel to Flow 78.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ASTM E831
 78.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ISO 11359-2
CTE, linear, Transverse to Flow 76.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ASTM E831
 76.0 µm/m-°C
@Temperature -40.0 - 40.0 °C
ISO 11359-2
Hot Ball Pressure Test 125 °CIEC 60695-10-2
Deflection Temperature at 0.46 MPa (66 psi) 138 °C
@Thickness 6.40 mm
unannealed; ASTM D648
Deflection Temperature at 1.8 MPa (264 psi) 127 °C1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 126 °C
@Thickness 3.20 mm
unannealed; ASTM D648
 132 °C
@Thickness 6.40 mm
unannealed; ASTM D648
Vicat Softening Point 143 °CRate B/50; ASTM D1525
 143 °CRate B/50; ISO 306
 145 °CRate B/120; ISO 306
 
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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PSABI10691 / 244158

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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