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USP Class VI adhesives

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SABIC LEXAN™ Healthcare HP1REU PC (Europe)
Categories: Polymer; Thermoplastic; Polycarbonate (PC)

Material Notes: LEXAN HP1REU is a high flow polycarbonate (PC) with an MVR (300°C/1.2kg) of 26. 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 in Europe only.

Information provided by SABIC

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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/cm
@Thickness 3.20 mm
SABIC method
Melt Flow 26 g/10 min
@Load 1.20 kg,
Temperature 300 °C
cm³/10 min; ISO 1133
 28 g/10 min
@Load 1.20 kg,
Temperature 300 °C
ASTM D1238
 
Mechanical PropertiesOriginal ValueComments
Tensile Strength at Break 50.0 MPa50 mm/min; ISO 527
 65.0 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 70 %50 mm/min; ISO 527
 120 %50 mm/min; ASTM D638
Elongation at Yield 6.0 %50 mm/min; ASTM D638
 6.0 %50 mm/min; ISO 527
Tensile Modulus 2350 MPa1mm/min; ISO 527
 2370 MPa50 mm/min; ASTM D638
Flexural Yield Strength 90.0 MPa2 mm/min; ISO 178
 93.0 MPa1.3 mm/min, 50 mm span; ASTM D790
Flexural Modulus 2300 MPa1.3 mm/min, 50 mm span; ASTM D790
 2300 MPa2 mm/min; ISO 178
Izod Impact, Notched 640 J/mASTM D256
 100 J/m
@Temperature -30.0 °C
ASTM D256
Izod Impact, Notched (ISO) 60.0 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 65.0 kJ/m²Edgew 80*10*3 sp=62mm; ISO 179/1eA
 10.0 kJ/m²
@Temperature -30.0 °C
Edgew 80*10*3 sp=62mm; ISO 179/1eA
Dart Drop, Total Energy 54.0 JASTM D3763
 
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
Deflection Temperature at 1.8 MPa (264 psi) 121 °C1.8 MPa Edgew 120*10*4 sp=100mm; ISO 75/Ae
 126 °C
@Thickness 3.20 mm
unannealed; ASTM D648
Vicat Softening Point 139 °CRate B/50; ISO 306
 139 °CRate B/50; ASTM D1525
 140 °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 - 300 °C
Melt Temperature 280 - 300 °C
Mold Temperature 80.0 - 100 °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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PSABI10666 / 244133

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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