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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.

Celanese Celanex® 2401 MT PBT, Medical Technology
Categories: Polymer; Thermoplastic; Polyester, TP; Polybutylene Terephthalate (PBT)

Material Notes: Celanex 2401 MT Natural is an unreinforced, high molecular weight PBT that complies with the requirements of CFR 21 177.1660 of the Food and Drug Administration (FDA) and is listed in the Drug Master File (DMF) 10047 (US) / 10033 (EU) and the Device Master File (MAF) 443 (US) / 1078 (EU).. 2401 MT also complies with the corresponding EU and national registry regulatory requirements. 2401 MT has displayed excellent biocompatibility in tests corresponding to USP 23 class VI. Celanex 2401 MT contains no animal derived materials.

Information provided by Celanese

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Physical PropertiesMetricEnglishComments
Density 1.31 g/cc0.0473 lb/in³ISO 1183
Linear Mold Shrinkage, Flow 0.018 - 0.020 cm/cm0.018 - 0.020 in/inISO 294-4
Melt Flow 20 g/10 min
@Load 2.16 kg,
Temperature 250 °C
20 g/10 min
@Load 4.76 lb,
Temperature 482 °F
[cm3/10min]; ISO 1133
 
Mechanical PropertiesMetricEnglishComments
Tensile Strength, Yield 60.0 MPa8700 psi50mm/min; ISO 527-2/1A
Tensile Stress at Strain 30.0 MPa
@Strain 50 %
4350 psi
@Strain 50 %
ISO 527-2/1A
Elongation at Break >= 50 %>= 50 %
Elongation at Yield 4.0 %4.0 %50mm/min; ISO 527-2/1A
Tensile Modulus 2.60 GPa377 ksi50mm/min; ISO 527-2/1A
Flexural Strength 80.0 MPa11600 psiISO 178
Flexural Modulus 2.50 GPa363 ksiISO 178
Izod Impact, Notched (ISO) 5.00 kJ/m²2.38 ft-lb/in²ISO 180/1A
Charpy Impact Unnotched NBNBISO 179/1eU
 19.0 J/cm²
@Temperature -30.0 °C
90.4 ft-lb/in²
@Temperature -22.0 °F
ISO 179/1eU
Charpy Impact, Notched 0.600 J/cm²2.86 ft-lb/in²ISO 179/1eA
 0.600 J/cm²
@Temperature -30.0 °C
2.86 ft-lb/in²
@Temperature -22.0 °F
ISO 179/1eA
 
Electrical PropertiesMetricEnglishComments
Volume Resistivity 1.00e+15 ohm-cm1.00e+15 ohm-cmIEC 60093
Surface Resistance 1.00e+15 ohm1.00e+15 ohmIEC 60093
Dielectric Constant  3.5
@Frequency 1e+6 Hz
3.5
@Frequency 1e+6 Hz
IEC 60250
 4.0
@Frequency 100 Hz
4.0
@Frequency 100 Hz
IEC 60250
Dielectric Strength 23.0 kV/mm584 kV/inIEC 60243-1
Dissipation Factor  0.0014
@Frequency 100 Hz
0.0014
@Frequency 100 Hz
IEC 60250
 0.022
@Frequency 1e+6 Hz
0.022
@Frequency 1e+6 Hz
IEC 60250
Comparative Tracking Index 600 V600 VIEC 60112
 
Thermal PropertiesMetricEnglishComments
CTE, linear, Parallel to Flow 110 µm/m-°C61.1 µin/in-°FISO 11359-2
Melting Point 225 °C437 °F10°C/min; ISO 11357-1,-2,-3
Deflection Temperature at 0.46 MPa (66 psi) 150 °C302 °FISO 75-1, -2
Deflection Temperature at 1.8 MPa (264 psi) 55.0 °C131 °FISO 75-1, -2
Vicat Softening Point 190 °C374 °FISO 306
Glass Transition Temp, Tg 60.0 °C140 °FISO 11357-1,-2,-3
Flammability, UL94 HB
@Thickness 0.800 mm
HB
@Thickness 0.0315 in
Oxygen Index 20 %20 %ISO 4589
 
Processing PropertiesMetricEnglishComments
Processing Temperature 65.0 - 93.0 °C149 - 199 °Fcavity
 250 - 260 °C482 - 500 °Fhot runner
Feed Temperature 230 - 240 °C446 - 464 °F
Zone 1 230 - 240 °C446 - 464 °F
Zone 2 235 - 250 °C455 - 482 °F
Zone 3 235 - 250 °C455 - 482 °F
Zone 4 240 - 260 °C464 - 500 °F
Die Temperature 250 - 260 °C482 - 500 °F
Melt Temperature 243 °C469 °FISO 294
 235 - 260 °C455 - 500 °F
Mold Temperature 82.0 °C180 °FISO 294
Injection Velocity 300 mm/sec11.8 in/secISO 294
Drying Temperature 120 - 130 °C248 - 266 °F
Dry Time 4.00 hour4.00 hour
Moisture Content <= 0.020 %<= 0.020 %
Hold Pressure 48.0 MPa6960 psiISO 294
 
Compliance PropertiesMetricEnglishComments
FDA YesYesSee notes for details.
USP Class VI YesYes
 
Descriptive Properties
Injection moldingYes
Injection speedmedium-fast
Processing conditions acc. ISO7792-2

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PHCQ033 / 178488

USP Class VI adhesives

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