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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.

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Celanese Celanex® 2402 MT PBT, Medical Technology
Categories: Polymer; Thermoplastic; Polyester, TP; Polybutylene Terephthalate (PBT)

Material Notes: Celanex 2402 MT Natural is an unreinforced PBT with improved flow 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).. 2402 MT also complies with the corresponding EU and national registry regulatory requirements. 2402 MT has displayed excellent biocompatibility in tests corresponding to USP 23 class VI. Celanex 2402 MT contains no animal derived materials.

Information provided by Celanese

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Physical PropertiesOriginal ValueComments
Density 1.31 g/ccISO 1183
Linear Mold Shrinkage, Flow 0.018 - 0.020 cm/cmISO 294-4
Melt Flow 40 g/10 min
@Load 2.16 kg,
Temperature 250 °C
[cm3/10min]; ISO 1133
 
Mechanical PropertiesOriginal ValueComments
Tensile Strength, Yield 60.0 MPa50mm/min; ISO 527-2/1A
Elongation at Break 15 %
Elongation at Yield 4.0 %50mm/min; ISO 527-2/1A
Tensile Modulus 2700 MPa50mm/min; ISO 527-2/1A
Flexural Strength 80.0 MPaISO 178
Flexural Modulus 2550 MPaISO 178
Charpy Impact Unnotched 135 kJ/m²ISO 179/1eU
 130 kJ/m²
@Temperature -30.0 °C
ISO 179/1eU
Charpy Impact, Notched 5.00 kJ/m²ISO 179/1eA
 4.50 kJ/m²
@Temperature -30.0 °C
ISO 179/1eA
 
Thermal PropertiesOriginal ValueComments
CTE, linear, Parallel to Flow 110 µm/m-°CISO 11359-2
Melting Point 225 °C10°C/min; ISO 11357-1,-2,-3
Deflection Temperature at 0.46 MPa (66 psi) 160 °CISO 75-1, -2
Deflection Temperature at 1.8 MPa (264 psi) 60.0 °CISO 75-1, -2
Vicat Softening Point 190 °CISO 306
Glass Transition Temp, Tg 60.0 °CISO 11357-1,-2,-3
Flammability, UL94 HB
@Thickness 0.800 mm
 
Processing PropertiesOriginal ValueComments
Processing Temperature 65.0 - 93.0 °Ccavity
 250 - 260 °Chot runner
Feed Temperature 230 - 240 °C
Zone 1 230 - 240 °C
Zone 2 235 - 250 °C
Zone 3 235 - 250 °C
Zone 4 240 - 260 °C
Die Temperature 250 - 260 °C
Melt Temperature 243 °CISO 294
 235 - 260 °C
Mold Temperature 82.0 °CISO 294
Injection Velocity 300 mm/secISO 294
Drying Temperature 120 - 130 °C
Dry Time 4.00 hour
Moisture Content <= 0.020 %
Hold Pressure 48.0 MPaISO 294
 
Compliance PropertiesOriginal ValueComments
FDA YesSee notes for details.
USP Class VI Yes
 
Descriptive Properties
Injection moldingYes
Injection speedmedium-fast
Processing conditions acc. ISO7792-2

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PHCQ034 / 178489

USP Class VI adhesives

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