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USP Class VI adhesives

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Eastman Tenite 360A4861307 Cellulose Acetate Propionate, Clear, Trsp
Categories: Polymer; Renewable/Recycled Polymer; Thermoplastic; Cellulosic; Cellulose Acetate Propionate, Molded

Material Notes: Applications:
  • Blood Therapy
  • Drug Delivery
  • IV Components
  • Medical Devices
  • Surgical Instruments

Key Attributes:

  • Chemical resistance to most medical solvents including lipids and IPA
  • Ease of processing
  • Gamma and E-beam color stability

Product Description: Tenite Propionate 360A4861307 has been tested for FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization. Tenite cellulosic plastics are noted for their excellent balance of properties - toughness, hardness, strength, surface gloss, clarity, and a warm feel. The mechanical properties of Tenite cellulosic plastics differ with plasticizer levels. Lower plasticizer content yields a harder surface, higher heat resistance, greater rigidity, higher tensile strength, and better dimensional stability. Higher plasticizer content increases impact strength. Tenite cellulosic plastics are available in natural, clear, selected ambers or smoke transparents and black translucent. Color concentrates are available in let-down ratios from 10:1 to 40:1. Tenite Cellulosic Acetate Propionate 360-7 has a plasticizer level of 7%.

Information provided by Eastman.

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.21 g/ccASTM D792
Water Absorption 1.7 %
@Time 86400 sec
Immersion; ASTM D570
Linear Mold Shrinkage 0.0020 - 0.0060 cm/cmASTM D955
 
Mechanical PropertiesOriginal ValueComments
Hardness, Rockwell R 95ASTM D785
Tensile Strength at Break 40.7 MPaASTM D638
Tensile Strength, Yield 41.4 MPaASTM D638
Elongation at Break 50 %ASTM D638
Flexural Strength 55.8 MPaASTM D790
Flexural Modulus 1862 MPaASTM D790
Izod Impact, Notched 85.0 J/m
@Temperature -40.0 °C
ASTM D256
 203 J/m
@Temperature 23.0 °C
ASTM D256
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity 1.00e+13 - 1.00e+15 ohm-cmASTM D257
Dielectric Constant 3.3 - 3.8
@Frequency 1e+6 Hz
ASTM D150
Dielectric Strength 11.8 - 18.7 kV/mmASTM D149
Dissipation Factor 0.010 - 0.15
@Frequency 1e+6 Hz
ASTM D150
 
Thermal PropertiesOriginal ValueComments
CTE, linear 110 - 170 µm/m-°CASTM D696
Specific Heat Capacity 1.26 - 1.67 J/g-°CDSC
Thermal Conductivity 0.170 - 0.330 W/m-KASTM C177
Deflection Temperature at 0.46 MPa (66 psi) 92.0 °CASTM D648
Deflection Temperature at 1.8 MPa (264 psi) 82.0 °CASTM D648
Vicat Softening Point 107 °CASTM D1525
 
Optical PropertiesOriginal ValueComments
Refractive Index 1.46 - 1.49
@Wavelength 589.3 nm
nD; ASTM D542
Haze <= 8.5 %ASTM D1003
Transmission, Visible >= 90 %ASTM E308
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
Formula Number360
Plasticizer7 percent
Soluble Matter Loss0.1 percentASTM D570
Weight Loss on Heating0.3 percentASTM D707, 72 hrs, 80°C

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PE8833 / 129678

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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