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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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Eastman Ecdel PCCE 9965 Copolyester Ether Elastomer  (discontinued **)
Categories: Polymer; Thermoplastic; Polyester, TP

Material Notes: Product Description: Meets ISO 10993 and/or USP Class VI biocompatibility requirement. Ecdel™ elastomers are medical grade copolyester ethers (COPE) tha t offer the clarity, toughness, and chemical resistance needed in a variety of flexible packaging including medical and pharmaceutical applications. Ecdel™ elastomer 9965 may be processed on standard injection molding, extrusion blow molding, profile extrusion, extrusion coating, or film extrusion equipment. Ecdel™ elastomers may be extrusion blow molded directly into bags or extruded into film for later fabrication into bags. Ecdel™ elastomers are radiation, electron beam, ethylene oxide, and autoclave sterilization stable. 9965's low inherent viscosity may be helpful for extrusion coating or cast film extrusion applications. This product has been CRADLE TO CRADLE CERTIFIED cm Silver.

Applications/Uses:

  • Bags
  • Flexible medical
  • Flexible packaging
  • IV Containers
  • Pharmaceutical packaging
  • Tubing
Key Attributes:
  • Chemical resistant with low extractables
  • Excellent clarity
  • Excellent toughness & flexibility without plasticizers
  • Heat & sterilization stability

Vendors: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
 
Physical PropertiesOriginal ValueComments
Density 1.13 g/ccASTM D792
Water Absorption 0.35 %
@Time 86400 sec
ASTM D570
Water Vapor Transmission 132 g/m²/day
@Temperature 38.0 °C
Film property at 0.13 mm; ASTM F372
Oxygen Transmission 841 cc-mil/100 in²-24hr-atm
@Temperature 30.0 °C
Film property at 0.13 mm; ASTM D1434
Viscosity 1.05 cPInherent, EMN-A-AC-GV- 1
Melt Flow 20 g/10 min
@Load 2.16 kg,
Temperature 230 °C
ASTM D 1238
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 95ASTM D2240
Hardness, Shore D 55ASTM D2240
Tensile Strength at Break 20.0 MPaASTM D638
Film Tensile Strength at Yield, MD 13.7 MPaFilm property at 0.13 mm; ASTM D882
Film Tensile Strength at Yield, TD 13.5 MPaFilm property at 0.13 mm; ASTM D882
Tensile Strength, Yield 14.0 MPa500 mm/min; ASTM D638
Film Elongation at Break, MD 550 %Film property at 0.13 mm; ASTM D882
Film Elongation at Break, TD 550 %Film property at 0.13 mm; ASTM D882
Film Elongation at Yield, MD 26 %Film property at 0.13 mm; ASTM D882
Film Elongation at Yield, TD 26 %Film property at 0.13 mm; ASTM D882
Elongation at Break 300 %ASTM D638
Elongation at Yield 30 %ASTM D638
Tensile Modulus 0.170 GPa1mm/min; ASTM D638
 0.179 GPaTD, Tangent, Film property at 0.13 mm; ASTM D882
 0.185 GPaMD, Tangent, Film property at 0.13 mm; ASTM D882
Flexural Modulus 0.150 GPaASTM D790
Izod Impact, Notched 50.0 J/m
@Temperature -40.0 °C
ASTM D256
Coefficient of Friction >= 1.0ASTM D1894
Tear Strength, Total 370 NASTM D1004
Film Tensile Strength at Break, MD 23.7 MPaFilm property at 0.13 mm; ASTM D882
Film Tensile Strength at Break, TD 22.6 MPaFilm property at 0.13 mm; ASTM D882
Torsional Stiffness 240 MPa
@Temperature -28.0 °C
Modulus; ASTM D1043
 930 MPa
@Temperature <=-70.0 °C
Modulus; ASTM D1043
 
Thermal PropertiesOriginal ValueComments
Heat of Fusion 27.0 J/gASTM E793
CTE, linear 15.0 µm/m-°CASTM D696
Specific Heat Capacity 1.60 J/g-°C
@Temperature 25.0 °C
solid
 1.80 J/g-°C
@Temperature 100 °C
solid
 2.00 J/g-°C
@Temperature 150 °C
solid
 2.30 J/g-°C
@Temperature 175 °C
solid
 2.30 J/g-°C
@Temperature 225 °C
melt
 3.10 J/g-°C
@Temperature 200 °C
transition
Thermal Conductivity 0.190 W/m-KASTM C177
Melting Point 208 °C
Crystallization Temperature 140 °CTemperature on Cooling
Vicat Softening Point 56.0 °C1 kg load; ASTM D1525
Brittleness Temperature <= -75.0 °CASTM D746
Glass Transition Temp, Tg -3.00 °C
 
Optical PropertiesOriginal ValueComments
Refractive Index 1.51Film property at 0.13 mm; ASTM D542
Haze 1.0 %
@Thickness 0.130 mm
Film; ASTM D1003
Gloss 80 %45°, Film property at 0.13 mm; ASTM D2457
Transmission, Visible 90 %Regular, Film property at 0.13 mm; ASTM D1003
 93 %Transmittance, Film property at 0.13 mm; ASTM D1003
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes

**
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PEAT6055 / 21294

USP Class VI adhesives

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