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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.

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 PropertiesMetricEnglishComments
Density 1.13 g/cc0.0408 lb/in³ASTM D792
Water Absorption 0.35 %
@Time 86400 sec
0.35 %
@Time 24.0 hour
ASTM D570
Water Vapor Transmission 132 g/m²/day
@Temperature 38.0 °C
8.50 g/100 in²/day
@Temperature 100 °F
Film property at 0.13 mm; ASTM F372
Oxygen Transmission 331 cc-mm/m²-24hr-atm
@Temperature 30.0 °C
841 cc-mil/100 in²-24hr-atm
@Temperature 86.0 °F
Film property at 0.13 mm; ASTM D1434
Viscosity 1.05 cP1.05 cPInherent, EMN-A-AC-GV- 1
Melt Flow 20 g/10 min
@Load 2.16 kg,
Temperature 230 °C
20 g/10 min
@Load 4.66 lb,
Temperature 446 °F
ASTM D 1238
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 9595ASTM D2240
Hardness, Shore D 5555ASTM D2240
Tensile Strength at Break 20.0 MPa2900 psiASTM D638
Film Tensile Strength at Yield, MD 13.7 MPa1990 psiFilm property at 0.13 mm; ASTM D882
Film Tensile Strength at Yield, TD 13.5 MPa1960 psiFilm property at 0.13 mm; ASTM D882
Tensile Strength, Yield 14.0 MPa2030 psi500 mm/min; ASTM D638
Film Elongation at Break, MD 550 %550 %Film property at 0.13 mm; ASTM D882
Film Elongation at Break, TD 550 %550 %Film property at 0.13 mm; ASTM D882
Film Elongation at Yield, MD 26 %26 %Film property at 0.13 mm; ASTM D882
Film Elongation at Yield, TD 26 %26 %Film property at 0.13 mm; ASTM D882
Elongation at Break 300 %300 %ASTM D638
Elongation at Yield 30 %30 %ASTM D638
Tensile Modulus 0.170 GPa24.7 ksi1mm/min; ASTM D638
 0.179 GPa26.0 ksiTD, Tangent, Film property at 0.13 mm; ASTM D882
 0.185 GPa26.8 ksiMD, Tangent, Film property at 0.13 mm; ASTM D882
Flexural Modulus 0.150 GPa21.8 ksiASTM D790
Izod Impact, Notched 0.500 J/cm
@Temperature -40.0 °C
0.937 ft-lb/in
@Temperature -40.0 °F
ASTM D256
Coefficient of Friction >= 1.0>= 1.0ASTM D1894
Tear Strength, Total 370 N83.2 lb (f)ASTM D1004
Film Tensile Strength at Break, MD 23.7 MPa3440 psiFilm property at 0.13 mm; ASTM D882
Film Tensile Strength at Break, TD 22.6 MPa3280 psiFilm property at 0.13 mm; ASTM D882
Torsional Stiffness  240 MPa
@Temperature -28.0 °C
34800 psi
@Temperature -18.4 °F
Modulus; ASTM D1043
 930 MPa
@Temperature <=-70.0 °C
135000 psi
@Temperature <=-94.0 °F
Modulus; ASTM D1043
 
Thermal PropertiesMetricEnglishComments
Heat of Fusion 27.0 J/g11.6 BTU/lbASTM E793
CTE, linear 15.0 µm/m-°C8.33 µin/in-°FASTM D696
Specific Heat Capacity  1.60 J/g-°C
@Temperature 25.0 °C
0.382 BTU/lb-°F
@Temperature 77.0 °F
solid
 1.80 J/g-°C
@Temperature 100 °C
0.430 BTU/lb-°F
@Temperature 212 °F
solid
 2.00 J/g-°C
@Temperature 150 °C
0.478 BTU/lb-°F
@Temperature 302 °F
solid
 2.30 J/g-°C
@Temperature 175 °C
0.550 BTU/lb-°F
@Temperature 347 °F
solid
 2.30 J/g-°C
@Temperature 225 °C
0.550 BTU/lb-°F
@Temperature 437 °F
melt
 3.10 J/g-°C
@Temperature 200 °C
0.741 BTU/lb-°F
@Temperature 392 °F
transition
Thermal Conductivity 0.190 W/m-K1.32 BTU-in/hr-ft²-°FASTM C177
Melting Point 208 °C406 °F
Crystallization Temperature 140 °C284 °FTemperature on Cooling
Vicat Softening Point 56.0 °C133 °F1 kg load; ASTM D1525
Brittleness Temperature <= -75.0 °C<= -103 °FASTM D746
Glass Transition Temp, Tg -3.00 °C26.6 °F
 
Optical PropertiesMetricEnglishComments
Refractive Index 1.511.51Film property at 0.13 mm; ASTM D542
Haze 1.0 %
@Thickness 0.130 mm
1.0 %
@Thickness 0.00512 in
Film; ASTM D1003
Gloss 80 %80 %45°, Film property at 0.13 mm; ASTM D2457
Transmission, Visible 90 %90 %Regular, Film property at 0.13 mm; ASTM D1003
 93 %93 %Transmittance, Film property at 0.13 mm; ASTM D1003
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes

**
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PEAT6055 / 21294

USP Class VI adhesives

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