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Technical Data Sheet
Ecdel™ Elastomer 9965


Applications
  • IV bags packaging
  • Medical tubing & bags - not IV
  • Pharmaceutical packaging
Key Attributes
  • Chemical resistant with low extractables
  • Excellent clarity
  • Excellent toughness & flexibility without plasticizers
  • Heat & sterilization stability

Product Description

Meets ISO 10993 and/or USP Class VI biocompatibility requirement.
Ecdel™ elastomers are medical grade copolyester ethers (COPE) that 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 CERTIFIEDTM Bronze, with Material Health Certificate, Platinum.
The CRADLE TO CRADLE CERTIFIED mark is a registered certification mark used under license through the Cradle to Cradle Products Innovation Institute, a nonprofit organization that administers the publicly available Cradle to Cradle CertifiedTM Product Standard which provides designers and manufacturers with criteria and requirements for continually improving product materials and manufacturing processes. The Cradle to Cradle CertifiedTM Product Standard guides designers and manufacturers through a continual improvement process that looks at a product through five quality categories—material health, material reutilization, renewable energy and carbon management, water stewardship, and social fairness. A product receives an achievement level in each category—Basic, Bronze, Silver, Gold, or Platinum—with the lowest achievement level representing the product’s overall mark.

The Material Health Certificate provides manufacturers with a trusted way to communicate their efforts to identify and replace chemicals of concern in their products. For more information about Cradle to Cradle certification and to obtain printable certificates for Eastman copolyesters, visit www.c2ccertified.org. Search for Eastman Chemical Company in Cradle to Cradle Certified Products Registry.



Typical Properties

PropertyaTest MethodbTypical Value, Unitsc
Film Properties
Thickness of Film Tested 0.13 mm (5 mils)
Refractive Index, nDD 5421.51
HazeD 10031 %
Gloss 
     @ 45°D 245780
Regular TransmittanceD 100390 %
Total TransmittanceD 100393 %
Tensile Strength @ Yield 
     M.D.D 88213.7 MPa (2000 psi)
     T.D.D 88213.5 MPa (2000 psi)
Tensile Strength @ Break 
     M.D.D 88223.7 MPa (3400 psi)
     T.D.D 88222.6 MPa (3300 psi)
Elongation @ Yield 
     M.D.D 88226 %
     T.D.D 88226 %
Elongation @ Break 
     M.D.D 882550 %
     T.D.D 882550 %
Tensile Modulus, Tangent 
     M.D.D 882185 MPa (26800 psi)
     T.D.D 882179 MPa (26000 psi)
Water Vapor Transmission RategF 372132 g/m2·24h (8.5 g/100in.2·24h)
Gas Permeability, O2 
     @ 30°C (86°F)D 1434841 cm3/m2*24h*atm (54 cm3/100in.2·24h·atm)
Coefficient of FrictionD 1894>1
Mechanical Properties
Specific GravityD 7921.13
Durometer Hardness 
     Shore A ScaleD 224095
     Shore D ScaleD 224055
Tensile Stress @ BreakdD 63820 MPa (2900 psi)
Tensile Stress @ YieldeD 63814 MPa (2030 psi)
Elongation @ YieldD 63830 %
Elongation @ BreakD 638300 %
Tensile ModulusD 638170 MPa (24650 psi)
Flexural ModulusD 790150 MPa (21750 psi)
Tear StrengthD 1004370 N (84 lbf)
Izod Impact Strength, Notched 
     @ -40°C (-40°F)D 25650 J/m (0.94 ft·lbf/in.)
Torsional Modulus Temperature 
     @ 240 MPa (35,000 psi)D 1043-28 °C (-18 °F)
     @ 930 MPa (135,000 psi)D 1043<-70 °C (<-94 °F)
Water Absorption, 24 h immersionD 5700.35 %
Thermal Properties
Inherent ViscosityEMN-A-AC-G-V-11.05
Flow Rate 
     (Condition 215°C/2.16 kg)D 123825 g/10 min
     (Condition 230°C/2.16 kg)D 123839 g/10 min
Crystalline Peak Melting Point (Tm)D 3418207 °C (405 °F)
Crystallization Temperature on Cooling (Tcc)DSC140 °C (284 °F)
Glass Transition Temperature (Tg)DSC-40 °C (-40 °F)
Specific Heatf 
     @ 100°C (212°F) - solidDSC1.8 kJ/kg·K (0.43 Btu/lb·°F)
     @ 150°C (302°F) - solidDSC2.0 kJ/kg·K (0.48 Btu/lb·°F)
     @ 175°C (347°F) - solidDSC2.3 kJ/kg·K (0.55 Btu/lb·°F)
     @ 200°C (392°F) - transitionDSC3.1 kJ/kg·K (0.74 Btu/lb·°F)
     @ 225°C (437°F) - meltDSC2.3 kJ/kg·K (0.55 Btu/lb·°F)
     @ 25°C (77°F) - solidDSC1.6 kJ/kg·K (0.38 Btu/lb·°F)
Heat of FusionE 79327 kJ/kg (11.6 Btu/lb)
Thermal ConductivityC 1770.19 W/m·K (1.3 Btu·in./h·ft2·°F)
Coefficient of Linear Thermal ExpansionD 69615 x 10-5 /°C (mm/mm·°C) (8 x 10-5 /°F (in./in.·°F))
Brittleness TemperatureD 746<-75 °C (<-103 °F)
Vicat Softening Temperature 
     @ 1 kg loadD 1525170 °C (338 °F)

aUnless noted otherwise, all tests are run at 23°C (73°F) and 50% relative humidity.
bUnless noted otherwise, the test method is ASTM.
cUnits are in SI or US customary units.
dD 412, Die C specimens, which are equivalent to ASTM D 638, Type IV specimens. Specimens were 2.0 mm (0.075 in.) thick and were tested using a crosshead speed of 500 mm (20 in.) per min.
eInjection molded ASTM D 638 Type I specimens, about 3 mm (1/8 in.) thick, were tested using a crosshead speed of 500 mm (20 in.) per min.
fFor 200°C (392°F) - transition, apparent specific heat, including the effects of the heat of fusion.
gTest conducted at 38°C (100°F) and 100% relative humidity.



Eastman Medical Disclaimer
It is the responsibility of the medical device manufacturer ("Manufacturer") to determine the suitability of all component parts and raw materials, including any Eastman product, used in its final product in order to ensure safety and compliance with requirements of the United States Food and Drug Administration (FDA) or other international regulatory agencies.

Eastman Chemical Company products have not been designed for nor are they promoted for end uses that would be categorized by either the United States FDA or by the International Standards Organization (ISO) as implant devices. Eastman products are not intended for use in the following applications: (1) in any bodily implant applications for greater than 30 days, based on FDA-Modified ISO-10993, Part 1 “Biological Evaluation of Medical Devices” tests (including any cosmetic, reconstructive or reproductive implant applications); (2) in any cardiac prosthetic device application, regardless of the length of time involved, including, without limitation, pacemaker leads and devices, artificial hearts, heart valves, intra-aortic balloons and control systems, and ventricular bypass assisted devices, or (3) as any critical component in any medical device that supports or sustains human life.

Eastman Chemical Company products offered for the medical market have met selected FDA-Modified ISO-10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less. The tests include: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), subchronic toxicity (sub-acute), implantation, hemocompatibility. The Manufacturer is responsible for the biological evaluation of the finished medical device.

The suitability of an Eastman Product in a given end-use environment is dependent upon various conditions including, without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses, and external loads. It is the responsibility of the Manufacturer to evaluate its final product under actual end-use requirements and to adequately advise and warn purchasers and users thereof.

Comments
Properties reported here are based on limited testing. Eastman makes no representation that the material in any particular shipment will conform exactly to the values given.


Eastman and its marketing affiliates shall not be responsible for the use of this information, or of any product, method, or apparatus mentioned, and you must make your own determination of its suitability and completeness for your own use, for the protection of the environment, and for the health and safety of your employees and purchasers of your products. No warranty is made of the merchantability of fitness of any product, and nothing herein waives any of the Seller's conditions of sale.


1/28/2019 2:27:43 PM