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Technical Data Sheet
Ecdel™ Elastomer 9966


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

Ecdel™ 9966 elastomer meets ISO 10993 and/or USP Class VI biocompatibility requirement.
Ecdel elastomers are plasticizer free copolyester elastomers (COPE) that offer clarity, toughness, flexibility, and chemical resistance needed in a variety of flexible packaging including flexible medical and pharmaceutical packaging applications. Ecdel elastomers are radiation, electron beam, ethylene oxide, and autoclave sterilization stable. Ecdel 9966 may be injection molded or extruded. Ecdel elastomers may be extrusion blow molded directly into bags or extruded into film for later fabrication into bags. Ecdel 9966's medium inherent viscosity makes it a good general purpose elastomer.

This product has received a Platinum level Material Health Certificate from the Cradle to Cradle Products Innovation Institute. A Material Health Certificate is awarded to products that meet the Material Health requirements of the multi-attribute Cradle to Cradle CertifiedTM Product Standard. The Cradle to Cradle Products Innovation Institute is 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 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 the Material Health Certificate Registry.


Typical Properties

PropertyaTest MethodbTypical Value, Unitsc
Electrical Properties
Arc Resistance 
     (tungsten electrodes)D 495Fails by melting
Comparative Tracking Index (CTI)IEC 112Fails by melting
Volume Resistivity 
     In AirD 2571014 ohm·cm
Surface ResistivityD 2571015 ohms/square
Dielectric Strength, Short Time, 500 V/sec rate-of-rise 
     In AirD 1496 kV/mm (152 V/mil)
     In OilD 14914 kV/mm (356 V/mil)
Dielectric Constant 
     1 kHzD 1503.9
     1 MHzD 1503.7
     10 kHzD 1503.8
Dissipation Factor 
     1 kHzD 1500.02
     1 MHzD 1500.02
     10 kHzD 1500.02
Film Properties
Thickness of Film Tested 0.11-0.14 mm (4.5-5.5 mils)
HazeD 10031 %
Gloss 
     @ 45°D 245785
Regular TransmittanceD 100394 %
Total TransmittanceD 100393 %
Refractive Index, nDD 5421.51
Tensile Stress @ Yieldg 
     M.D.D 88214 MPa (2030 psi)
     T.D.D 88212 MPa (1740 psi)
Elongation @ Break 
     M.D.D 882>400 %
     T.D.D 882>500 %
Tensile ModulushD 882180 MPa (26000 psi)
Coefficient of FrictionD 1894>1.0
Water Vapor Transmission RateiF 372190 g/m2·24h (12 g/100in.2·24h)
Gas Permeability, CO2j 
     @ 23°C (73°F)D 1434>1000 cm3·mm/m2·24h·atm (>2540 cm3·mil/100in.2·24h·atm)
Gas Permeability, O2j 
     @ 30°C (86°F)D 1434130 cm3·mm/m2·24h·atm (330 cm3·mil/100in.2·24h·atm)
Mechanical Properties
Specific GravityD 7921.13
Durometer Hardness 
     Shore A ScaleD 224095
     Shore D ScaleD 224055
Tensile Stress @ BreakdD 63822 MPa (3200 psi)
Tensile Stress @ YieldeD 63814 MPa (2030 psi)
Elongation @ YieldD 63838 %
Elongation @ BreakD 638400 %
Tensile ModulusD 638170 MPa (24650 psi)
Flexural ModulusD 790150 MPa (21750 psi)
Tear StrengthD 1004350 N (79 lbf)
Izod Impact Strength, Notched 
     @ -40°C (-40°F)D 25640 J/m (0.75 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 5700.4 %
Thermal Properties
Inherent ViscosityEMN-A-AC-G-V-11.16
Flow Rate 
     (Condition 215°C/2.16 kg)D 123811 g/10 min
     (Condition 230°C/2.16 kg)D 123818 g/10 min
Crystalline Peak Melting Point (Tm)D 3418205 °C (400 °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.
gCrosshead speed, 500 mm/min (20 in./min)
hCrosshead speed, 25 mm/min (1 in./min)
iData are based on limited testing. Test conducted at 38°C (100°F) and 100% relative humidity. Mocon values; confirmed by ASTM E 96E.
jData are based on limited testing.



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
Unless noted otherwise, properties reported here are typical of average lots. 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.


7/14/2020 4:11:26 PM