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Technical Data Sheet
Eastar™ Copolyester MN021


Applications
  • Blood contact and dialysis
  • Drug delivery
  • Fluid administration
  • Medical devices
Key Attributes
  • Chemical resistance to most medical solvents including lipids and IPA
  • Gamma and E-beam color stability

Product Description
Eastar™ Copolyester MN021 Natural has been tested for FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization. Eastar™ copolyester MN021 Natural is a thermoplastic condensation copolymer produced by a continuous melt-phase polymerization process followed by a solid-state polymerization process. It has a relatively high flex modulus and yield strength. This product does not contain a mold release. It is a thermoplastic condensation copolymer produced by a continuous melt-phase polymerization process followed by a solid-state polymerization process. It has been crystallized.

This product has been GREENGUARD INDOOR AIR QUALITY CERTIFIED
The GREENGUARD INDOOR AIR QUALITY CERTIFIED Mark is a registered certification mark used under license through the GREENGUARD Environmental Institute (GEI). GEI is an industry-independent, non-profit organization that oversees the GREENGUARD Certification Program. The GREENGUARD Certification Program is an industry independent, third-party testing program for low-emitting products and materials for indoor environments. For more information about GEI and to obtain printable certificates for Eastman™ Copolyesters, visit www.greenguard.org. Choose Eastman Chemical Company under the Manufacturer category and click search to display a list of our products.



Typical Properties

PropertyaTest MethodbTypical Value, Unitsc
General Properties
Specific GravityD 7921.33
Mechanical Properties
Tensile Stress @ YieldD 63858 MPa (8400 psi)
Tensile Stress @ BreakD 63825 MPa (3600 psi)
Elongation @ BreakD 638120 %
Tensile ModulusD 6382400 MPa (3.5 x 105 psi)
Flexural Yield StrengthD 79084 MPa (12200 psi)
Flexural ModulusD 7902500 MPa (3.6 x 105 psi)
Rockwell Hardness, R ScaleD 785112
Izod Impact Strength, Notched 
     @ 23°C (73°F)D 25640 J/m (0.75 ft·lbf/in.)
     @ -40°C (-40°F)D 25627 J/m (0.51 ft·lbf/in.)
Impact Strength, Unnotched 
     @ -20°C (-4°F)D 4812NB
     @ 23°C (73°F)D 4812NB
     @ -30°C (-22°F)D 4812NB
     @ -40°C (-40°F)D 4812NB
Impact Resistance (Puncture), Energy @ Max. Load 
     2.5-mm (0.100-in.) Thick Plaques, @ 23°C (73°F)D 376326 J (19 ft·lbf)
     2.5-mm (0.100-in.) Thick Plaques, @ -40°C (-40°F)D 37631.6 J (1.2 ft·lbf)
     3.2-mm (0.125-in.) Thick Plaques @ 23°C (73°F)D 376331 J (23 ft·lbf)
     3.2-mm (0.125-in.) Thick Plaques @ -40°C (-40°F)D 37632.1 J (1.6 ft·lbf)
Optical Properties
HazeD 10031.0 %
Total TransmittanceD 100384 %
Thermal Properties
Deflection Temperature 
     @ 0.455 MPa (66 psi)D 64869 °C (156 °F)
     @ 1.82 MPa (264 psi)D 64865 °C (149 °F)
Typical Processing Conditions
Drying Temperature 150-160 °C (300-320 °F)
Drying Time 4-6 hrs
Processing Melt Temperature 275-295 °C (530-565 °F)
Mold Temperature 10-30 °C (50-90 °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.


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 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.


1/21/2019 2:52:26 PM