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Technical Data Sheet
DuraStar™ Polymer MN631 Natural


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

Product Description
DuraStar™ Polymer MN631 has been tested for FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization. It contains a mold release. It has excellent appearance and is nearly water-clear. Its most outstanding features are toughness, chemical resistance, and excellent processing characteristics. MN631 has very good toughness. Easy to process with minimal drying time, it flows readily and fills the most intricate tools.

Typical Properties

PropertyaTest MethodbTypical Value, Unitsc
General Properties
Specific GravityD 7921.19
Mold ShrinkageD 9550.003 mm/mm (0.003 in./in.)
Water Absorption, 24 h immersionD 5700.15 %
Mechanical Properties
Tensile Stress @ YieldD 63850 MPa (7200 psi)
Tensile Stress @ BreakD 63843 MPa (6300 psi)
Elongation @ YieldD 6385 %
Elongation @ BreakD 638270 %
Flexural Yield StrengthD 79068 MPa (9800 psi)
Flexural ModulusD 7901900 MPa (2.7 x 105 psi)
Rockwell Hardness, R ScaleD 785107
Izod Impact Strength, Notched 
     @ 23°C (73°F)D 25680 J/m (1.5 ft·lbf/in.)
     @ -40°C (-40°F)D 25644 J/m (0.8 ft·lbf/in.)
Impact Strength, Unnotched 
     @ 23°C (73°F)D 4812NB
     @ -40°C (-40°F)D 4812NB
Impact Resistance (Puncture), Energy @ Max. Load 
     @ 23°C (73°F)D 376340 J (30 ft·lbf)
     @ -40°C (-40°F)D 376338 J (28 ft·lbf)
Optical Properties
Total TransmittanceD 100392 %
HazeD 1003< 1 %
Thermal Properties
Deflection Temperature 
     @ 0.455 MPa (66 psi)D 64873 °C (163 °F)
     @ 1.82 MPa (264 psi)D 64866 °C (150 °F)
Vicat Softening Temperature 
     @ 1 kg loadD 152586 °C (186 °F)
Typical Processing Conditions
Drying Temperature 70 °C (160 °F)
Drying Time 4 hrs
Processing Melt Temperature 230-280 °C (450-530 °F)
Mold Temperature 15-30 °C (60-80 °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.


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 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.


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.


2/28/2018 11:35:39 AM