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Technical Data Sheet
DuraStar™ Polymer MN611 Natural


Applications
  • Blood contact and dialysis
  • Fluid administration
  • Medical devices
  • Medical labware
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 MN611 has been tested for FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization. It contains a mold release to improve ejection. It has excellent appearance and is nearly water-clear. Benefits include toughness, chemical resistance, and excellent processing characteristics. MN611 has very good toughness.

Typical Properties

PropertyaTest MethodbTypical Value, Unitsc
General Properties
Specific GravityD 7921.2
Mold Shrinkage 
     Parallel to Flow, 3.2-mm (0.125-in.) thicknessD 9550.002-0.006 mm/mm (0.002-0.006 in./in.)
Mechanical Properties (ISO Method)
Tensile Strength @ YieldISO 52747 MPa
Tensile Strength @ BreakISO 52746 MPa
Elongation @ YieldISO 5274 %
Elongation @ BreakISO 527200 %
Tensile ModulusISO 5271800 MPa
Flexural ModulusISO 1781850 MPa
Flexural StrengthISO 17865 MPa
Izod Impact Strength, Notched 
     @ 23°CISO 1807.8 kJ/m2
     @ -40°CISO 1804.8 kJ/m2
Mechanical Properties
Tensile Stress @ YieldD 63847 MPa (6900 psi)
Tensile Stress @ BreakD 63851 MPa (7400 psi)
Elongation @ YieldD 6385 %
Elongation @ BreakD 638300 %
Flexural ModulusD 7902000 MPa (2.9 x 105 psi)
Flexural Yield StrengthD 79069 MPa (10000 psi)
Rockwell Hardness, R ScaleD 785103
Izod Impact Strength, Notched 
     @ 23°C (73°F)D 25680 J/m (1.5 ft·lbf/in.)
     @ -40°C (-40°F)D 25640 J/m (0.7 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 376342 J (31 ft·lbf)
     @ -40°C (-40°F)D 376348 J (35 ft·lbf)
Optical Properties
HazeD 10030.3 %
Regular TransmittanceD 100389 %
Total TransmittanceD 100391 %
Thermal Properties
Deflection Temperature 
     @ 0.455 MPa (66 psi)D 64874 °C (165 °F)
     @ 1.82 MPa (264 psi)D 64865 °C (149 °F)
Typical Processing Conditions
Drying Temperature 71 °C (160 °F)
Drying Time 3-4 hrs
Processing Melt Temperature 232-277 °C (450-530 °F)
Mold Temperature 16-38 °C (60-100 °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 2:46:41 PM