Technical Data Sheet
Eastman Tritan™ Copolyester MXF321-21061FC Med White
Applications
Medical equipment
Medical housings and hardware
Key Attributes
Ease of processing
Excellent chemical resistance
Excellent hydrolytic stability
Good toughness
Product Description
Eastman Tritan MXF321 copolyester has been formulated for medical devices and meets UL94 V2 compliance at 1.5 mm. Eastman Tritan MXF321 has passed ISO 10993 testing for cytotoxicity, skin sensitization, and intracutaneous reactivity. Tritan MXF321 has many outstanding features that include excellent toughness, hydrolytic stability, heat resistance, chemical resistance, and melt flowability. Eastman Tritan MXF321 contains a mold release derived from vegetable based sources.
Typical Properties
Property
a
Test Method
b
Typical Value, Units
c
General Properties
Specific Gravity
D 792
1.20
Mold Shrinkage
D 955
0.003-0.006 mm/mm
Mechanical Properties
Tensile Strength @ Yield
D 638
49 MPa
Tensile Modulus
D 638
1850 MPa
Elongation @ Break
D 638
>50 %
Izod Impact Strength, Notched
@ 23°C (73°F)
D 256
1100 J/m
Thermal Properties
Deflection Temperature
@ 0.455 MPa (66 psi)
D 648
76 °C
@ 1.82 MPa (264 psi)
D 648
66 °C
Flammability
@ Thickness 1.5 mm
UL 94
V2
Melt Flow
d
D 1238
9-13 g/10 min
Typical Drying Conditions
Drying Temperature
80 °C
Drying Time
4-6 hrs
Typical Processing Conditions
Mold Temperature
18-50 °C
Processing Melt Temperature
260-280 °C
a
Unless noted otherwise, all tests are run at 23°C (73°F) and 50% relative humidity.
b
Unless noted otherwise, the test method is ASTM.
c
Units are in SI or US customary units.
d
260 Celsius, 2.16 kg
General
Eastman makes no representation and disclaims any warranty that the material in any particular shipment will conform exactly to the values given. This is a compounded product produced from various components mixed together in an extruder. Values as well as the performance of the final molded article may be affected by various factors such as the part design, mold design or tooling, drying, processing conditions, as well as coloring or pigmentation of the product. No warranty of merchantability or fitness for use is made, and nothing herein waives any of the Seller''''s conditions of sale. You must make your own determination of the suitability of this product in your specific application due to the many factors (e.g. design, processing and conditions of use) that affect the performance of the final molded article. Suitability of use should be evaluated with appropriate testing and analysis. The processing melt temperature and mold temperature refer to the actual resin melt temperature and actual mold surface temperature respectively. Consider overall resin residence time, part shot size utilization and part geometry to set appropriate processing melt temperature and mold temperature in order to minimize IV loss and maximize molded part performance.
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 precommercial products offered the medical market will 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 test, skin sensitization test and intracutaneous inject test. 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.
2/18/2022 11:10:53 AM