Home Page

Technical Data Sheet
Eastar™ Copolyester MB002

Applications

Blood contact and dialysis
Fluid administration
Medical devices
Medical labware

Key Attributes

Chemical resistance to most medical solvents including lipids and IPA
Gamma and E-beam color stability
Good melt strength for EBM processes

Product Description
Eastar™ copolyester MB002 has been tested for FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization. It is a resin specifically developed for extrusion blow molding containers in medical applications where aesthetics such as high clarity and gloss, coupled with high toughness and chemical resistance, are desirable. Compared to many commonly used materials, Eastar™ copolyester MB002 runs on most standard processing equipment with broader processing conditions, and its toughness and melt strength enable blow molding of larger containers with greater design flexibility. This product meets the biocompatibility requirements under FDA/ISO 10993 and USP Class 6, Plastics.

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

Property^a	Test Method^b	Typical Value, Units^c
General Properties
Density	D 792	1.25 g/cm³
Mold Shrinkage	D 955	0.3 %
Mechanical Properties
Tensile Stress @ Yield	D 638	47 MPa (6900 psi)
Tensile Stress @ Break	D 638	48 MPa (7000 psi)
Elongation @ Yield	D 638	5 %
Elongation @ Break	D 638	300 %
Tensile Modulus	D 638	1900 MPa (2.7 x 10⁵ psi)
Flexural Modulus	D 790	1900 MPa (2.7 x 10⁵ psi)
Flexural Strength	D 790	65 MPa (9400 psi)
Rockwell Hardness, R Scale	D 785	105
Izod Impact Strength, Notched^d
@ 23°C (73°F)	D 256	NB
@ -40°C (-40°F)	D 256	63C J/m (1.2C ft·lbf/in.)
Impact Strength, Unnotched^e
@ 23°C (73°F)	D 4812	NB
@ -40°C (-40°F)	D 4812	NB
Impact Resistance (Puncture), Energy @ Max. Load
@ 0°C (32°F)	D 3763	41 J (30 ft·lbf)
@ 23°C (73°F)	D 3763	41 J (30 ft·lbf)
@ -40°C (-40°F)	D 3763	39 J (29 ft·lbf)
Optical Properties
Haze	D 1003	1.3 %
Gloss
@ 60°	D 2457	143
Regular Transmittance	D 1003	87 %
Total Transmittance	D 1003	91 %
Color
a*	D 2244	-0.2
b*	D 2244	0.6
L*	D 2244	95.0
Thermal Properties
Deflection Temperature
@ 0.455 MPa (66 psi)	D 648	73 °C (163 °F)
@ 1.82 MPa (264 psi)	D 648	63 °C (145 °F)
Vicat Softening Temperature	D 1525	85 °C (185 °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.
^dC = Complete Break; Nonbreak as defined by ASTM D 256.
^eNonbreak as defined by ASTM D 4812.

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.

1/22/2019 2:42:24 PM