Eastar™ 6763 copolyester meets ISO 10993 and/or USP Class VI biocompatibility requirement; Food Contact Status compliant.
Eastar 6763 is a clear, amorphous material that can be molded and extruded with ease. Its excellent performance properties include clarity, toughness, good melt strength, no dusting, no stress whitening, good heat sealability, easy cutting and thermoforming. Eastar 6763 may be colored using color concentrates, dry colors, or liquid colorants. Eastar 6763 can be safely sterilized with proper ethylene oxide, radiation, or electron beam methods without property loss or color shift.

Eastar 6763 provides:

• Superior, long-term clarity provides easy identification of instruments
• Excellent puncture resistance and impact toughness ensure package integrity
• Excellent ability to be subjected to several methods of sterilization, providing flexibility and security to the device manufacturer
• Excellent optical and physical property stability post sterilization
• Good melt strength offers wide processing latitude and ease in thermoforming

The production and trimming of rigid medical trays made from sheet of Eastar 6763 results in little or no dust or particulates. After the thermoformed trays are made, they are put in polybags. The polybags of trays are then placed in protective boxes for storage or shipment. As long as the polybags in the protective boxes are intact and no outside contamination is evident, the thermoformer or medical device manufacturer should not need to clean the tray prior to packaging a device and sealing the package. If contamination is found on the medical trays and cleaning is required, use a lint-free towel. Blowing the tray out with filtered, deionized, non-lubricated air is also acceptable, assuming this does not stir up dust from the surrounding area. Using alcohol, which could cause crazing, or water, which would not evaporate, is not recommended.

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.