Gentex Clearweld Laser Welding Joint Strength Not ...

1 Materials Tested:Eastalloy polymer DA003, eastar copolyester DN004, eastar copolyester MN005, DuraStar polymer :Several of the MN005 samples had brittle failures resulting in a large variability of the Peak Load/Stress. Most of the other samples failed in a ductilemode (yielded and elongated) and resulted in consistent peak load/stress suggest there is no significant effect of gamma sterilization on Clearweld Laser welded Joint Clearweld Laser Welding Joint Strength Not Compromisedby Gamma Sterilization ProcessGentex Corporation Develops New TechnologyHistorically, Through Transmission Laser Welding (TTLW) of plastics is used to weld transparent toopaque materials.

2 More specifically, the Laser beam is directed through the transparent material where it is absorbed on the surface of the opaque generated on the surface of the opaque materialmelts the surface on both substrates creating a weldedjoint between the two ProcessGentex developed a new technology which allows two transparent materials to be welded. In this process,a near infrared absorbing coating known as Clearweld is placed at the Joint interface. Laser energy is passedthrough the top substrate, where it is absorbed at theinterface. The coating concentrates the Laser energy toproduce sufficient heat to create a weld between the two effectiveness of the Clearweld Process is influencedby such factors as the transmission of the plastic at thelaser wavelength, Laser speed, Laser intensity, and clampingpressure between the two materials as they are Strength Before and After Gamma SterilizationPeak Load and Peak Shear Stress tests were conducted on Clearweld before and after gamma sterilization.

3 Thetest procedure was approximately five welded Joint pairs of each material gamma sterilized at 50 welded Joint samples of each material were kept unsterilized. Samples were then tensile tested at a rate of 2" per minute and sheer stress recorded forsterilized versus unsterilized samples. The joints werelap joints formed by overlapping ASTM tensile barsapproximately " and Welding a strip " using the Gentex Clearweld Process. Resultssuggested there was no significant effect of gamma sterilization on Clearweld Laser welded Joint areas include medical devices such as filters,microfluidic devices, IV sets, medical Load (lbs)DA003DN004MN005MN611 Sample #UnsterilizedSterilizedUnsterilizedSteri lizedUnsterilizedSterilizedUnsterilizedS terilized1234524632132224532229229930526 9262256289270255261272259251991529115325 9263107126269266263272239272212 Average291291269261148182266248 Peak Shear Stress (lbs/in2)

4 DA003DN004MN005MN611 Sample #UnsterilizedSterilizedUnsterilizedSteri lizedUnsterilizedSterilizedUnsterilizedS terilized1234527363567357427203578324633 1933902983291228423209300128312898302028 7227831098168610061704288029201190139729 87295329203020265030172351 Average32353234299129051643201829532759 Eastman Medical DisclaimerIt is the responsibility of the medical device manufacturer ( Manufacturer ) todetermine the suitability of all component parts and raw materials, including anyEastman product, used in its final product in order to ensure safety and compliancewith requirements of the United States Food and Drug Administration (FDA) or otherinternational regulatory Chemical Company products have not been designed for nor are theypromoted for end uses that would be categorized by either the United States FDAor by the International Standards Organization (ISO) as implant devices.

5 Eastmanproducts are not intended for use in the following applications: (1) in any bodilyimplant 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 prostheticdevice application, regardless of the length of time involved, including, withoutlimitation, pacemaker leads and devices, artificial hearts, heart valves, intra-aorticballoons and control systems, and ventricular bypass assisted devices, or (3) asany critical component in any medical device that supports or sustains human Chemical Company products offered for the medical market have metselected FDA-Modified ISO-10993, Part 1 Biological Evaluation of Medical Devices tests with human tissue contact time of 30 days or less.

6 The tests include:cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity(acute), subchronic toxicity (sub-acute), implantation, hemocompatibility. TheManufacturer is responsible for the biological evaluation of the finished medical suitability of an Eastman product in a given end-use environment is dependentupon various conditions including, without limitation, chemical compatibility,temperature, part design, sterilization method, residual stresses, and external is the responsibility of the Manufacturer to evaluate its final product under actualend-use requirements and to adequately advise and warn purchasers and users CorporationContact InformationGentex Box 315 Carbondale, PA 18407 Phone: (570) 282-8522 Fax: (570) 282-8555 Key contact.

7 Michelle BurrellKey contact e-mail: more information a registered trademark of TWI (oval) logo is a registered trademark of Gentex Corporation. Chemical CompanyContact InformationEastman Chemical Box 431 Kingsport, TN 37662 Phone: (423) 229-3609 Fax: (423) 229-1262 Key contact: Anthony PiferKey contact e-mail: more information , Eastalloyand Eastarare trademarks of Eastman Chemical Company.