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The challenge to create corrosion resistant marks and labeling has spanned across many industries that require robust traceability methods including medical devices and instruments. The unique properties of ultrashort laser pulses enable precise surface structuring to withstand the required manufacturing post-processes of passivation and autoclaving. The benefits of ultrashort laser marking are demonstrated with the results in a comparison to traditional nanosecond laser marking systems through observation of pulse energy and pulse duration effects, corrosion resistance and long term durability under clinical conditions on medical grade alloys. Moreover, an analysis of microstructure by use of EDX and XRD exhibits a visual advantage of formed laser induced periodic surface structures (LIPSS) evident only to ultrashort pulse marking techniques. Under this new approach the allowable process parameter window flexibility for varied material types specific to medical applications was noted with respect to pico- and femtosecond pulse techniques. Traceability through unique device identification (UDI) is realized by combining complimentary technologies to format compliant sequenced data. Such data has been demonstrated as verifiable and rated with a customized grade to ensure quality of the marked code. The read-out data as well as the quality grading of marking result can be further processed in the production environment for documentation reasons. Thereby, the obstacle of UDI and corrosion resistant marking for medical devices and instruments can be met with such an industrial solution.
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Christoph Neugebauer, Salay Quaranta, Steffen Ehrenmann, Christian Rest, Jon Sadowitz, "Latest advances in medical black marking: technology and techniques," Proc. SPIE 10906, Laser-based Micro- and Nanoprocessing XIII, 1090604 (4 March 2019); https://doi.org/10.1117/12.2508408