Reprocessing laser-marked medical devices

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Reprocessing laser-marked medical devices

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  • Author: Bernd Block

According to the EU Medical Device Regulation (MDR) and regulatory requirements set by the US Food and Drug Administration (FDA), medical devices must be clearly labeled with a mark that remains legible during their entire service life. In this paper, we present the results of a study into the reprocessing of laser-marked medical-grade stainless steel 1.4301. The results show that annealing with nanosecond lasers and black marking with ultrashort-pulsed lasers from TRUMPF are both ideally suited to the task of marking reprocessable medical devices. Even after 50 reprocessing cycles of alkaline cleaning and steam sterilization, the marks remained as corrosion-free and legible as they were when they were applied.

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