Abstract
Styles are invasive medical devices that are visible on images and are used in several medical specialties, including cardiology, neurology, orthopaedics, anaesthesia, oto-rhino-laryngology (ENT), and dentistry. With their thin and flexible design, they allow for the optimal positioning and precise guidance of medical devices such as nerve stimulation, defibrillation, electrode positioning, and catheter insertion. Generally, they are made of stainless steel, offering a combination of rigidity and flexibility. The aim of this study is to evaluate the sensitivity of austenitic stainless steel 304L used for the manufacture of J-stylets in uniform, pitting, crevice, and intergranular corrosion. We follow the manufacturing process step by step in order to analyse the risks of corrosion sensitisation and the cumulative effects of various forms of degradation, which could lead to a significant release of metal cations. Another objective of this study is to determine the optimal heat treatment temperature to minimise sensitivity to the intergranular corrosion of 304L,steel. Uniform corrosion: Two samples were taken at each stage of the manufacturing process (eight steps in total), in the form of rods. After one hour of immersion, potentiodynamic polarisation curves were plotted up to ± 400 mV vs. SCE. A coulometric analysis was also performed by integrating the anode zone between E (i = 0) and +400 mV vs. SCE. The values obtained by integration are expressed as mC/cm2. The test medium used was a simulated artificial plasma solution (9 g/L NaCl solution). Intergranular corrosion: (a) Chemical test: Thirty rod-shaped samples were tested, representing the eight manufacturing steps, as well as heat treatments at 500 °C, 620 °C, and 750 °C, in accordance with ASTM A262 (F method). (b) Electrochemical Potentiokinetic Reactivation (EPR) according to ASTM G108–94 (2015). Two samples were tested for each condition: without heat treatment and after treatments at 500 °C, 620 °C, and 750 °C. Release of cations: The release of metal ions was evaluated in the following two media: artificial sweat, according to EN 1811:2011+A1:2015, and bone plasma, according to the Fitton-Jackson and Burks-Peck method. Six samples that had been heat-treated at 500 °C for one hour were analysed. Results, discussions: (a) Analysis of the polarisation curves revealed significant disturbances in the heat treatment steps, as well as the μC/cm2 quantities, which were between 150,000 and 400,000 compared to only 40–180 for the other manufacturing steps; (b) Electrochemical Potentiokinetic reactivation (EPR) tests indicated that the temperature of 500 °C was a good choice to limit 304L steel sensitisation in intergranular corrosion; and (c) the quantities of cations released in EN 1811 sweat were of the order of a few μg/cm2 week, as for Fe: 2.31, Cr: 0.05, and Ni: 0.12.
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