earticle

영어

Advancements in 3D printing technology have facilitated the development of implantable medical devices capable of replacing damaged human tissues. These devices are primarily fabricated from synthetic polymers with biocompatible and biodegradable properties. In particular, biodegradable polymers require appropriate degradation rates that match the pace of tissue regeneration, making performance evaluation under conditions similar to the human body essential. In this study, we developed a testing method to assess the performance of 3D-printed absorbable barrier membrane fabricated from polycaprolactone. Human biomimetic conditions were simulated using artificial saliva and phosphate-buffered saline, and the changes in performance before and after exposure were evaluated. Domestic and international standards and guidelines were analyzed to determine relevant test items and procedures, and the reliability of the proposed evaluation method was verified through validation tests. The results showed no observable changes in appearance, while the changes in dimensional and porosity characteristics were not statistically significant. In contrast, decreases in mass and molecular weight were observed, and tensile strength showed a substantial reduction, with all three parameters exhibiting statistically significant changes. These findings indicate that performance degradation is more closely associated with the reduction in molecular weight and the resulting decrease in mechanical strength than with changes in appearance. Based on these results, the study highlights the necessity of evaluating biodegradable implantable medical devices under conditions that simulate the implantation environment, and it is expected to contribute to enhancing the reliability of performance evaluation for future devices.