Accelerated Aging Effect on the Stability of the 3D-Printed Biodegradable Implant for Bone Defect Repairs.

This article presents an evaluation of the accelerated aging impact on the structural properties of biodegradable PLA/HAp implants produced using 3D printing technology for use in traumatic bone defect repairs in individual patients. The designed biodegradable implants were sterilized with a radiation dose of 25 ± 0.99% kGy, then exposed to an accelerated aging process. Selected physicomechanical and chemical properties of biodegradable implants were evaluated with FT-IR spectra analyses and DSC. The accelerated aging process, carried out according to the ASTM F 1980:2002 "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices", simulates three years of implant usage. It confirmed the stability of structural, physical and mechanical properties and proved the effectiveness and safety of the implants' application. The present study was conducted to determine the shelf-life of newly developed biodegradable implants proposed for the treatment of children and adolescents where bone growth still occurs by using accelerated aging methodologies, allowing the assessment of changes in performance that do not result in a negative impact on the safety of the medical device.