Biocompatibility Testing for Implants: A Novel Tool for Selection and Characterization

Abstract

This review article dives into the complex world of biocompatibility testing: chemical, mechanical, and biological characterization, including many elements of biocompatibility, such as definitions, descriptive examples, and the practical settings. The focus extends to evaluating standard documents obtained from reliable organizations; with a particular focus on open-source information, including FDA-USA, ISO 10933 series, and TÜV SÜD. We found a significant gap in this field: biomaterial scientists and those involved in the realm of medical device development in general, and implants in particular, lack access to a tool that reorganizes the process of selecting the appropriate biocompatibility test for the implant being examined. This work progressed through two key phases that aimed to provide a solution to this gap. A straightforward “yes or no” flowchart was initially developed to guide biocompatibility testing decisions based on the previously accumulated information. Subsequently, the Python code was employed, generating a framework through targeted questions. This work reshapes biocompatibility evaluation, bridging theory and practical implementation. An integrated approach via a flowchart and the Python code empowers stakeholders to navigate biocompatibility testing effortlessly. To conclude, researchers are now better equipped for a safer, more effective implant development, propelling the field towards improved patient care and innovative progress.