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

Author:

Al-Zyoud Walid1ORCID,Haddadin Dana1,Hasan Sameer Ahmad1ORCID,Jaradat Hussamaldeen2ORCID,Kanoun Olfa2ORCID

Affiliation:

1. Department of Biomedical Engineering, School of Applied Medical Sciences, German Jordanian University, Amman 11180, Jordan

2. Measurement and Sensor Technology, Chemnitz University of Technology, 09126 Chemnitz, Germany

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.

Funder

DAAD

Publisher

MDPI AG

Subject

General Materials Science

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