Szymanski Lukasz, Kiernozek Magdalena, Gromadka Bartosz, Straszecka Weronika, Wiktorek-Smagur Aneta, Matak Damian
Department of Molecular Biology, Institute of Genetics and Animal Biotechnology, Polish Academy of Sciences, Postępu 36A, 05-552, Magdalenka, Poland.
European Biomedical Institute, Nalkowskiej 5, 05-410, Jozefow, Poland.
Ann Biomed Eng. 2025 May;53(5):1068-1079. doi: 10.1007/s10439-025-03702-5. Epub 2025 Mar 4.
The rigorous regulatory landscape for medical devices demands meticulous chemical characterization to ensure safety and compliance. This review examines the critical role of chemical characterization within regulatory frameworks, emphasizing its importance in the approval and market entry of medical devices. Key challenges, including the complexity of sample matrices, trace-level impurity detection, and the necessity of method validation, are thoroughly explored. In addition, the review addresses the dynamic nature of regulatory requirements, analyzing how updates in international standards, such as those from the International Organization for Standardization (ISO), the American National Standards Institute (ANSI), and the Association for the Advancement of Medical Instrumentation (AAMI), or the American Society for Testing and Materials (ASTM), shape the chemical characterization process. The review discusses future directions, including advancements in analytical technologies, the potential for increased automation and standardization, and the growing significance of managing emerging contaminants. By offering a comprehensive analysis of current practices and future trends, this review highlights the essential role of chemical characterization in ensuring the development and regulation of safe and effective medical devices.
医疗器械严格的监管环境要求进行细致的化学表征，以确保安全性和合规性。本综述探讨了化学表征在监管框架中的关键作用，强调了其在医疗器械批准和进入市场过程中的重要性。全面探讨了关键挑战，包括样品基质的复杂性、痕量杂质检测以及方法验证的必要性。此外，本综述还讨论了监管要求的动态性质，分析了国际标准（如国际标准化组织（ISO）、美国国家标准学会（ANSI）、医疗仪器促进协会（AAMI）或美国材料与试验协会（ASTM））的更新如何塑造化学表征过程。本综述讨论了未来的方向，包括分析技术的进步、自动化和标准化程度提高的潜力以及管理新兴污染物的重要性日益增加。通过对当前实践和未来趋势进行全面分析，本综述突出了化学表征在确保安全有效的医疗器械的开发和监管方面的重要作用。
