医疗器械物理学特性引发的生物学危害评价探讨

目的：阐述医疗器械物理学特性引发的生物学危害、对该危害的评价方法，并尝试建立系统性评价框架。方法：分析梳理国内外监管机构发布的监管文件、指南、指导性文件，以及相关领域的标准、文献等。结果与结论：当前对于医疗器械化学及生物性能引起的生物学危害的评价研究较多，对于医疗器械物理性能引发的生物学危害的评价研究较少，且医疗器械生物学评价系列标准对此要求讨论不多也不系统。本文概述了医疗器械物理学特性引发的生物学危害及其评价方式，希望能供相关机构及研发人员参考使用，并能在一定程度上推动相关标准的完善及评价体系的科学化。

Evaluation of Biological Hazards Caused by Physical Characteristics of Medical Devices

Objective: To describe the biological hazards caused by physical characteristics of medical devices and the evaluation methods for these hazards, and to establish a systematic evaluation framework. Methods: Regulatory documents, guidelines and guidance documents issued by domestic and foreign regulatory agencies, as well as standards and literature in related fields were analyzed and sorted out. Results and Conclusion: At present, there are more studies on the evaluation of biological hazards caused by chemical and biological properties of medical devices, and fewer studies on the evaluation of biological hazards caused by physical properties of medical devices. Moreover, the series of biological evaluation standards for medical devices have not been discussed extensively or systematically. This paper summarizes the biological hazards caused by the physical characteristics of medical devices and its evaluation methods, which would provide references for relevant institutions and researchers, and also promote the improvement of relevant standards and the scientific evaluation system to a certain extent.