| 孙妍妍,王涵,陈丹丹,李博.医疗器械生物相容性试验的国际标准和法规更新[J].中国药事,2024,38(2):152-159 |
| 医疗器械生物相容性试验的国际标准和法规更新 |
| Update of International Standards and Regulations for Biocompatibility Testing of Medical Devices |
| 投稿时间：2023-07-02 |
| DOI：10.16153/j.1002-7777.2024.02.005 |
| 中文关键词: 医疗器械 生物相容性 监管科学 安全性评估 风险管理 |
| 英文关键词: medical devices biocompatibility regulatory science safety assessment risk management |
| 基金项目: |
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| 中文摘要: |
| 目的：了解国际医疗器械生物相容性试验的发展方向，为更好地开展生物相容性评价提供参考。 方法：通过查阅ISO 10993等相关国际标准和法规，对医疗器械生物学评价的变化要点以及FDA评估指南的相应改变进行总结，并分别介绍了近年更新的ISO 10993中与材料化学特性、物理性质和刺激试验相关的标准。结果与结论：国际医疗器械生物相容性标准和法规的更新，在于通过生物评估指标（如材质、 物理/化学特性等）来决定是否进行相关试验，从而减少实验动物使用量。这对我国医疗器械相关规范性文件的完善提供了参考。 |
| 英文摘要: |
| Objective: To understand the development of international medical device biocompatibility testing and provide references for better biocompatibility evaluation. Methods: By consulting international standards and regulations such as ISO 10993, the key changes in the biological evaluation of medical devices and the corresponding changes in FDA evaluation guidelines were summarized. The updated standards in ISO 10993 related to material chemical characterization, physical characterization, and tests for irritation were introduced. Results and Conclusion: The update of international medical device biocompatibility standards and regulations aims to determine whether to conduct relevant experiments through biological evaluation indicators (such as material, physical/chemical characterization, etc.), thereby reducing the use of experimental animals. This provides a reference for the improvement of the relevant regulatory documents for medical devices in China. |
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