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| 医疗器械生物学评价新进展 | |
| 引用本文： | 刘成虎,施燕平,侯丽,孙晓霞. 医疗器械生物学评价新进展[J]. 中国医疗器械杂志, 2021, 0(1): 72-75,80 |
| 作者姓名： | 刘成虎 施燕平 侯丽 孙晓霞 |
| 作者单位： | 山东省医疗器械产品质量检验中心 |
| 摘 要： | 通过对医疗器械生物学评价的国内外新进展进行介绍,重点解读ISO 10993-1:2018新标准内容中全生命周期生物学评价、毒理学风险评估、评价终点和包装材料的生物学评价考虑等核心理念的变化要点以及如何科学、合理地使用该标准,旨在帮助大家了解医疗器械生物学评价的国内外发展方向,为更好地开展医疗器械生物学评价服务. |
| 关 键 词： | 医疗器械 生物学评价 风险管理 监管科学 |
Current Progress on Biological Evaluation for Medical Devices |
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| LIU Chenghu,SHI Yanping,HOU Li,SUN Xiaoxia. Current Progress on Biological Evaluation for Medical Devices[J]. Chinese journal of medical instrumentation, 2021, 0(1): 72-75,80 | |
| Authors: | LIU Chenghu SHI Yanping HOU Li SUN Xiaoxia |
| Affiliation: | (Shandong Quality and Inspection Center for Medical Devices/NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging/NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging/Shandong Provincial Key Laboratory of Biological Evaluation for Medical Devices,Jinan,250101) |
| Abstract: | To broadly understand the new direction of biological evaluation for medical devices,we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation,toxicological risk evaluation,evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices. |
| Keywords: | medical device biological evaluation risk management regulatory science |
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