| 叶成红,邓洁,肖丽,杨宇希,骆红宇,沈永.医疗器械可沥滤物安全性研究（Ⅱ）：残留量检测[J].中国药事,2019,33(10):1116-1120 |
| 医疗器械可沥滤物安全性研究（Ⅱ）：残留量检测 |
| Safety Study of Leachable Substances of Medical Devices (Ⅱ): Residue Detection |
| 投稿时间：2019-05-07 |
| DOI：10.16153/j.1002-7777.2019.10.006 |
| 中文关键词: 医疗器械 可沥滤物 安全性研究 残留量检测 |
| 英文关键词: medical devices leachable substances safety study residue detection |
| 基金项目: |
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| 中文摘要: |
| 医疗器械可沥滤物的安全性是医疗器械安全性的重要保证，也是近年来医疗器械审评过程中关注的重点。本文结合现有产品的审评，简述了高分子医疗器械可沥滤物安全性研究中残留量检测常见问题，并对其产生原因进行了解析，供相关机构及研发人员参考使用。 |
| 英文摘要: |
| The safety of leachable substances of medical devices is an important guarantee for the safety of medical devices, and has also been the focus in the review process of medical devices in recent years. Combined with the review of existing products, the common problems of residual detection in safety study of leachable substances were briefly described, and the causes were analyzed, which could be used as a reference for relevant institutions and R & D personnels. |
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