| 叶成红,王永清,杨宇希,孟颖,骆红宇,沈永.医疗器械可沥滤物安全性研究(Ⅰ):常见可沥滤物[J].中国药事,2019,33(8):875-879 |
| 医疗器械可沥滤物安全性研究(Ⅰ):常见可沥滤物 |
| Safety Study on Leachable Substances in Medical Devices(Ⅰ): Common Leachable Substances |
| 投稿时间：2019-05-07 |
| DOI：10.16153/j.1002-7777.2019.08.006 |
| 中文关键词: 医疗器械 可沥滤物 安全性研究 |
| 英文关键词: medical device leachable substances safety study |
| 基金项目: |
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| 摘要点击次数: 1480 |
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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。结合现有产品的审评，简述了常见医疗器械可沥滤物种类及相关示例，并对其常见毒性进行了解析，供相关机构及研发人员参考使用。 |
| 英文摘要: |
| Safety of leachable substances in 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. Based on the review of existing products, common types and related examples of leachable substances were briefly described. The common toxicity was analyzed in order to provide references for relevant institutions and researchers. |
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