| 叶成红,王永清,孟颖,王全军,刘成虎,柯林楠.医疗器械可沥滤物安全性研究（三）：允许限量建立[J].中国药事,2019,33(11):1259-1263 |
| 医疗器械可沥滤物安全性研究（三）：允许限量建立 |
| Safety Study of Leachable Substances in Medical Devices: Establishment of Allowable Limits |
| 投稿时间：2019-05-07 |
| DOI：10.16153/j.1002-7777.2019.11.008 |
| 中文关键词: 医疗器械 可沥滤物 安全性研究 允许限量 |
| 英文关键词: medical devices leachable substances safety studies allowable limits |
| 基金项目: |
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| 中文摘要: |
| 随着新材料、新设计等创新性医疗器械产品的不断涌现，可沥滤物的安全性研究也面临新的挑战，其中可沥滤物允许限量的建立是医疗器械安全性评价研究的重要方面。结合现有产品的审评，简述高分子医疗器械可沥滤物安全性研究中允许限量的建立环节中的常见问题，并对其原因进行解析，供相关机构及研发人员参考使用。 |
| 英文摘要: |
| With the emergence of innovative medical device products, such as new materials and new designs, the safety study of leachable substances is facing new challenges. The establishment of allowable limits of leachable substances is an important aspect of medical device safety evaluation. Based on the review of existing products, the common problems in the establishment of allowable limits in the safety study of leachable substances in polymer medical devices are briefly described, and the reasons are analyzed in order to provide references for relevant institutions and researchers. |
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