| 医疗器械可沥滤物安全性研究（三）：允许限量建立 |
| |
| 引用本文： | 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. |
| |
| 作者姓名： | 叶成红 王永清 孟颖 王全军 刘成虎 柯林楠 |
| |
| 作者单位： | 国家药品监督管理局医疗器械技术审评中心, 北京 100081,国家药品监督管理局医疗器械技术审评中心, 北京 100081,国家药品监督管理局医疗器械技术审评中心, 北京 100081,军事医学研究院毒物药物研究所, 北京 100850,国家药品监督管理局济南医疗器械质量监督检验中心, 济南 250101,中国食品药品检定研究院, 北京 102629 |
| |
| 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。
|
| 关 键 词： | 医疗器械 可沥滤物 安全性研究 允许限量 |
| 收稿时间： | 2019/5/7 0:00:00 |
Safety Study of Leachable Substances in Medical Devices: Establishment of Allowable Limits |
| |
| Ye Chenghong,Wang Yongqing,Meng Ying,Wang Quanjun,Liu Chenghu and Ke Linnan.Safety Study of Leachable Substances in Medical Devices: Establishment of Allowable Limits[J].Chinese Pharmaceutical Affairs,2019,33(11):1259-1263. |
| |
| Authors: | Ye Chenghong Wang Yongqing Meng Ying Wang Quanjun Liu Chenghu and Ke Linnan |
| |
| Affiliation: | Center For Medical Device Evaluation, NMPA, Beijing 100081, China,Center For Medical Device Evaluation, NMPA, Beijing 100081, China,Center For Medical Device Evaluation, NMPA, Beijing 100081, China,Institute of Pharmacology and Toxicology, Academy of Military Medical Science, Beijing 100850, China,Jinan Quality Inspection Center for Medical Devices National, Medical Products Administration, Jinan 250101, China and National Institutes for Food and Drug Control, Beijing 102629, China |
| |
| Abstract: | 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. |
| |
| Keywords: | medical devices leachable substances safety studies allowable limits |
|
| 点击此处可从《中国药事》浏览原始摘要信息 |
|
点击此处可从《中国药事》下载全文 |
|
