医疗器械可沥滤物研究过程中的挑战和应对初探

Challenges and Counter-measures of the Leachable Substances in Medical Devices

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。结合可沥滤物研究的热点和难点问题,简述了医疗器械可沥滤物研究过程中面临的挑战,并对应对措施进行了简述,供相关机构及研发人员参考使用。

The safety of leachable substances in medical devices is an important guarantee of the safety of medical devices,and is also the focus of attention in the review of medical devices in recent years.Combined with the difficult issues in the study of leachable substances,the challenges in the study of leachable substances in medical devices were briefly described,and the counter-measures were briefly described for reference by relevant institutions and researchers.