摘要
医疗器械标准预研对医疗器械标准制修订工作具有至关重要的作用。该研究从医疗器械标准预研工作的4个方面展开论述,探讨了如何科学合理地进行标准预研。结合医疗器械标准立项预研实践,提出了相关的工作思路和建议。
The pre-research of medical device standards is of great significance for the enactment and amendment of standards.This study discusses four aspects and explores how to promote more scientific and reasonable pre-research.Based on the pre-research practice of medical device standards project,this study puts forward relevant work ideas and suggestions.
作者
吕原原
陆离原
易力
董谦
杜晓丹
汤京龙
LYU Yuanyuan;LU Liyuan;YI Li;DONG Qian;DU Xiaodan;TANG Jinglong(National Institutes for Food and Drug Control(Center for Medical Device Standardization Administration,NMPA),Beijing,102629;Shanghai Institute of Medical Device Testing,Shanghai,201318;NMPA Key Laboratory for Medical Electrical Equipment,Shanghai,201318)
出处
《中国医疗器械杂志》
2024年第3期352-354,共3页
Chinese Journal of Medical Instrumentation
关键词
医疗器械
医疗器械标准
预研
medical device
medical device standard
pre-research
