摘要
通过对人类辅助生殖技术用医疗器械产品及国内和国际标准化现状进行研究,按照构建标准体系的目标明确、全面成套、层次适当和划分清楚四项基本原则,提出人类辅助生殖技术用医疗器械标准体系的建设思路,共分为基础与通用标准、产品标准、方法标准和其他标准四个方面,并给出建立科学完善的人类辅助生殖技术用医疗器械标准体系的建议,标准体系中各层次及分类中的部分标准需加快研究立项、制定和完善,尤其要重视共性、基础性标准的研究和制定。
Based on the research on the current status of domestic and international standardization of medical devices used in human assisted reproductive technology,according to the four basic principles of establishing the standard system:clear goal,complete set,appropriate level and clear division,the construction ideas of the standard system for medical devices used in human assisted reproduction technology are put forward.It can be divided into four aspects:fundamental and general standards,product standards,methodology standards and other standards.Perfect human assisted reproductive technology is given with the advice of the medical devices standards system,standard system of each parts of the hierarchy and part of the standard in the classification need to speed up the research project,formulate and perfect,especially should attach great importance to the study of common and basic standard and formulation.
作者
毛歆
韩倩倩
MAO Xin;HAN Qianqian(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国医药导报》
CAS
2022年第8期189-192,197,共5页
China Medical Herald
基金
中国科学院“器官重建与制造”战略性先导科技专项项目(XDA16040602)。
关键词
人类辅助生殖技术
医疗器械
标准体系
研究
Human assisted reproduction technology
Medical devices
Standard system
Research
