医疗器械标准体系进展  

Advances in Medical Device Standard System

作　　者：许慧雯[1] 王越[1] 杨晓芳[1] 李静莉[1] 

机构地区：[1]中国食品药品检定研究院,北京市102629

出　　处：《中国医疗器械杂志》2018年第1期49-52,共4页Chinese Journal of Medical Instrumentation

摘　　要：医疗器械标准是医疗器械监管的重要技术依据,是人民群众用械安全的重要技术保障。随着医疗器械产业的优化升级,医疗器械标准体系也随之不断更新发展,标准法规体系、组织管理体系和技术管理体系更加完善。该文根据医疗器械产业与标准发展的要求,提出了四项工作思路,以提高医疗器械标准的科学性与适用性。Medical device standards provide effective technique foundation for supervision to ensure medical device safety for the people. With the optimization and upgrading of the medical device industry, the medical devices standard system including law and regulation system, organization management system, and technical management system has been advanced and developed. According to the requirements of the development of medical device industry and its standards, we put forward four working ideas, in order to improve the scientificity and applicability of medical device standards.

关 键 词：医疗器械 标准化 安全可靠 

分 类 号：F203[经济管理—国民经济]