基于GS1编码体系的唯一器械标识UDI编码及实施研究

摘要

该文介绍了UDI的定义、组成及目前国际上先进国家UDI实施现状,重点对基于GS1标准的UDI编码体系进行分析研究.首先介绍了GS1编码体系,对比分析UDI与GS1编码体系的关系,然后举例说明基于GS1标准的UDI编码标识到规格型号、批次和单品的编码方法,并对UDI数据载体及载体间的优劣势进行比较,最后阐述了UDI的实施流程及效果.对引导医疗器械生产企业、经销商和医院正确使用UDI编码,推动国内医疗器械标准和法规的制定有一定的参考意义.%The paper introduced definition, composition and implementing situation on UDI in developed countries. The coding system based on GS1 standard was researched. First, the paper introduced GS1 coding system and analyzed the connection of UDI and GS1 coding system. Next, it gave examples to ilustrate the method to mark the type, batch and a single product. Besides, the superiority and inferiority of UDI data carrier were analyzed. Finaly, the implementing procedure and effect of UDI coding were described. it has some significance to guide medical device manufacturers, distributors and hospitals to use UDI coding correctly, and it is also beneficial to work out regulation and standard.