GS1标准作为我国UDI编码标准的应用研究

Application of GS1 standard as coding standard of unique devices identification in China

介绍了医疗器械唯一标识(unique device identification,UDI)编码体系的实施现状,论证了GS1标准在欧美等发达国家和国内作为UDI编码标准的可行性,提出了基于GS1标准的UDI编码体系及具体建议。指出了基于GS1标准的UDI编码标准可以准确追溯到产品的规格型号、批次及单品,实现了追溯信息的采集、记录和共享,使国内医疗器械与国际市场接轨,从而促进国内医疗器械的发展。

The present situation of implementing unique device identification (UDI) of medical devices was introduced,and the feasibility of using GS1 standard as the coding standard was demonstrated in developed countries and China.Some suggestions were proposed on the UDI coding standard based on GS1 standard and its implementation.It's pointed out the UDI coding standard based on GS1 standard facilitated to trace the specifications, batch and item,which realized acquisition,recording and sharing of traceability information so as to promote the development of the medical devices in China by enhancing its assimilation with those in other countries.