医疗器械行业标准编制中需注意的若干问题

Preliminary Discussion on the Preparation of Medical Device Standards

重点总结了医疗器械行业标准编制中需注意的部分要点,并结合GB/T1.1-2009对标准编制提出相应的意见和建议。

This paper discussed some specific issues in the preparation of medical device standards. On the basis of GB/T 1.1-2009, some preliminary suggestions were accordingly proposed.