对《医疗器械临床使用安全管理规范(试行)》的分析与解读

Analysis and Interpretation of Medical Device Clinical Use safety Management Standard(Trial)

介绍了《医疗器械临床使用安全管理规范(试行)》(以下简称《规范》)出台的背景,分析了《规范》中各项重要条款的内涵与主旨,根据条款的内容要求提出了医疗机构相应的工作内容,最后指出了《规范》中的亮点和在实施上可能存在的问题。

The background of issuing Medical Device Clinical Use safety Management Standard（Trial） is introduced,and the contents and purposes of its items are analyzed.The working contents resulting from the standard are also pointed out for medical facilities.The highlights of the standard and the problems maybe encountered during implementation are indicated.