北京生物医学工程

基于行动者网络理论的中国医疗器械标准化建设研究

Standardization development of medical devices in China based on the actor network theory

作者：杜然然欧阳昭连郭柯磊池慧

单位：中国医学科学院北京协和医学院医学信息研究所（北京 100020）

分类号：

出版年·卷·期（页码）：2012·31·2（208-212）

摘要：

目的对中国医疗器械标准化建设进行概念性梳理和动力机制揭示，探讨中国医疗器械标准化建设中应注意的问题。方法以行动者网络理论(actor network theory，ANT)为视角，通过对中国医疗器械领域战略性新兴产业的标准化进程进行分析，构建出标准化建设中的行动者网络框架，梳理医疗器械标准化进程中的主要行动者。结果理顺了行动者之间的普遍关系，归纳出当前标准化建设中应注意的重要问题。结论基于ANT的中国医疗器械标准化建设研究为医疗器械标准化管理工作提供理论支持。

Objective The important issues in the process of standardization development of medical devices in China were discussed through the conceptual carding and the analysis of dynamic mechanism.Methods In the view of the actor network theory (ANT)，firstly，the standardization process of the strategic new industry in Chinese medical devices was discussed.Then the standardization framework of the actor network was constructed，the main actors in the standardization process of medical devices were organized.Results The general relationship of the main actors was recognized，and the important issues in the current standardization process were summarized.Conclusions The theoretical support for the standardization management of the medical devices was provided through the standardization development of medical devices in China based on the ANT.

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