医用气体系统中的医疗器械及应用

The products belonging to medical devices in medical gas system and their application

目前,我国已经明文规定了各类医疗器械产品名称,但人们对于医用气体系统中哪些产品属于医疗器械的认识还不够明确,在实际应用中出现很多异议。我们根据国家相关法规,就有关医用气体现状、医用气体的用途及重要性、医用气体工程中哪些产品属于几类医疗器械以及医用气体医疗器械注册或备案形式等作了整理和归总,以供业界同仁参考。

At present,China has clearly defined the names of various medical device products,but it remains unclear which of them belong to medical devices in the medical gas system.There are many controversies in the practical application.According to relevant national laws and regulations,the authors summarized the current situation of medical gas,the use and importance of medical gas,and sorted out the products in medical gas engineering belonging to medical devices,and the registration or filing forms of medical gas medical devices,so as to provide references for colleagues in the industry.