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医疗器械是怎么分类的

医疗设备是指单独或组合使用在人体中的仪器设备器具材料或其他物品包括所需的软件;它们在体表和体内的功能不是通过药理学免疫学或新陈代谢获得的但它们可能参与并起一定的辅助作用;医疗器械分类类是指通过常规管理具有较低风险足够的安全性和有效性的医疗器械

include:手术器械(剪刀镊子镊子钩子),刮板医用X射线胶片手术服手术帽检查手套纱布绷带引流袋等第二类是具有中等风险的医疗器械需要严格的控制和管理以确保其安全性和有效性

include:(a)通用检查设备(6820):温度计血压计;(b)物理治疗和康复设备(6826):磁疗设备;(c)临床检查和分析设备(6840):家用血糖分析仪和试纸; (d)手术室急诊室诊疗室设备及设备(6854):便携式氧气发生器小型医用氧气发生器; (e)医疗卫生材料和敷料(6864):可选的吸收性棉医用吸收性纱布; (f)医用高分子材料和产品(6866)。

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