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(刀,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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