自动体外除颤仪 属于医疗器械吗? 中国的法律法规对其有什么规定? 请列明, 谢谢!

2025-04-06 18:45:20
推荐回答(4个)
回答1:

  属于医疗器械
  序号
  ​
  名
  称
  品
  名 举 例
  管理类别
  1
  用于心脏的治疗、急救装置

  植入式心脏起搏器、体外心脏起搏器、心脏除颤器、心脏调搏器、主动脉内囊反搏器、心脏除颤起搏仪
  Ⅲ
  2
  有创式电生理仪器及创新电生理仪器

  体外震波碎石机、病人有创监护系统、颅内压监护仪、有创心输出量计、有创多导生理记录仪、心内希氏束电图机、心内外膜标测图仪、有创性电子血压计
  Ⅲ
  3
  有创医用传感器

  各种植入体内的医用传感器
  Ⅲ
  无创医用传感器

  Ⅱ
  4
  心电诊断仪器

  单导心电图机、多导心电图机、胎儿心电图机、心电向量图机、心电图综合测试仪、晚电位测试仪、无损伤心功能检测仪、心率变异性检测仪、心电分析仪、运动心电功量计、心电多相分析仪、心电遥测仪、心电电话传递系统、实时心律分析记录仪、长程心电记录仪、心电标测图仪、心电工作站
  Ⅱ
  5
  脑电诊断仪器

  脑电图机、脑电阻仪、脑电波分析仪、脑地形图仪、脑电实时分析记录仪
  Ⅱ
  6
  肌电诊断仪器

  肌电图机
  Ⅱ
  7
  其他生物电诊断仪器

  眼动图仪、眼震电图仪、视网膜电图仪、诱发电位检测系统(含视、听、体)
  Ⅱ
  8
  电声诊断仪器

  听力计、小儿测听计、心音图仪、舌音图仪、胃电图仪、胃肠电流图仪
  Ⅱ
  9
  无创监护仪器

  心率失常分析仪及报警器、带S-T段的监护仪
  Ⅲ
  病人监护仪(监护参数含心电、血氧饱和度、无创血压、脉搏、体温、呼吸、呼吸末二氧化碳)、麻醉气体监护仪、呼吸功能监护仪、睡眠评价系统、分娩监护仪
  Ⅱ
  10
  呼吸功能及气体分析测定装置

  综合肺功能测定仪、呼吸功能测试仪、氧浓度测定仪、肺通气功能测试仪、CO2浓度测定仪、肺内气体分布功能测试仪、弥散功能测试仪、氮气计、微量气体分析器、压力型容积描绘仪、肺量仪
  Ⅱ
  11
  医用刺激器
  心脏工作站电刺激器
  Ⅲ

  声、光、电、磁刺激器
  Ⅱ
  12
  血流量、容量测定装置

  脑血流图仪、阻抗血流图仪、电磁血流量计、无创心输出量计、心脏血管功能综合测试仪
  Ⅱ
  13
  电子压力测定装置
  电子血压脉搏仪、动态血压监护仪
  Ⅱ
  14
  生理研究实验仪器

  方波生理仪、生物电脉冲频率分析仪、生物电脉冲分析仪、微电极控制器、微操纵器、微电极监视器
  Ⅱ
  15
  光谱诊断设备

  医用红外热象仪、红外线乳腺诊断仪
  Ⅱ
  16
  体外反搏及其辅助循环装置
  气囊式体外反搏装置
  Ⅲ
  17
  睡眠呼吸治疗系统

  Ⅱ
  18
  心电电极

  Ⅱ
  20
  心电导联线

  Ⅰ

回答2:

属于严格管理的医疗器械,至少满足 电气安全性标准GB9706.1 -2007还有行业标准等。

回答3:

自动体外除颤器,属于三类医疗器械2002版分类中的6821,2017版分类中的08大类。经营销售需要具备医疗器械经营许可证。

回答4:

属于医疗器械。
查看sfda法规要求。

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