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The armed companies note that in 2017, the 71 armed species will be tested by the state
 
Author:中国铭铉 企划部  Release Time:2017-6-6 8:42:48  Number Browse:649
 
On May 31, the website of the state administration of drug administration released a test plan for testing products for national medical devices in 2017. 
 
According to the plan, this year, a total of 71 species of medical equipment products will face a national sampling, sampling from the administration at the corresponding level 8 varieties, 58 of sampling observation of the central subsidies for local projects, has a sampling of five varieties. 
 
Included in the scope of national medical apparatus and instruments sampling products, if you have found to be of poor quality, or do not conform to the prescribed standards, such as label, instruction, and will be public access to the Internet, the agency and relevant enterprises and products will face administrative fines, restrict the net purchases, and the flight check, shall recall treatment measures, etc. 
 
The following is a list of specific sampling types:  

总局本级抽检项目
1
10010.  无创自动测量血压计(电子血压计)
2
10020.  呼吸机
3
10030.  EGFR基因突变检测试剂盒
4
10040.  人类免疫缺陷病毒抗体检测试剂盒(免疫层析法)
5
10051.  眼内填充物—眼科手术用硅油
6
10052.  眼内填充物—眼科手术用重水
7
10060.  眼科激光设备
8
10070.  聚合物基修复材料
有因抽检产品检验项目
1
50011/50012.  一次性使用静脉留置针
2
50020.  高频手术设备
3
50030.  医用氧气浓缩器(医用制氧机)
4
50040.  手提式压力蒸汽灭菌器
5
50050.  无创自动测量血压计(电子血压计)
中央补助地方抽检项目
1
30010.  金属带锁髓内钉
2
30020.  金属股骨颈固定钉
3
30030.  金属骨针
4
30040.  金属接骨螺钉
5
30050.  高电位治疗设备
6
30060.  射频消融设备
7
30070.  口腔颌面全景X线机
8
30080.  数字化摄影X射线机
9
30090.  医用低温箱
10
30100.  手术刀片
11
30110.  吻(缝)合器
12
30120.  一次性使用麻醉穿刺包
13
30130.  一次性使用无菌阴道扩张器
14
30140.  一次性使用无菌注射器(带针)
15
30150.  电动病床
16
30160.  电动手术台
17
30170.  输液泵(注射泵、镇痛泵、胰岛素泵)
18
30180.  心脏除颤器
19
30190.  医用氧气浓缩器(医用制氧机)
20
30200.  婴儿培养箱
21
30210.  神经和肌肉刺激器
22
30220.  电动轮椅车
23
30230.  呼吸道用吸引导管(吸痰管)
24
30240.  球囊扩张导管
25
30250.  手术单
26
30260.  手术衣
27
30270.  一次性使用鼻氧管
28
30280.  一次性使用滴定管式输液器
29
30290.  一次性使用静脉采血针
30
30300.  一次性使用无菌手术膜
31
30310.  一次性使用医用橡胶检查手套
32
30320.  医用电子体温计
33
30331/30332.  超声多普勒胎儿监护设备
34
30340.  医用超声雾化器
35
30350.  接触镜护理产品
36
30360.  人工晶状体
37
30370.  软性接触镜
38
30380.  眼用粘弹剂
39
30390.  正畸托槽
40
30400.  半导体激光治疗机
41
30410.  二氧化碳激光治疗机
42
30420.  光治疗设备
43
30430.  钬激光治疗机
44
30440.  裂隙灯显微镜
45
30450.  验光仪
46
30460.  α-羟基丁酸脱氢酶(HBDH)测定试剂盒
47
30470.  胆固醇检测试剂
48
30480.  人工心肺机体外循环管道
49
30490.  血液透析及相关治疗用浓缩物
50
30500.  立式蒸汽灭菌器
51
30510.  牙科手机
52
30520.  甲状腺球蛋白检测试剂
53
30530.  甲状腺球蛋白抗体检测试剂
54
30540.  人巨细胞病毒核酸检测试剂盒
55
30550.  一次性医用防护服
56
30560.  医用外科口罩
57
30570.  医用壳聚糖产品
58
30580.  一次性使用输液器
 
Of all varieties inspection, inspection items, and determine whether to the principle of qualified products, but to the administration of drug safety site administration of the general office of the sampling observation of 2017 national medical equipment product inspection plan notification (food do machinery drug safety supervisor [2017] no. 67), "in a specific view. 
 
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