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注册证编号：国食药监械（准）字2010第3660423号
产品结构：一次性使用带贴输液器带针产品是由一次性使用输液器带针和医用输液贴组成，只在一次性使用输液器带针的产品中包中添加了单独包装的医用输液贴。一次性使用输液器带针是由穿刺器保护套、穿刺器、进气器件（或空气过滤器）、滴管、滴斗、管路、流量调节器、药液过滤器、乳胶管（根据合同要求）、一次性使用静脉输液针组成。一次性使用静脉输液针由保护套、针管、针柄、软管、针座组成。
Disposable infusion sets with application with needle consist of disposable infusion setwith needle and medical infusion setapplication, only the disposable transfusion(with needle)there’s additional sole packed medical application.The disposable infusion set(with needle)consist of protective cover of the spike, spike, air vent parts(or air filter), drip tube, drip chamber, tube, flow rate regulator, liquid medicine filter, latex cover (according to the request of the contact), disposable IV infusion setneedle. The disposable IV infusion setneedle consist of protective cover, needle tube, needle handle, flexible tube, needle seat.
产品用途：供医护人员静脉输液时使用。For medics IV transfusion using.
产品型号Model:
A1、A2、A3、A4、A5、A6、A7、A8；
输液针Infusion setNeedle:
0.45mm、0.55mm、0.6mm、0.7mm、0.8mm、0.9mm
产品标准：YZB/国0090-2010《一次性使用带贴输液器带针》
产品特点：
1.本品采用医用高分子材料制造，经环氧乙烷气体灭菌、无菌、无热原、无溶血反应、无急性全身毒性。
The products are made of medical high polymer, steriled by EO-gas,sterile,non-progeny,non-hymolysis, no acute systemic toxicity.
2、输液器液体通道各组件的连接，不包括保护套，应承受不小于15N的静拉力，持续15S。
The joint of every part of the liquid channel in the infusion set, exclude the protective cover, should be support not less than 15N static pull, keep 15seconds.
3、由软质材料制成的软管塑化均匀，足够透明。当有气泡通过时，用正常或矫正视力可以发现水和空气的分界面。The flexible tube made of soft material should be plasticized evenly, transparent enough. The interface of the water and air could be seen under normal or rectified vision when air bubble passing.
4、软管壁厚不小于0.39mm，外径不小于3.65mm，输液器全长大于等于1600mm。
The flexible tube wall thickness is not short than 0.39mm, the outer diameter is not short than 3.65mm, the total length of the transfusion apparatus is equal or longer than 1600mm.
5、滴斗：平均壁厚≥0.5mm；外体积≥10cm3
Drip chamber: The average wall thickness is equal or thicker than 0.50mm; outer volume is equal or larger than 10cm3
6、药液过滤器滤除率不小于80%。
The filtering rate of the liquid medicine filter is not less than 80%
7、空过：对空气中0.5vm以上微粒的滤出率≥ 90%，流量降低≤ 20%
Air vent and filter: To the 0.5um or above particle in the air, the filtering rate is equal or bigger than 90%, flow rate reducing is equal or less than 20%.
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