圣光医用制品有限公司
东方医疗器械网客服中心
025-86978335
所在地区：河南
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025-86978335
| 器械类别 | 科室 | ||
| 功能 | 输液器 | 标准目录 | |
| 耗材类别 | 其他分类 | ||
| 家用与否 |
产品介绍：
规格型号 Model： A1、A2、A3、A4、A5、A6、A7、A8；输液针infusion setneedle：0.45mm、0.5mm、0.55mm、0.6mm、0.7mm、0.8mm、0.9mm
产品结构 product structure： 该产品是由瓶塞穿刺器保护套、瓶塞穿刺器、空气过滤器、软管、二通滴管、滴斗、流量调节器、药液过滤器、其他加药注射件及一次性使用静脉输液针组成。 There consists in spike protective cover, spike, air vent and filter, flexible tube, two-way drip tube, drip chamber, flow rate regulator, liquid medicine filter, other madicating injection part and disposable venous infusion set needle.
产品用途： 该产品与一次性使用静脉输液针配套使用， 主要用于临床重力式输液。
The products should be used with disposable venous infusion setneedle, and usually apply to gravity transfusion.
产品标准：YZB/国0089-2010《一次性使用输液器 带针》
技术指标:
Technique Data：
1、本产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。 All the products are made of medical grade high polymer material, and sterilized with EO, pyrogen-free, non-hemolys is reaction, non-toxic.
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 still 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 plastified 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，输液器总长度≥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、流速：滴管为20滴/ml的，10min≥ 1000ml，滴管60滴/ml的40min≥1000ml
Flow rate: For the 20drop/ml drip chamber, equal or more than 1000ml within 10min; for the 60drop/ml drip chamber, equal or more than 1000ml within 40min.
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%.
8、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%.
9、密封性能：高于大气压50kPa, 持续15s不泄漏 Sealability: 50Kpa higher than the barometric pressure, keeping 15s no air disclosing.
10、注射件：0.8#注射针扎入15s后拔出, 50kPa下保持1min 不漏气
Injection parts: Inserting and pulling out after 15s with 0.80mm injection needle, keeping 15min under 50Kpa barometric pressure, no are disclosing.
11、产品说明： 一次性使用, 用后销毁。仅适用于重力式输液
Specification: Single use only and discard after use. Only transferred under gravity.
12、有效期：2年 Validity: 2 years.
13、产品的其他相关技术指标均符合GB8368-2005的相关要求
包装要求 ：
Package Requirements:
单包装：生产批号和失效年月清晰正确，且无配件脱落、管子死折、破损和异物，标明输液针规格等
Single package: Manufacture lot and expiration date clear and correct, no accessory breaking off, tube dart, damaged and foreign matter, marking infusion set needle gauge, etc.
中包装：25套/包
Medium package: 25sets/bag
大包装：500套/箱
Large package: 500sets/ctn
材料：聚氯乙烯pvc （高弹料）
ABS
聚乙烯
Material: PVC （high elasticity）
ABS
Polyethylene
一次性使用无菌医疗器械中的输液器和注射器被国家归类为三类产品，特殊的高危产品，是直接应用于人体进入人体血液和无菌部位参与临床医疗，因此必须保证产品无菌、无热源、无异常毒性和溶血现象，化学性能符合要求，如稍有疏忽，将会危及病人的生命安全。因此一次性使用医疗器械是救死扶伤、治病救人的阳光企业。
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代理商要求：
