一次性使用輸液器 帶針產品說明:

規格型號(hao) Model： A1、A2、A3、A4、A5、A6、A7、A8；輸液針infusion setneedle：0.45mm、0.5mm、0.55mm、0.6mm、0.7mm、0.8mm、0.9mm

產品結構(gou) product structure： 該產品是由瓶(ping)塞(sai)穿刺器保(bao)護套、瓶(ping)塞(sai)穿刺器、空(kong)氣過(guo)(guo)濾器、軟(ruan)管、二(er)通滴(di)管、滴(di)斗、流量(liang)調節器、藥(yao)液(ye)過(guo)(guo)濾器、其(qi)他加(jia)藥(yao)注射件及一次性使用靜(jing)脈(mo)輸(shu)液(ye)針組成。 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.

產品用(yong)(yong)途： 該產品與一次性(xing)使用(yong)(yong)靜脈輸液(ye)針配套使用(yong)(yong)， 主要(yao)用(yong)(yong)于(yu)臨床重力式輸液(ye)。

The products should be used with disposable venous infusion setneedle, and usually apply to gravity transfusion.

產品標準：YZB/國0089-2010《一次性使用輸(shu)液器 帶針》

技術指標:

Technique Data：

1、本產品采用(yong)醫(yi)用(yong)高分子材料制造，經環氧乙烷(wan)氣體滅菌(jun)、無菌(jun)、無熱原、無溶血反應、無急性(xing)全身毒性(xing)。 All the products are made of medical grade high polymer material, and sterilized with EO, pyrogen-free, non-hemolys is reaction, non-toxic.

2、輸液器液體(ti)通(tong)道各組件的(de)連接，不(bu)包括(kuo)保護套，應承受(shou)不(bu)小于15N的(de)靜拉力，持續(xu)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、由軟質材料制成(cheng)的(de)軟管塑化均勻，足(zu)夠透(tou)明。當有氣泡通過時(shi)，用正常或(huo)矯正視力(li)可以(yi)發現水和空氣的(de)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、軟(ruan)管(guan)壁厚不(bu)小于(yu)0.39mm，外徑(jing)不(bu)小于(yu)3.65mm，輸液器總長(chang)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(ping)均壁厚(hou)≥0.5mm；外體(ti)積≥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(su)：滴管為20滴/ml的(de)，10min≥ 1000ml，滴管60滴/ml的(de)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(kong)(kong)過：對空(kong)(kong)氣中0.5vm以上微粒的濾(lv)出(chu)率≥ 90%，流(liu)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、藥液過濾器濾除率不小(xiao)于80%。The filtering rate of the liquid medicine filter is not less than 80%.

9、密封(feng)性能：高于大氣壓50kPa, 持續15s不(bu)泄漏 Sealability: 50Kpa higher than the barometric pressure, keeping 15s no air disclosing.

10、注射件：0.8#注射針扎(zha)入15s后拔出(chu), 50kPa下保持1min 不漏氣

Injection parts: Inserting and pulling out after 15s with 0.80mm injection needle, keeping 15min under 50Kpa barometric pressure, no are disclosing.

11、產品說(shuo)明： 一次性使用(yong)(yong), 用(yong)(yong)后(hou)銷毀。僅(jin)適用(yong)(yong)于重力式輸液

Specification: Single use only and discard after use. Only transferred under gravity.

12、有(you)效期(qi)：2年 Validity: 2 years.

13、產品的其(qi)他相關技(ji)術指標(biao)均(jun)符合GB8368-2005的相關要求(qiu)

包裝要求 ：

Package Requirements:

單(dan)包裝(zhuang)：生(sheng)產批號(hao)和失效年(nian)月清晰正確，且無配件脫落、管子死折、破損和異物(wu)，標明輸液針規格等

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(zhong)包(bao)裝：25套(tao)/包(bao)

Medium package: 25sets/bag

大包裝：500套/箱

Large package: 500sets/ctn

材料(liao)：聚氯乙烯pvc （高彈料(liao)）

ABS

聚乙烯(xi)

Material: PVC （high elasticity）

ABS

Polyethylene

一(yi)次性(xing)(xing)使(shi)用(yong)無(wu)(wu)(wu)菌醫療器(qi)械中的輸液器(qi)和注(zhu)射器(qi)被國家歸(gui)類(lei)為三類(lei)產(chan)品，特(te)殊的高危(wei)產(chan)品，是(shi)直接應用(yong)于(yu)人(ren)(ren)體進入人(ren)(ren)體血液和無(wu)(wu)(wu)菌部(bu)位參與臨床醫療，因此必(bi)須(xu)保證產(chan)品無(wu)(wu)(wu)菌、無(wu)(wu)(wu)熱(re)源、無(wu)(wu)(wu)異常毒性(xing)(xing)和溶血現(xian)象(xiang)，化學性(xing)(xing)能(neng)符合要(yao)求，如稍有疏忽，將會危(wei)及病(bing)(bing)人(ren)(ren)的生命安全(quan)。因此一(yi)次性(xing)(xing)使(shi)用(yong)醫療器(qi)械是(shi)救死扶(fu)傷(shang)、治(zhi)病(bing)(bing)救人(ren)(ren)的陽光企業。

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