一次性使用輸液器 帶針

一次性使用輸液器 帶針產(chǎn)品說(shuō)明:

規(guī)格型號(hào) 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(chǎn)品結(jié)構(gòu) product structure： 該產(chǎn)品是由瓶塞穿刺器保護(hù)套、瓶塞穿刺器、空氣過(guò)濾器、軟管、二通滴管、滴斗、流量調(diào)節(jié)器、藥液過(guò)濾器、其他加藥注射件及一次性使用靜脈輸液針組成。 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(chǎn)品用途： 該產(chǎn)品與一次性使用靜脈輸液針配套使用， 主要用于臨床重力式輸液。

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

產(chǎn)品標(biāo)準(zhǔn)：YZB/國(guó)0089-2010《一次性使用輸液器 帶針》

技術(shù)指標(biāo):

Technique Data：

1、本產(chǎn)品采用醫(yī)用高分子材料制造，經(jīng)環(huán)氧乙烷氣體滅菌、無(wú)菌、無(wú)熱原、無(wú)溶血反應(yīng)、無(wú)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、輸液器液體通道各組件的連接，不包括保護(hù)套，應(yīng)承受不小于15N的靜拉力，持續(xù)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(zhì)材料制成的軟管塑化均勻，足夠透明。當(dāng)有氣泡通過(guò)時(shí)，用正常或矯正視力可以發(fā)現(xiàn)水和空氣的分界面。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、軟管壁厚不小于0.39mm，外徑不小于3.65mm，輸液器總長(zhǎng)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；外體積≥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：滴管為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、空過(guò)：對(duì)空氣中0.5vm以上微粒的濾出率≥ 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、藥液過(guò)濾器濾除率不小于80%。The filtering rate of the liquid medicine filter is not less than 80%.

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

10、注射件：0.8#注射針扎入15s后拔出, 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(chǎn)品說(shuō)明： 一次性使用, 用后銷(xiāo)毀。僅適用于重力式輸液

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

12、有效期：2年 Validity: 2 years.

13、產(chǎn)品的其他相關(guān)技術(shù)指標(biāo)均符合GB8368-2005的相關(guān)要求

包裝要求 ：

Package Requirements:

單包裝：生產(chǎn)批號(hào)和失效年月清晰正確，且無(wú)配件脫落、管子死折、破損和異物，標(biāo)明輸液針規(guī)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.

中包裝：25套/包

Medium package: 25sets/bag

大包裝：500套/箱

Large package: 500sets/ctn

材料：聚氯乙烯pvc （高彈料）

ABS

聚乙烯

Material: PVC （high elasticity）

ABS

Polyethylene

一次性使用無(wú)菌醫(yī)療器械中的輸液器和注射器被國(guó)家歸類為三類產(chǎn)品，特殊的高危產(chǎn)品，是直接應(yīng)用于人體進(jìn)入人體血液和無(wú)菌部位參與臨床醫(yī)療，因此必須保證產(chǎn)品無(wú)菌、無(wú)熱源、無(wú)異常毒性和溶血現(xiàn)象，化學(xué)性能符合要求，如稍有疏忽，將會(huì)危及病人的生命安全。因此一次性使用醫(yī)療器械是救死扶傷、治病救人的陽(yáng)光企業(yè)。