一次性使用硅胶手术引流管产品技术要求航天卡迪

1、一次性使用硅胶手术引流管结构组成：本产品由引导针、连接管(圆形引流管除外)、引流管、引流球组成。其中引流管、连接管、引流球为硅橡胶材质、引导针为304H(0Cr18Ni9)医用不锈钢材质。预期用途：本产品用于胸腔积液及术后闭式引流。医疗署肺品技术要求鳄:,次性使用硅胶尸术引流管1 .产品型号/妞格及其划分说明1.1 型号规格：11.1组成本一品由弓I导针、连接管（图形引流管除外）、引流管、引出球绢成。宜中引流管、连接管、引流玳为让橡胶材质，引导升为304H（归H8N9）医用不燃纲材府。LL2分类一次性侵年任胶手求小差管中的引统管有图型、扁型、+空型三种形状，根据弓I流管的形状、直径不同划分为不

2、同的型号，引流球分为lOOni、200ml和400ml三种。引导针、引流管、引流环的结构见囹1、囹2、闺三、因4、图5,一次性使用硅胶手术引光管的组配及尺寸见裹1。1.1.3型号与帝名运一皂一注一X针工是否有针：有针.无针弓:流球（Al:100ml.A2:200mLA4:400ei1,无：D用流管宣经（P1-P18:0形，SLS2s彩.Fr8-Fr28:十里型）I引流管形状（YY：31彩，BY:窗彩，SY:十字型）型号命名示例：YY.P112.无针：引流管形状关圆形、直径0.6顺、长度EOOnm，引流球容积201KL的引流管;无引导针。BY-S1-AL有针：引流管形状为扁形、直径7X3、长黑2

3、00师，连接管直径4.&TOI、长度800jnno弓I充球容OUOOmb引导针直径3.2刖、长度IROmKrt引流管oSYFr26-无针：引流管形状为十字型、直径8.7m、长信250mm，连接管直径8.7jtoti.长度700mm：无引源球，无WI导件。1、弓I导针；2连接管；3引流管图3+字型引流管示意图1.球体；2.压紧盖；3.堵头；4.连接及；5.单向调；6.吊带；7.吊夹图4弓I流球（无尾型）示意图1.球体；2,压紧盖；3.堵头；4.连接颈；5.单向阀；6.吊带；7品夹曾尔接头图5引流球（有尾型）示意图（仅用于A1型引流球）引诫管更冬管引it募引导当二一直径G=05mm)；x5

4、0mn直径：=O.5mn(x50mre)一干(x5ml)直径W2mn长度VYP1AL无计0.6800/100/VYPlA2无计0.6200VYP1A4无纣0.6400VYPl无计0.6VYJ2A1.无计1.0100VYP2A2.无计1.0200VYP2A4无计1.0400VYP2/无计1.0VYP3Al爷计2.71002.4130rP3，Ai无针2.7100/YYP3A2.有计2.72002.4130VYP3A2.无纣2.7200/VY.P3.A1有升2.740024130VYP3A4无纤2.7400WP3爷针2.72.4130YYP3J疣针2.7VYP4Al有升3.31002.4130IYP

5、4.AL无针3.3100YYPLA2.有计3.32002.4130VYP4A2.无计3.3200VY?4A4有计(5形3.38004002.4130VY?4.A4无计3.3400n*.?4.节针3.32.4130无针3.3f/Y?5Al.有计4.01003.2130VY?5AL无计40100/Y?5A2有针4.02003.2130VY?5A2无计4.0200/Y?5AL有计4.040。3.2130VY?5A4无计4.0400VY.25市计4.03.2130fY?5"无针4.0VY?6Al.有计4.71004.0130Y?6AL无计4.7100Y?6A2有针4.72004.0130YY

6、？6A2无甘4.7200YY16A4有针4.74004.0130VY.A4无计4.7400VY?6用针4.74.0130VYI6无针4.7/VY77A1.有计5.01004.8130VY?7AL无计5.0100VY-77A2有计5.02004.8130VY；7A2无计5.0200VY?7A4有针504004SB0VY77A4无计5.0400VYI7.窄针5.04.8130VY77尢针5.0VY?8A1.有计5.31004.8130VYig-AL无计5.3100/VY?8A2.有针5.32004.8130VY?8A2无计5.3200厂好?84工有针5.34004.8130VY?8A4无计5.34

7、00/YY-P8.e纣5.34.8130VYIS-无计5.3/ryP9Ai节计圆形6.0800(/1004.8130VYP9.Al.无计6.0100rY"A2在针6.02004.S130VYP9A2.无针6.0200/VYP9A4有针6.04004.8130rY-P9，A*无纣6.0400/YP9羊针6.04.8130VYP9无计6.0VYP10-A1-有计6.71006.0130EPPIOAI尢计6.7100VY.PlOq荏针6.72006.0130VYP1O-A2-无计6.7200/VYP10AL有针6.74006.0130VYP1O-AL无纣6.7400VY.PIO-有针6.7

8、6.0130VY.P1OJ无针6.7YYPILAI军外7.31006.0130VYMLAI疣针73100/YP1LA2用针7320060130YYPILA2疣升7.3200/VYP1LAS市计734006.0130npnAL无计7.3400VYP1L有针7.36.0130VYPll，无针73VYP12-AL无针8.0100/VYP12A2.无针8.0200VYP12-AL无针80400VYP123无针8.0VY.P13.AI无针8.7100VYP13由无计8.7200n二P13AL无针8.7400VYP13，无针8.7VY114-AI无针9.3100YP14A2.无针9.3200VYP14-A

9、L无针9.3400VYP141无针93VYP6AL无针圆形10.0800100/VYP15A2无针10.0200r¥P15.A4无针10.0400VYP15V无针10.0VY.P1&A1疣针10.7100'YP1&A2.无针10.7200'YPI&A4无针107400VYPia无针10.7rypAi疣针11.3100VYP1-A2.天针11.3200VYP1'A4无计11.3400VYP17,无针11.3VYF18«A1无针12.01001YP18A2.无计12.0200YP6A4无针12.0430VYP1j无钟110/3Y-

10、SLA1爷针Si7X32004.8(001003.21303Y6LA1疣针7x3100/3YS1A2有针7X32003.21303YSLA2疣针7X3200/BYSLA4用纤7x34003.21305Y.SLA4疣针7X3400/3YS1有针7X3/3.21305YSI+无针7X3/5Y.S2.A14T>t10x4100481303YS2Al无针10X4100/BYS2A2、升10X42004.8130八S2A2无计10X42UU/3YS2A4书计10x44004.81305Y-S2-A4-3E#10X4400/3Y-S2一有针10X44.81303YS2+无针10X4，SYFt8Al无

11、计十字W2.62502.7:00100/SYa8A2无纤2.62.7200SfFrSA%无针十竽22.62502.700400SY&S无针2.62.7SYEWAl帝针3.23.31002.4130SfFriaAl无针3.23.3100/SYE1&A2率针3.23.32002.4130门EIC-A2无针3.23.3200SY&iaA4有针3.23.34002.4130SYE1JA4疣针3.23.3400/SYEG'壬针3.23.32.4130SYFrl3无针3.23.3SY¥U：A1窄针3.84.01003.2130SYEl2Al无针3.84.0100/

12、El：A2有针3.84.02003.2130SYE12A2疣针3.84.0200SYEl：A4军针3.84.04003.2130门EI二A4,无针3.84.0400SY.Frl2-.Wtt3.84.03.2130SYEI：-/无针3.84.0SYE14A1石针4.64.71004.0130SYE2AL无计4.64.7100/SYE14A2军针4.64.72004.0130；YFrl4A2针4.64.7200/SYFU，A4有针4.64.74004.0130SYE14A4无针4.64.7400,4口有针464740ISOSYE14/无针4.64.7/SYFHf-Al羊（针4.85.01004.8

13、130】A1无针4850100SYF"，A2有针4.85.02004.8130SYEIF-A2无针4.85.0200SYFT3A4有计4.85.04004.8130SYFrlfA4厅针4.85.0400SYE，.有针4.85.04.8130NYFrl%无计4.85.0/SYF"&A1窄针5.35.31004.8130SYEIaAI无针5.35.31005YErl&A2干针5.35.32004.8130SYE1&A2.无针5.353200SYEI&A4用台十三六5.32505.370040G4.8B05Y-F116-A4-XT-5.35.34O

14、CSYFrl6<有针5.35.34.8130SYElk-无针5.35.3V/SYEISAI爷台6.06.01064.8B0SY-FrlS-Al-X6.06.010CSYE1&A24r夕60602004.8B0SYFfA2一无台6.06.020G1$Y.Ffl8-A4-r6.06.040G4.8B06.06.0400$YE18<弟针6.06.04.8B0门石&'无针6.06.0SYE2M1用铲6.76.710G6.0B0$YE2aAi王吃6.76.710C；Y42“A2话6.7672OC601JOSYFf2G*A2无铲6.76.7200SYE2aA4号6.76

15、.740G6.0B0SYfr2aA4无铲6.76.74001SYFr2(k'有针6.76.76.01J0SYE2Q/无纣6.76.7/SYE22A14台7.37.310C6.0B0SYFr22Al.天铲7.37.310C；YFH2A2”7.37.320C(.0110门E22A2无台7.37.320C门E22A4有铲7.37.340G6。B0SYE22A4.无A7.37.340G5YE22"金针7.37.36.0130门后22无针7.37.3/；YFr2奉Al无冲8.08.010GSYTr24-A2-X8.08.0200SYE2AA4芝台8.08.040G；YFf24/无针8.

16、08.0/SYE2&AI.无铲8.78.710CHE2&A2卦8.78.7206SYG2&A4.无什8.78.740G门E2&J无针8.78.7/SYE2TAi无针十竽岂9.32509.3700100SYFCSA2.无针9.39.3200SYE2&A4.无针9.39.3400SYE2%疣针9.39.3/1-1.4产品有效期、灭苗方式及包装材料见附录B。24"克甘1.1.1 密封性封闭期有出口后，引题应密封性良好。1.1.2 进液口接头送液口接头在引流球内为负压时，石物液流进；内外压力平衡后，进液口接头的单向阀关闭，引流球倒置后，液体不应流出。1

17、.1.3 初始吸力及吸进液体否租对引流球最大限度的挤压后，其内部的初始吸力及吸入液体否积应符合裹3的规定。表3引流球答里初始吸力(MPa)吸进液体体积(ml：lOOrri不小于-100>20200rri不小于10.0>160400rrf不小干0.0>3201.1.4 刻度的准确度弓I流耕刻度的标定值与实际容量之差应不大于标定值的15%。1.1.5 抗冲击性按YY0489.2004明录B3.1试蛉时，引流球应无泄揄按B32时冲击前后压力差不大于冲击前压力值的10%。2.5 引导针2.5.1 引导针针尖应钱利，用2.5倍放大谊检宜时，针尖应无平头、毛刺、穹钩等缺陷。2.5.2 15GBT15811.2005明录A所给的方法试蛉时，引导针应无任何腐诧现象。2.5.3 引导针的保护套应保持叶尖和走面不搂坏，不应自然脱落并易干近除。2.6 吊夹吊夹的夹持应牢固，并能持续用受0.5kg的重物ID.5h，不脱落、不摸坏。2.7 连接牢固度引流管和引导针之间应能承受的最小分离力应苍台表4要求。表4公称外径(mm)最小分离力(N)2