2 Parts Lure Slip Steriled Blistered Disposable Syringe

2 Parts Lure Slip Steriled Blistered Disposable Syringe

2部件诱饵滑动灭菌一次性注射器

议价

加入意向
型号。 yd1092
材料 塑料
应用
证明 ce,sgs,fda,iso13485
用针
消毒 消毒
医疗器械监管类型 类型3
商标 接受oem
规范 1ml,2ml,3ml,5ml,10ml,20ml,30ml,50ml,60ml.100ml
HS编码 90183900
类型 注射器
1ml,3ml,5ml,10ml,20ml
特征 一次性
成人
注射器使用 肌内注射
医疗器械广告批准号 Ssyjxzz-2001-0249
医疗器械注册/记录号 Ssyjxzz-2001-0249
运输包装 1PC Per Blister,100PCS / Box,580carton / 40hq
起源 中国
2部分诱饵滑倒钝化一次性注射器
.
*清除桶的透明度,以更好的目视检查。
*医用级聚丙烯结构。
*通过高精度成型在卓越的品质。
*防漏平滑柱塞运动。
*清晰准确的毕业标记。
*无菌,无毒,无前列腺素。
* ISO9001 / CE认证/ GMP
指定:注射器:2ml,3ml,5ml,10ml,
针:20G〜27G

样品名称 一次性注射针与针 批量 2012 02 04
类型 2ml 22G×1 1/4“; 1 1/4”Prime;;1 1/4″ 制作日期 2012 02 04
数量 750000pcs 串口LOT 2012 02 04
测试标准 GB15810-2001和发票NO.YD-T111228 过期日期 2017 02 04
测试项目 标准要求和标准条款和条件 测试结果
生物学特性 不育症 应无菌 合格
热原 没有热原 合格
化学性质 易氧化物质 与相同批次和相同体积的对比液相比,高锰酸钾的消耗量为0.002mol /L≤0.5Ml单位:mL(5.11.3)1.3)1.3) 0.16
pH值 与同批次造影液相比,不超过1.0PH(5.11.2) 0.42
环氧乙烷 初始量≤10mg/ g单位:mg / g(5.11.4)1.4)1.4) 0.21
物理
属性
外锥点 符合GB 1962 / T规定;无水滴;
没有明显的连续气泡形成;不能
分离;没有发生应力裂纹。
合格
容许容许容限 标称体积的四分之一:±4%(mL)(5.10.3)L)(5.10.3)L) (5.10.3) 合格
设备密封特性 无水滴;无窜气时,活塞和芯棒不能分离 合格
打印测量尺 侧针样式:在锥体的相对侧打印 合格
中心针样式:在气缸短轴随机侧打印
标尺要求 1mL≥57mm;2-3mL≥27mm;5mL≥36mm;10mL≥44mm;20mL≥52mm;单位:mme; 52mm;单位:mme;52mm; unit: mm 32.2
滑动性能 最大起动张力≤25N;推力:不超过(2.0XF)或(F + 1.5N),选择最大值;最小值。推力:不小于(2.0X F)或(F-1.5N),选择最大值;平均推力:≤10N; le; 10N;le;10N; 合格
橡胶活塞 无橡胶线,废料,异物;
当活塞与外筒接合时,芯棒可以自重移动
合格
外观要求 清洁,无杂质;
无边缘,毛刺,塑料流动等缺陷
合格
剩余数量 1-3ml≤0.07mL; 5ml≤0.075mL; 10ml≤0.10mL; 0.10mL;; 0.10mL ;
20ml≤0.15mL;单位:mL:mL: mL
0.040
个人套餐 符合合同要求 合格
锥体要求 ≥1.2mm,2毫米2mm, 合格
量表毕业线 与活塞基线一致;偏差不超过1/4分钟。部门;应为主要分部线的1/2 合格
测试结果 合格
Model NO. YD1092
Material Plastic
Application Medical
Certification CE, SGS, FDA, ISO13485
Needle With Needle
Disinfection Disinfection
Medical Device Regulatory Type Type 3
Trademark ACCEPT OEM
Specification 1ML,2ML,3ML,5ML,10ML,20ML, 30ML,50ML,60ML.100ML
HS Code 90183900
Type Syringe
Volume 1ml, 3ml, 5ml, 10ml, 20ml
Feature Disposable
Group Adult
Syringe Use Intramuscular Injection
Medical Devices Ad. Approval No. Ssyjxzz-2001-0249
Medical Devices Reg./Record No. Ssyjxzz-2001-0249
Transport Package 1PC Per Blister, 100PCS/Box, 580carton/40hq
Origin CHINA
2 Parts Lure Slip Steriled Blistered Disposable Syringe
.
*Clear Barrel transparency for better visual inspection.
*Medical Grade Polypropylene Construction.
*In Superior quality by high accurate molding.
*Leak proof smooth plunger motion.
*Sharp and clear Graduation marks for Accurate Dosage.
*Sterile, Non-toxic and progen free.
*ISO9001/CE Authentication/GMP
Specify: Syringe: 2ml, 3ml, 5ml, 10ml,
Needle: 20G~27G

Name of Sample Disposable Syringe With Needle LOT 2012 02 04
Type 2ml 22G×1 1/4″;1 1/4″Prime;;1 1/4″ MFG DATE 2012 02 04
Quantity 750000PCS Serial LOT 2012 02 04
Testing Standards GB15810-2001and Invoices NO.YD-T111228 EXP DATE 2017 02 04
Testing Items Standard Requirement And Standard Term And Conditions Test Result
Biological Properties Sterility Should be Sterile Eligible
Pyrogen No pyrogen Eligible
Chemical Properties Readily Oxidizable Substance Comparing with the contrast liquid with same batch and same volume, the consumption deference of potassium permanganate 0.002mol/L≤0.5Ml unit: mL (5.11.3)1.3)1.3) 0.16
pH Comparing with contrast liquid in the same batch, not more than 1.0PH (5.11.2) 0.42
Ethylene Oxide Rudimental quantity ≤10mg/g unit: mg/g (5.11.4)1.4)1.4) 0.21
Physics
Properties
Outer Conical Point Meet regulations in GB 1962/T;No water drop;
Without obvious continuous bubbles formed;Can't be
separated;No stress cracks occurred.
Eligible
Permissible Tolerance Of Capacity ≥half of nominal volume: ±4%(mL) (5.10.3)L) (5.10.3)L) (5.10.3) Eligible
Device Sealing Character No water drops;Without blow-by, the piston and core bar can't be separated Eligible
Printing Of Measuring Scale Side Needle Style:Print at the opposite side of cone Eligible
Center Needle Style:Print at random side of minor axis of cylinder
Ruler Requirement 1mL≥57mm;2-3mL≥27mm;5mL≥36mm ;10mL≥44mm;20mL≥52mm; unit: mme;52mm; unit: mme;52mm; unit: mm 32.2
Sliding Performance Max starting tensile force ≤25N;Max. Thrusting force: not more than(2.0XF) or (F+1.5N), choose the maximum value;Min. Thrusting force: not less than(2.0X F) or (F-1.5N), choose the maximum value;Average thrusting force: ≤10N;le;10N;le;10N; Eligible
Rubber Piston Without rubber thread, scrap, foreign bodies;
When piston engaging with outer cylinder, the core bar can be move resulting from self weight
Eligible
Appearance Requirement Clean, without impurity ;
No raw edge, burr, plastic flow etc flaws
Eligible
Residual Quantity 1-3ml ≤ 0.07mL; 5ml ≤ 0.075mL;10ml ≤ 0.10mL ;; 0.10mL ;; 0.10mL ;
20ml ≤ 0.15mL; Unit: mL: mL: mL
0.040
Individual Package Meets the contract requirement Eligible
Cone Requirement ≥1.2mm,2mm,2mm, Eligible
Graduation Line Of Measuring Scale Coincide with piston baseline; the deviation is not more than 1/4 min. Division;Should be 1/2 of major division lines Eligible
Testing Results Eligible