Steriled 3 Parts Jack-Disable (Lure Lock) Disposable Syringe

Steriled 3 Parts Jack-Disable (Lure Lock) Disposable Syringe

Steriled 3部分杰克禁用（诱饵锁）一次性注射器

议价

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型号。 yd1081
材料 塑料
应用 医
证明 ce，sgs，iso13485
针 用针
消毒 消毒
医疗器械监管类型 类型3
商标 OEM
规范 1ml，2ml，3ml，5ml，10ml，20ml，30ml，50ml，100ml
HS编码 90183900
类型 注射器
卷 20毫升
特征 一次性
组 成人
注射器使用 高精度实验
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 /袋，100pc /箱，620ctn / 40ft
起源 中国
3部分Jack-Disable（诱饵锁）一次性注射器
用于皮下注射，肌内注射和静脉注射。
1.通过EO气体灭菌，无毒，无致热，仅一次使用。
Luer Slip或Luer Lock。
3.足够透明的桶容易测量注射器中容纳的体积和气泡的检测。
桶上刻度刻度很容易阅读。毕业印刷由不可磨灭的墨水。
柱塞非常适合于柱塞内部，以便自由平稳运动。
桶和柱塞材料：医用级PP（聚丙烯）。
7.垫片材质：天然胶乳/合成橡胶（无胶乳）。
有或没有针。
9.个人包装：吸塑包/ PE聚乙烯袋。
10.可用尺寸：1mL，2mL（2.5mL），3mL，5mL，10mL，20mL，30mL，50mL，60mL.100ml
11.标准：ISO 13485和CE 0123，GMP

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. YD1081
Material Plastic
Application Medical
Certification CE, SGS, ISO13485
Needle With Needle
Disinfection Disinfection
Medical Device Regulatory Type Type 3
Trademark OEM
Specification 1mL, 2mL, 3mL, 5mL, 10mL, 20mL, 30mL, 50mL, 100ML
HS Code 90183900
Type Syringe
Volume 20ml
Feature Disposable
Group Adult
Syringe Use High Precision Experiments
Medical Devices Ad. Approval No. Ssyjxzz-2001-0249
Medical Devices Reg./Record No. Ssyjxzz-2001-0249
Transport Package 1PC /Bag, 100PC/Box, , 620CTN/40ft
Origin CHINA
3 Parts Jack-Disable (Lure Lock) Disposable Syringe
for hypodermic, intramuscular and intravenous injection.
1. Sterilized by EO gas, non-toxic, non-pyrogenic, single use only.
2. Luer Slip or Luer Lock.
3. Sufficiently transparent barrel allows easy measurement of the volume contained in the syringe and detection of air bubble.
4. Graduated scale on the barrel is easy to read. Graduation is printed by indelible ink.
5. The plunger fits the inside of barrel very well to allow for free and smooth movement.
6. Material for barrel and plunger: Medical grade PP(polypropylene).
7. Material for gasket: Natural latex / Synthetic rubber(latex free).
8. With or without needle.
9. Individual pack: Blister pack / PE Polybag.
10. Available size: 1mL, 2mL(2.5mL), 3mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL.100ml
11. Standard: ISO 13485 and CE 0123 ,GMP

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