Disposable Syringes (Blistered Pack) with CE 0123 & ISO 13486 Approval
一次性注射器（Blistered包）与CE 0123和ISO 13486批准
议价
加入意向| 型号。 | 新1080 |
| 材料 | 塑料 |
| 应用 | 医 |
| 证明 | ce，sgs，fda，iso13485 |
| 针 | 用针 |
| 消毒 | 消毒 |
| 医疗器械注册/记录号 | Ssyjxzz-2001-0249 |
| 运输包装 | 每个吸塑1PS，每箱100PC，580CTN / 40ft |
| 起源 | 中国 |
| 类型 | 注射器 |
| 卷 | 10毫升 |
| 特征 | 一次性 |
| 组 | 成人 |
| 注射器使用 | 高精度实验 |
| 医疗器械监管类型 | 类型3 |
| 商标 | IU或接受OEM |
| 规范 | CE 0123证书和ISO 13485 |
| HS编码 | 90183900 |
一次性注射器（Blistered Pack）符合CE 0123和ISO 13486认证roval
一次性注射器（纸泡包装）
描述：
CE认证一次性注射器
Luer滑和鲁尔锁可用。
3.通过EO气体灭菌，无毒，无致热，仅一次使用。
4.注射器尺寸：1ml，2ml，2.5ml，3ml，5ml，10ml，20ml，30ml，50ml，60ml，100ml
5.注射器材料：无热原和无毒的医用级PP
形状注射针：18G，19G，21G，22G，23G，24G，25G，26G，27G，28G，29G，30G
7. 3份注射器：桶，柱塞，胶乳活塞
8.注射器包装：吸塑
9.注射器自体生存：5年
10.CE 0123和ISO 13486批准程序roval
一次性注射器（纸泡包装）
描述：
CE认证一次性注射器
Luer滑和鲁尔锁可用。
3.通过EO气体灭菌，无毒，无致热，仅一次使用。
4.注射器尺寸：1ml，2ml，2.5ml，3ml，5ml，10ml，20ml，30ml，50ml，60ml，100ml
5.注射器材料：无热原和无毒的医用级PP
形状注射针：18G，19G，21G，22G，23G，24G，25G，26G，27G，28G，29G，30G
7. 3份注射器：桶，柱塞，胶乳活塞
8.注射器包装：吸塑
9.注射器自体生存：5年
10.CE 0123和ISO 13486批准程序roval
| 样品名称 | 一次性注射针与针 | 批量 | 20120828 | ||||
| 类型 | 5ml 22G-11/4'“" | 制作日期 | 20120828 | ||||
| 数量 | 1920000pcs | 串口LOT | 20120828 | ||||
| 测试标准 | GB15810-2001和发票NO.YD-T120730 | 过期日期 | 20170828 | ||||
| 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) | 0.18 | ||||
| pH值 | 与同批次造影液相比，不超过1.0PH（5.11.2） | 0.38 | |||||
| 环氧乙烷 | 初始量≤10mg/ g单位：mg / g（5.11.4）1.4）1.4) | 0.20 | |||||
| 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 | 41.6 | |||||
| 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 | 0.05 | |||||
| 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. | NEO-1080 |
| Material | Plastic |
| Application | Medical |
| Certification | CE, SGS, FDA, ISO13485 |
| Needle | With Needle |
| Disinfection | Disinfection |
| Medical Devices Reg./Record No. | Ssyjxzz-2001-0249 |
| Transport Package | 1PS Per Blister, 100PC Per Box, 580CTN/40ft |
| Origin | CHINA |
| Type | Syringe |
| Volume | 10ml |
| Feature | Disposable |
| Group | Adult |
| Syringe Use | High Precision Experiments |
| Medical Device Regulatory Type | Type 3 |
| Trademark | IU or accept OEM |
| Specification | CE 0123 certificate and ISO 13485 |
| HS Code | 90183900 |
Disposable Syringes (Blistered Pack) With CE 0123 & ISO 13486 Approvalprovalroval
Disposable Syringes ( paper blistered packing )
Description:
1. CE certificated Disposable Syringe
2. Luer slip and luer lock available.
3. Sterilized by EO gas, non-toxic, non-pyrogenic, single use only.
4. Syringe Sizes: 1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml, 100ml
5. Syringe Material: Pyrogen-free and atoxic Medical grade PP
6. Shape syringe needle: 18G, 19G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G
7. 3 parts Syringe: Barrel, plunger, latex piston
8. Syringe packing: Blister
9. Syringe selflife: 5 years
10.CE 0123 & ISO 13486 Approvalprovalroval
Disposable Syringes ( paper blistered packing )
Description:
1. CE certificated Disposable Syringe
2. Luer slip and luer lock available.
3. Sterilized by EO gas, non-toxic, non-pyrogenic, single use only.
4. Syringe Sizes: 1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml, 100ml
5. Syringe Material: Pyrogen-free and atoxic Medical grade PP
6. Shape syringe needle: 18G, 19G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G
7. 3 parts Syringe: Barrel, plunger, latex piston
8. Syringe packing: Blister
9. Syringe selflife: 5 years
10.CE 0123 & ISO 13486 Approvalprovalroval
| Name of Sample | Disposable Syringe With Needle | LOT | 20120828 | ||||
| Type | 5ml 22G-11/4'"" | MFG DATE | 20120828 | ||||
| Quantity | 1920000PCS | Serial LOT | 20120828 | ||||
| Testing Standards | GB15810-2001and Invoices NO.YD-T120730 | EXP DATE | 20170828 | ||||
| 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) | 0.18 | ||||
| pH | Comparing with contrast liquid in the same batch, not more than 1.0PH (5.11.2) | 0.38 | |||||
| Ethylene Oxide | Rudimental quantity ≤10mg/g unit: mg/g (5.11.4)1.4)1.4) | 0.20 | |||||
| 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 | 41.6 | |||||
| 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 | 0.05 | |||||
| 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 | ||||||
