Disposable Steriled Infusion Sets with CE &ISO Approvaled
一次性消毒套装，CE＆ISO认证
议价
加入意向| 型号。 | neo -105 |
| 材料 | 塑料 |
| 环氧乙烷灭菌 | 无环氧乙烷灭菌 |
| 组 | 成人 |
| 医疗器械监管类型 | 类型3 |
| 商标 | IU |
| 规范 | CE认证和ISO |
| HS编码 | 90183900 |
| 类型 | 输液器 |
| 证明 | ce，sgs，fda，iso13485 |
| 质量保证期 | 5年 |
| 标志印刷 | 使用徽标打印 |
| 医疗器械注册/记录号 | Ssyjxzz-2001-0249 |
| 运输包装 | 每袋1PC，每个CTN 500PS，800CTN / 40hq容器 |
| 起源 | 中国江苏 |
一次性灭菌输液器，经CE＆ISO认证，符合21G注射需要eedle
包括：
1）通过EO气体灭菌，产物为非热原，无毒
2）材质：聚丙烯
3）适用范围：用于体静脉输液
4）大ABS钉和塑料滴注
5）厚乳胶管
6）用于连接针的鲁尔锁
7）欢迎完成定制规格
内包装：
单独的塑料袋或个人塑料袋与透析器或个人吸塑袋
资格
CE和ISO证书
质量稳定，质量控制严格
3.生产能力强
有利的价格
备注：您也可以给我们您的具体要求，以确认您最终需要的产品。
包括：
1）通过EO气体灭菌，产物为非热原，无毒
2）材质：聚丙烯
3）适用范围：用于体静脉输液
4）大ABS钉和塑料滴注
5）厚乳胶管
6）用于连接针的鲁尔锁
7）欢迎完成定制规格
内包装：
单独的塑料袋或个人塑料袋与透析器或个人吸塑袋
资格
CE和ISO证书
质量稳定，质量控制严格
3.生产能力强
有利的价格
备注：您也可以给我们您的具体要求，以确认您最终需要的产品。
| 样品名称 | 一次性输液器套针 | 类型 | is-vz 0.7 | ||||
| 很多不 | 20130618 | 测试标准 | 合同要求 | ||||
| 灭菌批次 | 20130618 | 测试批量 | 1260000 pcs | ||||
| 样品数量 | 50PCS | 测试日期 | 2013年7月7日 | ||||
| 类型 | 测试项目 | 标准要求和标准条款和条件 | 实际测试结果 | 结论 | |||
| 生物学特性 | 不育症 | 个别包装中的输液器应无菌（8.2） | 失踪 | / | |||
| 热原 | 输液器没有热原（8.3） | 失踪 | / | ||||
| 化学性质 | 减量事 | 测试液体和空白液体消耗的高锰酸钾“c（kmno4 = 0.002mol / L”）的体积差异应不大于2.0 ml（7.1） | 0.5毫升 | 合格 | |||
| 博士 | 试液与空白液的PH差异不大于1.5（7.3） | 0.19 | 合格 | ||||
| 紫外线吸收 | 试液的吸光度应不大于0.1（7.5） | 0.046 | 合格 | ||||
| 环氧乙烷残留物 | 环氧乙烷残留应不大于0.5mg;单位：mg（7.6） | 0.29 | / | ||||
| 物理性质 | 粒子内容 | 对于在200ml洗脱液中的15-25min颗粒数量，不超过1个/ ml | 合格 | 合格 | |||
| 超过25min的颗粒数不超过0.5粒/ ml（6.1） | 合格 | ||||||
| 密封性 | 输液器无漏气（6.2） | 合格 | 合格 | ||||
| 连接强度 | 连接输液器液体通道的部件可承受不超过15N的静态张力15秒。 （6.3） | 合格 | 合格 | ||||
| 瓶塞穿刺装置 | 根据合同要求 ABS材料。 | 合格 | 合格 | ||||
| 液体药物垫 | 输液器应配备液体机器过滤器 | 合格 | 合格 | ||||
| 液体药物的过滤率应不低于80％。 （6.7） | 98.7% | ||||||
| 输血流速（流量） | 对于20滴/ ml的输液器，静置压力为1m，氯化钠溶液流动不应小于1000ml，持续10分钟 单位：ml（6.10） | 合格 | 合格 | ||||
| 进气装置（气垫） | 空气中0.5μm颗粒的过滤率应不小于90％。 （6.5.2）5.2）5.2) | 失踪 | / | ||||
| 进气装置（流量减少率） | 与具有自由空气输入的容器相比，流出物流量应减少20％。 （6.5.5） | 合格 | 合格 | ||||
| 包装要求 | 根据合同要求 | 合格 | 合格 | ||||
| 流量调节器 | ABS材料。 | 合格 | 合格 | ||||
| 软管（长度） | 根据合同要求 | 合格 | 合格 | ||||
| 针 | 根据合同要求 | 合格 | 合格 | ||||
| 测试结果 | 被检产品符合要求 合同 。 | ||||||
| Model NO. | NEO -105 |
| Material | Plastic |
| Ethylene Oxide Sterilization | Without Ethylene Oxide Sterilization |
| Group | Adult |
| Medical Device Regulatory Type | Type 3 |
| Trademark | IU |
| Specification | CE certificate and ISO |
| HS Code | 90183900 |
| Type | Infusion Set |
| Certification | CE, SGS, FDA, ISO13485 |
| Quality Guarantee Period | 5 Year |
| Logo Printing | With Logo Printing |
| Medical Devices Reg./Record No. | Ssyjxzz-2001-0249 |
| Transport Package | 1PC Per Bag, 500PS Per CTN, 800CTN /40hq Container |
| Origin | Jiangsu, China |
Disposable steriled Infusion Sets with CE &ISO approvaled with 21G injection needleneedleeedle
Consist of:
1) Sterilized by EO gas, the product is non pyrogen and non-toxic
2) Material: Polypropylene
3) Application: Used for body vein infusion
4) Big ABS spike and molding plastic drip
5) Thick latex tube
6) luer lock for connecting needles
7) Custom specifications welcomed for completion
Inner packing:
Individual polybag or individual polybag with dialyzer or individual blister bag
Qualifications
1. CE and ISO certificate
2. Stable quality and strict quality control
3. Great production capacity
4. Favourable price
Remark: You can also give us your specific requirements to confirm the products you need finally.
Consist of:
1) Sterilized by EO gas, the product is non pyrogen and non-toxic
2) Material: Polypropylene
3) Application: Used for body vein infusion
4) Big ABS spike and molding plastic drip
5) Thick latex tube
6) luer lock for connecting needles
7) Custom specifications welcomed for completion
Inner packing:
Individual polybag or individual polybag with dialyzer or individual blister bag
Qualifications
1. CE and ISO certificate
2. Stable quality and strict quality control
3. Great production capacity
4. Favourable price
Remark: You can also give us your specific requirements to confirm the products you need finally.
| Name of Sample | Disposable Infusion Set with needle | Type | IS-VZ 0.7 | ||||
| LOT NO | 20130618 | Testing Standards | contract requirements | ||||
| Sterilization Lot | 20130618 | Quantity of Tested Batch | 1260000 pcs | ||||
| Quantity Of Sample | 50pcs | Testing Date | SEP 7, 2013 | ||||
| Type | Testing items | Standard Requirement and Standard Term and Conditions | Actual Testing Result | Conclusion | |||
| Biological Properties | Sterility | The infusion set in individual package should be sterile (8.2) | Missing | / | |||
| Pyrogen | Infusion set has no pyrogen (8.3) | Missing | / | ||||
| Chemical Properties | Reduction Matter | Difference of volumes of potassium permanganate [ c(kmno4 = 0.002mol/L)] consumed by test liquid and blank liquid should be not more than 2.0 ml (7.1) | 0.5ml | Eligible | |||
| Ph | The PH difference between testing liquid and blank liquid is not more than 1.5 (7.3) | 0.19 | Eligible | ||||
| Ultraviolet Absorbance | The absorbance of testing liquid should be not more than 0.1 (7.5) | 0.046 | Eligible | ||||
| Ethylene Oxide Residuum | The ethylene oxide residuum should be not more than0.5mg; Unit: mg (7.6) | 0.29 | / | ||||
| Physical Properties | Particle Content | For the number of 15-25min particles in 200ml eluent, not more than 1 particle/ml | Eligible | Eligible | |||
| For the number over 25min particles, not more than 0.5 particle/ml (6.1) | Eligible | ||||||
| Sealing Property | No air leakage of infusion set (6.2) | Eligible | Eligible | ||||
| Connection Intensity | Connection of parts for liquid channel of infusion set can bear the static tensile force not less than 15N for 15 seconds. (6.3) | Eligible | Eligible | ||||
| Puncture Device Of Bottle Stopper | According to the contract requirements ,Materials for ABS. | Eligible | Eligible | ||||
| Liquid Medicine Fitter | The infusion set should be equipped with a liquid machine filter | Eligible | Eligible | ||||
| The filtering rate of liquid medicine should be not less than 80%. (6.7) | 98.7% | ||||||
| Flow Speed Of Transfusion (Flow Quantity) | For the infusion set with 20drops/ml, with 1m static press end, the sodium chloride solution flowed should be not less than 1000ml for 10 minutes Unit: ml (6.10) | Eligible | Eligible | ||||
| Air Inlet Device (Air Fitter) | The filtering rate against particles 0.5μm in air should be not less than 90%. (6.5.2)5.2)5.2) | Missing | / | ||||
| Air Inlet Device (Flow Reduction Rate ) | Comparing with vessel with free air input, the flow of effluent should be reduced by 20%. (6.5.5) | Eligible | Eligible | ||||
| Packaging requirements | According to the contract requirements | Eligible | Eligible | ||||
| Flow Adjustor | Materials for ABS. | Eligible | Eligible | ||||
| Soft Pipe (Length) | According to the contract requirements | Eligible | Eligible | ||||
| needle | According to the contract requirements | Eligible | Eligible | ||||
| Testing Results | The seized products meet the requirements of the contract . | ||||||
