Dispsoable Medical Infusion Sets with Butterfly Needle (modle YD-I)
带蝴蝶针的可调式医疗输液器（型号YD-I）
议价
加入意向| 型号。 | YD-I |
| 材料 | 塑料 |
| 环氧乙烷灭菌 | 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 9001：2000/13485 |
| HS编码 | 90183900 |
| 类型 | 输液器 |
| 证明 | ce，sgs，fda，iso13485 |
| 质量保证期 | 两年 |
| 标志印刷 | 使用徽标打印 |
| 医疗器械注册/记录号 | ssyjxzz-2001-024 |
| 运输包装 | 58 * 38 * 38 / cm，870ctn / 40hq |
| 起源 | 中国 |
具有蝴蝶针的可分离医疗输液器
INFUSION SET带两个塑料插入器两个调节器
产品编号：HB6-08
这是一次性输液器，带有两个塑料插入器和两个调节器。
Assesoris：通风尖，滴水cham，滚筒夹，溶液过滤器，乳胶管。
特征：
1）单次使用
2）带过滤器的透明滴水室
3）标准长度为135cm的柔性管
4）厚乳胶连接器
5）Luer锁适配器与皮下注射针
6）灭菌：乙烯气灭菌
INFUSION SET带两个塑料插入器两个调节器
产品编号：HB6-08
这是一次性输液器，带有两个塑料插入器和两个调节器。
Assesoris：通风尖，滴水cham，滚筒夹，溶液过滤器，乳胶管。
特征：
1）单次使用
2）带过滤器的透明滴水室
3）标准长度为135cm的柔性管
4）厚乳胶连接器
5）Luer锁适配器与皮下注射针
6）灭菌：乙烯气灭菌
| 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. | YD-I |
| Material | Plastic |
| Ethylene Oxide Sterilization | Ethylene Oxide Sterilization |
| Group | Adult |
| Medical Device Regulatory Type | Type 3 |
| Trademark | IU |
| Specification | CE Certificate and ISO 9001:2000/13485 |
| HS Code | 90183900 |
| Type | Infusion Set |
| Certification | CE, SGS, FDA, ISO13485 |
| Quality Guarantee Period | Two Years |
| Logo Printing | With Logo Printing |
| Medical Devices Reg./Record No. | ssyjxzz-2001-024 |
| Transport Package | 58*38*38/Cm, 870CTN /40hq |
| Origin | China |
Dispsoable Medical Infusion Sets with butterfly needle
INFUSION SET with two plastic inserters two adjustors
Item No: HB6-08
This is disposable infusion set with two plastic inserters and two adjustors.
Assesoris: Vented spike, dripping champer, roller clamp, solution filter, emulsion tube.
Features:
1) For single use
2) Transparent drip chamber with filter
3) Flexible tubing with standard length of 135cm
4) Thick latex connector
5) Luer lock adapter with hypodermic needle
6) Sterilization: Ethylene-gas-sterilization
INFUSION SET with two plastic inserters two adjustors
Item No: HB6-08
This is disposable infusion set with two plastic inserters and two adjustors.
Assesoris: Vented spike, dripping champer, roller clamp, solution filter, emulsion tube.
Features:
1) For single use
2) Transparent drip chamber with filter
3) Flexible tubing with standard length of 135cm
4) Thick latex connector
5) Luer lock adapter with hypodermic needle
6) Sterilization: Ethylene-gas-sterilization
| 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 . | ||||||
