
| Model NO. | YD1097 |
| Material | Plastic |
| Application | Medical |
| Certification | CE, FDA, ISO13485 |
| Needle | With Needle |
| Disinfection | Disinfection |
| Medical Devices Reg./Record No. | Ssyjxzz-2001-0249 |
| Trademark | IU |
| Specification | CE certificate and ISO 9001: 2000/13485 |
| HS Code | 90183900 |
| Type | Syringe |
| Volume | 1ml-100ml |
| Feature | Disposable |
| Group | Adult |
| Syringe Use | High Precision Experiments |
| Medical Device Regulatory Type | Type 3 |
| Size | 1-100ml |
| Transport Package | 1PC Per Bag, 100PCS/Box |
| Origin | CHINA |
| Name of Sample | Disposable Syringe With Needle | LOT | 20120204 | ||||
| Type | 10ml 22G*11/4 | MFG DATE | 20120204 | ||||
| Quantity | 1084800PCS | Serial LOT | 20120204 | ||||
| Testing Standards | GB15810-2001and Invoices NO.YD-T111228 | EXP DATE | 20170204 | ||||
| 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) | 0.35 | ||||
| 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) | 0.19 | |||||
| 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 | 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 | 57.8 | |||||
| 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 | 0.089 | |||||
| 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 | ||||||