60ml Disposable Steriled Syringe with Catheter Tip

60ml Disposable Steriled Syringe with Catheter Tip

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Model NO. YD600
Material Plastic
Application Medical
Certification CE, SGS, FDA, ISO13485
Needle Without Needle
Disinfection Disinfection
Medical Devices Reg./Record No. ssyjxzz-2001-024
Trademark NEO
Specification CE 0123 certificate and ISO13485
HS Code 90183900
Type Syringe
Volume 1ml-60ml
Feature Disposable
Group Adult
Syringe Use Pumping Water
Medical Device Regulatory Type Type 3
Size 50-60ml
Transport Package 100PCS/Box, 640carton/40hq
Origin China
Disposable Syringe (Lure Slip ) for Single use
Isposable 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 / Polybag.
10. Available size: 1mL, 2mL(2.5mL), 3mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL. 100ML
11. Standard: ISO 13485 AND CE 0123
12. Valide: 5 year
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