Disposable Syringes (Blistered Pack) with CE 0123 & ISO 13486 Approval

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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

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