Disposable infusion se with Y site with needle 21G
Disposable syringe with all Certification
Name of Parts Name & Code of Raw Materials
1. Cover Polypropylene P. P HT-022
2. Cannula Stainless Steel 1Cr18Ni9Ti
3. Hub Polypropylene P. P HT- 022
4. Plunger Polypropylene P. P HT-022
5. Barrel Polypropylene P. P HT-022
6. Piston Natural rubber for medical
7. Needle Stainless steel
B. Microbiologic, Chemical and Physical Properties
1. Microbiologic and Chemical properties
A. Sterility: Sterility
B. Pyonenicity: Non-pyroenicity
C. Limit for extractable metal: For the metals content of the control fluid, contain not greater than a combined total of 5mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1mg/l
D. Titration acidity: When determinded with a laboratory PH meter and using a general purpose electrode, the PH value of an extract prepared in accordance with annex A shall be within one unit of PH of that of the control fluid evaporation.
2. Physical Property
A. Cleanliness
When inspected by normal or corrected-to-noumal visio without magnification
Under an luminance of 300ix to 700ix, the surface of the hypodermic syringe which comes in contact with injection fluids during normal use shall be free from particles and extraneous matter.
B. Lubricant
An acceptable lubricant, applied undiluted, for three-piece syringes is polydimethylsiloxane complying with a national or the European Pharmacopoeia. The quantity of lubricant used should be exceed 0.25mg per square centimeter of the internal surface area of the syringe barrel.
C. Tolerance on graduated capacity
The tolerance on the graduated capacity shall be as table 1 of ISO7886-1: 1993
D. Graduated scale
The graduated scale should be as 10 of ISO7886-1: 1993.
E. Barrel
Dimensions should be accordance with 11.1 of ISO7886-1: 1993
Finger grips should be accordance with 11.2 of ISO7886-1: 1993
F. Piston/plunger assembly
Design should be accordance with 12.1 of ISO7886-1: 1993
Fit of piston in barrel should be 12.2 of ISO7886-1: 1993
Fiducial line should be accordance with 12.3 of ISO7886-1: 1993
G. Nozzle
Conical fitting should be accordance with 13.1 of ISO7886-1: 1993
Position of nozzle on end of barrel should be accordance with 13.2 of ISO7886-1: 1993
Nozzle lumen should be accordance with 13.3 of ISO7886-1: 1993
H. Performance
Dead space should be accordance with 14.1 of ISO7886-1: 1993
Disposable syringe with all Certification
Name of Parts Name & Code of Raw Materials
1. Cover Polypropylene P. P HT-022
2. Cannula Stainless Steel 1Cr18Ni9Ti
3. Hub Polypropylene P. P HT- 022
4. Plunger Polypropylene P. P HT-022
5. Barrel Polypropylene P. P HT-022
6. Piston Natural rubber for medical
7. Needle Stainless steel
B. Microbiologic, Chemical and Physical Properties
1. Microbiologic and Chemical properties
A. Sterility: Sterility
B. Pyonenicity: Non-pyroenicity
C. Limit for extractable metal: For the metals content of the control fluid, contain not greater than a combined total of 5mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1mg/l
D. Titration acidity: When determinded with a laboratory PH meter and using a general purpose electrode, the PH value of an extract prepared in accordance with annex A shall be within one unit of PH of that of the control fluid evaporation.
2. Physical Property
A. Cleanliness
When inspected by normal or corrected-to-noumal visio without magnification
Under an luminance of 300ix to 700ix, the surface of the hypodermic syringe which comes in contact with injection fluids during normal use shall be free from particles and extraneous matter.
B. Lubricant
An acceptable lubricant, applied undiluted, for three-piece syringes is polydimethylsiloxane complying with a national or the European Pharmacopoeia. The quantity of lubricant used should be exceed 0.25mg per square centimeter of the internal surface area of the syringe barrel.
C. Tolerance on graduated capacity
The tolerance on the graduated capacity shall be as table 1 of ISO7886-1: 1993
D. Graduated scale
The graduated scale should be as 10 of ISO7886-1: 1993.
E. Barrel
Dimensions should be accordance with 11.1 of ISO7886-1: 1993
Finger grips should be accordance with 11.2 of ISO7886-1: 1993
F. Piston/plunger assembly
Design should be accordance with 12.1 of ISO7886-1: 1993
Fit of piston in barrel should be 12.2 of ISO7886-1: 1993
Fiducial line should be accordance with 12.3 of ISO7886-1: 1993
G. Nozzle
Conical fitting should be accordance with 13.1 of ISO7886-1: 1993
Position of nozzle on end of barrel should be accordance with 13.2 of ISO7886-1: 1993
Nozzle lumen should be accordance with 13.3 of ISO7886-1: 1993
H. Performance
Dead space should be accordance with 14.1 of ISO7886-1: 1993