General information
Sterile unidose disposable syringe with fixed needle for administration of injectable vaccines; a locked piston prevents reuse. The self-blocking syringe presents the lowest possible risk of pathogenic agent transmission.
Recommended by the WHO and UNICEF, particularly for immunization campaigns; the International Federation and the ICRC follow these recommendations.
Specifications
Auto-disable syringe
Material:
Needle: stainless steel Barrel Transparent
Syringe: polypropylene(PP)
Plunger: plunger in polypropylene (PP)
Specifications:
NEEDLE: 23G (0.6 x 25 to 30 mm), fixed to syringe
Secured by a protector
SYRINGE:
- Barrel:
Capacity: 0.5 ml + 20% to allow removal of air
Graduation: 0 and 0.5 ml only
Maximum deadspace: 50 microlitres
Prefer small diameter barrel (about 5 mm) to facilitate aspiration of vaccine without air bubbles and to reduce waste to incinerate.
- Plunger: prevented from re-use by a ratched pawls and a clip
- Gasket: Transparent situated at the end of the plunger, must ensure a good seal (ideal =double lips)
Unit presentation:
1 syringe + needle in a peel off sachet
Labelling:
Multilingual to mention:
- Product name, size, single use- auto-destructive
- Lot number, expiry date, sterile- sterilisation mode
- Manufacturer name and addressee
- Mark CE + notify body number
Packaging:
Dispenser box of 100 unit, sterile
Same labelling as unit presentation + total number of units + user recommendation
Protective packaging:
Cardboard box ensuring adapted protection in normal handling
Same labelling as unit presentation + total number of dispenser box.
storage recommendation.
Other Requirements:
ISO 7886-3:2005: Sterile hypodermic syringes for single use
Part 3: Auto-disable syringes for fixed-dose immunization