Syringe

Components:

BARREL, with finger grip.

- Materials: medical grade PE (polyethylene) or PP (polypropylene); transparent for easy reading and for detecting air bubbles.

- Cylindrical shape.

- Graduation scale: clear, water resistant:

for 2ml syringe every 0.1ml

for 5ml syringe every 0.2ml

for 10ml syringe every 0.5ml

for 20ml syringe every 1ml

- Ends in a male Luer tip (conical with 6% taper).

Concentric for 2 and 5ml syringes.

Eccentric for 10 and 20ml syringes.

Plunger:

- Material: PP (polypropylene)

- Slides inside the barrel.

Seal:

- In two-part syringes, the seal results from the local distortion of the barrel when the plunger is displaced.

Barrel:

Same as 2-piece syringe:

-1ml syringe, graduation line every 0.01ml.

Plunger:

Same 2-piece syringe:

Gasket:

- Material: elastomer, medical grade.

- Located at the end of the plunger.

- Ensures a secure and safe seal.

Syringe (3-part type):

Identification: orange (cap and/or marking), international colour code system.

Barrel:

Graduations are adapted for insulin concentrations of 100 IU.

Larger graduations every 10 IU (Scale: 0.01ml = 1IU).

Plunger:

the end of the plunger head - used as a reference line-  must be visible and  well defined in order to determine the graduated capacity corresponding to all graduations on the syringe barrel

 Needle:

Stainless steel, fixed syringe.

Length: 12 to 16mm (27 to 29G).

External Ø maximum 0.45mm (ISO 7864 standard).

Quality  requirements:

Complies with European Medical Devices Directive, Council Directive 93/42/EEC or equivalent.

- EN-ISO7886-1: Sterile hypodermic syringe for single use: part 1: syringe for manual use

- EN-ISO20594-1: Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements

Unit presentation:

One syringe, single-use, sterile, individually peel packed

Primary packaging:

Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with sterilization method, lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.

Secondary packaging:

Protected unit, one (1) box 100-unit presentation; labelling is the same as that of the primary packaging.

Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).

Transport packaging:

Labelling: Same as secondary packaging with product-specific transport  and storage instructions, where applicable, and quantity of secondary packages.