General Description:

Syringe, two pieces: barrel with Luer nozzle and piston/plunger or three
pieces: barrel with luer nozzle, stopper and piston/plunger. The
syringe has a reuse-prevention technology feature that either
automatically activates upon or during administration of the intended
dose or is activated by the user to prevent subsequent re-use of the
syringe. The RUP feature is categorized as follows:

i) Activation: Passive (Type 1) or active (Type 2).

ii)Application: one plunger movement (Type A) or multiple Plunger
movements (Type B).

Syringes with re-use prevention feature conform to ISO 7886-4:2006.

Blister packed.

Intended use: vaccine reconstitution

Technical specifications:

Syringe capacity: 2ml

Syringe graduation: Graduated scale on the barrel, easy to read. Scale
intervals of 0.1 or 0.2ml. Graduation lines of 1.0ml volume increment
conform to ISO 7886-1:1993.

Syringe Barrel: sufficiently transparent to allow easy measurement of
the volume contained in the syringe and detection of air bubbles. Length
with a maximum usable capacity of at least 10% more than the nominal
capacity conform to ISO 7886-1:1993. The Luer nozzle shall be situated
centrally.

Syringe Material: medical grade plastic (Polyethylene (PE)/
polypropylene (PP)/ polystyrene (PS).

Needle: Fixed needle with protective cap conform to ISO 7864:1993.

Needle Material: Stainless steel conform to ISO 9626-1:1991.

Base and protective cap: medical grade plastic.

Measurements: External diameter expressed in Gauge and millimeters.

Length expressed in inch and millimeters.

Size selected: 21Gx1 1/2” (0.8x40mm).

Syringe with fixed needle: Disposable.

Sterile, (ethylene oxide sterilisation and compiles to BS EN
550:1994-ISO 11135-1:2007)

Standards:

Product and packaging conform to ISO 7886-1:1993, ISO 7886-4:2006, ISO
7864:1993, ISO 9626-1:1991, BS EN 550:1994, ISO 11135-1:2007.

Product listed under WHO Performance Specification (PQS) Category E013
Hypodermic syringe with reuse prevention feature (RUP).

Quality management system (QMS): Products and manufacturer must be
certified and comply with ISO 13485: 2003 and 2008 requirements (or
equivalent).

Marketing approval certificate: Product and manufacturer must conform to
European Directive MDD 93/42/EEC on Medical Devices (or equivalent).

Shelf life:

5 years (60 month)

Packaging and labelling:

Primary packaging

Unit of use 1 syringe packed in an individual sterilised peel-pack made
of paper and/or plastic.

Labelling on the primary packaging

Name and/or trade mark of the manufacturer.

Manufacturer's product reference.

Type of product and main characteristics. If the packaging is not
transparent, it must bear a diagram (preferably actual size) showing the
essential parts of the product and indicating the position of the
product in the packaging.

Nominal capacity of the syringe.

External diameter and length of the needle, if included.

The words "for single use" (or equivalent harmonised symbol).

The symbol for "re-use prevention feature".

The word "sterile" (or equivalent harmonised symbol).

Sterilisation method (or equivalent harmonised symbol).

Lot number prefixed by the word "LOT" (or equivalent harmonised symbol).

Expiry date (year and month), prefixed by the word "EXP" (or equivalent
harmonised symbol).

Secondary packaging

Protected unit 1 box of 100 blister packed syringes.

Labelling on the secondary packaging

Name and/or trade mark and address of the manufacturer.

Manufacturer's product reference.

Type of product and main characteristics.

Nominal capacity of the syringe.

External diameter and length of the needle, if included.

The words "for single use" (or equivalent harmonised symbol).

The symbol for "re-use prevention feature".

The word "sterile" (or equivalent harmonised symbol).

Sterilisation method (or equivalent harmonised symbol).

Lot number prefixed by the word "LOT" (or equivalent harmonised symbol).

Expiry date (year and month), prefixed by the word "EXP" (or equivalent
harmonised symbol).

The number of units per secondary packaging.

A warning to check the integrity of the primary packaging before use.

A warning not to recap the needle (or equivalent symbol).

Information for handling, storage and disposal of syringe.

Manufacturer's instruction for use, including instructions appropriate
to the re-use prevention feature.

Instructions for use shall be given either on the package or on a
separate insert.

Related products

S0782208Safety box f.used syrgs/ndls 5lt/BOX-25

Useful links

http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue
/categorypage.aspx?id_cat=42