Syringe,RUP,1ml,w/ndl,bi-pack/BOX-100

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 7886-4:2018.
Blister packed.

Needle: preference is fixed needle

Intended use:
Vaccine delivery

Technical specifications:
Syringe:
Capacity: 1ml
Syringe graduation: Graduated scale on the barrel, easy to read. Scale intervals of 0.05 ml. Graduation lines of 1.0ml volume increment conform to ISO 7886-1:2017.

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 conforms to ISO 7886-1:2017.

Barrel Nozzle:
Luer lock or luer slip in accordance with ISO 80369-7:2021. The Luer nozzle shall be situated centrally.

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

Needle:
Components: Needle with base (Luer type fitting and complies with ISO 80369-7:2021 and and protective cap.
Needle Material: Stainless steel conform to ISO 9626:2016.
Base and protective cap: medical grade plastic.
Measurements:External diameter expressed in Gauge and millimeters. Length expressed in inch and millimeters.
Size selected: 23G x 1” (0.60 x 25 mm)
Color code: visible at the base of the needle and complies with ISO 6009:2016
Sterile, (ethylene oxide sterilization and compiles to 11135:2019)
Dead space of syringe and needle combination: ≤ 0.035mL

Standards:
Product and packaging conform to ISO 7886-1:2017, ISO 7886-4:2018, ISO 7864:2016, ISO 9626:2016, ISO 11135:2019.
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: 2016 requirements (or equivalent).
Marketing approval certificate: Product and manufacturer must conform to European Medical Device Regulation (EU) 2017/745 (or equivalent).


Packaging and labelling:
Primary
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