Syringe,disp,20ml,ster/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.

Blister packed.

Intended use: inject fluids into, or withdraw fluids from, the body

Technical specifications:
Syringe capacity: 20ml

Syringe graduation: Graduated scale on the barrel, easy to read. Scale intervals of 2.0 ml. Graduation lines of 5.0 ml or 10.0 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.

Barrel Nozzle: Luer lock in accordance with ISO 594-2:1986 or luer slip in accordance with ISO 594-1:1986. Luer nozzle is centric or acentric.

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

Syringe: 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, BS EN 550:1994, ISO 11135-1:2007.

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).

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.
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 by year and month, prefixed by the word "EXP"
(or equivalent harmonised symbol).
The words "or single use" (or equivalent harmonised symbol).
The words "check the integrity of the individual sterilised pack before use" (if space allows).
The words "destroy after use" (if space allows).

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.
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 by year and month, prefixed by the word "EXP"
(or equivalent harmonised symbol).
The words "for single use" (or equivalent harmonised symbol).
The words "check the integrity of the individual sterilised pack before use" (if space allows).
The words "destroy after use" (if space allows).
Number of units per secondary packaging.
Information for particular storage conditions
(Temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Information for handling, if applicable
(or equivalent harmonised symbol).
Manufacturer's instruction for use.
Alternatively, the instruction for use can be indicated on a separate insert.

CE marking.
 
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