Compress, Non-woven, 10x10cm,Ster./PAC-5

INTENDED USE:
A non-medicated, sterile compress made from non-woven material and primarily designed to absorb fluids for medical purposes.
It is used to cover/clean wounds and absorb their exudates, to apply topical medications or disinfect healthy skin prior to a venipuncture or an injection.
It produces less lint, is less adherent and less abrasive compared to basic woven pads.

TECHNICAL SPECIFICATIONS
A non-medicated, sterile compress made from non-woven material
Synthetic material:
viscose: 70% (± 3 %)
polyester: 33% (± 3%)
Weight: ± 40 g / m² +/- 10%
Thickness: 8 plies
latex-free
Sterile, for single use
Dimensions: Folded: 10 x 10 cm

SHELF LIFE:
60 months, after production date

REGULATION & CONFORMITY REQUIREMENTS:
CE mark conforming to Medical Device Directive 93/42/EEC (or Medical Devices Regulation (EU 2017/745)).
CE self- declaration
ISO 13485:2003 certificate

CLASSIFICATION:
Class I sterile or higher -Medical Device Directive 93/42/EEC (or Medical Devices Regulation (EU 2017/745))

PACKAGING AND LABELLING
Primary packaging: Unit of use.
A pack of 5 Compress, Non-Woven, Sterile, 10x10cm in an individual sterilised peel pack.
Labelling on the primary packaging:
Name and/or trademark 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 "for single use" (or equivalent harmonised symbol).
The words "check the integrity of the individual sterilised pack before use" (if space allows).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).

Secondary packaging: Protected unit.
(X) box of Compress, Non-Woven, Sterile, 10x10cm/PAC-5
Labelling on the secondary packaging:
Labelling to be the same as primary packaging;
Extra information required:
Number of units per secondary packaging.

Over packaging: Packaging unit.

Weight/Volume/Dimensions
Estimated weight: xx kg
Estimated volume: xx cdm

INSTRUCTIONS FOR USE
Sterile dressings: cleaning and covering of wounds, absorption of exudates, wound dressings.
It is better to use sterile compresses rather than non-sterile compresses that are sterilized in the field. This is important for quality, hygiene, time and cost reasons.

STORAGE INSTRUCTIONS:

ENVIRONMENTAL CONDITIONS 
Storage conditions:
Transport conditions:

WEIGHT AND VOLUME: 
Unit weight in KG: xx Kg
Unit volume in M3: xx M3
,10x10cm,ster/BOX-10