Eurofarm S.p.A. - Zona Industriale – 95040 Piano Tavola (CT)
TECHNICAL SPECIFICATIONS
Product: EUROPOR “H”
REF. N°, SIZES AND PACKING:
522001 cm 1,25 x m 5
522002 cm 2,5 x m 5
522005 cm 5
xm5
522101 cm 1,25 x m 9,14
522102 cm 2,5 x m 9,14
522105 cm 5
x m 9,14
30 boxes x 36 pcs.
30 boxes x 24 pcs.
30 boxes x 12 pcs.
30 boxes x 36 pcs.
30 boxes x 24 pcs.
30 boxes x 12 pcs.
PACKAGING:
Each box is labelled according to MDD 93/42 EEC. The quantities differ according to the width of
the tapes.
DESCRIPTION OF PRODUCT: Europor is a non-woven porous adhesive plaster, breathable,
radio transparent, hypoallergenic. Suitable for the fixation of medical devices.
Europor is latex free.
Tapes for medical use are class I (non-sterile) products according to the MDD 93/42 EEC of
14.06.1993 (Annex IX, Rule 1).
STORAGE: Keep dry and far from heating sources.
Shelf life: 5 years since manufacturing date.
IDENTIFICATION OF RISKS:
Injurious effects on health:
Injurious effects on the environment:
Ways of fire extinguishing:
Special packaging conditions:
not determinable
Does not represent risks for the
Environment provided that the national laws
for the refuses are respected.
Suitable: Foam, Powder, and CO2.
Contra-indicated: none of our knowledge,
next to fire suitable ways of fire
extinguishing have to be used.
None.
WARNINGS:
Do not apply on damaged skin
Clean the part before applying the tape
The tape doesn’t cause any allergic reaction
In case of intolerance to the tape, remove and carefully wash
Rev. 02 ST 08/05 EU OF 02/09/10
Eurofarm S.p.A. - Zona Industriale – 95040 Piano Tavola (CT)
PHYSICAL CHARACTERISTICS:
BACKING:
White non-woven
Weight: 30  5 g/m²
ADHESIVE:
Polyacrylic, dry weight: 30  5 gr/m².
Laboratory tests on guinea pigs found it skin-friendly, nonsensitising.
COLOUR:
White
PEEL STRENGTH at 180°:
450  50 g / 2,5cm
TEARING STRENGTH:
3  0,5 kg / 2,5cm
SHEAR STRENGTH: less than 25mm under the conditions described in the Off. Ital.
Pharmacopoeia, 9th Ed.
JOINTS:
none or within the limits allowed by the Off. Ital. Pharmacopoeia, 9th Ed.
WIDTH:
within the limits of tolerance of the Off. Ital. Pharmacopoeia, 9th Ed. (±4%).
LENGTH: within the limits of tolerance of the Off. Ital. Pharmacopoeia, 9th Ed. (±1%).
AIR PERMEABILITY: 1200 l/m2/s at 200 Pa (Method FX 3300)
WATER VAPOUR PERMEABILITY: 1400  50 g/m² in 24 hours
MANUFACTURING OF THE PRODUCT:
Europor is manufactured in a clean room (Class 100.000) under following conditions:
Temperature:
18° - 25° C
Relative humidity:
30% - 80%
These conditions are regularly verified by suitable instruments (thermo-hygrometer).
Rev. 02 ST 08/05 EU OF 02/09/10