Product description
Foliodrape Protect are soft, two-layer drape sheets. They are water and bacteria proof.
Foliodrape Protect drape sheets are CE marked in accordance with EU Directive 93/42/EC and Royal Decree 1591/2009 concerning medical devices. They are classified as sterile Class I (TÜV SUD 0123). A conformity assessment carried out for Foliodrape Protect has shown that this product satisfies all applicable requirements of the aforementioned Directive. Therefore, the safety and performance of Foliodrape Protect drape sheets are guaranteed as long as it is used according to its intended purpose.
Applications and indications:
For sterile draping of the patient and the medical staff.
Features:
Foliodrape Protect meets all the requirements of the European Standard EN 13795, including the requirements for the maximum level of quality "High performance, critical zone".
- Structure: Two layers (non-woven foil laminated and film).
- Non-woven (top layer): Hydrophilic polypropylene, aqua-colored.
- Film (bottom layer): Polyethylene, aqua-colored.
- For self-adhesive drape sheets: Latex-free synthetic rubber adhesive covered with silicone paper.
- Sterilisation: ethylene oxide according to EN 556-1 and EN 11135-1.
- Latex and rosin-free.