FITT Refittex AS EN 5359

Antistatic hose for medical gas transfer compliant with EN ISO 5359.

The FITT Refittex AS EN 5359 is an antistatic hose designed for the transfer of medical gases and for integration into hospital systems, medical gas distribution networks, and medical devices. It complies with EN ISO 5359 in terms of performance, safety, and durability, and with EN ISO 8031, ensuring controlled electrical resistance for the safe dissipation of electrostatic charges. The hose has been tested according to ISO 10993-5, demonstrating the absence of in vitro cytotoxic effects and confirming that the material does not release substances harmful to cells. The product supports manufacturers in biological evaluation processes, but it is a technical component and not a medical device within the meaning of Regulation (EU) 2017/745. Certification and CE marking remain the responsibility of the manufacturer of the final device.

Structure

4-layer hose. PVC cover, high-tenacity polyester textile reinforcement, PVC intermediate layer, and antistatic TPU inner layer.

-20°C / +60°C.

  • Antistatic
  • High flexibility

    • Compliant with EN ISO 5359. Low-pressure flexible hoses for use with medical gases.
    • Compliant with EN ISO 8031. Determination of electrical resistance and conductivity.
    • Compliant with cytotoxicity testing according to ISO 10993-5, confirming the absence of cytotoxic effects in vitro.

    Features

    Biological evaluation support

    The hose has been evaluated through cytotoxicity testing according to ISO 10993-5, the international standard used for in vitro biological evaluation of materials intended for medical device applications.

    Testing was conducted by an independent accredited laboratory using the XTT cell viability assay on L-929 mammalian fibroblast cells.

    Under the applied test conditions, the extract obtained from the hose material did not show cytotoxic effects, confirming the absence of inhibition of cell growth in vitro.

    Test report reference: CYTOTOX-PH-26/0088

    Request more information
    Technical data

    Download technical documentation

    impact passport

    FITT S.p.A.
    is a Benefit Company

    FITT meets high standards of positive environmental and social impact.