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    SEFAR MEDIFAB Quality

    • Passes USP plastics class VI tests
    • Biocompatible according to ISO 10993
    • Pyrogen-free
    • Non-hemolytic, non-cytotoxic, low extractables
    • Precision monofilament fabrics having defined surface characteristics
    • Customer specific fabrication in a clean room class 7 (ISO 14644-1)
    • Raw materials comply with FDA 21 CFR 177
    • Raw materials used are polyester (PETP) and polyamide (PA)
    • Non-standard materials, e.g. polyetheretherketone (PEEK) or polypropylene (PP)
    • can be supplied in MEDIFAB quality upon request
    • ISO 13485 certified production processes
    • Validated washing and finishing process in accordance with GMP guidelines
    • ISO 9001 quality system and ISO 14001 environment management system


    Packaging / Labeling

    • Stamped pieces are packed into sealed PE bags
    • Stamped pieces made of SEFAR MEDIFAB fabrics are double bagged
    • The label contains the following standard information: manufacturer, material, outer dimensions, manufacturing date, order number, batch number
    • If it is packed according to medical standards (double-layer packaging), the label is attached to the inner bag


    Product forms

    • Cold stamping is the most economical process and provides standard-tolerance pieces with edges that are not sealed. Cold stamping is possible for all fabrics. Piece dimensions range up to 1000 x 1000 mm
    • Laser stamping provides a heat-sealed edge. Maximum dimensions are 480 x 480 mm
    • Ultrasonic stamping is available for fabrics having mesh openings < 400 um. It ensures tight tolerances and provides high-quality sealed edges which do not fray
    • Stamped discs with a diameter range of 6 to 95 mm are possible. Multilayer pieces are possible