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