Product consists of filter body and filter mesh. Filter mesh should have cells no more than 170 mkm. Filter bottom must have block stops.
Inadmissible defects:
- shortrun, spallings, crazing in filter body;
- shrinkage cavity, foreign inclusions, air bubbles in filter body;
- burr more than 0,2mm;
- foreign inclusions in filter mesh;
- full or partial tearing/displacement of filter mesh from filter body;
- oil spots, dirt in filter mesh and on the filter body;
blocking of holes for liquid outflow by the material
Product material:
- Filter body - ABS (Acrylonitrile - butadiene - styrene) Medical grade.
- Filter mesh - PA (polyamide) Medical grade
Material must withstand sterilization by ethylene oxide and be compatible with blood and blood components according to standard series ISO 10993 and/or requirements of European Pharmacopoeia (7th Edition).
Item | Feature |
Production Material Standard | According to standard series ISO10993 or European Pharmacopoeia (7th. Edition) |
Physical and Chemical Properties | Heavy metal 1 ug |
Reducing substances<=2.0ml | |
Evaporation residue<=2.0ug | |
PH<=1.5 | |
Hold-up Volume | Filter hold up volume < 20ml |
Micro aggregate | 200um pre-filter for micro aggregare remove |
Priming | No priming with saline required |
Filtration pressure | In case of emergencies blood can be filtered with max. pressure of 300MmHg |