Antibacterial filter WF4C2S-DPSHF-2222

waterfor healthcare facilitiesfor medical devices

CE MARK 0476 Features Disposable filter for the production of water free of bacteria in general (including fungi, protozoa and other equivalent particles) at the points of use, specifically designed for problems hospital for potential contamination of the water network and suitably tested and validated for an average duration of use up to 31 days without loss of performance. To be used downstream of the dispenser or in line for washing and cleaning procedures Water Filter 4 (shower) - SHOWER HANDSET - cod. WF4C2S-DPSHF-2222 Application and Description of use Production of microbiologically controlled water ready for use to be used for washing and cleaning procedures of medical devices for the prevention of infections Tests and Validations 1. Specific validations for the retention of bacteria at the passage of the flow: • Bacterial challenge according to the standardized method ASTM F838-05 compared to Brevundimonas Diminuta, Bacillus Clausii, Total Bacterial Load, Aspergillus Niger, Mycobacter and Legionella Test; 2. Specific validations for the prevention of retrograde contamination: • Test according to ISO 22196 • Test under conditions of use with Staphylococcus Aureus, Pseudomonas Aeruginosa, E. Coli and MRSA 3. Specific validations for the sterilization of medical devices: • Bioburden assessment in accordance with ISO 11137-2: 2015, ISO 11737-1: 2006 / AC: 2009 and ISO 11737-2: 2009