CE MARK 0476
Features:
TERMINAL ABSOLUTE POINT OF USE FILTER
Disposable filter for the production of water free of bacteria in general (including fungi, protozoa and other equivalent particles) at the points of use, designed specifically for the problems hospital for potential contamination of the water network and suitably tested and validated for a maximum duration of use up to 62 days without deterioration of performance. To be used downstream of the dispenser or in line for washing and cleaning procedures of medical devices.
Application and description of use:
Production of microbiologically controlled water ready for use to be used for
washing and cleaning procedures for medical devices for the prevention of infections.
Water Filter 2 (direct outlet) - SHOWER WF2C2S-DPSHF2210
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
Decreased Brevundimonas, Total Bacterial Load 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