MARKED CE 0476
Disposable filter for the production of water free of bacteria in general (including mushrooms,
protozoa, and other equivalent particles) at the points of use, specifically designed for hospital
problems of potential contamination of the water supply; suitably tested and validated for a
maximum duration of use up to 62 days without loss of performance. To be used downstream of the dispenser or in line for the washing and cleaning procedures of medical devices.
Application and Description of use:
Production of microbiologically controlled ready-to-use water to be used for washing and cleaning procedures of medical devices for the prevention of infections.
Water Filter 1 (direct exit) – SINK - cod. WF1C2S-DPSHF-2210
Test 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 about:
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 evaluation in accordance with ISO 11137-2:2015,
ISO 11737-1:2006/AC:2009 e ISO 11737-2:2009.