CE MARK 0476
Features
Disposable filter for the production of microbiologically pure water (obtained by eliminating bacteria, fungi, protozoa and other equivalent particles), specifically designed for hospital problems of potential contamination of the water network and suitably tested and validated for an average duration of use up to 62 days without deterioration of performance. To be used In-line for washing and cleaning procedures of medical devices as well as in the case of dental units, delivery tubs,
Water Filter 3 (in line) - CPC IN / OUT connection - cod. WF3C2S-DPSHF-2210
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.
2.2 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, Citrobacter SP. 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 validation in the reduction of the virus concentration in aqueous suspension
compared to Adenovirus type 5, Poliovirus 1 and Murine Norovirus
4. 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