Page 22 - Water_Controls_for_Healthcare

DE : Endständige Keimfilter
DE : Endständige Keimfilter
NL : Antibacteriële eindfilters
NL : Antibacteriële eindfilters
DK : Antibakterie-endefiltre
DK : Antibakterie-endefiltre
/ Point-of-use filters EN : All-germ point-of-use filters EN : All-germ point-of-use filters

BACTERIAL CHALLENGE EN : All-germ point-of-use filters
EN : All-germ point-of-use filters
DE : Endständige Keimfilter DE : Endständige Keimfilter
NL : Antibacteriële eindfilters NL : Antibacteriële eindfilters
DK : Antibakterie-endefiltre DK : Antibakterie-endefiltre
BIOFIL filters are approved using the ASTM F838* Individual packet label
method. All BIOFIL filters have a unique batch number
This test confirms the effective bacterial retention power which can be easily traced back through the
of the filters used for the decontamination of liquids. production process.
The microbiological challenges carried out on
BIOFIL filters in laboratories using the species
Brevundimonas diminuta, Legionella pneumophila
Bacteriologically controlled water and Pseudomonas aeruginosa demonstrate a 30261 Qty: 1 BIOFIL 2
retention efficiency of 7 log for all waterborne
microorganisms which are larger than the filter pores STERILE FR : Filtres terminaux anti-tous germes
NON
EN : All-germ point-of-use filters
EN : All-germ point-of-use filters
DE : Endständige Keimfilter
DE : Endständige Keimfilter
which have a nominal porosity rating of 0.1 m MD NL : Antibacteriële eindfilters
NL : Antibacteriële eindfilters
DK : Antibakterie-endefiltre
DK : Antibakterie-endefiltre
and absolute porosity rating of 0.2 m. PL : Filtry przeciw wszystkim drobnoustrojom
18, rue du Maréchal Foch RO : Filtre terminale împotriva germenilor
F-80130 Friville
When subjected to this test, all BIOFIL filters delivered T : +33 (0)3.22.60.22.74 ES : Filtros terminales antigérmenes de todo tipo
PT : Filtros terminais anti todos os germes
Filter Hollow an effluent free from bacteria, so they have a UDI www.delabie.com IT: Filtri terminali antibatterici
unit fibres sterilising grade of 0.1 micron nominal-rated. GTIN
Resin
* Standard Test Method for Determining Retention of Membrane Double labelling on the filter
Filters Utilized for Liquid Filtration. All filters are supplied with 2 waterproof labels which
identify the product and ensure traceability when the
Section of the BIOFIL tap filter
filter is changed.
LIFESPAN One is positioned on the product, the other can be
removed and transferred to the record log, ensuring
2 3 BIOFIL anti-Legionella and all-germ filters can traceability. 
MONTHS MONTHS be used for up to 4 months after initial installation
(depending on the model installed).
4 After the time period marked on the filter (2, 3 or 4 months),
DELABIE recommends changing the filter to avoid
MONTHS any risk of retro-contamination from the bacteria
concentrated in the filter especially in at-risk areas.
Maximum lifespan
Note: The amount of impurities in the water will vary
between water systems. Filters will, therefore,
become clogged at different rates.
If the filter becomes clogged prematurely, it is necessary COMPLIANCE
to change it. We recommend pre-filtration upstream to
filter out suspended solids and/or colloids, etc. CE marked class I Medical Devices
Bacterial proliferation is significantly reduced in an BIOFIL non-sterile filters comply with the European
installation where the water is pre-filtered, and the Regulation EU 2017/745 and benefit from the CE
lifespan of all equipment is greatly increased. Mark.
CE marked class Is Medical Devices
Tilted to optimise the position
of the tap filter RESISTANT TO DIFFERENT WATER BIOFIL sterile filters comply with the European
SYSTEM TREATMENTS Regulation EU 2017/745 and benefit from the CE
Mark.
BIOFIL filters will withstand thermal and chemical Sterilisation complies with European standard
shocks. During chemical or thermal shocks, impurities EN ISO 11137
become trapped in the filter and reduce its lifespan. After manufacture, BIOFIL sterile filters are sterilised
DELABIE, therefore, recommends changing the filter using gamma rays. Each box has a visual marker
after any treatment. showing that the filters have been sterilised.
After sterilisation, BIOFIL filters have a shelf life of 3
Resistance to thermal shocks:
Temperatures of 70°C for a cumulative period years. The product expiry date is marked on the label.
of 30 minutes during the filter lifetime.
CE marked class I Medical Certificate of sanitary compliance
Devices for non-sterile filters Resistance to chemical shocks: All BIOFIL filters comply with the CPDW directive
CE marked class Is Medical Chlorine levels for 2-month filters: 2 hours at 100ppm; and the Order of 29 May 1997, as amended,
Devices for sterile filters
3-month filters: 3 hours at 100ppm; and the French Ministry of Health Circular
and 4-month filters: 4 hours at 100ppm. DGS/SD7A2002 no. 571 of 25 November 2002.
WRAS
OPTIMISED TRACEABILITY Our BIOFIL filters are WRAS approved. WRAS
Approval demonstrates that a product complies
To control the health risks associated with water, with the Water Supply (Water Fittings) Regulations
the whole process from the manufacture of the and Scottish Water Byelaws. The WRAS approval
medical device components to the use of the finished standard is accepted as a quality benchmark by water
product must be completely traceable. suppliers who enforce the Water Regulations and
Byelaws.

20 Point-of-use filters