Page 6 - BIOFIL

EN : All-germ point-of-use filters
DE : Endständige Keimfilter
DE : Endständige Keimfilter
NL : Antibacteriële eindfilters
NL : Antibacteriële eindfilters
DK : Antibakterie-endefiltre EN : All-germ point-of-use filters
DK : Antibakterie-endefiltre
/ 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
BIOFIL filters are approved using the ASTM F838* Individual packet label NL : Antibacteriële eindfilters
DK : Antibakterie-endefiltre
DK : Antibakterie-endefiltre
method. All BIOFIL filters have a unique batch number
This test confirms the effective bacterial retention power which can be easily traced back through
of the filters used for the decontamination of liquids. the production process.
The microbiological challenges carried out on
BIOFIL filters in laboratories using the species
Brevundimonas diminuta, Legionella pneumophila
and Pseudomonas aeruginosa demonstrate
Bacteriologically controlled water 30261 Qty: 1 BIOFIL 2
a retention efficiency of log for all waterborne
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micro-organisms which are larger than the filter pores
FR : Filtres terminaux anti-tous germes
which have a nominal porosity rating of 0.1 m STERILE EN : All-germ point-of-use filters
EN : All-germ point-of-use filters
NON
DE : Endständige Keimfilter
DE : Endständige Keimfilter
NL : Antibacteriële eindfilters
and absolute porosity rating of 0.2 m. MD NL : Antibacteriële eindfilters
DK : Antibakterie-endefiltre
DK : Antibakterie-endefiltre
PL : Filtry przeciw wszystkim drobnoustrojom
When subjected to this test, all BIOFIL filters delivered 18, rue du Maréchal Foch RO : Filtre terminale împotriva germenilor
F-80130 Friville
Filter Hollow an effluent free from bacteria, so they have a T : +33 (0)3.22.60.22.74 ES : Filtros terminales antigérmenes de todo tipo
PT : Filtros terminais anti todos os germes
unit fibres UDI www.delabie.com IT: Filtri terminali antibatterici
sterilising grade of 0.1 micron nominal-rated.
Resin GTIN

* Standard Test Method for Determining Retention of Membrane
Filters Utilized for Liquid Filtration. Double labelling on the filter
All filters are supplied with 2 waterproof labels
Section of the BIOFIL tap filter which identify the product and ensure traceability
LIFESPAN
when the filter is changed.
One is positioned on the product, the other can be
BIOFIL anti-Legionella and all-germ filters can removed and transferred to the record log, ensuring
2 3 be used for up to 4 months after initial installation traceability.
MONTHS MONTHS (depending on the model installed). 
After the time period marked on the filter (2, 3 or
4 months), DELABIE recommends changing the filter
4 to avoid any risk of retro-contamination from the
MONTHS 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 COMPLIANCE
necessary to change it. We recommend pre-filtration
upstream to filter out suspended solids CE marked class I Medical Devices
and/or colloids, etc.
BIOFIL non-sterile filters comply with the European
Bacterial proliferation is significantly reduced Regulation EU 2017/745 and benefit
in an installation where the water is pre-filtered, from the CE Mark (2022).
and the lifespan of all equipment is greatly increased.
CE marked class Is Medical Devices
Tilted to optimise the position of RESISTANT TO DIFFERENT WATER BIOFIL sterile filters comply with the European
the tap filter Regulation EU 2017/745 and benefit
SYSTEM TREATMENTS from the CE mark (2022).
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
Resistance to thermal shocks:
Temperatures of 70°C for a cumulative period 3 years. The product expiry date is marked on the label.
of 30 minutes during its lifetime.
Certificate of sanitary compliance
CE marked class I Medical Resistance to chemical shocks: All BIOFIL filters conform to the CPDW directive
Devices for non-sterile filters
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
product must be completely traceable. water suppliers who enforce the Water Regulations
and Byelaws.

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