Delabie BIOFIL 30261 Manual Del Usuario página 7

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PRODUCT COMPLIANCE
BIOFIL Disposable Water Filters:
• Are Class I Medical Devices in France - complying with European directive 2017/745. CE marking: year 2021.
• Comply with drinking water certifications (ACS-France, KTW-Germany, WRAS-United Kingdom).
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MANUFACTURING INFORMATION
BIOFIL Disposable Water Filters are manufactured in France by:
DELABIE | 18, rue du Maréchal Foch | 80130 FRIVILLE | France
For more information, visit our website at: www.delabie.co.uk
or contact us: tel.: Tel. +33 (0)3 22 60 22 74 - email: [email protected]
References:
A. Sterilising grade filter is defined in "American standard Test Method ASTM F838-20 and in FDA - Guidance for Industry
- Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice" as a filter ability to sustain
a bacterial challenge of 10
Product label - meaning of symbols
Catalogue number
Sterilised using irradiation
Free from natural latex
NON
STERILE
Non-sterile
CFU of Brevundimonas diminuta per cm² of filtration surface.
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Do not resterilise
Consult instructions for use
Batch code
STERILIZE
Manufacturer
Use by
Do not use if packaging is damaged
Compliant with the general requirements
for safety and performance