Delabie BIOFIL Manual De Instrucciones página 7

8
UNDESIRABLE SIDE EFFECTS
The studies carried out have not demonstrated any adverse effects on the health of patients.
9
PRODUCT COMPLIANCE
BIOFIL filters:
• are sterilised by gamma irradiation in accordance with NF EN ISO 11137 standard. Do not resterilise.
• have international drinking water compliance validations (ACS - France, KTW - Germany, WRAS - United Kingdom).
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I MANUFACTURER DETAILS
BIOFIL filters are manufactured by:
DELABIE | 18, rue du Maréchal Foch | 80130 FRIVILLE | France
1. For more information, visit our website: www.delabie.com.
or contact us: tel.: + 33 (0)3 22 60 22 74 - E-mail: sav@delabie.fr.
2. The paper version of the notices remains available on request.
Reference:
A sterilising grade filter is defined in the "American Standard Test Method ASTM F838-20 and FDA - Guidance for Industry
- Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice.
Product label - meaning of the pictograms
Catalogue reference
Filter sterilised by irradiation
Manufacturer's address
Do not reuse
Batch code
STERILIZE
Do not resterilise
Sterile barrier system only.
A
Commissioning date
2 3 4
Use-by date after commissioning
2M: 2 months - 3M: 3 months - 4M: 4 months
Expiration date
Do not use if the packaging is damaged.
Consult the precautions for use
B
Decommissioning date