
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
FILTRO PER CONTENITORI PER STERILIZZAZIONE,
DIAMETRO CA. 19 CM CON INDICATORE DI VAPORE DI TIPO 1
CONTAINER FILTER,
ROUND 19CM DIAMETER, WITH STEAM INDICATOR TYPE 1
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità
competente dello Stato membro in cui si ha sede.
All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent authority of
the member state where your registered ofce is located.

ENGLISH
REF: 901.101.1000 , with steam indicator in the middle
Product Description
The Container Filter is developed to use at rigid containers with a lter holder 190 mm diameter. The Container Filter
is intended to form a Sterile barrier which is able to let steam in during sterilization conditions. It provides a steam indicator Type
1 to distinct whether a container has undergone sterilization or not.
The
Type 1 indicator is not giving any conclusion on the sterility of the container nor its content.
Characteristics
This Container Filter is composed of white medical grade Soft Crepe material and a special indicating steam ink which
is turning into end color (brown) under steam sterilization conditions. The inks used are non- toxic, heavy metal free inks.
For more details please refer to the technical data sheet.
The dimensions of the Container Filter is 190 mm diameter.
Use recommendations
This Container Filter is recommended for steam sterilization cycles parameters between 121°C - 15 min and 134°C - 3,5min.
Warning
Do not use this Container Filter in any other sterilization cycle than Steam cycles with the SV as displayed above.
Instructions for use
Place the Container Filter in the designated area of the rigid container. After sterilization the steam indicator should have
reached the end color (brown).
Storage
Maintain the Container Filters in a dry place, protected from light, preferably in their box and plastic pouch, and at
a temperature between 10 and 40°C, relative humidity between 20 and 80%.
Do not expose the Container Filters to sterilizing agents or other chemical products of any kind.
Shelf life
The Container Filters have a shelf life of 5 years from manufacturing date, when stored in the recommended conditions.
The manufacturing and expiry date as well as lot number are indicated on the packaging label.
Do not use the Container Filters after the expiry date.
Compliancy to standard
The Container Filters for Steam Sterilization Processes are manufactured according to EN ISO 11140- 1:2014 Standard for its
steam indicator Type 1 and ISO 11607 - 1 for its material.
IT Codice prodotto
GB Product code
IT Numero di lotto
GB Lot number
IT Fabbricante
GB Manufacturer
IT Attenzione: Leggere e seguire attentamente
le istruzioni (avvertenze) per l’uso
GB Caution: read instructions (warnings) carefully
IT Conservare al riparo
dalla luce solare
GB Keep away from sunlight
IT Dispositivo medico
GB Medical Device
IT Data di fabbricazione
GB Date of manufacture
IT Conservare in luogo fresco
ed asciutto
GB Keep in a cool, dry place
IT Data di scadenza
GB Expiration date
IT Leggere le istruzioni per l'uso
GB Consult instructions for use
IT Dispositivo monouso, non riutilizzare
GB Disposable device, do not re-use
IT Dispositivo medico
GB Medical Device
IT Limite di umidità
GB Humidity limit
IT
Limite di temperatura
GB
Temperature limit
2
.2
11
901.101.1000 (GIMA 37328)
SP Medikal San. Ltd. Şti.
Deliklikaya Mah. Cubuklu Cad. No: 39
Arnavutköy-Istanbul/TÜRKIYE
Made in Turkey
M37328-IT-GB-Rev.1.
10°C
40°C
80%
%
20%