Eighteeth Fast-Fill User Manual page 27

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Inspection
7 Packaging
8 Sterilization
9 Storage
The instructions provided above have been validated by the manufacturer of
the medical device as being capable of preparing a medical device for use. It
remains the responsibility of the processor to ensure that the processing, as
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Pack each component in a separate steam-
sterilization pouch.
WARNING
⚫ Check the validity period of pouch given by the
manufacturer to determine the shelf life.
⚫ Use pouches which resist to a temperature up to
141℃(286°F) and in accordance with EN 868.
Steam sterilization at 134℃ at least 5 minutes.
Minimum drying time after sterilization: 10 minutes.
WARNING
⚫ Use only approved autoclave devices according
to EN 13060 or EN 285.
⚫ Use a validated sterilization procedure according
to ISO 17665.
⚫ Respect the maintenance procedure of the
autoclave device given by the manufacturer.
⚫ Use only this
procedure.
⚫ Control the efficiency (packaging integrity, no
humidity, color change of sterilization indicators,
physicochemical integrators, digital records of
cycles parameters).
⚫ The sterilization procedure must comply with ISO
17665.
⚫ Waiting for cooling before touching.
Keep the components in sterilization packaging in a
dry and clean environment.
WARNING
⚫ Sterility cannot be guaranteed if packaging is
open, damaged or wet.
⚫ Check the packaging before using it (packaging
integrity, no humidity and validity period).
recommended sterilization
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