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Pack each component in a separate steam-
sterilization pouch.
⚫ 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.
⚫ 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 recommended sterilization
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.
⚫ Sterility cannot be guaranteed if packaging is
open, damaged or wet.
⚫ Check the packaging before using it (packaging
integrity, no humidity and validity period).
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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