Dentsply Sirona ProTaper Universal A0409 Protocole D'utilisation page 12

4b.iii Drying - Devices should be thoroughly
5. Inspection - If applicable assemble the
- Inspect the devices functionality.
- Visually inspect devices with
6. Packaging - Place the devices in a kit,
7. Sterilization - The following sterilization cycles
8. Storage - Keep devices in sterilization
B EN PTU0 DFU WEB / Rev.12 / 11-2017
dried before inspection and
packaging.
devices (including the placement
of new silicon stops).
naked eye under appropriate
lighting (min 500 lux) and sort
out those with defects.
support or container to avoid any
contact between instruments or
posts and pack the devices in
"Sterilization pouches".
can be used :
• 132°C (269.6°F), 4 minutes;
• 134°C (273.2°F), 3 minutes;
• 134°C (273.2°F), 18 minutes.
We recommend a steam
sterilization at 134°C / 273.2°F
during 18 minutes for the
purpose of de-activating
potential prions.
packaging in a clean
environment, away from sources
of moisture and direct sunlight.
Store at ambient temperature
(typically 15 - 25°C (59 - 77°F)).
- Dry with a single use non-woven cloth.
- Devices should be dried until visual traces of moisture are eliminated.
- Particular attention has to be paid to effectively dry joints or cavities within a
device.
- Dirty devices must be cleaned again.
- Do not re-use silicon stops.
- Discard devices, which show any defect as described in the General
Recommendation above (point 4).
- Device must be double-packaged using paper-plastic pouches for steam
sterilization prior sterilization. Ensure that the pouches are suitable for steam
sterilization and were validated and manufactured as per ISO 11607 and
EN 868-5.
- Use an appropriate packaging, moist-heat resistant (141°C, 286°F) and compliant
with ISO 11607.
- Avoid any contact between instruments or posts during sterilization. Use kits,
supports or containers.
- For sharp devices that are not contained within a box, silicon tubes should be
placed around the devices to prevent packaging piercing.
- Seal the pouches according to the recommendation of the pouch manufacturer.
If a thermo-sealer is used, the process must be validated and the thermosealer
must be calibrated and qualified.
- Check the validity period of the pouch given by the pouch manufacturer to
determine the shelf life.
- The instruments and posts must be sterilized according to the packaging labelling.
- When sterilizing multiple instruments in one autoclave cycle ensure that the
sterilizer's maximum load is not exceeded.
- Place the pouches in the steam sterilizer according to the recommendation given
by the sterilizer manufacturer.
- Use only Pre-Vacuum air Removal steam sterilizer that are matching the
requirements of EN 13060 (class B, small sterilizer) and EN 285 (full size
sterilizer), with saturated steam.
- Use a validated sterilization procedure according to ISO 17665 with a minimum
drying time of 20 min.
- Respecting the maintenance procedure of the sterilizer is under the responsibility
of the the owner and should be performed following the requirements for
medical devices sterilization (examples: planning of maintenance, qualification,
acceptance criteria of condensate and water as per EN 285, annex 2).
- Control the efficiency and acceptance criteria of the sterilization procedure
(packaging integrity, no humidity, no colour change of packaging, positive
physico-chemical indicators, conformity of actual cycle parameters, to reference
cycle parameters). A special attention should be paid to the packaging integrity if
the sterilization cycle 134°C (273.2°F), 18 minutes was used.
- Store traceability records and define shelf-life according to packaging
manufacturer guidelines.
- Shorter sterilization cycles according to local regulations are possible but are not
guaranteed to de-activate prions.
- After sterilization, the product should be manipulated with care in order to keep
the integrity of the packaging (sterile barrier).
- Sterility cannot be guaranteed if packaging is open, damaged or wet.
- Check the packaging and the medical devices before using them (packaging
integrity, no humidity and use by date). In case of damage, a complete rework
should be performed.
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