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7.2 Step-by-step procedure
A. Devices
Operation
Operating mode
1. Pre-Disinfection or
Soak immediately just after
Decontamination
usage all instruments in a
disinfectant solution combined
with proteolytic enzyme if
possible.
2a. Automated
-
Disassemble the devices
Cleaning /
(silicone stops to be
Disinfection
removed)
-
Place them in a kit, support or
container
-
Put them in the
thermodisinfector (for at least
10 min at 93°C or Ao value >
3000).
2b. Manual Cleaning /
-
Disassemble the devices
Disinfection
(silicone stops to be
removed)
-
Immerse them in the
disinfectant solution assisted
with ultrasonic device if
suitable.
-
Rinse the devices thoroughly
with clean, demineralised or
distilled water and then dry
them with fi ltered compressed
air.
3. Inspection
-
Inspect devices and sort out
those with defects.
-
Assemble the devices (stops)
4. Packaging
-
Pack the devices in
"Sterilisation pouches".
5. Sterilization
-
Steam sterilisation at:
134°C (237°F) during 18 min
for endodontics instruments
and root canal fi lling
instruments
134 °C (237°F) during at least
5 min for all other devices.
6. Storage
-
Keep devices in sterilization
packaging in a dry and clean
environment.
A2. Implantable devices
A1. Instruments
Warning
-
Follow instructions and observe concentrations and immersion time
given by the manufacturer (an excessive concentration may cause
corrosion or others defects on instruments).
-
The disinfectant solution should be aldehyde free (to avoid blood
impurities fi xation).
-
Do not use disinfectant solution containing Phenol or any products
which are not compatible with the instruments (See general
recommendation).
-
For visible impurities are observed on instruments a pre-cleaning is
recommended by brushing them manually with softmaterial.
-
Discard any instruments with large obvious defects (broken, bent).
-
Avoid any contact between instruments or posts when placing in the
thermodisinfector.
-
Follow instructions and observe concentrations given by the
manufacturer (see also general recommendation).
-
The thermodisinfector is not recommended for instruments made
of aluminium, tungsten carbide or carbon steel. In case of chemical
disinfection, there is a danger of remnants of the disinfectant on the
instruments.
-
Suffi cient rinsing step should be available in the program. Use purifi ed
water for rinsing (max 10 germs/ml and max 0.25 endotoxin units/ml)
like Aqua Purifi cata.
-
Use fi ltered air for drying the instruments or posts.
-
Use only approved thermodisinfector according to EN ISO 15883,
maintain and calibrate it regularly.
-
If possible, an automated procedure is preferred.
-
No visible impurities should be observed on the instruments.
-
Discard any instruments with large obvious defects (broken, bent, and
twisted).
-
Avoid any contact between instruments or posts when placing in the
solution, use kits, supports or container.
-
Follow instructions and observe concentrations and time given by the
manufacturer (see also general recommendation).
-
Use purifi ed water for rinsing (max 10 germs/ml and max 0.25
endotoxin units/ml) like Aqua Purifi cata.
-
If a disinfectant solution contains a corrosion inhibitor, it is
recommended to rinse the instruments just before autoclaving.
-
Dirty instruments must be cleaned and disinfected again.
-
Discard instruments which show any deformations (bent, twisted),
damages (broken, corroded) or defects (loss of colour coding or
marking) affecting the resistance, the safety or the performance of the
instrument or posts.
-
Protect carbon steel bur with corrosion inhibitor before packaging.
-
Check the validity period of the pouch given by the manufacturer to
determine the shelf life.
-
Use packaging which are resistant up to a temperature of 141°C
(286°F) and in accordance with EN ISO 11607.
-
The instruments, posts and the plastic supports must be sterilized
according to the packaging labelling.
-
Use fractionated vacuum or gravity (less preferred) autoclaves
(according to EN 13060, EN 285).
-
Use validated sterilisation procedure according to ISO 17665-1
-
Respect maintenance procedure of the autoclave device givenby the
manufacturer.
-
Use only the listed sterilization procedures.
-
Sterility cannot be guaranteed if packaging is open, damaged or wet
(check the packaging before using the instruments).
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