DIS/CLE-0

Disinfection, Cleaning and Sterilization

Reprocessing procedure for dental instruments and implantable radicular devices

Foreword
For hygiene and sanitary safety purposes, all instruments not marked sterile must be cleaned,
disinfected and sterilized before each usage to prevent any contamination. This concerns the first
use as well as the subsequent ones.

Area of application
Disinfection and sterilization before first usage and reprocessing procedures concerning.

Instruments
Cutting instruments (hand and engine driven)
Endodontic instruments (files, reamers, endodontic burs)
Rotary cutting instruments (diamond burs, stainless steel reamer and drills)
Root canal filling instruments (reverse spirals)

Implantable devices
Dentinal and radicular posts made of steel, titanium and glass fibers.
.
Exclusion
Equipment such as Hand Pieces, Contra Angles and Air Motors with reprocessing procedures
included in the individual Direction for Use.

General recommendation
Single use marked products are not approved for re-use.

The user is responsible for the sterility of the product for the first cycle and each further usage as
well as for the usage of damaged or dirty instruments.

For your own safety, please wear personal protective equipment (gloves, safety glasses, etc).

Use only a disinfecting solution which is approved for its efficacy (VAH/DGHM-listing, CE
marking, and FDA approval) and in accordance with the DFU of the disinfecting solution
manufacturer.

For all metal instruments, it is recommended to use anticorrosion disinfecting and cleaning
agents.

Limitations and restrictions on reprocessing
The individual DFU indicates if the useful life of a device might be reduced by the number of
reprocessing cycles. Furthermore, the appearance of defects such as cracks, deformations (bent,
twisted), corrosion, loss of color coding or marking, are indications that the devices are not able to
fulfill the intended use with the required safety level.

The water quality has to be convenient to the local regulations especially for the last rinsing step
or with a washer-disinfector.

Hand instruments and NiTi instruments are degraded by Hydrogen Peroxide (H2O2) solution.

NiTi Instruments are degraded if immerged more than 5 minutes in a solution of NaOCl at more
than 5%.
DIS/CLE-0



1 Pre-disinfection or Decontamination

Operating Mode
Soak immediately just after usage all instruments in a disinfectant solution.

Warning
* Following instructions and observe concentrations and immersion time given by the
manufacturer (an excessive concentration may cause corrosion or other defects on
instruments).
* The disinfectant solution should be aldehyde free (to avoid blood impurities fixation).
* Do not use disinfectant solution containing Phenol or any products which are not compatible
with the instruments (see general recommendation).
* For visible impurities observed on instruments a pre-cleaning is recommended with a soft
material.

2 Automated Cleaning Disinfection

Operating Mode
* Dissemble the device (silicone stops removed).
* Put them in a kit, support or container.
* Put them in the thermo disinfector (for at least 10 min at 200
o
F or 93
o
C).

Warning
* Discard any instruments with large obvious defects (bent, broken, etc).
* Avoid contact between instruments, drills or posts when placing in the thermo disinfector.
* Follow instructions and observe concentrations given by the manufacturer (see general
recommendations).
* The thermo disinfector is not recommended for instruments made of aluminum, tungsten
carbide or carbon steel. In case of chemical disinfection, there is a danger of remnants of the
disinfectant on the instruments.
* Sufficient rinsing step should be available in purified water (max 10 germs/ml
and max 0.25 endotoxin units/ml).
* Use filtered air for drying the instruments, reamers, drills or posts.
* Use only approved thermo disinfectors according to EN ISO 15883. Maintain and calibrate
regularly.
* If possible an automated procedure is preferred.

3 Manual Cleaning Disinfection

Operating Mode
* Dissemble the device (silicone stops removed).
* Immerse them in the disfectant solution assisted with ultrasonic device if possible.
* Rinse the device thoroughly with clean, dematerialized or distilled water and then dry them with
filtered compressed air.

Warning
* No visible impurities should be observed on the instrument.
* Discard any instruments with large obvious defects (broken, bent or twisted, etc.).
* Avoid any contact between instruments, reamers, drills or posts when placing in the solution.
Use kits, supports, trays or containers.
* Follow instructions and observe concentrations given by the manufacturer (see general
recommendations).
* Use purified water for rinsing (max 10 germs/ml and max 0.25 endotoxin units/ml).
* If a disinfectant solution contains a corrosion inhibitor, it is recommended to rinse the
instruments just before autoclaving.



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4 Inspection

Operating Mode
* Inspect devices and discard those with defects.
* Assemble the devices (silicone stops).

Warning
* Dirty instruments must be cleaned and disinfected again.
* Discard instruments which show any deformation or defects (bent, twisted, broken, corroded,
etc.) affecting the resistance, safety or the performance of the instruments, reamers, drills or
posts.

5 Packaging

Operating Mode
* Place the device in a kit, support or container to avoid any contact between instruments,
reamers, drills or posts and pack the device in a sterilization pouch.

Warning
* Avoid any contact between instruments, reamers, drills or posts during sterilization. Use kits,
supports or containers.
* Check the validity period of the pouch given by the manufacturer to determine the shelf life.
* Use the packaging which are resistant up to a temperature of 141
o
C or 286
o
F and in
accordance with EN ISO 11607.

6 Sterilization

Operating Mode
* Steam sterilization at 134
o
C or 273
o
F during 18 min.

Warning
* The instruments, reamers, drills or posts must be sterilized according to the packaging labeling.
* Use only autoclaves that are matching the requirements of EN ISO 13060, EN 285.
* Use a validated sterilization procedure according to ISO 17665.
* Follow the maintenance procedure of the autoclave device given by the manufacturer.
* Control the efficiency of the sterilization (packaging, integrity, no humidity, color change of
sterilization indicators, physico-chemical integrators and digital records of cycle parameters).
* Traceability of procedure records.

7 Storage

Operating Method
* Keep devices in sterilization packaging in a dry clean environment.

Warning
* 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 validity period).