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Step C2. Automated Cleaning, disinfection and drying
process
Automated Cleaning, disinfection and drying validation
has been performed using a Miele 7735CD washing
machine, and the cleaning agent Neodisher® Mediclean.
EMS recommends using Neodisher® Mediclean for their
products.
For this step, a Washer/Disinfector machine must have
suitable baskets to hold small, fragile products and rinsing
connections for the attachment to product lumina.
The program of the Washer/Disinfector machine shall be
able to perform the following steps.
Place the instrument in a suitable rack and start the
program. The Vario TD programs have been shown to
be effective:
• 2 min pre-washing with cold water (<40°C). Drain;
• 5 min washing with 0.5% detergent at 55°C. Drain;
• 3 min neutralising with warm water (>40°C). Drain;
• 2 min intermediate rinsing with warm water
(>40°C). Drain.
Special instructions of the manufacturer for the Washer/
Disinfector must be followed.
Disinfection (if required by national laws)
Automated Thermal Disinfection in a Washer/Disinfector
taking into consideration national requirements in regards
to A0-Value (see EN 15883) e.g. 93°C for 3 minutes.
A machine cleaning and disinfection method should
always be used for cleaning/disinfection because of the
increased effectiveness of this method.
Sterilization must be performed after disinfection.
Drying
Drying of outside of instrument through drying cycle of the
Washer/Disinfector. If needed, additional manual drying
can be performed using a lint-free towel and filtered
compressed air (max. pressure 3 bar).
The instrument must never be heated >138°C.
Step D. Functional Testing, Maintenance
If stains are still visible on the product after cleaning/
disinfection, the entire cleaning/disinfection procedure
must be repeated. Products with visible damage, chips/
akes, corrosion or bent out of shape must be disposed
of (no further use is permissible).
Step E. Packaging for sterilization
Prior to sterilization, the products must be placed in a
suitable sterilization container or sterilization packaging:
Compliant with EN ISO 11607 or EN 868.
Step F. Sterilization
Sterilization of instruments by applying a fractionated
pre-vacuum process (according ISO 13060 and
ISO 17665) taking into consideration the respective
country requirements.
Do not exceed the maximum number of sterilization
cycles, please refer to the instruction manual.
Step F1. Prevacuum sterilization
Parameters for the pre-vacuum cycle:
• 3 prevacuum phases
• Sterilization temperature of 132°C for 3 minutes
• Drying time: minimum 20 min
• Do not exceed a sterilization temperature of 138°C
and a holding time of 20 min.
Step K. Storage
Storage of sterilized instruments in a dry, clean and dust
free environment at modest temperatures of 5°C to 40°C.
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