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4.5 Manual cleaning and disinfection
Use a liquid detergent suitable for the preparation of a dipping
bath.
Use a disinfectant compatible with the detergent suitable for the
preparation of a dipping bath.
The detergent and disinfectant must be suitable for medical de-
vices made of plastic and metal and have a pH value between 5.5
and 11.
Observe the specifications from the manufacturer of the deter-
gent and disinfectant and in the chapter “Overview of validated
procedures“.
1. Prepare a cleaning bath and a separate disinfectant bath.
2. Immerse the product completely in a cleaning bath, ensuring
that the product does not come into contact with other com-
ponents in the bath.
3. Clean the surfaces thoroughly using a soft disposable cloth.
4. Rinse the surfaces with sterile, deionized water (at least
1 minute).
5. Repeat the preceding cleaning steps if the product still
shows visible contamination.
6. Immerse the product completely in a disinfectant bath, en-
suring that the product does not come into contact with oth-
er components in the bath.
7. Rinse the surfaces with sterile, deionized water (at least
1 minute).
8. Dry the product until there are no more fluid residues visible
(e.g. with filtered compressed air).
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