36
6.6 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 12.3.
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. In addition, prepare a fresh immersion bath with purified wa-
ter (aqua purificata).
3. Immerse the product completely in a cleaning bath, ensuring
that the product does not come into contact with other com-
ponents in the bath.
4. Thoroughly clean the surfaces with a soft brush/soft dispos-
able cloth.
5. Rinse the surfaces with tap water (at least 1 minute).
6. Repeat the preceding cleaning steps if the product still
shows visible contamination.
7. Dry the product until there are no more fluid residues visible
(e.g. with filtered compressed air).
8. 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.
9. Wipe all bubbles off the product surface with a soft dispos-
able cloth. Move/turn the product a number of times so that
the disinfectant solution reaches all parts of the product.
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