22
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.
10. To rinse, fully immerse the product in the prepared immer-
sion bath. Leave it in the water for at least one minute, mov-
ing it back and forth several times.
Repeat this procedure twice more, using a freshly prepared
and uncontaminated immersion bath each time.
11. Dry the product until no residual liquid is visible, using a ster-
ile lint-free disposable cloth.
5.6 Cleaning
by
Machine
The washer/disinfector must be in accordance with applicable
national standards and regulations (e.g. ANSI/AAMI ST15883).
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. Carefully place the product in a suitable rinsing basket. In
doing so, make sure the product is not touching other com-
ponents in the rinsing basket.
2. Start a tested program with the following properties:
– A cleaning cycle consisting of prewash, main wash, final
rinse and product drying.
– The maximum temperature for all stages of the process
is 167°F (75°C). Do not use thermal disinfection.
– Final rinse with hot tap water (at least 1 minute).
– Sufficient product drying (no visible fluid residues).
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