37
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.
6.7 Cleaning and Disinfection 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 12.3.
Observe the specifications from the manufacturer of the deter-
gent and disinfectant and in the chapter “Overview of Validated
Procedures“.
1. Roll up the product loosely and lay it in a suitable rinsing
basket. In doing so make sure the product is not touching
other instruments or parts of instruments.
2. Start a tested program with the following properties:
– A cleaning cycle consisting of prewash, main wash, final
rinse and product drying.
– Final rinse with hot tap water (at least 1 minute).
– Sufficient product drying (no visible fluid residues).
– Thermal disinfection (5 to 10 minutes at 194 to 203 °F
[90 to 95 °C], A
0
≥
3000).
3. If contaminants are still visible on the product after the end
of the routine, repeat precleaning and machine cleaning and
disinfection.
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