Cleaning And Disinfection; Machine Cleaning And Disinfection - KLS Martin group L1 Rib Gebrauchsanweisung

L1 Rib
Instructions for Use
5.4

Cleaning and Disinfection

5.4.1

Machine Cleaning and Disinfection

When selecting the W/D, it must be ensured that
• the W/D always has a verified effectiveness (e.g. DGHM or FDA approval/clearance/registration or
CE marking in accordance with DIN EN ISO 15883),
• a tested thermal disinfection program (A0 value > 3000 or - in the case of older devices - at least 5 min
at 90°C/194°F) is used wherever possible (danger of disinfectant residues on the products in the case of
chemical disinfection),
• the program used is suitable for the products and includes a sufficient number of flushing cycles.
Detergent residues can be effectively prevented with one of the following measures:
a) carry out at least three removal steps after cleaning or neutralization, or
b) conductivity value control of the W/D
• using only sterile or low-germ (max. 10 germs/ml) as well as low endotoxin load (max. 0.25 endotoxin
units /ml) water (e.g. purified water/highly purified water)
• the air used for drying is filtered (oil-free, low in germs and particles), and
• the W/D is regularly serviced, checked and calibrated.
When selecting the cleaning agent system, it must be ensured that
• it is generally suitable for cleaning invasive medical devices made of metals and plastics,
• a suitable disinfectant with verified effectiveness (e.g. VAH/DGHM or FDA/EPA
approval/clearance/registration or CE marking) is also used if no thermal disinfection is used and that it
is compatible with the cleaning agent used, and
• the chemicals used are compatible with the products.
When selecting cleaning agents and disinfectants, it must be ensured that the following
included:
• organic, mineral and oxidizing acids (minimum permissible pH value 5.5)
• organic solvents (e.g. alcohols, ether, ketones, benzines)
• oxidizing agents (e.g. hydrogen peroxide)
• halogens (chloride, iodine, bromine)
• aromatic/halogenated hydrocarbons
For products made of aluminum or other materials that are alkali-sensitive, use only alkalis/strong
alkalis/neutral/enzymatic agents with a maximum pH-value of 8.5 or alkaline cleaning agents with a
maximum pH-value of 11.
The concentrations, temperatures and exposure times specified by the manufacturer of the cleaning agent
and/or disinfectant as well as the specifications for rinsing must be observed under all circumstances.
If, in the context of national recommendations (e.g. in Germany KRINKO/RKI/BfArM recommendation on processing), a lower water quality
2
is considered sufficient, this is the sole responsibility of the processor.
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