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Sterilising
CAUTION
Risk of infection by residual germs
If there is dirt on the parts, germs capable of reproduction
may remain despite the sterilisation process. As a result,
there is a danger of infection.
• Clean, disinfect, and dry all parts thoroughly before steril-
ising.
• Use only validated procedures for cleaning and disinfec-
tion.
EQUIPMENT:
The method has been validated in Europe using:
– Steam steriliser with fractionated pre-vacuum in accordance
with DIN EN 285 or DIN EN 13060 (Type B)
– Sterile barrier system
– Temperature: 132 °C/134 °C
– Holding time: min. 3 minutes
PROCEDURE:
• Place all the disassembled parts in a sterile barrier system
which complies with DIN EN 11607-1 (e.g. foil-paper pack-
aging).
• Carry out the sterilisation in a steam steriliser in accordance
with the manufacturer's instructions.
Sterilisation temperature and holding time:
132 °C/134 °C, at least 3 minutes.
DRYING:
Ensure that there is no residual moisture remaining in the com-
ponents. If necessary:
• Shake the water out of all of the parts.
• Place all parts on a dry, clean and absorbent surface, and
allow them to dry completely.
– 36 –
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