5.5 Sterilisation
NOTICE
A validated sterilisation process can only be carried out on
products that have been cleaned and disinfected.
Information on sterilising the
child/adult mask soft:
Always use the mask stabiliser
when sterilising these masks, be-
cause otherwise they may lose
their shape under the effects of
high temperatures. For this pur-
pose, follow the instructions for
use of the mask stabiliser as well.
EQUIPMENT
Steam steriliser – preferably with fractionated pre-vacuum – in
accordance with DIN EN 285 or DIN EN 13060 (type B)
PROCEDURE
• Pack all of the disassembled parts in a sterile barrier sys-
tem in accordance with DIN EN 11607 (e.g., foil-paper
packaging).
Maximum sterilisation temperature and holding time:
121 °C, at least 20 min. or
132 ºC / 134 ºC, at least 3 min.
VALIDATION
The method has been validated according to
DIN EN ISO 17665-1 using:
– Euro-Selectomat 666 from MMM (fractionated pre-vacuum
method)
– Varioklav 400 E from H+P Labortechnik (gravitation
method)
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