PROCEDURE
• Pack all of the disassembled parts in a sterile barrier sys
tem in accordance with DIN EN 11607 (e.g., foilpaper
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
176651 using:
– EuroSelectomat 666 from MMM (fractionated prevacuum
method)
– Varioklav 400 E from H+P Labortechnik (gravitation
method)
5.6 Visual inspection
Inspect all product components after each cleaning, disinfec
tion and sterilisation. Replace any broken, misshapen or seri
ously discoloured parts.
5.7 Storage
Store the nebuliser and the accessories used in a dry, dust
free location equipped with protection against contamination. It
is recommended to use sterile packaging.
– 60 –
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