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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 system 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)
4.6 Visual inspection
Inspect all product components after each cleaning, disinfection and sterilisation. Re-
place any broken, misshapen or seriously discoloured parts.
4.7 Storage
Store the assembled VORTEX and the accessories used in a dry, dust-free location
equipped with protection against contamination.