6 Steam Sterilisation
Conditioning Instruction BIOM® 5 (G/55185/0818/en)
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6.1.3
Packaging
The sterilisation container (incl. filter material) must meet the following
criteria:
Compliance with the standards DIN EN 868 / ANSI AAMI ISO 11607
Suitable for steam sterilisation (heat resistant up to 137°C, adequate
steam permeability).
Prior to sterilisation, place the components in a sterilisation tray and
put this into the sterilisation container.
If you use disposable sterilisation packages, these must also meet the
criteria specified above.
6.2
Steam Sterilisation
Make sure that only cleaned and disinfected components are
sterilised.
The optics can be either be double shrink-wrapped or secured in the
sterilisation insert from OCULUS Optikgeräte GmbH for autoclaving.
Use one of the following sterilisation processes:
Fractionated Pre-Vacuum Process
Use a steam steriliser validated according to DIN EN 13060 or DIN
EN 285 and DIN EN 17665-1/GOST R ISO 11134 (valid
commissioning and product-specific performance evaluation).
The parameters for this process are as follows:
3 Pre-vacuum phases
Sterilisation temperature: 132°C
Minimum exposure time: 3 min
Drying time: 1 min
Gravitation Process:
The minimum parameters for this process are as follows:
Sterilisation temperature: 132°C
Minimum exposure time: 15 min
Drying time: 1 min
Adhere to the specified times and temperatures at minimum.
Generally speaking, you may exceed the specified times and
temperatures. However, longer sterilisation times and higher
temperatures increase the stress on the materials, which could cause
them to age prematurely.
The maximum sterilisation temperature is 134° (plus tolerance in
acc. with GOST R ISO 11134).
