Bowa ARGON Mode D'emploi page 23

5. Autoclaving
The instruments may be sterilized only after they are disassembled.
Only the sterilization methods listed below are to be used;
other methods are not permitted.
Steam sterilization
- Fractionated vacuum method1 (with suffi cient device drying)
- Steam sterilizer in accordance with DIN EN 13060 or DIN EN 285
- Validated in accordance with DIN EN (ANSI AAMI) ISO 17665 (pre-
viously DIN EN 554/ANSI AAMI ISO 11134) (valid IQ/OQ (commissi-
oning) and product-specifi c performance quality (PQ)).
- Maximum sterilization temperature 134°C (plus tolerance according
to DIN EN (ANSI AAMI) ISO 17665 (previously DIN EN 554/ANSI
AAMI ISO 11134)
- Sterilization time at least 20 minutes (at 121 °C) or 5 to 20 minutes at
132/134 °C.
The suitability of the devices for effective sterilization was proven by
BOWA with the fractionated vacuum method using the sterilization times
and temperatures above.
The basic suitability of the instruments for effective steam sterilization
was documented by an independent accredited testing laboratory using
the fractionated vacuum method (EuroSelectomat from MMM Münchener
Medizin Mechanik GmbH in Planegg, Germany. The process described
above was taken into account for this.
Hot air sterilization must not be used (because the instruments will be destroyed).
The manufacturer is not responsible for the use of other sterilization me-
thods (such as ethylene oxide, formaldehyde, radiation and low tempe-
rature plasma sterilization). In this case the applicable standards are to
be considered in each case (DIN EN ISO 14937/ANSI AAMI ISO 14937
and/or method-specifi c standards) and the suitability and basic effective-
ness of the method (possibly including residue analyses of the sterilization
medium) are to be documented taking into account the specifi c device
geometry as part of the validation.
1 The use of the less effective gravitation method must be backed up by an additional validation (longer
sterilization times may be required).
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