Bowa 101-000 Série Mode D'emploi page 24

performance assessment)
• Maximum sterilisation temperature 134 - 137°C (plus
tolerance according to DIN EN 554/ANSI AAMI ISO
11134)
• Sterilisation time at least 20 min (at 121°C) or 3 to 20
min at 132/134°C
¹ The use of the less effective gravitation method must be safeguarded by
additional validation (longer sterilisation times may be necessary).
The suitability of the products for effective sterilisation has
been proved by BOWA using the fractionated vacuum
method with the above sterilisation times/temperatures.
The basic suitability of the instruments for effective steam
sterilisation has been proved by means of an independent
accredited test laboratory using the fractionated vacuum
me- thod (EuroSelectomat from the company MMM
Münchener Medizin Mechanik GmbH, Planegg). The
method described above was taken into account here.
The hot air sterilisation method must not be used as a
basic principle (damage to instruments).
The use of other sterilisation methods (e.g. ethylene oxide,
formaldehyde, radiation and low-temperature plasma
sterilisation) is outside the manufacturer's responsibility. In
this case, the respectively applicable standards must be
taken into account (DIN EN ISO 14937/ANSI AAMI ISO
14937 and process-specific standards), and evidence must
be provided of the suitability and effectiveness in principle
of the process (including tests of the sterilisation medium if
necessary) taking into account the specific product
geometry as part of the validation.
7.7 Store for use
MN009-029-S8 EN 24