Bowa NightKNIFE - Autoclaving Procedures

7 Preparation
48 NightKNIFE / Ligator MN031-447-S0-20101217-EN
7.8. Autoclaving
X
Always dismantle the ligation instrument for sterilization.
NOTE
Risk of destruction of the ligation instrument from hot-
air sterilization
X
Use a suitable sterilization method.
Use only steam sterilization with the following specifications:
x Fractional vacuum method (with adequate device
drying)
x Compliant with EN 13060 or EN 285
x Validation in accordance with EN ISO /
ANSI AAMI ISO 17665 (formerly EN 554 / ANSI AAMI
ISO 11134) (with applicable IQ/OQ (commissioning) and
product-specific performance assessment (PQ))
x Maximum sterilization temperature 134 °C plus
tolerance in accordance with EN ISO /
ANSI AAMI ISO 17665 (formerly EN 554 / ANSI AAMI
ISO 11134)
x Minimum sterilization time 20 minutes at 121 °C or
5 minutes at 132 or 134 °C
Using the less effective gravitation method must be secured
by means of additional validation (longer sterilization times
may be necessary).
MN031-447-S1 EN