BENPPIQDFUWEB / Rev.04 / 08-2018
47/74
Cleaning, Disinfection and Sterilization
7.4
Sterilization of the File Clip and Lip Clip
The sterilization process applies only to the lip clip and file clip. The maximum number of
sterilization cycles is:
•
File clip: 120;
•
Lip clip: 120.
Proceed with the sterilization as follows:
N°
Sterilization steps for file clip and lip clip
A
Pack and seal accessories into single-use, undamaged sterilization packaging (single-
layer packaging) that complies with the following requirements:
•
DIN EN ISO / ANSI AAMI ISO 11607;
•
Suitable for steam sterilization (withstands temperatures of up to 142 °C (288 °F) or
more, sufficient vapor permeability).
B
Sterilize the file clip and lip clip by
Pre-Vacuum Displacement
(3 times pre-vacuum
< 60 mbar).
•
At 134 °C (273°F) for 3 minutes, drying time 20min (EU Market only);
•
at 132 °C (270 °F) for 4 minutes, drying time 20min (US Market only).
Please note:
•
Do not exceed a sterilization temperature of 135°C (275°F) and a sterilization
duration of 18min;
•
Always observe the operating instructions of the manufacturer for your sterilizer,
especially about the loading weight, the operating time and functional testing;
•
Use steam sterilizers in accordance with DIN EN 13060 or DIN EN 285, ANSI /
AAMI ST 79.
C
Inspect the file clip and the lip clip before use after they have been reprocessed. If
visible signs of moisture are present (damp spots on sterile packaging, pooled water in
the load) at the end of the sterilization cycle, repackage and re-sterilize using a longer
drying time. Dispose of any defective accessories immediately. If the press-release
mechanism of the file clip does not function properly, repeat the complete reprocessing
procedure. Discard the file clip if the press-release mechanism does not work properly.
The sterilization process must be validated in accordance with DIN EN ISO 17665 (valid installation and
operational qualification (IQ and OQ) and product-specific performance qualification (PQ)).
