1.
Observe the following if such methods are used:
EN ISO 14937 / ANSI AAMI ISO 14937;
standards relevant to the method.
2.
Demonstrate the suitability and effectiveness of the method,
taking into account the specific product geometry in the context of
validation (including investigation of sterilization medium residues
if appropriate).
7.8.
Storage
1. Store the ligation instrument in a location where it is protected
against:
strong mechanical stresses such as shocks, falling or
blows;
direct exposure to sunlight;
X-ray radiation.
2. Store the ligation instrument in a dry place at room temperature.
The storage life of the sterilized ligation instrument depends on
the type of packaging and the storage conditions.
The shipping box is not intended for storing the device.
Storage conditions:
Temperature:
Relative humidity:
Atmospheric pressure: 500–1600 hPa
MN031-543-S0 EN
+ 10 °C - + 40 °C
0 – 75%
TissueSeal / TissueSeal PLUS COMFORT
7 Preparation
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