33
6.4.7 Packaging
Install the disinfected and dried product and quickly package it in a medical sterilization bag (or
special holder, sterile box).
Notes:
•
The package used conforms to ISO11607
.
•
It can withstand
a
high temperature of
up to
138°
C (280°F)
and has sufficient steam
permeability
.
•
The packaging environment and related tools must be cleaned regularly to ensure cleanliness
and prevent the introduction of contaminants
.
•
Avoid contact with parts of different metals when packaging.
6.4.8 Sterilization
6.4.6.1 Inspection
Use only the following steam sterilization procedures (fractional pre-vacuum procedure*) for
sterilization, and other sterilization procedures are prohibited:
•
The steam sterilizer complies with EN13060 or is certified according to EN 285 to comply with
EN ISO 17665.
•
The highest sterilization temperature is 138°
C (280°F)
.
•
The sterilization time is at least 4 minutes at a temperature of 132°
C
/ 134°
C (270°F / 273°F)
and a pressure of 2.0
-
2.3 bars.
•
Allow a maximum sterilization time of 20 minutes at 134°C (273°F).
Verification of the fundamental suitability of the products for effective steam sterilization was
provided by a verified testing laboratory.
