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8.6.3 Check the product. If the accessories are found to be damaged,
please replace it before use. And the new accessories for replacement
must be cleaned, disinfected and dried.
8.6.4 If the service time (number of times) of the product reaches the
specified service life (number of times), please replace it in time.
8.7 Packaging
Install the disinfected and dried product and quickly package it in a
medical sterilization bag (or special holder, sterile box).
Notes:
a) The package used conforms to ISO 11607;
b) It can withstand high temperature of 138 °C and has sufficient steam
permeability;
c) The packaging environment and related tools must be cleaned
regularly to ensure cleanliness and prevent the introduction of
contaminants;
d) Avoid contact with parts of different metals when packaging.
8.8 Sterilization
Use only the following steam sterilization procedures (fractional pre-
vacuum procedure*) for sterilization, and other sterilization procedures
are prohibited:
1. The steam sterilizer complies with EN13060 or is certified
according to EN 285 to comply with EN ISO 17665;
2. The highest sterilization temperature is 138 ° C;
3. The sterilization time is at least 4 minutes at a temperature of
132℃/134℃ and a pressure of 2.0 bar ~ 2.3 bars.
4. Allow a maximum sterilization time of 20 minutes at 134 °C.
Verification of the fundamental suitability of the products for effective
steam sterilization was provided by a verified testing laboratory.
Notes:
a) Only products that have been effectively cleaned and disinfected are
allowed to be sterilized;
b) Before using the sterilizer for sterilization, read the Instruction
Manual provided by the equipment manufacturer and follow the
instructions.
c) Do not use hot air sterilization and radiation sterilization as this may
result in damage to the product;
d) Other sterilization procedures (e.g., ethylene oxide, formaldehyde
and bottom temperature plasma sterilization) may be used other than
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