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9.8 Sterilization
Use only the following steam sterilization procedures (fractional pre-
vacuum procedure*) for sterilization, and other sterilization procedures are
not recommended:
1.The steam sterilizer complies with EN13060 or is certified according to
EN 285 to comply with EN ISO 17665;
2.The sterilization time is 5 minutes at a temperature of 134°C and a
pressure of 2.0 bar ~ 2.3 bars.
Verification of the fundamental suitability of the products for effective
steam sterilization was provided by a verified testing laboratory.
Notes:
a) Only the product 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) Please use the recommended sterilization procedures for sterilization.
It is not recommended to sterilize with other sterilization procedures such
as ethylene oxide, formaldehyde and low temperature plasma sterilization.
The manufacturer assumes no responsibility for the procedures that have
not been recommended. If you use the sterilization procedures that have
not been recommended, please adhere to related effective standards and
verify the suitability and effectiveness.
e) * Fractional pre-vacuum procedure = steam sterilization with repetitive
pre--vacuum. The procedure used here is to perform steam sterilization
through three pre-vacuums.
9.9 Storage
1.Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative
humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa,
and a temperature of -20 °C to +55 °C;
2.After sterilization, the product should be packaged in a medical
sterilization bag or a clean sealing container, and stored in a special storage
cabinet. The storage time should not exceed 7 days. If it is exceeded, it
should be reprocessed before use.
Notes:
a) The storage environment should be clean and must be disinfected
regularly;
b) Product storage must be batched and marked and recorded.
9.10 Transportation
1.Prevent excessive shock and vibration during transportation, and handle
with care;
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