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contaminants;
d) Avoid contact with parts of dierent metals when packaging.
4.8 Sterilization
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;
• The sterilization time is at least 4 minutes at a temperature of
132℃/134℃ and a pressure of 2.0 bar ~ 2.3 bars.
• Allow a maximum sterilization time of 20 minutes at 134 °C.
Verication of the fundamental suitability of the products for eective
steam sterilization was provided by a veried testing laboratory.
Notes
a) Only products that have been eectively 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
eective standards and verify the suitability and eectiveness.
* Fractional pre-vacuum procedure = steam sterilization with
repetitive pre-vacuum. The procedure used here is to perform steam
sterilization through three pre-vacuums.
4.9 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
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