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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 º C;
• The sterilization time is at least 4 minutes at a temperature of 132C/134C and a pressure of 2.0 bar - 2.3 bars.
• 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) 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 manu-
facturer 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.
* 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 ºC to +55 ºC;
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 repro-
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