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regularly to ensure cleanliness and prevent the introduction of
contaminants;
d) Avoid contact with parts of different metals when packaging.
5.8 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) 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.
* Fractional pre-vacuum procedure = steam sterilization with repetitive
pre-vacuum. The procedure used here is to perform steam sterilization
through three pre-vacuums.
Summary of Contents for LED.D
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