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7.7 Packaging
Install the disinfected and dried product and quickly package it in a medical sterilization bag
(or special holder, sterile box).
Note:
1. The package used conforms to ISO 11607;
2. It can withstand high temperature of 138 °C and has sufficient steam permeability;
3. The packaging environment and related tools must be cleaned regularly to ensure
cleanliness and prevent the introduction of contaminants;
4. Avoid contact with parts of different metals when packaging.
7.8 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°C / 134°C 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.
Note:
1. Only products that have been effectively cleaned and disinfected are allowed to be
sterilized;
2. Before using the sterilizer for sterilization, read the Instruction Manual provided by the
equipment manufacturer and follow the instructions.
3. Do not use hot air sterilization and radiation sterilization as this may result in damage to the
product;
4. 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