Sterilization; Prior To Sterilization; Steam Sterilization - KLS Martin group Instruments de chirurgie généraux Mode D'emploi

Instructions for Use
Surgical Instruments
4.8

Sterilization

4.8.1

Prior to Sterilization

Prior to sterilization, the instruments must be adequately packaged, e.g. using containers
•
that meet EN 868-8 requirements.
The packaging method used must comply with the relevant standards.
•
Check the instruments for cleanness and integrity.
•
Clean and disinfect the instruments and rinse them with distilled water, then dry them
•
carefully, see sections 4.2 to 4.5.
4.8.2

Steam Sterilization

WARNING
Danger of infection due to non-sterile handling!
Improper sterilization and non-sterile handling of the instruments can lead to serious health
hazards for patients.
Sterilization must be carried out according to a validated sterilization process, for example in
a sterilizer satisfying EN 285:2009 and validated in accordance with
ISO 17665-1:2006 requirements.
It is essential to keep the steam free from any foreign bodies such as rust particles and other
impurities. This helps to prevent instrument corrosion or surface damage caused by deposits.
The steam used for sterilization must comply with EN 285:2009 The user instructions provided
by the steam sterilizer manufacturer must be duly observed. Instruments incorporating locks
or ratchets must be sterilized in an open condition or with the ratchet set to the first notch.
The following program variants can be used:
Validated steam sterilization process, "134°C (273°F)/2 bar" program
•
Validated steam sterilization process, "121°C (250°F)/1 bar" program
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The sterilization and holding times are subject to national provisions and regulations and
therefore cannot be defined in general. It is the operator's responsibility to ensure that the
desired results will be achieved with the implemented processing and sterilization procedure,
including the equipment and materials used and the staff employed in the processing and
sterilization department (CSSD). This requires validation and routine monitoring of the process
used.
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