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Periodic sterilizer validation
As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in performance and the effectiveness of components
along its lifespan, in a period of time dependent on its frequency of use.
To guarantee the safety of the process over time, it is periodically (possibly annually) necessary to verify
the thermodynamic process
parameters (pressure and temperature), to check if they continue to remain within allowed limits or not.
The requalification of the sterilizer's performance is the responsibility of the user
of the product.
The reference European standards EN 554 (Sterilization of the medical devices - Method for the validation and systematic control of the steam
sterilization) and EN 556 (Sterilization of the medical devices – Requirements for the medical devices marked with “STERILE” indication) supply
an effective guide tool for carrying out the verifications on the steam sterilizers.
Since, in addition to specific experience and training, these controls require the use of special equipment (high-precision sensors and probes,
data loggers, dedicated software, etc.) suitably verified and calibrated, it is necessary to contact a company specializing
in these activities.
e M.O.COM. customer service is available to provide any information relative to the periodic validation of steam sterilizers
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