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APPENDIX C – MAINTENANCE
71
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.
NOTE
T
HE
M.O.COM. S
RL CUSTOMER SUPPORT DEPARTMENT
(
SEE
A
PPENDIX
Z)
IS
AVAILABLE TO PROVIDE ANY INFORMATION RELATIVE TO THE PERIODIC VALIDATION OF
STEAM STERILIZERS
.
RECYCLING /
DISPOSAL
INSTRUCTIONS
The sterilizer is mainly built from fiber-reinforced polymers, metals and electronic components.
In case of disposal:
-
Separate the various components according to the materials they are made of.
-
Drop the sterilizer with a company specialized on recycling these products.
-
Do not abandon the sterilizer in unsecured places.
-
Always refer to current/applicable laws in the country of use.