Specifications

APPENDIX C – MAINTENANCE
76
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 17665 (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
THE M.O.COM. SRL CUSTOMER SUPPORT DEPARTMENT (SEE APPENDIX Z) IS
AVAILABLE TO PROVIDE ANY INFORMATION RELATIVE TO THE PERIODIC VALIDATION OF
STEAM STERILIZERS
.
DISPOSAL AT END-
OF-LIFE
In accordance with Directives 2002/95/ EC, 2002/96/ EC and 2003/108/ EC, regarding the
reduction in use of dangerous substances in electrical and electronic equipment, as well as
waste disposal, such equipment may not be disposed of as normal urban waste and must be
separated accordingly. When purchasing a new, equivalent piece of equipment, the old piece
of equipment that has reached its end-of-life must be handed over to the reseller for proper
disposal. The Manufacturer will carry out the functions defined by individual national legislation
with respect to the reuse, recycling and other forms of salvaging of the above-mentioned
waste.
The proper collection and separation of such equipment for recycling, treatment and disposal
helps avoid any possible negative effects on the environment and health and facilitates the
recycling of the materials of which the equipment is made. The crossed out rubbish can
symbol indicates that the product, at the end-of-life, must be collected separately from other
types of waste.
WARNING!
Improper disposal of the product results in the application of sanctions which are
defined by individual national laws..