70
PERIODIC STERILIzER
VALIDATION
DISPOSAL AT
END-OF-LIFE
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.
Customer support department (see
Appendix
is available to provide any information relative to
the periodic validation of steam sterilizers.
In accordance with
Directives 2011/65/EU, 2012/19/UE and 2004/108/CE
, 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. as regards reuse, recycling and other forms of recovery of the above mentioned
waste, the manufacturer
carries out the functions defined in the individual national legislations.
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.
Summary of Contents for B Classic-28
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