Bravo G4 17 / Bravo G4 22 / Bravo G4 28
72
EN
14.4. PERIODIC STERILISER VALIDATION
As happens with all devices, it is possible, and sometimes inevitable, to have a decrease in performance and the effectiveness of components along their
lifespan, in a period of time dependent on its frequency of use.
To guarantee the safety of the process over time, it is periodically (depending on local guidelines or regulations) 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 sterilis
er’s performance is the
responsibility of the user
of the product.
The reference European standards
EN 17665
(Sterilisation of the medical devices - Method for the validation and systematic control of the steam
sterilisation) and
EN 556
(Sterilisation 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 sterilisers.
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 specialising i
n these activities.
Customer support department (see Appendix) is available to provide any information relative to the periodic validation of steam sterilisers.
14.5. DEVICE USEFUL LIFE
Steam steriliser service life is of 10 years (average use: 5 cycles/day, for 220 days/year). For normal use, it is expected that the device is used and
maintained according to the instructions provided by the manufacturer.
The expected useful life of the device is subject to risk analysis carried out in compliance with requirements of standard EN ISO 14971:2012.
14.6. DISPOSING THE EQUIPMENT WHEN NO LONGER USED
According to Directive 2012/19/EU concerning waste disposal, the units must not be disposed of as municipal waste, but must be separated. When
purchasing a new device of an equivalent type, one for one, the device that has come to the end of its lifetime should be returned to the dealer for disposal.
Regarding reuse, recycling and other forms of recovery of the above mentioned waste, the manufacturer carries out the functions defined in the individual
national legislations.
Appropriate differentiated waste collection for subsequent recycling treatment and environmentally friendly disposal contributes to preventing possible
negative effects on the environment and health, and encourages recycling of the materials of which the device is made up. The symbol indicating separate
collection for electrical and electronic equipment consists of the crossed out bin marked on the device.
Under national legislation, fines can be imposed if the product is disposed in an illegal manner.
