Rev.1
Page 1-
64
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
Summary of Contents for millennium B
Page 1: ...Rev 1...
Page 243: ...Rev 1 Gr7 INDEX GROUP 7 COVERS FRAME COVER 1 DOOR COVER 2 FRONT FRAME 3 SERVICE DOOR 4...
Page 270: ...Rev 1 Page 4 4 HYDRAULIC DIAGRAM CHAMBER HEAT EXCHANGER WP VP Main tank...
Page 271: ...Rev 1 Page 4 5 EXPLODED VIEWS TABLE 1...
Page 272: ...Rev 1 Page 4 6 TABLE 2...
Page 273: ...Rev 1 Page 4 7 TABLE 3...
Page 274: ...Rev 1 Page 4 8 TABLE 4...
Page 275: ...Rev 1 Page 4 9 TABLE 5...
Page 276: ...Rev 1 Page 4 10 TABLE 6...