70
OPERATOR'S MANUAL
EN
PERIODIC THERMO-
DISINFECTOR
VALIDATION
The reference Standard for a thermo-disinfector performance is UNI EN ISO 15883.
Referring to par. 6 of EN ISO 15883-1, in addition to the conformity to the device 'as
supplied', borne by the manufacturer, the regulations require further checks on the device 'as
installed' through a process called 'validation'. The validation process is borne by the user
(responsible authority).
VALIDATION
The validation process of a thermo-disinfector in accordance with EN ISO 15883-1 is
composed of 3 different phases:
1. Installation qualification - IQ
2. Operational qualification - OQ
3. Performance qualification - PQ
Installation qualification
IQ - Process to obtain and document the evidence that the device has been supplied and
installed in accordance with the relevant specification.
Operational qualification
OQ - Process to obtain and document the evidence that the device installed operates within
the predefined limits when it is used according to its operational procedures.
Performance qualification
PQ - Process to obtain and document the evidence that the device, as installed and operated
according to the operational procedures, works coherently as per predefined criteria and then
the product meets its specifications.
NOTE
PERFORMANCE QUALIFICATION MUST BE CARRIED OUT AFTER THE
COMPLETION OF INSTALLATION QUALIFICATION AND OPERATIONAL
QUALIFICATION.
PERFORMANCE QUALIFICATION MUST BE CARRIED OUT WHEN
INTRODUCING NEW OR MODIFIED OBJECTS TO CLEAN AND
DISINFECT, OR NEW LOADING SYSTEMS, UNLESS THE EQUIVALENCE
WITH A VALIDATED REFERENCE LOAD OR AN OBJECT OR A LOADING
SYSTEM PREVIOUSLY VALIDATED HAS BEEN PROVEN.
PERFORMANCE QUALIFICATION MUST BE CARRIED OUT WHEN
INTRODUCING NEW PROCESS PARAMETERS (INCLUDING PROCESS
CHEMICALS).
Operational qualification should be repeated at predetermined intervals to check periodically
the proper operation of the device.
We suggest to carry out performance qualification of the machine every year.