WD3060 - WD5090
USER MANUAL
7
The responsible authority should be clearly identified within the facility where the appliance is used, (for example by
recording the relative names and responsibilities on corporate forms).
3.2
STANDARD 15883
The standard of reference for the performance of a thermal disinfection appliance is
EN ISO 15883.
With reference to the point 6 of 15883-1: as well as the compliance of the device “as supplied”, in charge of the manufacturer, the
standard requires to undertake further checks relating to the device “as installed”, in a sequence of processes known as “validation”. The
validation process is in charge of the Responsible authority for the device.
VALIDATION
The validation process for a thermal disinfection device under EN ISO 15883-1 involves 3 different phases.
1.
Installation Qualification - IQ
2.
Operational Qualification - OQ
3.
Performance Qualification - PQ
installation qualification - IQ
process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification
operational qualification - OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance
with its operational procedures
performance qualification - PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational
procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification
Note on performance qualification
Performance qualification must be carried out after completion of installation and operational qualification.
Performance qualification must be carried out whenever new or modified objects are placed in the appliance for washing and
disinfection, or new load systems are used, unless proof is provided that they are equivalent to an approved reference load or an object
or load system already approved in the past.
Performance qualification must be carried out when new process parameters (including process chemicals) are adopted.
Operational qualification should be repeated at set intervals to provide regular verification of the appliance’s operation.
Repetition of performance qualification for each appliance every year is suggested.
WARNING - USE OF PROBES FOR VALIDATION
The basic appliance does not feature a physical port as envisaged by the EN ISO 15883 standard for the insertion of probes with cable:
the use of wireless probes (dataloggers or similar) is recommended.
