3.3 STANDARD 15883
The reference standard for the operating performance of a thermal disinfector is EN ISO 15883.
With reference to paragraph 6 of standard 15883-1, besides being compliant with the device as supplied, at
the manufacturer’s expense, the standard requires additional tests for the device as installed, in a process
called validation. The user (responsible body) is responsible for the device validation.
VALIDATION
Compliant with the EN ISO 15883-1 standard, validation of the device occurs in three different phases:
1. Installation qualification – IQ
2. Operational qualification – OQ
3. Performance qualification – PQ
Installation qualification
QI - 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 the performance qualification
Performance qualification must be executed after the installation qualification and operational qualification
phases have been successfully completed.
Performance qualification is executed after introducing new or modified items to be cleaned and disinfected,
or new loading systems, as long as there is demonstrated equivalence to a reference validated load or to an
item or loading system previously validated.
Performance qualification is executed after introducing new procedural parameters (including chemical
agents).
Operational qualification should be repeated at preset intervals to check periodically that the appliance
operates correctly.
It is recommended that the machine performance requalification is carried out every year.
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