Standard En Iso 15883 - Smeg BPW1260 User Manual

2.4

STANDARD EN ISO 15883

The standard of reference for the performance of a washer disinfector is EN ISO 15883.
Point 6 of standard 15883-1 not only states that the manufacture must ensure the compliance of the device as supplied
but also requires it to perform additional checks on the device as installed in a process referred to overall as
"validation". The validation process of the installed device must be performed by the user (responsible body).
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 device 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 validated 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 device's operation.
Repetition of performance qualification for each device every year is recommended.
WARNING – USE OF PROBES FOR VALIDATION
The device has a physical port for the insertion of probes. The port can only be accessed by authorised
engineers, in accordance with the procedure established by the Manufacturer.
If probes are utilised by the user or other parties, the use of wireless probes (datalogger or similar) is
recommended.
User Manual 193909105 rev.02 BPW1260 Page 10 – 93