Process Validation; Routine Checks - Miele G 7825 Operating Instructions Manual

Maintenance
50

Process validation

The standard of cleaning and disinfection in the disinfection pro-
grammes must be confirmed by the user as a routine matter.
Safety checks and performance validation must be carried out in ac-
cordance with the internationally recognised norm EN ISO 15883. In
some countries national regulations guidelines and recommendations
also apply.
In the UK these are:
– The Medical Devices Directive (MDD)
– The Medical Devices Operation Ordinance
– National Health and Safety regulations regarding disinfection, e.g.
CFPP 01-01 or CFPP 01-05 (depending on machine) in the UK.

Routine checks

Before the start of each working day the user must carry out a num-
ber of routine checks. A check list is supplied with the machine for
this purpose.
The following need to be inspected:
– All filters in the wash cabinet
– The spray arms in the machine and in any mobile units or baskets
– The wash cabinet and the door seal
– The dispensing systems and
– Mobile units, baskets, modules and inserts.