Process Validation - Miele PG 8591 Operating Instructions Manual

Test point for
measuring
sensors

Process validation

The standard of cleaning and disinfection in the disinfection
programmes must be confirmed by the user as a routine matter.
Safety checks and performance validation must be carried out in
accordance 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.
On the top of the machine, at the front right under the lid or worktop
is the test point for validation purposes. To gain access to this the lid
of the washer-disinfector must be removed or the washer-disinfector
must be pulled out from under the worktop.
Open the door.

Unscrew the fixing screws.

Then remove the safety screws on the back of the machine from

the lid and lift the lid to remove it.
or
Pull the washer-disinfector out by approx. 15 cm from under the

worktop.
Maintenance
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