Maintenance
119
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 standard
ENISO15883. In some countries, national regulations, guidelines and
recommendations also apply.
In Germany, these are:
- Transposition of the Medical Device Directive into national
legislation (German Medical Devices Act in the UK)
- German Medical Device Ordinance
- The recommendations of the Commission for Hospital Hygiene and
Infection Prevention (KRINKO) and the German Federal Institute for
Drugs and Medical Devices (BfArM)
- The general guidelines of the German Society for Hospital Hygiene
(DGKH), the German Society for Sterile Supplies (DGSV) and the
Instrument Reprocessing Working Group (AKI)
Test point for
measuring
sensors
The sensor test point for validation is located at the front right on the
top of the machine under the lid or the worktop. To reach the access
point, the lid of the machine must be removed or the machine 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. 15cm from under the
worktop.
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