Maintenance measures
107
Process validation
The standard of cleaning and disinfection in the disinfection programs
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 recognized standard EN ISO 15883.
In some countries, national regulations, guidelines, and recommenda-
tions also apply.
For the reprocessing of medical devices in Germany, these are:
- Transposition of the Medical Device Directive into national legisla-
tion (German Medical Devices Act)
- German Medical Device Ordinance (MPBetreibV)
- The recommendations of the Commission on Hospital Hygiene and
Infection Prevention (KRINKO) and the German Federal Institute for
Drugs and Medical Devices (BfArM)
- The general guidelines of the German Association for Hospital Hy-
giene (DGKH), the German Society for Sterile Supplies (DGSV), and
the Instrument Reprocessing Working Group (AKI)
Test point for
measuring sen-
sors
The sensor test point for validation is located at the front right on the
top of the machine under the lid or the countertop. To reach the ac-
cess point, the lid of the machine must be removed or the machine
must be pulled out from under the countertop.
Open the door.
Unscrew the retaining 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 machine out by approx. 6" (15 cm) from under the
counter-
top
.
