-22- Q1E-EP1412
Levels of reprocessing requirements:
Depending on the application of the product and with regard to risk
evaluation, the user has to classify the medical device according to
the current Medical Device Directive for processing of medical devices
as uncritical, semi-critical or critical. Supporting information
concerning this topic is listed in the table below. The user is
responsible for correct classification of the medical device.
Classification Definition Processing
uncritical
Application part only contacts
intact and uninjured skin
Cleaning
Disinfection
semicritical
Application part contacts
mucosa (intracavitary
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly (operative
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
The flowchart of the reprocessing process of this probe is as follows.
Point of use
(Pre-cleaning)
Manual Cleaning
Rinsing after
anual
cleaning
Manual Disinfection
Drying
M
nual cleaning and
disinfection
Rinsing after manual
disinfection
Packing
terilization
Containment and
transportation