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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
uncritical
semicritical
critical
According to the intended use, EUP-L53, L53S, L53L, and L52 probes
are classified as uncritical.
Application part only
contacts intact and uninjured
skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly (operative
application)
Processing
Cleaning
Disinfection
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
-11-
Q1E-EP0348
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