Hitachi EUP-O732T Instruction Manual page 19

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
uncritical
semicritical
critical
According to the intended use, EUP-O732T probe is classified as
critical.
Definition
Application part only
contacts intact and
uninjured skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly (operative
application)
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Processing
Cleaning
Disinfection
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
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