Hitachi S21 Instruction Manual page 13

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, S21 probe is classified as uncritical.
Definition
Application part only
contacts intact and
uninjured skin
Application part contacts
mucosa (intracavitary
application)
Application part contacts
intracorporeal tissue
directly
(operative application)
(Disinfectant with
virucidal effect)
(Disinfectant with
virucidal effect -
- 7 -
Processing
Cleaning
Disinfection
Cleaning
Disinfection
Cleaning
Disinfection
minimum)
Sterilization
Q1E-EP1377