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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
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
- 18 -
Q1E-EP1199
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