-11-
Q1E-EP0348
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
According to the intended use, EUP-L53, L53S, L53L, and L52 probes
are classified as uncritical.
Содержание EUP-L52
Страница 29: ... 23 Q1E EP0348 2200 108 5 27 87 60 150 65 Unit mm Fig 9 Dimension Diagram of Probe EUP L53 ...
Страница 30: ... 24 Q1E EP0348 60 150 65 2200 109 108 23 Fig 10 Dimension Diagram of Probe EUP L53L Unit mm ...
Страница 31: ... 25 Q1E EP0348 65 26 46 102 2200 60 150 Unit mm Fig 11 Dimension Diagram of Probes EUP L53S and EUP L52 E ...
