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7.
Cleaning and sterilization/high level disinfection of L34
The probe is not sterilized, but must be sterilized or disinfected
before initial use, and after each subsequent use, following the
directions given below and working in accordance with standard
hospital practice. (For reference, consult "Good Hospital Practice:
Handling and Biological Decontamination of Reusable Medical Devices:
ANSI/AAMI ST35-1991", published by the Association for the
Advancement of Medical Instrumentation.)
Levels of Disinfection Requirement
7.1
To choose an appropriate disinfectant, the user must determine
the required level of disinfection, based on the following
classification (See Table.5) and the regulation of each
country.
Table.5 Levels of Disinfection Requirements
Classification
Critical
Semi-critical
Non-critical
DM 120918 v2
Definition
Device directly contacts
tissue (Intraoperative
applications)
Device contacts mucous
membranes
(Intracavity applications)
Device contacts intact skin
- 10 -
Levels of
disinfection
Sterilization
Sterilization or
minimally High
Intermediate or
low
Q1E-EP1441
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