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Glossary
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Glossary
Basic function test
The basic function test checks the basic function of the
device and is part of the annual inspection.
EMC
The electromagnetic compatibility describes the ability of a
device to function satisfactorily within an electromagnetic
environment without adding unacceptable electromag-
netic interferences/disturbances to the environment that
may cause problems for other devices or equipment located
nearby.
Functional test
The function test must be carried out before each surgery
to ensure the respective device is fully functional.
ME Device
Medical electrical device used for therapy, monitoring or
diagnosis of patients, equipped with no more than one con-
nection to a supply network and which necessarily comes
into physical or electrical contact with the patient or which
transfers energy to or from the patient or which records or
captures such energy transfer to or from the patient.
ME System
Medical electrical system consisting of a combination of
devices, of which at least one is classified as a medical elec-
trical device and specified by the manufacturer as such and
which are joined together by a functional connection or by
using a power strip.
Safety test
The safety test is part of the annual inspection.
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Содержание A127
Страница 1: ...A127 Pump for Arthroscopy A127 Instructions for Use en...
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