13.
This appliance conforms to the following
standards:
EN12470-5 and ASTM E1965-1998
EN980: Graphical symbols for use in the labeling of
medical devices
EN 1041: Information supplied by the manufacturer
with medical devices
EN 60601-1: Medical electrical equipment Part 1:
General requirements for safety (IEC:60601-1:1998)
EN 60601-1-2: Medical electrical equipment Part 1-2:
General requirements for safety Collateral standard
Electromagnetic compatibility Requirements and test
(IEC 60601-1-2:2001)
EMC Statement
This device has been tested and homologated in
accordance with EN60601-1-2:2007 for EMC. This does
not guarantee in any way that the device will not be
affected by electromagnetic interference. Avoid using
the device in high electromagnetic environment.
The MEDICAL DELECTRICAL EQUIPMENT needs special
precautions regarding EMC and needs to be installed and
put into service according to the EMC information
provided in the ACCOMPANYING DOCUMENTS.
Содержание MIB-393
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