CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:
•
used as a stand-alone unit, or
•
connected to other products recommended or described in the user documentation,
and
•
used in the same state as it was delivered from GE Healthcare, except for alterations
described in the user documentation.
International standards
Harmonized standard requirements fulfilled by this product are summarized in the fol-
lowing table:
NotesDescriptionStandard
EN ISO standard is har-
monized with EU direc-
tive 2006/42/EC
Safety of machinery. General
principles for design. Risk as-
sessment and risk reduction.
EN ISO 12100
EN standard is harmo-
nized with EU directive
2006/95/EC
Safety requirements for electri-
cal equipment for measure-
ment, control, and laboratory
use.
EN/IEC 61010-1,
UL61010-1, CAN/CSA
C22.2 No. 61010-1
EN standard is harmo-
nized with EU directive
2004/108/EC
Electrical equipment for mea-
surement, control and laborato-
ry use - EMC requirements
EN/IEC 61326-1
(Emission according
to CISPR 11, Group 1,
class A)
10 ÄKTA ready Operating Instructions 28960345 AD
1 Introduction
1.2 Regulatory information
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