CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the instru-
ment when it is:
•
used as a stand-alone unit, or
•
connected to other CE marked instruments, 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.
UL conformity
The system is listed according to UL508a.
A UL inspection report is provided in the documentation package.
Regulatory compliance of
connected equipment
Any equipment connected to ÄKTAprocess should meet the safety requirements of EN
61010-1/IEC 61010-1, or relevant harmonized standards. Within EU, connected equipment
must be CE marked.
ÄKTAprocess Operating Instructions 29-0252-49 AA 13
1 Introduction
1.3 Regulatory information
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