Regulatory Information - GE AKTAavant Getting Started

1 About this guide

1.2 Regulatory information

1.2 Regulatory information
Introduction
This section describes the directives and standards that are fulfilled by the ÄKTAavant
system.
CE conformity
This product complies with the European directives listed in the table below, by fulfilling
the corresponding harmonized standards. A copy of the Declaration of Conformity is
available on request.
Directive
2006/42/EC
2006/95/EC
2004/108/EC
1999/5/EC
CE marking
The CE marking and the corresponding declaration of conformity, is valid for the
instrument when it is:
•
•
•
•
10
used as a stand-alone unit, or
connected to other CE marked GE Healthcare 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.
Title
Machinery Directive
Low Voltage Directive
ElectroMagnetic Compatibility (EMC) Directive
Radio Equipment and Telecommunications Terminal
Equipment Directive
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB