1.3 Regulatory information
Introduction
This section lists the directives and standards that are fulfilled by ÄKTAprocess.
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EC Declaration of Conformity (DoC) document.
ContentRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala,
Sweden
See EC Declaration of ConformityPlace and date of declaration
See EC Declaration of ConformityIdentity of person authorized to sign DoC
CE Conformity
This product complies with the European directives listed in the table, by fulfilling the
corresponding harmonized standards.
A copy of the EC Declaration of Conformity is available on request.
TitleDirective
Machinery Directive (MD)2006/42/EC
Electromagnetic Compatibility (EMC) Directive2004/108/EC
Low Voltage Directive (LVD)2006/95/EC
10 ÄKTAprocess Operating Instructions 29-0252-49 AA
1 Introduction
1.3 Regulatory information