1.3
Regulatory information
Introduction
This section lists the directives and standards that are fulfilled by BioProcess LPLC and
MPLC columns.
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EC Declaration Of Conformity document.
Content
Requirement
GE Healthcare Bio-Sciences AB,
Name and address of manufacturer
Björkgatan 30, SE 751 84,
Uppsala, Sweden
Inspecta Sweden AB, NB 0409
Name and ID of notified body for Euro-
pean market (97/23/EC)
See EC Declaration of Conformity
Place and date of declaration
See EC Declaration of Conformity
Identity of person authorized to sign DoC
International standards
The standard requirements fulfilled by this product are summarized in the table below.
Notes
Description
Standard
Harmonized with
2006/42/EC
Safety of machinery. General princi-
ples for design. Risk assessment and
risk reduction.
EN ISO 12100
May be supplemented
or replaced by EN
13445-3
Pressure vessel and tubing stan-
dards
ASME-BPVC VIII
div. 1
May be supplemented
or replaced by ASME-
BPVC VIII div. 1
Unfired pressure vessels - Part 3:
Design
EN 13445-3
10
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
1 Introduction
1.3 Regulatory information
