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Inquiry – Steam Turbine Lot

Document 7.7

Requirements for CE labelling and risk


assessments
2016-12-14
HØK 2 (4)
INQUIRY – STEAM TURBINE LOT 2016-12-14
7.7 REQUIREMENTS FOR CE LABELLING AND RISK ASSESSMENTS

Content

7.7 CE Labelling and risk assessments ........................................................................... 3


7.7.1 General............................................................................................................... 3
7.7.2 CE labelling ........................................................................................................ 3
7.7.3 Risk analyses and risk assessment .................................................................... 4
HØK 3 (4)
INQUIRY – STEAM TURBINE LOT 2016-12-14
7.7 REQUIREMENTS FOR CE LABELLING AND RISK ASSESSMENTS

7.7 CE Labelling and risk assessments

7.7.1 General
The Contractor has the full responsibility for and shall bear the costs for the CE Labelling, of
the Works.
The Contractor shall participate in the Purchaser’s effort to perform CE labelling of the
modification of the plant.
The Contractor shall hand over the entire Technical Dossier, including risk assessments and
technical documentation to the Purchaser as specified in Agreement Document 8.

7.7.2 CE labelling
The required CE Labelling of the Works and of parts thereof shall be performed and
Declarations of Conformity shall be issued in accordance with applicable EU Directives and
their implementation into Danish legislation.
For the complete Works, the following shall apply:
 The Contractor shall be regarded the manufacturer of the complete modification
Works.
 With respect to the European Machine Directive, 2006/42/EC a Declaration of
Conformity shall be issued. This means that the Works is a Machinery, not a partially
completed machinery.
 In the Declaration of Conformity there shall be a list of all EU Directives that are
applicable for the Works and to all EU harmonized standards (norms) used in the
fulfilling of each Directive. This includes but is not necessarily limited to
o Machine Directive 2006/42/EC
o Pressure equipment Directive (PED) 97/23/EC
o Low Voltage Directive 2006/95/EC
o EMC Directive 2004/108/EC
o Atex Directive 94/9/EC (ATEX 95)
 The Declaration of Conformity shall include a list of all pressure parts subject to PED
with design data and reference to the applicable module and class of PED.
 The Declaration of Conformity shall include, as appendices, all Certificates of
Conformity issued by the Contractors Notified Body.
 The Declaration of Conformity shall include references to documentation which makes
the scope of the Declaration of Conformity clear.
 The Declaration of Conformity shall include, as an appendix, the full risk assessment
performed for the Works as well as reference to SIL verifications performed. Any
remaining risk shall be noted.
 The Declaration of Conformity shall include any other information as requested by
Directives or by the Purchasers Notified Body.
 The Contractor shall supply the complete technical dossier for the Works.
 The Contractor shall supply maintenance and operating instructions, including safety
instructions, in Danish Language.
HØK 4 (4)
INQUIRY – STEAM TURBINE LOT 2016-12-14
7.7 REQUIREMENTS FOR CE LABELLING AND RISK ASSESSMENTS

 A label with the CE logo and other relevant information shall be attached to the
generator and gear box in a suitable location.
 The requirements as stated above apply also for sub-contractors’ deliveries. Each
individual sub-contractor shall undertake the necessary Risk Assessments and prepare
the Technical Dossier including technical documentation, user and maintenance
manuals (in Danish language) and issue a Declaration of Conformity.
For the individual components of the Works, the following shall apply:
 Declaration of Conformity as well as the technical dossier and operation and
maintenance manuals (in Danish language) shall be included for all supplied
components, where applicable.
 Risk Assessments shall be undertaken and Declarations of Conformity shall be issued
for the interconnection of individual Machines and partial Machines. The Purchaser
shall be invited to be present at the accomplishment of all risk assessments. The risk
assessment shall be part of the final documentation.
 Each Machine shall be furnished with a CE Label and a Declaration of Conformity
according to Annex II, 1A.
 Delivery of all Components and Safety Components shall include Component
Declarations, type B and C, respectively.
The definition of a Machine, Components and Safety Components shall be according to the
European Machine Directive, 2006/42/EC and the Contractor shall be regarded as the
Manufacturer for the Works as defined by the same Directive.
The directions of the Directives shall in so far as possible be implemented by using
harmonized norms (EN).

7.7.3 Risk analyses and risk assessment


Risk analyses and risk assessment as required by Directives and by other documentation shall
be carried out by the Contractor. The Purchaser shall be invited to participate in the risk
analyses and the risk assessments.
A preliminary risk assessments shall be performed in an early stage of the project and
submitted to the Purchaser. The comments from the Purchaser shall then be used as an input
to the further risk assessments.
SIL verifications shall be performed by the Contractor for all SIL rated circuits. The principles in
EN 61508 and EN 61511 shall be guiding.

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