ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Anna Sol Mena Policy Officer - European Commission DG Enterprise
and Industry
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Approval Schemes for Electrical Equipment in the EU EU-Taiwan high
voltage equipment management forum 25/26 March 2014 Anna Sol Mena
DG Enterprise and Industry European Commission
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Overlap Products between 600-1000(1500) V For this reason we will
provide information on EU Low Voltage Directive EU Low Voltage
Directive (2006/95/EC) Taiwanese Directive 401 Over 600 V
Electrical Equipment: High and Low Voltage
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Electrical Equipment High Voltage For equipment of higher voltage
than 1000 V (AC) and 1500 V (DC) : No EU-wide Directive Ensuring
safety is the responsibility of the manufacters themselves. EU
Member States can take corrective actions and punishments if
necessary, such as prohibiting placing the products on the market
We will hear the examples of the Netherlands and Germany, but all
MS proceed similarly.
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
EU Low voltage Directive MANDATORY: Products placed on the market
must fulfil safety objectives (defined by Directive) VOLUNTARY:
Harmonised standards: Presumption of conformity Conformity
Assessment Procedures must be followed. The manufacturer must :
establish Technical Documentation proving the product's safety and
keep it at the disposal of the authorities issue a Declaration of
Conformity affix the CE marking on the product
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
CONFORMITY ASSESSMENT FOR ELECTRICAL EQUIPMENT Internal control of
production : At all times manufacturers must ensure that only
compliant products reach the market The Government role is to
police the market (market surveillance): we achieved a very high
safety record
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Safety objectives of the LVD Article 2 1. The Member States shall
take all appropriate measures to ensure that electrical equipment
may be placed on the market only if, having been constructed in
accordance with good engineering practice in safety matters in
force in the Community, it does not endanger the safety of persons,
domestic animals or property when properly installed and maintained
and used in applications for which it was made. 2. The principal
elements of the safety objectives referred to in paragraph 1 are
listed in Annex I.
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Safety objectives of the LVD 1. General conditions a)The essential
characteristics shall be marked on the equipment b)The
manufacturers or brand name or trade mark should be clearly printed
on the electrical equipment c)ensure that it can be safely and
properly assembled and connected. d) protection against the hazards
is assured providing that the equipment is used in applications for
which it was made and is adequately maintained. 2. Protection
against hazards arising from the electrical equipment a)protection
against danger of physical injury or other harm which might be
caused by electrical contact direct or indirect; b)that
temperatures, arcs or radiation which would cause a danger, are not
produced; c)protection non-electrical dangers caused by the
electrical equipment which are revealed by experience; d)insulation
must be suitable for foreseeable conditions. 3. Protection against
hazards which may be caused by external influences a)electrical
equipment meets the expected mechanical requirements b)electrical
equipment shall be resistant to non-mechanical influences in
expected environmental conditions c)protection in foreseeable
conditions of overload.
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Presumption of Conformity-Harmonised Standards Harmonised European
standards elaborated by CEN / CENELEC / ETSI Publication of
reference in the Official Journal ! Voluntary application by
manufacturers: presumption of conformity 75% of European Harmonised
Standards IDENTICAL to international standards (ISO/IEC).
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Technical file and DoC Technical file must contain trustworthy
evidence of compliance (design, tests done, etc.) DoC: Drawn up and
signed by the manufacturer (or his authorised representative) on
own responsibility The information must include the product, the
manufacturer, applicable directives, applied harmonized standards,
assurance of conformity and, - if used - the Conformity Assessment
Body Notified to COM and MS
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
CE Marking Affixed visibly, legibly and indelibly on the own
responsibility by manufacturer or his authorised representative
Means that the manufacturer DECLARES to meet the legal requirements
and to be marketable It is not a quality mark or a mark of
origin
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Enforcement-Post Market Control EU Market Surveillance Framework
(Regulation 765/2008) National Responsibility (principle of
subsidiarity) to organise and carry out surveillance and organise
cooperation Carried out by Government Officials: Market
Surveillance Authorities can perform controls, withdraw dangerous
products EU level: coordination, uniform enforcement, risk
assessment methodologies, international cooperation Rapid exchange
of information on products posing a risk to health and safety
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
THIRD COUNTRIES Extension of EU Internal Market: EEA States
(Iceland, Norway, Liechtenstein) Customs Union with Turkey
(equivalent legislation) Mutual Recognition Agreements: Switzerland
equivalent legislation US 2000 Electrical Safety Annex Japan 2002
Electrical Products
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Conclusion We oblige manufacturers to ensure that products are
totally safe They must at all times be able to proof that the
products are safe and keep technical documentation at the disposal
of the authorities While the EU encourages the use of international
standards, ISO/IEC 17025 only sets general requirements for the
competence of testing and calibration laboratories, while ISO/IEC
9001 refers to quality management. They do not aim directly at the
safety of products. In the EU we do not require testing/third party
certification in government recognised laboratories The
Government's role is to police the market: we achieve a very high
safety record.
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ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission
Thank you for your attention