|
|
Guidelines on the requirements of Directive 73/23/EEC
HOW TO ENSURE CONFORMITY TO THE REQUIREMENTS OF THE
LV DIRECTIVE
(Summary)
Products are presumed to conform to the safety objectives
of the "Low Voltage" Directive where the equipment
has been manufactured in accordance with technical standards,
which, in the order laid down by the Directive, are
as follows:
- European standards (EN or HD), which are referred
to as harmonised standards in the Directive, drawn
up in accordance with Article 5 by the bodies notified
by the Member States (in fact, these are standards
made by CENELEC). (The harmonised standard for
switchgear and controlgear is EN 60439-1);
- where standards as defined in Article 5 have
not yet been drawn up and published, international
rules issued by the two international bodies, the
International Commission on the rules for the approval
of electrical equipment (CEE) or the International
Electrotechnical Commission (IEC) (Article 6(1)),
and published in accordance with the procedure laid
down in Article 6(2) and (3);
- where standards as defined in Article 5 or international
standards as defined in Article 6 do not yet exist,
the national standards of the Member State of manufacturer
(Article 7).
The standards referred to in Articles 5, 6 and 7,
the application of which remains voluntary, provide
a presumption of conformity for equipment manufactured
in accordance with those standards.
The presumption of conformity provided by harmonised
standards arises at the moment of national publication
of standards, according to article 5; the listing in
the Official Journal of the EC is only for information.
Alternatively, the manufacturer may construct the
product in conformity with the essential requirements
(safety objectives) of the directive, without applying
harmonised, international or national standards. In
such a case the product will not benefit from presumption
of conformity conferred by the use of such standards
and the manufacturer must include in the technical documentation
(see below) a description of the solutions adopted to
satisfy the safety aspects of the Directive.
CONFORMITY ASSESSMENT PROCEDURES UNDER THE
"LOW VOLTAGE" DIRECTIVE
What are the conformity assessment procedures to
be applied?
Article 8 and Annex IV of the Directive describe
the procedure by which the manufacturer ensures and
declares conformity of the electrical equipment with
the provisions of the Directive. This includes three
main elements:
- Technical documentation.
Before a product
is placed on the market the manufacturer puts together
the technical documentation, which makes it possible
to assess whether the electrical equipment complies
with the requirements of the Directive (see below).
- Declaration of conformity.
The manufacturer
is also required, and is the only one authorised
to do so, to draw up in writing a declaration of
conformity (see below) before placing the product
on the market.
- CE marking.
Before it is placed on the market
the electrical equipment must have the "CE"
marking affixed. Only the manufacturer is authorised
to affix the "CE" marking (see below).
Where no standards within the meaning of the Directive
have been applied, the manufacturer has to provide within
the technical documentation a description of the solutions
adopted to satisfy the safety requirements of the Directive.
In case of challenge by the authorities in charge
of market surveillance, a report in the sense of Article
8(2) (which however is not obligatory) is considered
an element of proof. In fact, in addition to the three
basic conformity assessment measures, mentioned above,
Article 8(2) provides, in the event that conformity
is challenged, for the possible submission to the market
surveillance authority of a report drawn up by a notified
body as evidence that the electrical equipment complies
with the safety objectives (Article 2 and Annex I).
The manufacturer may wish in certain cases to ask
in advance for a report to be drawn up by a notified
body in accordance with the procedure provided for in
Article 11 and to keep it together with the technical
documentation. The availability of such a report would
make matters easier and speedier in the event of a challenge
by the authorities.
The main function of article 8.2 is to provide the
conditions most favourable to progress and dynamism
in the Electrotechnical industry. It thus facilitates
the marketing of high-tech electrical equipment, which,
being such, cannot benefit from the support of any technical
standards since often such standards are drawn up after
the development of a technical innovation.
What must be included in the technical documentation?
It must include details of the design, manufacture
and operation of the electrical equipment in so far
as these details are needed to assess the conformity
of the electrical equipment with the requirements of
the Directive.
Accordingly, it contains:
- a general description of the electrical equipment,
- design and manufacture drawings plus diagrams
of components, sub- assemblies, circuits, etc.,
- descriptions and explanations needed to understand
the above-mentioned drawings and diagrams plus the
operation of the electrical equipment,
- a list of the standards used, in full or in
part, and a description of the solutions employed
to meet the safety aspects of this directive when
standards have not been applied,
- the results of design calculations and of checks
carried out, etc.,
- test reports (in fact, the test reports which
may be available, either established by the manufacturer
or a third party).
Who must keep the technical documentation and
where?
The manufacturer must keep this documentation at
the disposal of the national authorities for inspection
purposes for at least ten years from the last date of
manufacture of the product. The technical documentation
may be kept on electronic support, provided that it
is easily accessible for inspection.
Who must keep the declaration of conformity and
where?
The manufacturer must keep a copy of the declaration
of conformity at the disposal of the national authorities
for inspection purposes, in the same way as the technical
documentation. Thus the national market surveillance
authorities may, if appropriate, require a copy of the
declaration of conformity.
|
