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Monday, July 5, 2010

CE Marking LVD and EMC


1.1 The EMC Directive (89/336/EEC) is primarily concerned with removing trade barriers in the area of electromagnetic compatibility and, being a total harmonization directive, it replaces national provisions where they previously existed.
It is a new approach directive, which means that it lays down mandatory essential requirements and describes the methods by which conformity with these requirements can be demonstrated.

1.2 The directive relies on the availability of harmonised standards which provide test methods and limits, and significant work has been done to provide such methods and limits for the major industrial sectors.

2.1 The following represents a necessarily brief overview of the subject. The text of the directive is at all times the definitive guide to its requirements. Under its terms apparatus shall be constructed so that;
a) the electromagnetic disturbance it generates does not exceed a level allowing radio and telecommunication equipment and other apparatus to operate as intended, and that
b) the apparatus has an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as intended.
2.2 There have been difficulties in establishing exactly what equipment comes within the scope of the directive, and in October 1993 the Commission published "Guidelines on the Application of the Council Directive 89/336/EEC"
2.3 The directive applies to 'all electrical and electronic appliances' together with equipment and installations containing electrical and/or electronic components liable to cause electromagnetic disturbance, and the performance of which is liable to be affected by such disturbance.
2.4 In order to clarify this point, the guideline document defines a 'non-restrictive' but comprehensive range of equipment which must be considered as being covered by the directive, as follows :-
a) Emission and Immunity aspects
I. Telecommunications terminal equipment (in so far as the protection requirements are not peculiar to this equipment) (see 13th recital of Directive 91/263/EEC).; [Note: "recital" is a reference to the numerous clauses commencing with the word "whereas", with which Directives begin.]
II. Electrical household appliances, portable tools and similar equipment (last recital of the EMC Directive and Annex III (g));
III. Radio equipment used by radio amateurs if it is available commercially (Article 2(3) and Annex III (c) and (d));
IV. Radio and television receivers (Annex III (a));
V. Aeronautical and marine radio apparatus (Annex III (h));
VI. Radio and television broadcast transmission (Annex III (k));
VII. Fluorescent lighting luminaries fitted with starters (last recital of the relevant Directive);
VIII. Lights and Fluorescent lamps (Annex III (I));
IX. Industrial equipment (Annex III (b));
X. Telecommunications apparatus (Annex III (j));
XI. Information technology equipment (Annex III (f));
XII. Educational electronic equipment (Annex III (i));
b) Emission aspect only
I. Non-automatic weighing instruments (immunity aspect is covered by Annex I, paragraph 8(2), Directive 90/384/EEC)

c) Immunity aspect only
I. Agricultural and forestry tractors (the emission aspect is covered by Directive 75/322/EEC).

2.5 The following is a non-restrictive list of apparatus specifically excluded from the scope of the directive.
a) Emission and immunity aspects
I. Radio equipment used by radio amateurs unless the apparatus is commercially available (Article 2 (3)).
II. Motor vehicles (covered by Directive 72/245/EEC).
III. Active implantable medical devices (covered by Specific Directive 90/385/EEC).
IV. Medical devices (covered by Directive 93/42/EEC).

b) Emission aspects only
I. Agricultural or forestry tractors (covered by Directive 75/332/EEC).

c) Immunity aspects only
I. Non-automatic weighing instruments (covered by Annex 1, para 8 (90/384/EEC).

3 Definitions
3.1 Some important definitions are listed below
a) Manufacturer
The person who accepts responsibility for the design and manufacture of a product covered by the directive with a view to placing it on the Community market on his own behalf. As part of this responsibility he takes on the obligation.

to design and manufacture the product in line with the essential requirements of the directive.
to follow the relevant conformity assessment procedures as detailed in the directive.
b) Authorized representative
This is the person who is expressly appointed by the manufacturer and who acts on his behalf in respect of certain obligations laid down under the directive.

c) Importer
This is the person who places on the Community Market products covered by the directive and imported and a third country. The importer must keep the manufacturer's declaration of conformity and technical file at the disposal of the authorities, where neither the manufacturer nor his authorized representative is established within the Community. (Article 10(1) 3rd paragraph and Article 10(2), 3rd paragraph).

d) Components
The directive does not apply to components, which are defined as any item which is used in the composition of an apparatus and which is not itself an apparatus with an intrinsic function intended for the final consumer.

e) Apparatus
The directive applies to all apparatus as defined in the directive : that is, a finished product with an intrinsic function intended for the final user and intended to be placed on the market as a single commercial unit. The term equipment is synonymous with an apparatus.

f) Systems
The directive applies to systems, which are several items of apparatus combined to fulfill a specific objective and intended to be placed on the market as a single functional unit.

g) Installations
The directive does not apply to installations, which are defined as several combined items of apparatus or systems put together at a given place to fulfill a specific objective but not intended to be placed on the market as a single functional unit. Apparatus and systems which make up the installation are however subject to the provisions of the Directive.

h) Placing a product on the market
This means the first making available against payment, or free of charge, of a product covered by the directive in the Community Market for the purpose of distribution and/or use on the Community territory.

i) Putting into service
This means the first use on the Community territory, by its final user, of a product referred to in the directive.

Conformity Assessment

4.1 Conformity assessment is the means of demonstrating that the apparatus complies with the essential requirements of the directive. These means are described in Article 10 of the Directive. Article 10 describes the procedure by which the manufacturer applies harmonised standards. This is a self-certification approach, whereby having satisfied himself that this equipment compiles with the relevant harmonised standards, the manufacturer makes a declaration of conformity as defined in Annex I(I) and applies the CE Marking. (This follows Module A of the Council Directive 93/465/EEC on page 5 of this document).
4.2 Article 10(2) describes the procedure where the manufacturer has not applied the standards or has applied them only in part, or in the absence of relevant standards. Under these circumstances, the manufacturer compiles a technical construction file containing all the relevant technical data required to assess the product.
The file must include a certificate or technical report form a Competent Body, confirming compliance with the relevant standards.

4.3 Having satisfied himself that the equipment complies with the directive's requirements, the manufacturer draws up the declaration of conformity ( Annex I(I) ) and applies the CE Marking. This also follows Module Aa of Directive 93/465/EEC. (Page 5).
4.4 Under each approach the manufacturer must take all measures necessary to ensure that products within the scope of the directive comply with the protection requirements described in the declaration of conformity in the former case, and the technical construction file and the applicable requirements of relevant standards in the latter.
Article 10 (5)

5.1 This article concerns equipment designed for transmission of radio communications.
The manufacturer must obtain an EC Type-Examination certificate from a Notified Body, and declare that his series - manufactured products conform to the type as described in the certificate, and ensure that they satisfy the protection requirement of the directive.

He then declares conformity with directive (Annex I(I) ) and applies the CE Marking.

Bodies defined under the EMC Directive

6.1 Competent Authorities
These are the administrations of the Member States which are responsible for Market Control.

6.2 Competent Bodies
The EMC Directive defines a body as competent if it fulfills the Annex II of the Directive criteria. They are presumed competent if they can prove their conformity with the appropriate harmonised standard of the EN 45000 series.

The Competent body issues the technical reports or certificates referred to in Article 10 (2) of the Directive. The "guideline document" lists the known Competent Bodies.

6.3 Notified Bodies
A notified body must fulfill the requirements as set out an Annex II of the directive. It must be able to furnish proof that it conforms to the appropriate harmonised standards in the EN 45001.


7.1 The provisions of this directive have applied since 1st January 1992. However due to its wide scope, it was necessary to introduce a transitional period in order to ensure that a smooth changeover from purely national systems to an exclusively community-wide system took place. On 28th April 1992, the Council adopted Directive 92/31/EEC to allow a transitional period until 31st December 1995. During this transitional period, national systems may continue to be used, alongside the system given in the directive. Since 1st January 1996, the EMC Directive has become mandatory.

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