salient features of CE Marking not widely known

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ANNEX IV

INTERNAL PRODUCTION CONTROL

I. Internal production control is the procedure whereby the manufacturer or his authorized representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that the electrical equipment satisfies the requirements of this Directive that apply to it. The manufacturer or his authorized representative established within the Community must affix the CE marking to each product and draw up a written declaration of conformity.

2. The manufacturer must establish the technical documentation described in point 3 and he or his authorized representative established within the Community must keep it on Community territory at the disposal of the relevant national authorities for inspection purposes for a period ending at least 10 years after the last product has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the Community, this obligation is the responsibility of the person who places the electrical equipment on the Community market.

3. Technical documentation must enable the conformity of the electrical equipment to the requirements of this Directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the electrical equipment. It must include:
a general description of the electrical equipment, conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment, a list of the standards applied in full or in part, and descriptions of the solutions adopted to satisfy the safety aspects of this Directive where standards have not been applied, results of design calculations made, examinations carried out, etc., test reports.

4. The manufacturer or his authorized representative must keep a copy of the declaration of conformity with the technical documentation.

5. The manufacturer must take all measures necessary in order that the manufacturing process shall ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.


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ANNEX I

PRINCIPAL ELEMENTS OF THE SAFETY OBJECTIVES FOR ELECTRICAL EQUIPMENT DESIGNED FOR USE WITHIN CERTAIN VOLTAGE LIMITS

I. General conditions

a) The essential characteristics, the recognition and observance of which will ensure that electrical equipment will be used safely and in applications for which it was made, shall be marked on the equipment, or, if this is not possible, on an accompanying notice.

b) The manufacturers or brand name or trade mark should be clearly printed on the electrical equipment or, where that is not possible, on the packaging.

c) The electrical equipment, together with its component parts should be made in such a way as to ensure that it can be safely and properly assembled and connected.

d) The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards set out in points 2 and 3 of this Annex 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

Measures of a technical nature should be prescribed in accordance with point I, in order to ensure:

a) that persons and domestic animals are adequately protected 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) that persons, domestic animals and property are adequately protected against non-electrical dangers caused by the electrical equipment which are revealed by experience;

d) that the insulation must be suitable for foreseeable conditions.

3 Protection against hazards which may be caused hy external influences on the electrical equipment

Technical measures are to be laid down in accordance with point I, in order to ensure:

a) that the electrical equipment meets the expected mechanical requirements in such a way that persons, domestic animals and property are not endangered;

b) that the electrical equipment shall be resistant to non-mechanical influences in expected environmental conditions, in such a way that persons, domestic animals and property are not endangered;

c) that the electrical equipment shall not endanger persons, domestic animals and property in foreseeable conditions of overload.


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ANNEX 11

EQUIPMENT AND PHENOMENA OUTSIDE THE SCOPE OF THE DIRECTIVE

Electrical equipment for use in an explosive atmosphere Electrical equipment for radiology and medical purposes Electrical parts for goods and passenger lifts Electricity meters Plugs and socket outlets for domestic use Electric fence controllers

Radio-electrical interference

Specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.


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the Community market shall be obliged to make the electrical equipment comply as regards the provisions concerning the CE marking and to end the infringement under conditions imposed by the Member State;

(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the electrical equipment in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 9.';

5. in Article II the second indent is deleted;

6. the following Annexes are added:

'ANNEX flI

CE CONFORMITY MARKING AND EC DECLARATION OF CONFORMITY

A. CE conformity marking

The CE conformity marking shall consist of the initials "CE" taking the following fonn:

If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.

B. EC declaration of conformity

The EC declaration of conformity must contain the following elements:

name and address of the manufacturer or his authorized respresentative established within the Community,

a description of the electrical equipment,

reference to the harmonized standards,

where appropriate, references to the specifications with which conformity is declared,

identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorized representative established within the Community,

the last two digits of the year in which the CE marking was affixed.

ANNEX IV INTERNAL PRODUCTION CONTROL

1. Internal production control is the procedure whereby the manufacturer or his authorized representative established within the Community, who carries out the obligations laid


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down in point 2, ensures and declares that the electrical equipment satisfies the requirements of this Directive that apply to it. The manufacturer or his authorized representative established within the Community must affix the CE marking to each product and draw up a written declaration of conformity.

2. The manufacturer must establish the technical documentation described in point 3 and he or his authorized representative established within the Community must keep it on Community territory at the disposal of the relevant national authorities for inspection purposes for a period ending at least 10 years after the last product has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the Community, this obligation is the responsibility of the person who places the electrical equipment on the Community market.

3. Technical documentation must enable the conformity of the electrical equipment to the requirements of this Directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the electrical equipment. It must include:

a general description of the electrical equipment,

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment,

a list of the standards applied in full or in part, and descriptions of the solutions adopted to satisfy the safety aspects of this Directive where standards have not been applied,

results of desigil calculations made, examinations carried out, etc.

test reports.

4. The manufacturer or his authorized representative must keep a copy of the declaration of conformity with the technical documentation.

5. The manufacturer must take all measures necessary in order that the manufacturing process shaIl ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.'

Article 14

I. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by I July 1994. They shall forthwith inform the Commission thereof.

They shall apply these provisions from I January 1995.

When Member States adopt these measures, they shaIl contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

2. Until 1 January 1997 Member States shall aIlow the placing on the market and the bringing into service of products which comply with the marking arrangements in force before 1 January 1995.


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The notified body must affix, or cause to be affixed, its identification number to the approved appliance and must draw up a written certificate of conformity concerning the tests carried out.

6.3. The aim of the technical documentation relating to the design of the instrument, as referred to in Annex IV, is to enable conformity to the requirements of this Directive to be assessed and the design, manufacture and operation of the appliance to be understood.

The design documentation referred to in Annex IV must be made available to the notified body.

6.4. If deemed necessary by the notified body, the examinations and tests may be carried out after installation of the appliance.

6.5. The manufacturer or his authorized representative must ensure that he is able to supply the notified body's certificates of conformity on request.';

8. Annex III is replaced by the following text:

'ANNEX III CE CONFORMITY MARKING AND INSCRIPTIONS

I. The CE conformity marking consists of the initials "CE" as shown below:

The CE marking must be followed by the identification number of the notified body involved in the production control phase.

2. The appliance or its data plate must bear the CE marking together with the following inscriptions:

the manufacturer's name or identification symbol,

the trade name of the appliance,

the type of electrical supply used, if applicable,

the appliance category,

the last two digits of the year in which the CE marking was affixed.

Information needed for installation purposes may be added according to the nature of the appliance.

3. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.'

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(c) in point 3.1 the second sentence is replaced by the following text:

'The manufacturer or his authorized representative established within the Community must affix the CE marking to each appliance and draw up a written declaration of conformity.';

(d) in point 3.1 the last sentence is replaced by the following text:

'The CE marking must be followed by the identification number of the notified body responsible for EC surveillance.';

(e) in point 4.1 the second sentence is replaced by the following text:

'The manufacturer or his authorized representative established within the Community must affix the CE marking to each appliance and draw up a written declaration of conformity.';

(f) in point 4.1 the last sentence is replaced by the following text:

'The CE marking must be followed by the identification number of the notified body responsible for EC surveillance.';

(g) points 5 and 6 are replaced by the following text:

'5. EC VERIFICATION

5.1. EC verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the appliances subject to the provisions of point 3 are in conformity to the type as described in the EC typeexamination certification and satisty the requirements of this Directive that apply to them.

5.2. The manufacturer or his authorized representative established within the Community must take all measures necessary in order that the manufacturing process ensures conformity of the appliances to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community must affix the CE marking to each appliance and draw up a written declaration of conformity. The declaration of conformity may cover one or more appliances and must be kept by the manufacturer or his authorized representative established within the Community.

5.3. The notified body must carry out the appropriate examinations and tests in order to check the confon11ity of the appliance to the requirements of this Directive by examination and testing of every appliance, as specified in point 5.4, or by examination and testing of appliances on a statistical basis, as specified in point 5.5, at the choice of the manufacturer.

5.4. Verification by checking and testing of each appliance

5.4.1. All appliances must be individually examined and appropriate tests, as set out in the relevant standard( s) referred to in Article 5, or equivalent tests, must be carried out in order to verify their conformity with the type as described in the EC type-examination certificate and the requirements of this Directive that apply to them.

5.4.2. The notified body must affix, or cause to be affixed, its identification number on each appliance and draw up a written certificate of conformity relating to the tests carried out. The certificate of conformity may cover one or more appliances.


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5.4.3. The manufacturer or his authorized representative must ensure that he is able to supply the notified body's certificates of confonnity on request.

5.5. Statistical verification

5.5.1. Manufacturers must present the appliances manufactured in the form of uniform batches and must take all necessary measures in order that the manufacturing process ensures the unifonnity of each batch produced.·

5.5.2. Statistical control is as follows:

Appliances are subject to statistical control by attributes.
They should be grouped into identifiable batches consisting of units of a single model manufactured under the same conditions. A batch is examined at random intervals. The appliances constituting a sample are examined individually and appropriate tests, as laid down in the respective standard(s) referred to in Article 5, or equivalent tests are carried out to determine whether the batch is to be accepted or rejected.

A sampling system with the following characteristics is applied:

a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,5 and 1,5 %,

a limit quality corresponding to a probability of acceptance of 5 %, with a percentage of non-conformity of between 5 and 10%.

5.5.3. Where batches are accepted, the notified body must affix, or cause to be affixed, its identification number to each appliance and draw up a written certificate of conformity relating to the tests carried out. All appl iances in the batch may be placed on the market except for those products from the sample which were found not to be in confirmity.

Where a batch is rejected, the notified body must take appropriate measures to prevent the placing on the market of that batch. In the event offrequent rejection of batches the notified body may suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process.

5.5.4. The manufacturer or his authorized representative must ensure that he is able to supply the notified body's certificates of confonnity on request.

6. EC UNIT VERIFICATION

6.1. EC unit verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the appliance concerned, which has been issued with the certificate referred to in point 2, conforms to the requirements of this Directive that apply to it. The manufacturer or his authorized representative must affix the CE marking to the appliance and draw up a written declaration of conformity which he must keep.

6.2. The notified body must examine the appliance and carry out the appropriate tests, taking account of the design documentation in order to ensure its conformity with the essential requirements of this Directive.


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the products to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity.

3. The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements of this Directive.

4. The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system. This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them:

(i) any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in his state of health;

(ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer.

5. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of products on a statistical basis, as specified in section 6. The manufacturer must authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate.

6. Statistical verification

6.1. Manufacturers shall present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

6.2. A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in Article 5, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected.

6.3. Statistical control of products shall be based on attributes, entailing a sampling system with the following characteristics:

a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,29 and I %,

a limit quality corresponding to a probability of acceptance of 5 %, with a percentage of non-conformity of between 3 and 7 %.

6.4. Where batches are accepted, the notified body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity.


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Where a batch is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the notified body may suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body, affix the latter's 'identification number during the manufacturing process.

6.5. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body's certificates of conformity on request.';

II. the second subparagraph of section 2 of Annex V is replaced by the following text:

'The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and draw up a written declaration of conformity. This declaration shall cover one or more identified specimens of the product and shall be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible.' ;

12. Annex IX is replaced by the following text:

'ANNEX IX CE CONFORMITY MARKING

The CE conformity marking shall consist of the initials "CE" taking the following form:

If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.

This minimum dimension may be waived for small-scale devices.'

Article 10

Directive 90/396/EEC is hereby amended as follows:

1. throughout the text, the term 'EC mark' is replaced by 'CE marking' ;

2. in Article 4 the first paragraph is replaced by the following text:

'I. Member States may not prohibit, restrict or impede the placing on the market and the putting into service of appliances which comply with all the provisions of this Directive, including the conformity assessment procedures laid down in Chapter II, and which bear the CE marking provided for in Article 10.';

3. in Article 8 the fifth paragraph is replaced by the following text:

'5. (a) Where the appliances are covered by other Directives dealing with other aspects and specitying the affixing of the CE marking, the latter shall indicate that the appliances


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ANNEX 11/

Illustrative list of the principal protection requirements

The maximum electromagnetic disturbance generated by the apparatus shall be such as not to hinder the use of in particular the following apparatus:

(a) domestic radio and television receivers

(b) industrial manufacturing equipment

(c) mobile radio equipment

(d) mobile radio and commercial radiotelephone equipment

(e) medical and scientific apparatus

(f) infoffi1ation technology equipment

(g) domestic appliances and household electronic equipment

(h) aeronautical and marine radio apparatus

(i) educational electronic equipment

(j) telecommunications networks and apparatus

(k) radio and television broadcast transmitters

(I) lights and fluorescent lamps.

Apparatus, and especially the apparatus referred to in (a) to (I), should be constmcted in such a way that it has an adequate level of electromagnetic immunity in the usual electromagnetic compatibility environment where the apparatus is intended to work so as to allow its unhindered operation taking into account the levels of disturbance generated by apparatus complying with the standards laid down in Article 7.

The infonnation required to enable use in accordance with the intended purpose of the apparatus must be contained in the instructions accompanying the apparatus.


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ANNEX fI

Criteria for the assessment of the bodies to be notified

The bodies designated by the Member States must fulfil the following minimum conditions:

1. availability of personnel and of the necessary means and equipment;

2. technical competence and professional integrity of personnel;

3. independence, in carrying out the tests, preparing the reports, issuing the certificates and perfoffi1ing the verification function provided for in this Directive, of staff and technical personnel in relation to all circles, groups or persons directly or indirectly concerned with the product in question;

4. maintenance of professional secrecy by personnel;

5. possession of civil liability insurance unless such liability is covered by the State under national law.

Fulfilment of the conditions under points I and 2 shall be verified at intervals by the competent authorities of the Member States.