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Royal Decree 1580 / 2006 Of 22 December, Which Regulates The Electromagnetic Compatibility Of Electrical And Electronic Equipment

Original Language Title: Real Decreto 1580/2006, de 22 de diciembre, por el que se regula la compatibilidad electromagnética de los equipos eléctricos y electrónicos

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TEXT

Royal Decree 444/1994 of 11 March, as amended by Royal Decree 1950/1995 of 1 December 1995, laid down the assessment procedures and the protection requirements relating to the electromagnetic compatibility of the equipment, systems and facilities.

This royal decree and its amendment came to transpose Council Directive 89 /336/EEC of 3 May 1989 on the electromagnetic compatibility and subsequent amendments made by the Directives. 92 /31/EEC of 28 April 1992 and 93 /68/EEC of 22 July 1993.

The European Parliament and the Council of the European Union subsequently adopted Directive 2004 /108/EC on the approximation of the laws of the Member States relating to compatibility with the provisions of Directive 2004 /108/EC Electromagnetic field and repealing Directive 89 /336/EEC.

In compliance with the obligations arising from the provisions of Article 16 of that Directive, it is necessary to lay down the national provisions which provide for and adopt the provisions contained in that Directive.

This royal decree aims to transpose into national law the aforementioned Directive 2004 /108/EC, harmonizing the national provisions of protection against electromagnetic disturbances, in order to guarantee in the free movement of electrical and electronic equipment in this field and in the operation of the internal market.

In the framework established by Law 21/1992, of 16 July, of Industry and Law 32/2003, of 3 November, General of Telecommunications, as well as by Royal Decree 2200/1995, of December 28, for which the Regulation of the Infrastructure for Quality and Industrial Safety, this provision regulates the electromagnetic compatibility of electrical and electronic equipment and tries to ensure that radio communications, supply networks power, telecommunications networks and equipment connected to these networks are protected against the electromagnetic disturbances. In order to achieve this objective, manufacturers of electrical and electronic equipment must build them in such a way that other equipment or networks are not affected by an unacceptable degradation of the service when used in conditions (a) normal operating conditions and network operators must be constructed in such a way that manufacturers of equipment which can be connected to them are not exposed to disproportionate constraints in order to prevent the degradation of service in such networks; taking into account also the cumulative aspects of electromagnetic phenomena which may originate.

According to the provisions of Article 24.1.c) of Law 50/1997 of 27 November 1997, the present provision has been submitted to the hearing, referring to the industrial sectors concerned. The competent bodies of the autonomous communities and submitted to the Coordination Council for Industrial Safety have also been consulted.

In accordance with the provisions of paragraph 2 of the fifth additional provision of Law 32/2003 of 3 November, General Telecommunications, this provision has been submitted to the Advisory Board of the Telecommunications and the Information Society. On the other hand, it has been informed by the Telecommunications Market Commission

In its virtue, on the proposal of the Minister of Industry, Tourism and Trade, according to the Council of State and after deliberation of the Council of Ministers at its meeting of 22 December 2006, I have:

CHAPTER I

General provisions

Article 1. Object.

This royal decree regulates the electromagnetic compatibility of electrical and electronic equipment that can create electromagnetic disturbances, or whose normal operation may be impaired by such equipment. disturbances, requiring them to comply with an appropriate level of electromagnetic compatibility in order to ensure the functioning of the internal market.

Article 2. Definitions.

For the purposes of applying this royal decree, the following definitions shall apply:

a) "Equipment": any fixed apparatus or installation.

(b) "Appliances" means any finished apparatus, or a combination of them marketed as a single functional unit intended for the end user, and which can generate electromagnetic disturbances, or whose operation may be seen affected by these disturbances.

(c) "Fixed installation" means a particular combination of several types of apparatus and, where applicable, other devices, assembled, installed and intended for permanent use on a given site.

d) "Electromagnetic compatibility" means the ability of a team to function satisfactorily in its electromagnetic environment and without introducing intolerable electromagnetic disturbances for other equipment in that environment.

e) "Electromagnetic disturbance" means any electromagnetic phenomenon that can create problems for a team. An electromagnetic disturbance may consist of an electromagnetic noise, an unwanted signal, or a modification of the propagation medium itself.

(f) "Immunity" means the ability of a team to function in the intended form without experiencing degradation in the presence of electromagnetic disturbances.

g) "Electromagnetic environment": all observable electromagnetic phenomena in a given location.

(h) "Technical specification" means a specification in a document defining the technical characteristics of a team, as well as the procedures for the verification of such characteristics, enabling the correct operation of this one and that enables it for the intended purpose for which it has been designed.

i) "Standard": any technical specification adopted by a recognized standardisation body.

(j) "harmonised standard" means any rule adopted, in accordance with a mandate of the European Commission, in accordance with the procedures laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998, the establishment of a procedure for the provision of information in the field of technical standards and regulations, for the purpose of establishing a European requirement, the observance of which is not mandatory.

k) "Standard harmonised by the European Union": that harmonised standard, the reference of which, at least, is published in the Official Journal of the European Communities.

(l) "Marketing": the action of putting in place for the first time an apparatus, including in this royal decree, (referred to each individual apparatus) available (for consideration or free) of the Community market with a view to its distribution and use in the European Community.

(m) "Put into service": takes place at the time of the first use of an apparatus included in this royal decree within the Community market by the end user.

n) "Manufacturer" means a natural or legal person responsible for the design and manufacture of a team included in this royal decree with a view to its marketing and use on the Community market for its own account.

The manufacturer assumes the sole and absolute responsibility for the compliance of his or her team included in this royal decree, whether designed or manufactured as if it is considered a manufacturer by the fact that the equipment is markets for your own account.

o) 'authorised representative or authorised representative' means a natural or legal person established within the European Community, expressly designated by the manufacturer to act on his behalf in the performance of certain tasks required by this royal decree.

p) "Importer" means a natural or legal person established in the European Community who markets a team included in this royal decree from a third country on the Community market.

In the event that the manufacturer is not established in the European Community and does not have an authorised representative in the European Community, the importer must ensure that he is in a position to facilitate, where appropriate and when required in this case. royal decree, to market surveillance authorities the necessary information on the equipment (EC Declaration of Conformity and Technical Documentation).

q) "Notified Body" means a body designated to carry out the tasks related to a given conformity assessment procedure contained in this royal decree, where third party intervention is required. These bodies are communicated by the General Administration of the State, through the established notification procedure, to the services of the European Commission.

Article 3. Scope of application.

1. The provisions of this royal decree shall apply to equipment, finished and marketed on the Community market, as defined in Article 2 (a). Among the equipment covered by the scope of this royal decree shall be include both the apparatus and the fixed installations. However, separate provisions should be laid down for each group, as soon as the apparatus is free to move within the Community territory and fixed installations are installed for permanent use at a given location and do not circulate in the European Union.

2. In this regard and for the purposes of the scope of its application, apparatus shall also be considered:

(a) the "components" or "subassemblies" intended to be incorporated into an apparatus by the end user, which may generate electromagnetic disturbances, or whose operation may be affected by such disturbances,

(b) "mobile installations", defined as a combination of apparatus and, where appropriate, other devices, intended to be moved and used in different locations. For the purposes set out in this royal decree they will not have the consideration of mobile facilities facilities that do not function or can be put into service while they are being moved.

3. This royal decree will not apply specifically to:

(a) the equipment covered by Directive 1999 /5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity; (a) to be transposed into Spanish legislation by Royal Decree 1890/2000 of 20 November establishing the Regulation laying down the procedure for the assessment of the conformity of telecommunications equipment; manufacturer or his authorised representative established in the European Union has decided to apply the established in Article 18.2 of the Regulation incorporating the aforementioned royal decree.

(b) the aeronautical products, components and equipment referred to in Regulation (EC) No 1592/2002 of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and for which it is creates a European Aviation Safety Agency, as amended by Commission Regulation (EC) No 1701/2003 of 24 September 2003 adapting Article 6 of Regulation (EC) No 1592/2002 of the European Parliament and of the Council.

(c) radio equipment used by radio amateurs, within the meaning of the Radio Regulations adopted in the framework of the Constitution and the International Telecommunication Union Convention, except that the equipment are marketed. Equipment shall not be considered to be placed on the market for component kits to be mounted by radio amateurs and commercial equipment modified by and for the use of such radio amateurs.

4. This royal decree shall also not apply to equipment which is intrinsically harmless in electromagnetic compatibility, the physical characteristics of which are such that:

(a) cannot generate or contribute to electromagnetic emissions that exceed a level that prevents radio and telecommunications equipment, and other equipment, from functioning as intended; and

(b) operate without unacceptable degradation in the presence of normal electromagnetic disturbances arising from their intended use.

5. Where there are other Community Directives which regulate in a more specific way all or part of the requirements set out in Annex I to this Royal Decree, in the case of equipment referred to in paragraph 1, the latter shall not apply, or shall cease to apply, apply to that team in respect of those requirements as from the date of application of those Directives.

6. This royal decree shall not affect the application of Community or national legislation governing the safety of equipment, such as the protection of the health and safety of users.

Article 4. Import, marketing and commissioning.

The General Administration of the State or the competent authorities of the autonomous communities, within the scope of their powers, shall take all appropriate measures to ensure that they are only marketed and put into service. equipment that meets the requirements of this royal decree when they are correctly installed, maintained and used for the intended purpose.

Equipment that does not comply with the provisions of this royal decree may not be imported unless they are included in the exceptions provided for therein.

Article 5. Free movement of equipment.

1. The import, placing on the market and putting into service of equipment complying with this royal decree shall not be prohibited, limited or impeded for reasons of electromagnetic compatibility, except for the derogations provided for in paragraphs 2 and 3. of this article.

2. The requirements of this royal decree shall not prevent the application of the following special measures relating to the putting into service or use of equipment:

a) measures to overcome an existing or predicted electromagnetic compatibility problem at a specific location; and

(b) measures taken for safety reasons to protect public telecommunications networks or receiving or transmitting stations when used for security purposes by issuing on authorised frequencies and defined.

3. The presentation, display or demonstration at trade fairs, exhibitions or similar events of equipment which do not comply with the provisions of this royal decree shall not be impeded, provided that it is clearly indicated by a visible sign, that such equipment may not be placed on the market or put into service until it complies with this royal decree. The demonstration may only take place if appropriate measures are taken to avoid electromagnetic disturbances.

Article 6. Essential requirements.

The equipment referred to in Article 2 (a) shall comply with the essential requirements set out in Annex I. This shall be taken into account in both the design and manufacturing processes of the equipment referred to.

Article 7. Harmonised standards.

1. Harmonised standards, which are not mandatory, are technically reflected in the latest developments generally recognised in terms of electromagnetic compatibility in the European Union. They are technical specifications adopted by a European standardisation body recognised under the mandate of the Commission in order to establish a European requirement.

2. Compliance with the essential requirements set out in Annex I to this Royal Decree shall be presumed if the conformity of the equipment has been verified by compliance with the harmonised standards published in the Official Journal of the European Union, under the scope of Directive 2004 /108/EC of 15 December 2004.

This presumption of conformity shall be limited to the scope of the harmonised standards applied and the relevant essential requirements covered by such harmonised standards.

3. Where the General Administration of the State considers that the standard harmonised by the European Union does not fully satisfy the essential requirements referred to in Annex I, it shall bring this matter before the Standing Committee set up by the Directive. 98 /34/EC of the European Parliament and of the Council of 22 June 1998, stating their reasons.

Once the opinion of the committee has been received, and once the European Commission has adopted a decision and communicated it to the Member States, the General Administration of the State shall take appropriate measures for its implementation. application as soon as possible.

CHAPTER II

Appliances

Article 8. Procedure for assessing the conformity of appliances.

The conformity of an apparatus with the essential requirements set out in Annex I shall be demonstrated by the procedure described in Annex II (internal manufacturing control).

However, at the choice of the manufacturer or his authorised representative in the European Community, the procedure described in Annex III may also be used.

Article 9. CE marking.

1. Equipment which has been carried out in accordance with this royal decree by means of one of the procedures laid down in Article 8 shall bear the CE marking, thereby confirming that the assessment carried out has been complete and correct. The affixing of the CE marking shall be the responsibility of the manufacturer or his authorised representative established within the European Community. The CE marking shall be affixed in accordance with Annex V.

2. The competent authorities shall take the necessary measures to prohibit the placing on the apparatus, in its packaging or in instructions for use of other similar markings, either in meaning or in graphic form, which may mislead the third parties and create confusion with the CE marking.

3. Any other marking may be affixed to the apparatus, its packaging or the instructions for use, provided that it does not affect the visibility or legibility of the CE marking.

4. Without prejudice to Article 11, if the competent authority determines that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the European Community shall adjust the apparatus to the relevant provisions. the CE marking. In any event, the competent authority shall take appropriate measures against those responsible for the affixing of such marking or against the person or persons responsible for placing the product on the national market.

Article 10. Other markings and information.

1. Each apparatus shall be identified in terms of type, lot, serial number or any other information enabling the identification of the apparatus.

2. Each apparatus shall be accompanied by the name and address of the manufacturer and, if not established within the European Community, the name and address of his authorised representative or of the person established within the responsible European Community. of the placing on the market of the apparatus on the Community market.

3. The manufacturer shall provide information on any specific precautions to be taken when mounting, installing, maintaining or using the apparatus, in order to ensure that, once put into service, the appliance complies with the protection requirements. set out in point 1 of Annex I.

4. Equipment whose compliance with the protection requirements is not guaranteed in residential environments or areas shall be accompanied by a clear indication of this restriction of use, which shall also appear on the packaging if appropriate.

Places, such as buildings or apartments for housing, characterised by being fed directly in low voltage (up to 1000v) by the electricity grid or by the electricity grid, will be considered as residential environments or areas. a specific continuous stream source (up to 1500v), intended to serve as an interface between the connected devices and the power supply network of low voltage.

5. The information necessary to enable the apparatus to be used in accordance with the intended purpose shall be provided in the instructions accompanying the apparatus.

6. All the information referred to in points 3, 4 and 5 must be written in Spanish and may also include other identical texts in other languages.

Article 11. Safeguards.

1. Where the competent authorities verify that an apparatus with the CE marking does not meet the requirements of this royal decree, they shall take all appropriate measures to withdraw the apparatus from the market, prohibit their placing on the market or service, or restrict its free movement and take the necessary measures against the person who has set such marking or put the apparatus on the domestic market.

2. The Administration which has adopted one of these measures shall immediately inform the Ministry of Industry, Tourism and Trade, which shall inform the European Commission and the other Member States of any such measure, indicating the reasons and specifying, in particular, whether the non-compliance is due to:

(a) failure to comply with the essential requirements referred to in Annex I, where the apparatus does not comply with the harmonised standards laid down in Article 7;

(b) incorrect application of the harmonised standards provided for in Article 7; or

(c) deficiencies in the harmonised standards provided for in Article 7.

3. The General Administration of the State shall take appropriate action on the basis of information from the European Commission on the justification for the measure.

4. Where the measure referred to in paragraph 1 has been adopted as a result of a deficiency in the harmonized standards, the General Administration of the State shall initiate the procedure provided for in Article 7 (3) in order to maintain the application of such a measure.

5. Where the non-compliant apparatus has undergone the conformity assessment procedure laid down in Annex III, the competent authorities shall take the necessary measures in respect of the author of the declaration referred to in point 3. of Annex III and shall communicate it, where appropriate, to the General Administration of the State, which shall inform the European Commission and the other Member States.

Article 12. Decisions on the withdrawal, prohibition or restriction of the free movement of equipment.

1. Any decision taken in accordance with this Royal Decree on the withdrawal of an apparatus from the market, the prohibition or restriction of its placing on the market or putting into service, or the restriction of its free movement, shall include: exact motivation on which that decision is based. These decisions shall be notified as soon as possible to the party concerned, which shall be informed at the same time of the available resources and of the time limits for their submission, in accordance with the provisions of Law No 30/1992 of 26 November 1992 on the Legal of Public Administrations and of the Common Administrative Procedure.

2. Where a decision is taken in accordance with paragraph 1, the manufacturer, his authorised representative or any other interested party may submit in advance his opinion, unless it is impossible due to the urgency of the measure to be taken by the manufacturer. be taken, in particular, for public interest needs.

Article 13. Notified bodies.

1. The Spanish notified bodies involved in the conformity assessment procedure in accordance with Annex III to this Royal Decree shall comply with the minimum conditions laid down in the criteria for the assessment established. in Annex VI of this royal decree.

2. Two types of notified bodies are established in Spain:

(a) Notified bodies to assess compliance with the essential requirements identified in this Royal Decree on Telecommunications Equipment and

(b) notified bodies to assess compliance with the essential requirements set out in this Royal Decree in the other equipment to which it applies.

3. In Spain, it is designated as a notified body to the Secretariat of State of Telecommunications and to the Information Society for telecommunications equipment. The procedure for the designation of other notified bodies for this type of equipment shall be governed by ministerial order, in which it shall be determined:

a) scope of designation,

b) the requirements for obtaining the designation,

c) the causes of extinction of the designation and

(d) the rights and obligations of the designated entities

4. Notified bodies which are designated for equipment other than those for telecommunications to which this royal decree applies shall have the status of approved inspection bodies referred to in Chapter I of the Title III of Law 21/1992 of 16 July 1992 on Industry, developed in Chapter IV of the Infrastructure Regulation for Industrial Quality and Safety, adopted by Royal Decree 2200/1995 of 28 December 1995. To this end, they will request the National Accreditation Entity (ENAC) for their corresponding accreditation to act as a control body, presenting to that Entity the complete information that will allow to check the compliance of the criteria referred to in Annex VI, accompanying the relevant supporting elements.

5. The control bodies referred to in paragraph 4 shall be authorised by the competent authority of the autonomous territory in which the bodies initiate their activities or radiate their premises and following the procedures established in the aforementioned Law on Industry and Regulations to develop it. The competent authority of the Autonomous Community which is to process and grant the authorization shall forward to the Ministry of Industry, Tourism and Trade a copy of the authorization granted to carry out the duties referred to in Annex III for the purposes of its national dissemination and any communication to the other competent authorities expressly indicating whether the bodies have been authorised for all the equipment covered by this royal decree and the essential requirements referred to therein. Annex I, or whether the scope of the authorisation is limited to certain specific aspects or categories of equipment.

6. The Ministry of Industry, Tourism and Trade shall notify the European Commission of the bodies designated to carry out the tasks referred to in Annex III, both for telecommunications equipment and for the rest of the equipment.

7. The list of notified bodies and their updates shall be published in the Official Journal of the European Union in accordance with the Community rules governing this matter.

8. Designated notified bodies shall be inspected on a regular basis.

9. The approved inspection bodies, as provided for in Royal Decree 2200/1995 of 28 December 1995, shall be inspected by the competent authority of the Autonomous Community which has authorised them for the purposes of verifying that they comply with the requirements of this Regulation. faithfully its role in relation to the application of this royal decree.

If it is found that a notified body no longer meets the conditions laid down in paragraph 1, the competent authority which granted the authorisation shall withdraw it and shall immediately inform the Ministry of Industry, Tourism and Trade, which, in turn, will communicate to the other competent authorities, as well as to the European Commission and the other Member States, for the purposes of cancelling the notification and the exclusion of this body from the list referred to in paragraph 7.

10. Bodies which fulfil the assessment criteria laid down in the relevant harmonised standards shall be presumed to fulfil the minimum conditions on the criteria for the assessment of the bodies set out in Annex VI to this Regulation. this royal decree. This presumption of conformity shall be limited to the scope of the harmonised standards applied and the minimum conditions laid down in that Annex VI covered by such harmonised standards, which, in accordance with Community legislation, are published in the Official Journal of the European Union. However, in this case, the competent authority responsible for the designation may lay down additional requirements for authorisation.

CHAPTER III

Fixed installations

Article 14. Fixed installations.

1. The apparatus placed on the market and which may be incorporated into a fixed installation shall be subject to all the relevant provisions for the apparatus set out in this royal decree.

However, the provisions of Articles 6, 8, 9 and 10 shall not be binding in the case of an apparatus intended for incorporation into a specific fixed installation and which otherwise would not be placed on the market. In such cases, the documentation attached to the apparatus shall identify the fixed installation and its electromagnetic compatibility characteristics and shall indicate the precautions to be taken for the incorporation of the apparatus into the fixed installation. do not compromise the conformity of that installation. In addition, it shall include the information referred to in Article 10 (1) and (2

.

2. Where there are indications of the non-compliance of the fixed installation, in particular where there are complaints about disturbances which it generates, the competent authorities may request evidence of the conformity of the fixed installation and, where proceed, perform an assessment.

Where non-compliance is demonstrated, the competent authorities may impose appropriate measures to ensure that the fixed installation complies with the protection requirements set out in point 1 of Annex I.

3. The conformity of a fixed installation with the conditions and requirements required under this royal decree and its maintenance shall be the responsibility of the owner and, where appropriate, of the owner of the installation.

CHAPTER IV

Control and administrative action

Article 15. Competent bodies.

1. For telecommunications equipment, the authority responsible for the implementation of the provisions of this royal decree will be the Ministry of Industry, Tourism and Commerce, through the Secretariat of State of Telecommunications and the Society of the Information.

2. For the rest of the equipment to which this royal decree applies, the competent bodies shall be the corresponding of the Autonomous Communities, in accordance with the provisions of Law 21/1992, of 16 July, of Industry and other Provisions applicable in the field of Industry.

Article 16. Sanctioning regime.

The breaches of this royal decree will be sanctioned, as appropriate, in accordance with the provisions of Title V of Law 21/1992, of 16 July, of Industry and Title VIII of Law 32/2003, of 3 of November, General Telecommunications and, where appropriate, its regulatory development standards.

Single additional disposition. References to Royal Decree 1890/2000 of 20 November 2000 approving the Regulation laying down the procedure for the assessment of the conformity of telecommunications equipment.

1. All the references in the Regulation laying down the procedure for the assessment of the conformity of telecommunications equipment, approved by Royal Decree 1890/2000 of 20 November, are carried out in respect of the Royal Decree 444/1994, of 11 March, shall be understood as being made to this royal decree.

2. Without prejudice to the provisions of this royal decree, all the provisions contained in the Regulation laying down the procedure for the assessment of the conformity of telecommunications equipment, approved by the Royal Decree of Decree 1890/2000 of 20 November relating to market surveillance activities, procedures for the withdrawal from the market of equipment and apparatus, the application of safeguard measures by other Member States of the European Union sanctioning, seizure of equipment and return of seized devices, always referred to equipment and Telecommunications equipment shall be applicable to the telecommunications equipment to which this royal decree applies.

Single transient arrangement. Validity of the assessments carried out pursuant to Royal Decree 444/1994 of 11 March establishing the procedures for the assessment of conformity and the protection requirements relating to electromagnetic compatibility of equipment, systems and facilities.

1. By way of derogation from the single derogation provision, it may continue to be placed on the market and put into service until 20 July 2009 equipment complying with the provisions of Royal Decree 444/1994 of 11 March 1994 and having been placed on the market before 20 July 2007, under the following application criteria:

(a) The apparatus for which the manufacturer or his authorised representative has made public, before 20 July 2007, a declaration of conformity in accordance with the procedure for the assessment of Article 8 of the Royal Decree 444/1994, of 11 March, may continue to be manufactured and marketed until 20 July 2009.

(b) Equipment for which the manufacturer or his authorised representative has obtained, before 20 July 2007, a technical report or certificate from a competent body in accordance with the procedure for the assessment of Article 9 Royal Decree 444/1994, of 11 March, may continue to be manufactured and marketed until 20 July 2009.

2. It is considered that fixed installations are excluded from the scope and application of the transitional period, since their application is established for equipment which is placed on the market and fixed installations are put into service, but are not on the market. Therefore, fixed installations put into service after 20 July 2007 will have to comply with this royal decree.

Single repeal provision. Regulatory repeal.

Royal Decree 444/1994 of 11 March 1994 laying down the procedures for the assessment of conformity and the protection requirements relating to electromagnetic compatibility of equipment, systems and systems is hereby repealed. facilities.

Final disposition first. Competence title.

This royal decree is dictated by the provisions of the rules 13. and 21. of Article 149.1 of the Constitution, which attribute to the State the competence on bases and coordination of the general planning of the economy and on telecommunications, respectively.

Final disposition second. Incorporation of European Union law.

This royal decree incorporates into Spanish law Directive 2004 /108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to the electromagnetic compatibility and repealing Directive 89 /336/EEC.

Final disposition third. Development, implementation and adaptation of the royal decree.

1. The Minister of Industry, Tourism and Trade will, in the field of his competences, dictate the necessary provisions for the development and implementation of the provisions of this royal decree.

2. It is also empowered to amend, by ministerial order, the technical conditions laid down in this royal decree and, in particular, its annexes, in order to keep it adapted to innovations in the state of the art. in the field, and in particular the provisions of the rules of law of the European Union.

Final disposition fourth. Advertisement of harmonised standards and notified bodies.

The Ministry of Industry, Tourism and Trade shall publish by resolution of the competent management centre, for information purposes, the lists corresponding to the harmonised standards and the approved inspection bodies and notified to the services of the European Commission to act in the field of this royal decree.

In addition to being published in the "Official State Gazette", these lists will be published, with the same information, on the website of the Ministry of Industry, Tourism and Trade.

Final disposition fifth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on December 22, 2006.

JOHN CARLOS R.

The Minister of Industry, Tourism and Trade,

JOAN CLOS I MATHEU

ANNEX I

Essential Requirements

1. Protection requirements.

The design and manufacture of equipment, taking into account the latest developments, will ensure:

(a) that the electromagnetic disturbances generated are limited to a level that allows radio and telecommunications equipment or other equipment to operate for the purpose for which they have been intended; and

(b) a level of protection against foreseeable electromagnetic disturbances that allows the equipment to operate without unacceptable degradation in its intended use.

2. Specific requirements for fixed installations

Fixed installations must meet the following specific and additional requirements regarding the installation and intended use of the components:

(a) To be performed by competent personnel, in order to ensure good engineering practice. If a notified body intervenes and issues a declaration confirming compliance with those aspects of the essential requirements of a fixed installation which are to be assessed by that body, it is understood that good practice of engineering have been correctly applied in the field assessed by the notified body.

(b) To be carried out in accordance with the information on the intended use of its components, with a view to meeting the protection requirements set out in point 1.

(c) Good engineering practice must be documented and the person responsible for the installation shall keep such documentation at the disposal of the competent authorities for inspection purposes during the operation of the fixed installation or while in service.

ANNEX II

Compliance assessment procedure referred to in Article 8 (internal manufacturing control)

1. The manufacturer shall carry out an assessment of the electromagnetic compatibility of the apparatus, based on the relevant phenomena, with a view to complying with the protection requirements set out in point 1 of Annex I. The correct application of all relevant harmonised standards whose references have been published in the Official Journal of the European Union shall be equivalent to the performance of the electromagnetic compatibility assessment.

2. The electromagnetic compatibility assessment shall take into account all the normal operating conditions. In cases where the apparatus may have different configurations, the electromagnetic compatibility assessment shall confirm whether the apparatus, in all possible configurations identified by the manufacturer as representative of its use In such cases, it is sufficient to carry out an assessment on the basis of the configuration most likely to cause the maximum and the maximum disturbances to be carried out. configuration most susceptible to these disturbances.

3. In accordance with the provisions laid down in Annex IV, the manufacturer shall draw up the technical documentation demonstrating the conformity of the apparatus with the essential requirements of this Royal Decree.

The manufacturer or his authorised representative established within the European Community shall keep the technical documentation at the disposal of the competent authorities for a period of at least 10 years after the date on which the This device was last manufactured.

4. In accordance with the provisions laid down in Annex IV, the manufacturer or his authorised representative established within the European Community shall issue an EC declaration of conformity certifying that the apparatus meets all the requirements relevant essential.

The manufacturer or his authorised representative established within the European Community shall keep the EC declaration of conformity at the disposal of the competent authorities for a period of at least 10 years after the date of in which this device was last manufactured.

5. Where neither the manufacturer nor his authorised representative is established within the European Community, the importer or, where appropriate, the person placing the appliance on the Community market or placing the apparatus on the Community market shall be responsible for maintaining the EC declaration of conformity and the technical documentation at the disposal of the competent authorities.

6. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the products manufactured with the technical documentation referred to in point 3 and with the provisions of this royal decree which are applicable.

7. The technical documentation and the EC declaration of conformity shall be drawn up in accordance with the provisions of Annex IV.

ANNEX III

Compliance assessment procedure referred to in Article 8

This procedure consists of applying Annex II, which will be completed as follows:

1. The manufacturer or his authorised representative established within the European Community shall submit the technical documentation to the notified body referred to in Article 13 and shall request an assessment of that body. The manufacturer or his authorised representative established within the European Community shall specify to the notified body those aspects of the essential requirements to be assessed by the notified body.

2. The notified body shall review the technical documentation and assess whether such documentation duly demonstrates that the requirements of this Royal Decree to be assessed have been met. If compliance with the requirements is confirmed by the apparatus, the notified body shall submit a declaration to the manufacturer or his authorised representative established within the European Community confirming compliance. This declaration shall include aspects of the essential requirements assessed by the notified body.

3. The manufacturer shall incorporate the notified body's declaration to the technical documentation.

ANNEX IV

Technical Documentation and CE Declaration of Compliance

1. Technical documentation

The technical documentation, drawn up in one of the official languages of the European Union and preferably in Spanish for devices marketed in Spain, must allow the conformity of the apparatus with the essential requirements to be assessed. It must cover the design and manufacture of the apparatus and in particular it shall contain:

a) a general description of the appliance;

(b) tests of conformity with harmonised standards, if they exist, applied in whole or in part;

(c) where the manufacturer has not applied harmonised standards, or has only partially done so, a description and explanation of the measures taken to meet the essential requirements of this Royal Decree, including a description, where appropriate, of the electromagnetic compatibility assessment set out in point 1 of Annex II, the results of the calculations carried out in their design, the examinations made, the test reports, etc.

(d) a statement of the notified body, where the procedure referred to in Annex III has been followed.

2. EC declaration of conformity

The EC declaration of conformity, drawn up in one of the official languages of the European Union and preferably in Spanish for equipment marketed in Spain, shall contain at least the following:

(a) a reference to this Royal Decree or to Directive 2004 /108/EC of 15 December 2008;

(b) the identification of the apparatus to which it refers, in accordance with Article 10 (1

;

(c) the name and address of the manufacturer and, where applicable, the name and address of his authorised representative within the European Community;

(d) a reference dated to the specifications under which conformity is declared, in order to ensure the conformity of the apparatus with the provisions of this royal decree;

e) the date of issue of the declaration and

(f) the identification and signature of the person empowered to commit the manufacturer or his authorised representative.

If the declaration of conformity is made as specified in EN 45014, it shall be presumed to be in accordance with the provisions of this Annex.

ANNEX V

CE marking referred to in Article 9

CE marking will consist of the initials "CE" with the following form:

Imagen: img/disp/2007/015/00973_001.png

The CE marking must have a height of at least 5 mm. If the CE marking is reduced or extended, the proportions indicated in the previous graduated drawing must be respected.

The CE marking shall be affixed to the apparatus or to its nameplate. Where it is not possible or cannot be ensured due to the nature of the apparatus, it must be placed on the packaging, if it exists, and on the accompanying documents.

When the apparatus is subject to other Community directives covering other aspects and which also provide for the CE marking, the latter shall assume that the apparatus is also in conformity with the provisions of those other Directives.

However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose the implementing rules, the CE marking shall only be in conformity with the directives applied by the manufacturer. In this case, details of the directives applied, as published in the Official Journal of the European Union, shall be given in the documents, particulars or instructions required by the Directives and accompanying such apparatus.

ANNEX VI

Criteria for the assessment of the bodies to be notified

1. The bodies notified by the Member States shall comply with the following minimum conditions:

a) availability of the required personnel and equipment;

b) technical competence and professional integrity of staff;

c) independence in the preparation of reports and in the performance of the verification function provided for by this royal decree;

(d) independence of general and technical staff with respect to all interested parties, groups or persons directly or indirectly related to the equipment concerned;

e) maintenance by professional secrecy personnel and

(f) tenure of civil liability insurance unless such liability is covered by the State in accordance with national law.

2. The competent authorities shall regularly check compliance with the conditions set out in point 1.

3. Where the body which wishes to be notified for telecommunications equipment, is satisfied that compliance with the EN 45011 standard, as assessed by a recognised Accreditation Entity in the European Union, shall be presumed to comply with the above requirements. However, in this case, the Secretary of State for Telecommunications and the Information Society may lay down additional requirements concerning the conditions to be met by that body.