Government Decree No. 616 / 2006 Coll.
Government regulation on technical requirements for products in terms of their electromagnetic compatibility
Valid
Effective from 20.07.2007
616
GOVERNMENT REGULATION
of 20 December 2006
on technical requirements for products with regard to their electromagnetic compatibility
The Government hereby orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 205 / 2002 Coll., (hereinafter referred to as "the Act") to implement Sections 7 (7) and (8), 11 (2), 12 (1) and (3) and 13 of the Act:
Basic provisions
(1) This Regulation implements the relevant provisions of the European Communities (1) and regulates the technical requirements for products in terms of their electromagnetic compatibility.
(2) This Regulation shall apply:
(a) apparatus or fixed installation,
(b) an instrument completed by the apparatus, or an assembly of instruments placed on the market as a separate functional unit intended for the end-user, which may cause electromagnetic interference or whose operation may be affected by electromagnetic interference;
(c) by fixed installation, a set of several types of apparatus, and, where appropriate, devices which are assembled, installed and intended for permanent use at a pre-specified location;
(d) the electromagnetic compatibility of the equipment to operate satisfactorily in the electromagnetic environment without causing unacceptable electromagnetic interference of any other device in that environment;
(e) by electromagnetic interference, an electromagnetic phenomenon which may impair the functioning of the equipment; electromagnetic interference may be electromagnetic noise, unwanted signal or change in the environment itself,
(f) resistance to the capability of the equipment to function properly without deterioration of the quality of the function in the presence of electromagnetic interference;
(g) the purpose of ensuring the protection of human health, life or property;
(h) the electromagnetic environment of any electromagnetic phenomena observed at the site.
(3) An apparatus as defined in paragraph 2 (b) shall also:
(a) components or sub-assemblies intended for incorporation into the apparatus by the end-user which may be a source of electromagnetic interference or whose operation may be affected by electromagnetic interference;
(b) mobile installations defined as a set of instruments, or means, to move and operate at different locations.
(4) The specified products under this Regulation are all establishments within the meaning of Article 12 (1) (a) of the Act, except those referred to in paragraph 5.
(5) This Regulation shall not apply to:
(a) radio and telecommunications terminal equipment covered by specific legislation (2);
(b) the products, components and equipment of aviation technology 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 establishing a European Aviation Safety Agency;
(c) radio equipment used by radio amateurs within the meaning of radio communications regulations adopted in the framework of the Constitution and the Convention of the International Telecommunications Union3), where the equipment is not available on the market; construction kits with components designed to be assembled by radio amateurs and those equipment modified by radio amateurs for own use are not considered available on the market,
(d) establishments having, by their very nature, such physical characteristics that:
1. they cannot cause or contribute to electromagnetic radiation exceeding a level enabling radio, telecommunications and other equipment to operate in accordance with the purpose; and
2. they will function without an acceptable deterioration in the presence of electromagnetic interference, which is common for the purpose of their use.
Essential requirements
(1) The essential requirements to be met by the products concerned are set out in Annex 1 to this Regulation.
(2) The essential requirement to which it relates shall be deemed to be fulfilled.
(a) a harmonised European standard to which a reference is published in the Official Journal of the European Union;
(b) a harmonised Czech technical standard transposing the standard referred to in (a); or
(c) a foreign technical standard in a Member State of the European Union which transforms the standard referred to in (a);
and the equipment complies with the relevant provisions of these harmonised technical standards. This assumption does not apply if the reference from the Official Journal of the European Union has been withdrawn.
(3) The requirements laid down for installations in specific legislation4) are not affected by this Regulation as regards the essential requirements referred to in paragraph 1.
Placing on the market or putting into service of equipment
(1) Equipment may only be placed on the market or put into service if it is so designed that, provided it is properly installed, maintained and used for the purposes for which it is intended, it complies with the requirements of this Regulation.
(2) Where an installation complying with paragraph 1 is concerned, it shall:
(a) overcoming an existing or anticipated problem of electromagnetic compatibility at a particular location; or
(b) the protection of public telecommunications networks or receivers and transmitters when used for safety purposes in clearly defined situations;
in order to limit the placing into service under specific legislation, such restriction shall be notified without undue delay to the Technical Standardisation, Metrology and State Testing Office, which shall inform the Commission of the European Communities and the other Member States of the European Union thereof. This is without prejudice to procedures under the specific legislation5).
(3) Equipment which does not comply with the requirements of this Regulation may be exhibited or shown at fairs, exhibitions and similar events, provided that it is clear from a visible sign that they must not be placed on the market or put into service until their conformity with the requirements of this Regulation has been ensured; demonstration may take place provided that appropriate measures are taken to prevent electromagnetic interference.
Conformity assessment procedures for instruments
(1) Assessment of conformity with the essential requirements referred to in Paragraph 2 (1) shall be carried out in accordance with the procedure set out in Annex 2 to this Regulation. The manufacturer or his authorised representative may also use the procedure set out in Annex 3 to this Regulation. The conformity of the apparatus shall be certified by the manufacturer or his authorised representative by issuing the EC declaration of conformity and by the measures of the apparatus with the CE marking referred to in Article 5 (1) and (2).
(2) Evidence of conformity assessment (Section 13 (7) of the Act) includes the EC Declaration of Conformity (Section 13 (2) of the Act) and the technical documentation referred to in paragraph 4.
(3) The EC declaration of conformity shall contain:
(a) reference to the relevant European CommunityRegulation (1);
(b) the information referred to in Article 5 (3) (a) on the instrument to which it relates;
(c) details of the manufacturer or authorised representative - for a natural person, the name and surname or business name and permanent residence or address of the place of residence or place of business, the name or business name of the legal person and its registered office or location of the organisational component (hereinafter referred to as "identification details");
(d) particulars of the technical standards or other documents which the apparatus meets and on the basis of which compliance with the provisions of this Regulation is declared, indicating the date of issue of those standards or documents;
(e) date of declaration,
(f) identification of the person authorised to act on behalf of the manufacturer or authorised representative and his signature.
(4) The technical documentation shall make it possible to assess the conformity of the apparatus with the essential requirements applicable to it. It shall include the design and manufacture of the apparatus, including:
(a) the overall description of the apparatus;
(b) demonstration of compliance with harmonised technical standards applied either in whole or in part;
(c) where the manufacturer has not applied harmonised technical standards, or has applied them only partially, a description and explanation of the procedure to ensure compliance with the essential requirements, including a description of the assessment of electromagnetic compatibility referred to in point 1 of Annex 2 to this Regulation, the results of the project calculations carried out, test reports and, where appropriate, other appropriate documents;
(d) the statement of the notified person when the procedure set out in Annex 3 to this Regulation has been applied.
CE marking and other marking and information
(1) The CE marking (Paragraph 13 (3) of the Act), the graphic form of which is laid down in a separate legislature6), is placed on the instrument or the data label. If this is not possible or cannot be ensured with regard to the nature of the apparatus, the label shall be placed on the packaging if the apparatus is supplied in it and on the accompanying documents. The apparatus shall not bear a marking which could mislead anyone with regard to the CE marking. The apparatus, its packaging or instructions for use may include marking other than the CE marking, but this shall not reduce the visibility and legibility of the CE marking.
(2) If, for a transitional period, the legislation which applies to the product and which the CE marking provides or allows, allows the manufacturer to choose which provisions it will follow, the CE marking shall only indicate compliance with those provisions or their provisions used by the manufacturer. In this case, the documents, warnings or instructions required by the relevant legislation and annexed to the product concerned shall indicate the relevant European Community legislation or provisions applied by the manufacturer.
(3) Each instrument shall be indicated:
(a) the type, series, serial number or other information enabling its identification;
(b) the manufacturer's identification data and, if the manufacturer is not established in a Member State of the European Community, the authorised representative or other person responsible for placing the apparatus on the market in the European Community.
(4) The manufacturer shall draw attention to the specific measures to be taken in the installation, installation, maintenance or use of the apparatus in order to ensure that, after putting into service, the apparatus complies with the protection requirements set out in point 1 of Annex 1 to this Regulation ("the protection requirements').
(5) On an apparatus for which the requirements for protection are not guaranteed when it is used in residential areas, such restriction of use shall be clearly indicated on the apparatus or on its packaging.
(6) The information necessary for the use of the apparatus in accordance with the purpose to which it is intended must be included in the instructions accompanying the apparatus.
Notification of the imposition of a safeguard measure
Where a protective measure has been imposed on the apparatus under a special legislature (7), the notification referred to in Article 7 (8) of the Act shall state whether the non-compliance with the requirements under Article 3 (1) was caused by:
(a) failure to comply with the requirements of Article 2 (1) where the apparatus does not comply with the harmonised technical standards referred to in Article 2 (2);
(b) incorrect application of the harmonised technical standards referred to in Article 2 (2); or
(c) shortcomings in the harmonised technical standards referred to in Article 2 (2).
Authorisation conditions
The conditions set out in Annex 4 to this Regulation shall apply to the authorisation of legal persons for activities under this Regulation. Legal persons meeting the assessment criteria set out in the relevant harmonised European standards to which references are published in the Official Journal of the European Union shall be considered as meeting the criteria set out in Annex 4 to this Regulation to which those standards apply.
Fixed installations
(1) An apparatus which is intended solely for incorporation in a fixed installation and is otherwise not separately placed on the market may not comply with the essential requirements laid down in Article 2 (1) and the requirements laid down in paragraphs 4 and 5, provided that the accompanying documentation indicates:
(a) data identifying the fixed installation for which the apparatus is intended, the characteristics of its electromagnetic compatibility and the measures to be taken with regard to the installation of the apparatus in the fixed installation so as not to jeopardise the conformity of the installation with the protection requirements; and
(b) the information referred to in Article 5 (3).
(2) Assessment of the conformity of fixed installations with the protection requirements shall be provided by the installation operator or by the authorised person where:
(a) in the case of fixed installations, show signs of non-compliance with the protection requirements, in particular when referring to interference; and
(b) The Czech Telecommunications Authority shall not find sufficient evidence of compliance by the installation operator or by a person authorised by it (accompanying documentation, documentation referred to in point 2 of Annex 1 to this Regulation or other documents, as the case may be) in accordance with the procedure laid down in the specific legislature8.
(3) The operator ensures compliance of fixed installation with the protection requirements.
Transitional provision
Equipment complying with the requirements of Government Regulation No. 18 / 2003 Coll., laying down technical requirements for products with regard to their electromagnetic compatibility, may be placed on the market until 19 July 2009. Such equipment may still be put into service after that date.
Repeal
Government Regulation No. 18 / 2003 Coll., laying down technical requirements for products with regard to their electromagnetic compatibility, is repealed.
Efficacy
This Regulation shall enter into force on 20 July 2007.
Prime Minister:
Ing. Topolánek v. r.
Minister for Industry and Trade:
Ing. Roman v. r.
Příloha č. 1
Annex No. 1 to Government Decree No. 616 / 2006 Coll.
ESSENTIAL REQUIREMENTS
1. Protection requirements
The device shall be so designed and constructed as to ensure that, taking into account the state of the technique achieved, that:
(a) the electromagnetic interference which it causes does not exceed the level at which the radio and telecommunications equipment or other equipment is unable to function as intended;
(b) the level of resistance to electromagnetic interference assumed when used for the purpose allows it to function without unacceptable deterioration of the specified functions.
2. Specific requirements for fixed installation and use of components for a given purpose
The fixed installation shall be installed using the correct technical procedures and respecting data on the use of components for the purpose in order to meet the protection requirements of point 1. Such good technical procedures shall be documented and the documentation shall be kept by the operator for the duration of the operation of the fixed installation for inspection by the competent authorities.
Příloha č. 2
Annex No 2 to Decree No 616 / 2006 Coll.
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 4 (1)
(Internal production control)
1. The manufacturer shall assess the electromagnetic compatibility of the apparatus on the basis of the relevant phenomena in order to meet the protection requirements. The correct application of all relevant harmonised standards to which references have been published in the Official Journal of the European Union is equivalent to an assessment of electromagnetic compatibility.
2. When assessing electromagnetic compatibility, all normal specified operating conditions shall be taken into account. If the apparatus can have different configurations, the electromagnetic compatibility assessment shall confirm that the apparatus meets the protection requirements in all possible configurations defined by the manufacturer as an example of use for that purpose.
3. The manufacturer shall process the technical documentation in accordance with the provisions of Section 4 (4) showing compliance of the apparatus with the essential requirements of this Regulation.
4. The manufacturer or his authorised representative shall keep the technical documentation at the disposal of the competent authorities for at least 10 years from the end of production of the apparatus.
5. The manufacturer or his authorised representative shall confirm the compliance with all relevant essential requirements with the apparatus by issuing an EC declaration of conformity.
6. The manufacturer or his authorised representative shall keep the EC declaration of conformity at the disposal of the competent authorities for a period of 10 years from the end of production of the apparatus.
7. Where the manufacturer is not established in the European Community or there is no authorised representative, the person placing the apparatus on the market in the European Community shall be responsible for maintaining the EC declaration of conformity and the technical documentation for the purposes of the competent authority.
8. The manufacturer shall take all necessary measures to ensure that the products are manufactured in accordance with the technical documentation referred to in point 3 and with the provisions of this Regulation which apply to the product.
9. The EC declaration of conformity shall be drawn up in accordance with the provisions of Paragraph 4 (3).
Příloha č. 3
Annex No. 3 to Government Decree No. 616 / 2006 Coll.
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 4 (1)
This procedure shall consist of the procedure set out in Annex 2, supplemented as follows:
1. The manufacturer or his authorised representative shall submit the technical documentation to the notified person and request his assessment. The manufacturer or his authorised representative shall communicate to the notified person which aspects of the essential requirements he requires to be assessed.
2. The notified person shall examine the technical documentation and assess whether he or she has duly demonstrated that the requirements of this Regulation to be evaluated have been met. If it is confirmed that the apparatus complies with them, the notified person shall give a statement confirming that conformity to the manufacturer or his authorised representative. That statement shall be limited to the aspects of the essential requirements assessed by the notified person.
3. The manufacturer shall attach the statement of the notified person to the technical documentation.
Příloha č. 4
Annex No. 4 to Government Decree No. 616 / 2006 Coll.
AUTORISATION CONDITIONS
The conditions of authorisation under Section 11 (2) of the Act are:
1. Required staffing and necessary means and equipment.
2. Professional competence and professional integrity of workers.
3. Independence in the processing of reports and the performance of functions under this Regulation.
4. Independence of employees and technical staff vis-à-vis all stakeholders, groups or persons directly or indirectly interested in the product concerned.
1) 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 electromagnetic compatibility and repealing Directive 89 / 336 / EEC.
2) Government Decree No. 426 / 2000 Coll., laying down technical requirements for radio and telecommunications terminal equipment, as amended by Government Decree No. 483 / 2002 Coll. and Government Decree No. 251 / 2003 Coll.
(3) The Constitution and Convention of the International Telecommunications Union adopted at the additional Conference of Authorised Representatives (Geneva, 1992), as amended by the Conference of Authorised Representatives (Kyoto, 1994).
4) For example, Government Decree No. 464 / 2005 Coll., laying down technical requirements for measuring instruments, Government Decree No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended.
5) Government Decree No. 339 / 2002 Coll., on procedures for providing information in the field of technical regulations, technical documents and technical standards, as amended by Government Decree No. 178 / 2004 Coll.
6) Government Decree No. 291 / 2000 Coll., laying down the graphic form of the CE marking.
7) For example § 7a paragraph 1 (a) and (b) of Act No. 64 / 1986 Coll., on Czech Trade Inspection, as amended by Act No. 22 / 1997 Coll. and Act No. 205 / 2002 Coll.
8) Act No. 127 / 2005 Coll., on electronic communications and amending certain related laws (Act on electronic communications), as amended.
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Regulation Information
| Citation | Government Decree No. 616 / 2006 Coll., on technical requirements for products in terms of their electromagnetic compatibility |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.12.2006 |
|---|---|
| Effective from | 20.07.2007 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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