Government Decree No. 18 / 2003 Coll.
Government Regulation laying down technical requirements for products with regard to their electromagnetic compatibility
Valid
Effective from 01.05.2004
18
GOVERNMENT REGULATION
of 9 December 2002
laying down technical requirements for products with regard to their electromagnetic compatibility
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., ("the Act ') to implement Sections 11 (2), 12 (1) and (3) and 13 (2) of the Act:
Basic provisions
(1) This Regulation lays down, in accordance with European Community law, technical requirements for products with regard to their electromagnetic compatibility.
(2) For the purposes of this Regulation:
(a) the apparatus shall consider any electrical or electronic device, including equipment and installations, containing electrical or electronic components;
(b) electromagnetic interference shall mean any electromagnetic phenomenon which may impair the functioning of any device or system, whereby electromagnetic interference may be an electromagnetic noise, an undesirable signal or a change in the characteristics of the environment itself in which the electromagnetic phenomenon is spread;
(c) the resistance considers the ability of the equipment or system to operate without deterioration of the quality of their function when electromagnetic interference occurs;
(d) electromagnetic compatibility shall consider the capability of the equipment or system to operate satisfactorily in the electromagnetic environment in which they are located without causing unacceptable electromagnetic interference of anything in that environment themselves;
(e) the EC type-examination certificate shall consider a document in which the notified person2) certifies that the type of instrument tested complies with the provisions of this Regulation which apply to it.
(3) The specified products under this Regulation are, within the meaning of Article 12 (1) (a) of the Act, all apparatus which may cause electromagnetic interference or whose functions may be affected by electromagnetic interference (hereinafter referred to as "instruments").
(4) This Regulation shall not apply to radio equipment used by radio amateurs in accordance with specific legislation, (3) where such equipment is not available on the trading network.
(5) (4) This Regulation shall not apply to such instruments or to such requirements where the technical requirements set out in Annex 1 to this Regulation (hereinafter referred to as protection requirements) are laid down in a specific legislation for certain apparatus.
(6) This Regulation shall not apply if it prevents the adoption of:
(a) measures relating to the putting into service and use of apparatus intended for specific location aimed at overcoming existing or anticipated electromagnetic compatibility problems;
(b) measures relating to the installation of equipment aimed at protecting public telecommunications networks or reception or broadcasting stations used for security purposes.
(7) The measures adopted pursuant to paragraph 6 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.
Conditions for placing on the market or putting into service
(1) The apparatus may be placed on the market or put into service only if it complies with the protection requirements and must be so carried out as to ensure that it is properly installed, maintained and used for the purposes for which it is intended,
(a) the electromagnetic interference which it causes does not exceed the level permitted or determined for the operation of radio-communications, telecommunications or other devices in accordance with the intended purpose;
(b) it has adequate resistance to electromagnetic interference to enable it to operate in accordance with the intended purpose.
(2) The conditions referred to in paragraph 1 shall be deemed to be met if the apparatus is in conformity with:
(a) harmonised Czech technical standards or, where applicable, foreign technical standards transposing harmonised European standards in the Member States of the European Union (Section 4a of the Act); or
(b) with designated standards (Section 4a of the Act) covering Czech or foreign technical standards notified for this purpose by the Commission of the European Communities, where there are no standards under (a) in the relevant field.
Conformity assessment procedures
(1) For apparatus for which the manufacturer has applied the technical standards referred to in Article 2 (2), the manufacturer or his authorised representative shall certify the conformity of the apparatus with the provisions of this Regulation by issuing the EC declaration of conformity and the CE marking referred to in Article 4.
(2) In the case of apparatus for which the manufacturer has not used or has only partly applied the technical standards referred to in Article 2 (2), or where such standards do not exist, the manufacturer or his authorised representative must have a set of design documentation available before being placed on the market. This file shall describe the apparatus, the procedures used to ensure compliance of the apparatus with the requirements referred to in Article 2 (1) and include a technical report or certificate issued by a person authorised to do so by the authorisation decision and notified as competent pursuant to Article 7 (7) (b) of the Act or by a foreign competent person. The conformity of apparatus with the apparatus described in the design documentation file shall be certified by the manufacturer or his authorised representative in accordance with the procedure referred to in paragraph 1.
(3) In the case of radio broadcasting apparatus as defined in the international agreement, (5) Except for those referred to in Paragraph 1 (4), the manufacturer or his authorised representative shall certify the conformity of the apparatus with the provisions of this Regulation only after having received the EC type-examination certificate of the instrument, issued by the notified person.
(4) The conformity assessment documents (Section 13 (7) of the Act) include the EC declaration of conformity and, where the conformity assessment procedure referred to in paragraph 2 is applied, a set of design documentation referred to in paragraph 2. Where the manufacturer is not established in the territory of the European Community or there is no authorised representative, the person who places the product on the market shall be responsible for providing evidence of conformity assessment at the request of the supervisory authority.
(5) The EC declaration of conformity shall contain:
(a) a description of the instrument to which it relates;
(b) a reference to the technical specifications on the basis of which conformity is declared and a reference to legislation4) related to ensuring the conformity of the apparatus with the provisions of this Regulation, where such provisions have been applied;
(c) identification of the person authorised to act on behalf of the manufacturer or authorised representative (for a natural person, name and last name and permanent address or place of business, name or business name and registered office),
(d) a reference to the EC type-examination certificate issued by the notified person, where such certificate has been issued.
CE marking and other marking
(1) The CE marking, the graphic form of which is laid down in a specific legislation, (6) shall be placed directly on the apparatus or, if this is not possible, on its packaging, instructions for use or guarantee sheet. The apparatus shall not bear a marking which could mislead anyone with regard to the CE marking. A marking other than the CE marking may be affixed to the apparatus, its packaging, the instructions for use or the guarantee sheet, but this shall not reduce the visibility and, where appropriate, the legibility of the CE marking.
(2) The CE marking shall state on the apparatus that the product complies with the technical requirements laid down in all the legislation applicable to it and which provides for or allows such marking and that the procedure laid down in the conformity assessment procedure has been followed. However, if one or more laws allow the manufacturer, for a transitional period, to choose which provisions he will follow, the CE marking shall indicate compliance only with those laws or their provisions used by the manufacturer. In this case, the documentation, warnings or instructions required by the legislation concerned and annexed to the products concerned shall indicate the relevant European Community legislation or provisions applied by the manufacturer.
Notification of the imposition of a safeguard measure
In the event that a protective measure has been imposed on the apparatus under a special legislation, (7) the notification of the decision to impose a protective measure under Article 7 (8) of the Act shall indicate whether the non-compliance with the requirements under Article 2 (1) was caused by:
(a) failure to comply with the requirements of Article 2 (1) where the apparatus does not comply with the technical standards referred to in Article 2 (2); or
(b) incorrect application of the technical standards referred to in Article 2 (2); or
(c) shortcomings in the technical standards referred to in Article 2 (2).
Authorisation conditions
(1) In authorising legal persons to issue EC type-examination certificates or legal persons to issue technical reports or certificates referred to in Article 3 (2), the conditions set out in Annex 2 to this Regulation shall apply. Legal persons meeting the criteria laid down in the relevant harmonised technical standards shall be deemed to comply with the relevant conditions.
(2) The authorised person responsible for issuing EC type-examination certificates shall become a notified person in accordance with the procedure laid down in Article 11 (7) of the Act.
Transitional and final provisions
(1) Valid certificates or other documents issued pursuant to Government Decree No. 169 / 1997 Coll., as amended by Government Decree No. 282 / 2000 Coll., may be used for the purposes of conformity assessment under this Regulation unless they are repealed under the conditions laid down by law.
(2) Persons entrusted with activities in conformity assessment pursuant to § 1 (2) (e) of Government Decree No. 169 / 1997 Coll., as amended by Government Decree No. 282 / 2000 Coll., shall be deemed to be competent persons under § 3 (2) of this Regulation.
(3) Persons authorised to carry out conformity assessment activities as authorised persons issuing an EC type-examination certificate within the meaning of Article 1 (2) (f) of Government Regulation No 169 / 1997 Coll., as amended by Government Regulation No 282 / 2000 Coll., shall be deemed to be authorised persons authorised to issue EC type-examination certificates under this Regulation.
The following shall be deleted:
1. Government Decree No. 169 / 1997 Coll., laying down technical requirements for products with regard to their electromagnetic compatibility.
2. Government Decree No. 282 / 2000 Coll., amending the Government Decree laying down technical requirements for products with regard to their electromagnetic compatibility.
Efficacy
This Regulation shall enter into force on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Prime Minister:
PhDr. Špidla v. r.
Minister for Industry and Trade:
Ing. Rusnok v. r.
Příloha č. 1
Annex No. 1 to Government Decree No. 18 / 2003 Coll.
LIST OF MAIN PROTECTION REQUIREMENTS
The maximum electromagnetic interference generated by the apparatus must not make it difficult to use in particular:
(a) domestic radio and television receivers;
(b) industrial production facilities;
(c) mobile radio equipment;
(d) mobile radio and commercial radio telephony equipment;
(e) medical and scientific instruments;
(f) information technology equipment;
(g) household appliances and electronic household appliances;
(h) radio equipment for navigation and aviation;
(i) electronic teaching equipment;
(j) telecommunications networks and equipment;
(k) radio and television transmitters;
(l) lamps and fluorescent lamps.
The apparatus, and in particular the apparatus referred to in points (a) to (l), shall be so designed that, in the normal environment of electromagnetic compatibility in which it is intended to be used, it has an adequate level of electromagnetic resistance to enable its uninterrupted operation, taking into account the level of interference generated by the apparatus which complies with the technical standards referred to in Article 2 (2) of this Regulation.
The information necessary for the use of the apparatus, in accordance with its intended purpose, shall be contained in the instructions attached to the apparatus.
Příloha č. 2
Annex No 2 to Decree No 18 / 2003 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 employees.
3. The independence of staff and technical staff who carry out tests, prepare reports, issue certificates and carry out verifications pursuant to this Regulation, to all organisations, groups or persons directly or indirectly interested in the product concerned.
4. Maintaining the confidentiality of employees (Section 20a of the Act).
5. Damage liability insurance (§ 11 (3) of the Act).
1) Council Directive 89 / 336 / EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, as amended by Council Directive 91 / 263 / EEC, Council Directive 92 / 31 / EEC and Council Directive 93 / 68 / EEC.
2) § 2 (i) of Act No. 22 / 1997 Coll., as amended by Act No. 205 / 2002 Coll.
3) Decree No. 201 / 2000 Coll., on technical and operational conditions of amateur radio communication service.
4) For example, Government Regulation No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 336 / 2001 Coll.
5) International Convention on Telecommunications, established under No 190 / 1968 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.
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Regulation Information
| Citation | Government Regulation No. 18 / 2003 Coll., laying down technical requirements for products with regard to their electromagnetic compatibility |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.02.2003 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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