Regulations On Electromagnetic Compatibility Of Equipment

Original Language Title: Noteikumi par iekārtu elektromagnētisko saderību

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/138154

Cabinet of Ministers Regulations No. 483 in Riga, 20 June 2006 (pr. Nr. 33. § 12) the rules on the electromagnetic compatibility of equipment Issued in accordance with the law "on conformity assessment" article 7 General questions 1. determines the electromagnetic compatibility requirements, which apply to all market jam the electrical and electronic equipment (hereinafter equipment) that can cause electromagnetic interference or whose activities may affect such disorders, as well as the conformity assessment and market surveillance procedures and market surveillance authorities. 2. The equipment is any apparatus or fixed installation: 2.1.-any apparatus ready device or a combination thereof, which is commercially available as a single functional unit, intended for the consumer and which can cause electromagnetic interference or whose functioning can be affected by such disturbance;
2.2. fixed installation-various types of machines, and other devices of a certain combination, which assembled and installed at a designated place where it is intended to be used permanently. 3. Electromagnetic compatibility is the ability of equipment to function of electro magnetic environment without unacceptable electromagnetic disturbance to other equipment in that environment. 4. Electromagnetic interference is any electromagnetic phenomenon which may degrade the performance of equipment. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the electromagnetic wave propagation in the environment. 5. the provisions do not apply to: 5.1. radio equipment, electronic communications terminal equipment and Aero navigation equipment, which is subject to special regulations for electro magnetic compatibility requirements;
5.2. radio equipment used by radio, if radio equipment is not available on the market;
5.3. facilities for physical characteristics, is unable to create or supplement the electromagnetic radiation that is higher than the level at which operating radio equipment, electronic equipment or other equipment, and their actions could not appreciably degrade when using this equipment, electromagnetic disturbance occurs. 6. the equipment shall be designed and manufactured as to ensure that: 6.1 the electromagnetic disturbance generated does not interfere with radio equipment, communications equipment and other equipment for smooth operation, which has been specified by the manufacturer;
6.2. its ability to function without solid due to the presence of an electromagnetic disturbance, which usually occur when using the machine in the form provided. 7. The Ministry of economy in cooperation with the Technical Committee for Standardization recommends that the limited liability company "Latvian standards", reliance standard. 8. Limited liability company "Latvian standards" published in the newspaper "Latvian journal" the national status of the standards in the European Union adapted the harmonized standard list that you can apply those rules specified requirements (applicable standards). 9. Allow to offer the market and put into use only equipment that meets the requirements set out in these rules, if they are installed and used according to their intended purpose. 10. Trade fairs, exhibitions and similar events allowed exhibit equipment that does not meet the requirements of this regulation, unless there is a conspicuous sign clearly indicates that such equipment may not be placed on the market and to operate, as long as there is compliance with the requirements of this regulation. Installations may be played only if there are appropriate measures of electromagnetic disturb you. 11. market surveillance functions take the consumer protection Centre (hereinafter market supervisory authority). 12. equipment electromagnetic compatibility compliance assess certification bodies accredited by the State Agency "Latvian National Accreditation Bureau" (hereinafter-the accreditation Office) to the standard LVS EN 45011:2004 "General requirements for bodies dealing with product certification schemes", or any other of the European Union or the European economic area, notified body for which the accreditation of the Ministry of economy has published a notice in the newspaper "Gazette" (notified body). 13. the notified body shall meet the following minimum requirements: 13.1. it has the staff and technical equipment technical and administra tratīv tasks, related to electromagnetic compatibility test procedures;
13.2. the personnel have appropriate professional and technical training of the inspection procedures, as well as review, report and certificate in design;
13.3. the Director and the staff responsible for EMC conformity assessment and attestation of conformity procedures, not the equipment Designer, manufacturer, supplier or installer, or their authorized representative. This prohibition does not preclude the possibility of exchanges of technical information between the manufacturer and the notified body;
13.4. the staff remuneration does not depend on the inspection or test and the results of many ma;
13.5. the personnel shall respect the confidentiality of information acquired by the performance of work tasks, with the exception of information that is provided by a reasoned request for the market surveillance authority;
13.6. It provides its own insurance against civil liability in respect of actions it may take. 14. the Office for Accreditation, which is assessed by a notified body, checks that the rule contained in paragraph 13 requirements. 2. requirements for apparatus and their conformity assessment 15. apparatus shall be considered relevant electromagnetic compatibility requires good on, if the manufacturer or its authorised representative has proved that machines are designed and manufactured according to this provision, paragraph 6. 16. Machine manufacturer adds instructions for use of the apparatus, which includes the following information: 16.1. purpose of use of the apparatus;
16.2. the manufacturer's name or business name and address of the economic operator or the manufacturer's authorized representative, the name and surname or business name and address of the operator;
16.3. the identification of the apparatus (type, batch, serial number or any other information that allows the machines to be identified);
16.4. any special precautions to be observed when mounting the installing and using AIDS or carrying out maintenance, to ensure compliance with this provision of the apparatus (6);
16.5. a clear indication regarding restrictions on use, if compliance with this provision apparatus 6. requirements set out in paragraph not residential areas. In this case, the following also need to machine and packaging. 2.1. Internal production control by the manufacturer, making 17, evaluate its electromagnetic compatibility compliance with this provision in point 6. Correct use of the relevant applicable standards ensures compliance with this provision of the apparatus 6. requirements set out in paragraph 1 and is equivalent to the electromagnetic compatibility assessment of the apparatus. 18. If the manufacturer does not use the relevant applicable standards or use them, you need the machine conformity assessment on the dzētaj all its configurations, taking into account the machine operating conditions envisaged. 19. in order to verify the conformity of the apparatus requirements of this regulation, the manufacturer shall establish the technical documentation according to these regulations, paragraph 20. 20. The technical documentation shall include: 20.1. General description of the apparatus;
20.2. the manufacturer's certification of the conformity of the apparatus with the applicable standards and their listing if they used in whole or in part;
20.3. descriptions and explanations of all the measures taken to comply with this rule 6. punk the requirements (including electromagnetic compatibility assessment, Project calculates results, details of inspections carried out) if the manufacturer does not use any applicable standards or use repeated the part;
20.4. the notified body, if the certificate supplied by the apparatus into conformity assessed the notified body. 21. in order to verify the conformity of the apparatus requirements of this regulation, the manufacturer or its authorised representative draws up the EC declaration of conformity according to the provisions in point 22. 22. The EC declaration of conformity shall include the following information: 22.1. a reference to those rules and regulations that meet the requirements of the machine;
22.2. the identification of the apparatus (type, batch, serial number or any other information that allows the machines to be identified);
22.3. the manufacturer's name or business name and address of the economic operator or the manufacturer's authorized representative, the name and surname or business name and address of the operator;
22.4. dated reference to the specifications under which conformity is declared by the manufacturer of the apparatus of the requirements of this regulation;
22.5. The EC declaration of conformity date;

22.6. the manufacturer or his authorized representative name and signature. 23. the manufacturer or his authorised representative shall keep the technical documentation and the EC declaration of conformity for a period of 10 years after the manufacture of the apparatus and, if not difficult, presented them to the market surveillance authorities. If the manufacturer or his authorized representative does not perform commercial activities in the Member States of the European Union and European economic area countries, technical documentation and the EC declaration of conformity is kept and the market surveillance authority presented to the person who registers on the market. 2.2. Machine conformity assessment notified bodies 24. If the manufacturer or his authorised representative, before placing the apparatus on the market wants to take the assessment of conformity of the apparatus in the notified body, the manufacturer or his authorised representative shall refer the notified body at the disposal of the machine and its technical documentation. To check the machine's electromagnetic compatibility, specifies the essential requirements for the notified body to evaluate. 25. The notified body according to the manufacturer or its authorised representative the following essential requirements: 25.1. check the technical documentation of the apparatus, the apparatus has been manufactured in accordance with the submitted documentation and the requirements of these provisions, identify the ingredients that are used for designing applicable standards, and components in the design of the applicable standards are not used;
15.7. if applicable standards are used to assess electromagnetic compatibility or provide its assessment to establish whether the apparatus meets the provisions in point 6;
25.3. the examinations and tests carried out or taken to establish whether the manufacturer has used the applicable standards for which it has reported. 26. where apparatus meets the requirements of these provisions, the notified body shall issue the manufacturer or his authorised representative certificate of conformity of the apparatus, according to the estimate. 27. If the notified body shall take a decision not to issue a certificate of conformity, it shall give a reasoned refusal of the manufacturer or his authorised representative. Notified body's decision is final in the Ministry of the economy of the administrative procedure law. 3. apparatus apparatus marking of 28 that meets the requirements of this regulation, the manufacturer shall be marked with the CE marking (annex) under this provision in paragraph 29 and 30. 29. If the apparatus must also comply with other laws and regulations concerning the apparatus requirements in relation to the CE marking, the apparatus may be marked only if it also meets these requirements. The CE marking shall indicate conformity only to those laws and regulations that are applied by the manufacturer of the apparatus. 30. The CE marking shall be affixed to the instrument or its data plate, but if that is not possible, on the packaging and to the accompanying documents. 31. On the apparatus, its packaging or accompanying documents any other mark may be affixed, which do not impair the visibility and legibility of the CE marking, and may not deploy the mark, which is identical to the CE marking and is likely to mislead as to the meaning and form. 4. fixed setting of complex 32. Stationary complexes set up by using the good inženierpraks that documents using a stationary complex components which meet the requirements of these provisions, and accurately comply with complex components (and device) manufacturer instructions. 33. the apparatus which offers on the market and which can include site com, pleks all the requirements laid down in these rules relating to AIDS. 34. where the apparatus is intended to be included in the fixed installation, not otherwise commercially available, authorized not to apply the provisions of paragraph 6, section 2.1 and section 3 requirements for these machines. In such cases, the documentation accompanying the apparatus, in particular hospital complex and the electro magnetic compatibility parameters as well: 34.1. each machine ID (type, batch, serial number or other information that allows the machines to be identified);
21.3. in documentation accompanying the apparatus indicates the manufacturer's name or business name and address of the economic operator or the manufacturer's authorized representative, the name and surname or business name and address of economic operator;
21.3. the precautionary measures to be taken to include the fixed installation of the apparatus, without compromising the complex. 35. Stationary complexes are presumed to comply with the electromagnetic compatibility requirements if they comply with the provisions of paragraph 6, and paragraph 32 of the guarantees set out in the requirements. 36. in order to verify the compliance of the fixed installation requirements of these provisions, the installer or his authorized representative established in the hospital complex technical documentation according to the rules in paragraph 38. 37. The technical documentation shall include: 37.1. fixed installation General description, which contains information about the setup of the fixed installation environment requirements, additional accessories (such as protection devices, filters), determine the length of the cable of the external communication of the fixed installation, service life and special EMC precautions (such as aizsargiezemējum);
37.2. the description and explanation of all the measures taken to comply with this rule 6. punk, in including the electromagnetic compatibility assessment, Project calculates results, details of inspections carried out;
37.3. using good inženierpraks's documentation;
37.4. This provision referred to in paragraph 34 of the accompanying documents, where the fixed installation are used in these rules referred to in paragraph 34. 38. A Person who is in possession of fixed installation (hereinafter possessor) technical documentation as long as operating stationary complex, and, if necessary, the presentation of the market surveillance authority. 5. Market surveillance 39. Where the market surveillance authorities find that the apparatus does not meet the requirements laid down in these rules, the market surveillance authorities shall take all market surveillance regulations regulatory measures envisaged to remove the apparatus from the market, prohibit or restrict the marketing and circulation of its reports to the Ministry of Economy of the non-compliant apparatus for detection of indicating non-compliance reasons: 24.3. non-compliance with the rules laid down in point 6 of the requirements because of failure to comply with the requirements of applicable standards;
24.4. the wrong use of applicable standards;
39.3. lack of applicable standards specific requirements;
24.5. other reasons for non-compliance, if the applicable standards have not been used. 40. the Ministry of the economy shall report to the European Commission and the Member States of the European Union on detected cases of non-compliance of the apparatus and the measures taken, adding to the market surveillance authorities a report on the reasons for non-compliance. 41. The market surveillance authority shall inform the manufacturer or his authorized representative does not comply with the withdrawal from the market of the apparatus and the prohibition of free movement, indicating the reasons for the decision and the decision of the opposition and appeal procedures. 42. The manufacturer or his authorised representative shall have the right to express their views on the lack of conformity of the apparatus the requirements of these regulations before the market surveillance authority adopted a decision on the withdrawal from the market of the apparatus and the prohibition of free movement, except if the decision acceptable urgent consumer protection. 43. The market surveillance authorities may request evidence of compliance of the fixed installation, and to propose a conformity assessment body notified, if a fixed installation of signs show that this does not meet the requirements of this regulation, or if there are complaints about the fixed installation malfunctions. 44. where the market surveillance authority finds non-compliance of the fixed installation, its market surveillance regulations governing the order take measures to ensure the compliance of the fixed installation in point 6 of these rules. 6. Closing issues 45. Be declared unenforceable in the Cabinet may 30, 2000 regulations No 188 "equipment electromagnetic compatibility rules" (Latvian journal, 2000, 201./204.nr.). 46. following the entry into force of these provisions allowed to operate freely and marketed equipment conform to the Cabinet on May 30, 2000 regulations No 188 "equipment electromagnetic compatibility rules" and placed on the market before 20 July 2009. 47. the rules shall enter into force on the 20 July 2007. Informative reference to European Union Directive provisions included standards resulting from European Parliament and Council of 15 December 2004, Directive 2004/108/EC on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC. Prime Minister a. Halloween Minister of economy-Finance Minister O. Spurdziņš attachment of the Cabinet of Ministers of 20 June 2006 regulations no 483 CE marking the CE marking 1. certifying equipment, electromagnetic compatibility requirements, the large letters "CE": 2. If the CE marking is reduced or enlarged the size, proportions in the sample. 3. Label the vertical size may not be less than 5 mm. Minister of economy-Finance Minister o. Spurdziņš