Published: 2015-07-18
Key Benefits:
Passed 14.07.2015 Annex 91
This Regulation is enacted on the basis of Section 5(4) of the Product Conformity Act, Section 1(1)(4) and 1(2) of Government of the Republic Regulation No 123 of 26 August 2010 on the granting of powers to establish requirements for products and a conformity assessment procedure and to designate a market surveillance authority, and Section 5(3) of the Equipment Safety Act.
The requirements set out in this Chapter apply to low-voltage electrical equipment covered by Directive 2014/35/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357), i.e. to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current (‘low-voltage equipment’).
(1) Low-voltage equipment must have been constructed in accordance with the good engineering practice in safety matters in force in the European Union and it must not endanger the health and safety of persons and domestic animals, or property, when properly installed and maintained and used in applications for which it was made.
(2) The essential characteristics of low-voltage equipment, the recognition and observance of which ensure that the equipment is used safely and in applications for which it was made, shall be marked on the equipment or, if this is not possible, in an accompanying document.
(3) Low-voltage equipment, together with its component parts, shall be made in such a way as to ensure that it can be safely and properly assembled and connected.
(4) Low-voltage equipment shall be so designed and manufactured as to ensure protection against the hazards set out in Sections 4 and 5 of this Regulation, provided that the equipment is used in applications for which it was made and is adequately maintained.
(1) Low-voltage equipment shall bear a type, batch or serial number or another label that enables the equipment to be identified. Where the size or nature of the equipment does not allow this, the corresponding information shall be provided in a document accompanying the equipment or on its packaging.
(2) The name, registered trade name or trademark and contact details (address) of the manufacturer shall be indicated on low-voltage equipment. Where the size or nature of the equipment does not allow this, the corresponding information shall be provided in a document accompanying the equipment or on its packaging. The contact details shall be in a language easily understood by the end-user and the market surveillance authority.
(3) Low-voltage equipment must be accompanied by instructions and safety information in a language understood by the end-user. Such instructions and safety information, as well as any labelling, must be clear, understandable and intelligible. Information that is aimed at the consumer and accompanies low-voltage equipment to be marketed in Estonia must be in Estonian.
The manufacturer shall take technical measures to ensure that:
1) persons and domestic animals are adequately protected against the danger of physical injury or other harm which might be caused by direct or indirect contact with the electrical equipment;
2) dangerous temperatures, arcs or radiation are not produced;
3) persons, domestic animals and property are adequately protected against non-electrical dangers shown by experience to be caused by the electrical equipment;
4) the insulation is suitable for the foreseeable conditions.
The manufacturer shall take technical measures to ensure that the low-voltage equipment:
1) meets the expected mechanical requirements in such a way that persons, domestic animals and property are not endangered;
2) is resistant to non-mechanical influences in the expected environmental conditions, in such a way that persons, domestic animals and property are not endangered;
3) does not endanger persons, domestic animals and property in foreseeable conditions of overload.
(1) Low-voltage equipment that meets the appropriate requirements set out in the harmonised standards shall be presumed to be in conformity with the requirements set out in Sections 2, 4 and 5 of this Regulation.
(2) Where there are no harmonised standards, low-voltage equipment shall be presumed to meet the requirements if it meets the safety requirements which are set out in the standards of international standard-setting organisations and which the European Commission has notified to the Member States.
(3) Where there are no harmonised standards or no notified safety requirements set out in the standards of international standard-setting organisations, low-voltage equipment shall be presumed to meet the requirements if it meets the safety requirements set out in the national standard of the Member State of the European Economic Area in which it is manufactured, on condition that the level of safety required in Estonia and conformity to the requirements set out in Sections 2, 4 and 5 of this Regulation are guaranteed.
(4) The conformity of low-voltage equipment to the requirements shall be attested by following the procedure set out in Section 7.
The conformity of low-voltage equipment to the requirements shall be attested by the following activities as part of internal production control:
1) drawing up the technical documentation;
2) drawing up the declaration of conformity;
3) affixing the conformity marking.
(1) The manufacturer of low-voltage equipment shall draw up the technical documentation. The technical documentation shall make it possible to assess the conformity of the low-voltage equipment to the relevant requirements, and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the low-voltage equipment. The technical documentation shall, wherever applicable, contain at least the following elements:
1) a general description of the low-voltage equipment;
2) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
3) descriptions and explanations necessary for understanding of the designs and schemes referred to in indent 2 and of the operation of the low-voltage equipment;
4) a list of the harmonised standards that have been applied either in part or in full or, in the cases referred to in Section 6(2) and (3) of this Regulation, a list of the international and national standards or, where no standards have been applied, a list of other measures to ensure the conformity of the low-voltage equipment. Where standards are applied in part, the technical documentation shall specify the parts which have been applied;
5) results of design calculations made, examinations carried out, etc.;
6) test reports.
(2) The manufacturer of electrical equipment shall take measures to ensure that the manufacturing process conforms to the technical documentation and the requirements set out in the legislation.
(1) By drawing up a declaration of conformity, a manufacturer of low-voltage equipment demonstrates the compliance of the equipment with the requirements and assumes responsibility for the compliance of the equipment.
(2) A declaration of conformity shall be drawn up for each product model. The declaration shall be updated continuously and kept at the disposal of the market surveillance authorities for 10 years after the electrical equipment is placed on the market.
(3) Where low-voltage equipment is subject to more than one European Union act requiring a declaration of conformity, a single declaration shall be drawn up in respect of all such acts. That declaration must contain information on the European Union acts concerned, including their publication references.
(4) A declaration of conformity must follow the model set out in Annex IV to Directive 2014/35/EU of the European Parliament and of the Council.
(5) The declaration of conformity shall be drawn up by the manufacturer. It may also be drawn up by the manufacturer’s authorised representative, if the manufacturer has issued a written mandate to that effect.
(1) Low-voltage equipment that meets the requirements must bear a conformity marking before it is placed on the market. The provisions of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30) apply to the conformity marking.
(2) The manufacturer of low-voltage equipment shall affix the conformity marking to the electrical equipment or, where this is not possible, to the packaging and instructions for use or to another document accompanying the equipment. The conformity marking may also be affixed by the manufacturer’s authorised representative, if the manufacturer has issued a written mandate to that effect.
(3) Where low-voltage equipment is subject to the requirements of another European Union act that also lays down the obligation to affix a conformity marking before the equipment is placed on the market, the manufacturer or the manufacturer’s authorised representative confirms by affixing a conformity marking that the low-voltage equipment also meets the requirements of that act.
(1) The requirements set out in this Chapter apply to electrical equipment and installations covered by Directive 2014/30/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
(2) Electrical equipment which has been placed on the market and which may be incorporated into an electrical installation shall be subject to all the requirements set out for electrical equipment.
(3) Electrical equipment which is intended for incorporation into a particular electrical installation and is not commercially available shall not be subject to the requirements set out in Sections 13 and 14 of this Regulation or to the requirements set out in this Chapter concerning the conformity assessment of electrical equipment.
(4) In the case referred to in subsection 3 of this Section, the documents accompanying the electrical equipment shall identify the electrical installation and its electromagnetic compatibility characteristics and shall indicate the precautions to be taken when incorporating the electrical equipment into the electrical installation so as not to compromise the conformity of that installation.
(1) ‘Electrical equipment’ means any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance. Components or sub-assemblies intended for incorporation into electrical equipment by the end-user, which are liable to generate electromagnetic disturbance or the performance of which is liable to be affected by such disturbance, and mobile installations defined as a combination of electrical equipment and, where applicable, other devices, which are intended to be moved and operated in a range of locations, are also deemed to be electrical equipment.
(2) ‘Electrical installation’ means a particular combination of several types of electrical equipment and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location.
(3) ‘Electromagnetic compatibility’ means the ability of electrical equipment and electrical installations to function satisfactorily in their electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment.
(4) ‘Electromagnetic disturbance’ means any electromagnetic phenomenon which may degrade the performance of electrical equipment or an electrical installation. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself.
(5) ‘Immunity’ means the ability of electrical equipment or an electrical installation to perform as intended without degradation in the presence of an electromagnetic disturbance.
(6) ‘Electromagnetic environment’ means all electromagnetic phenomena observable in a given location.
(1) Electrical equipment and electrical installations shall be so designed and manufactured, having regard to the state of the art, as to ensure, when they are used in applications for which they are made, that:
1) the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other electrical equipment or installations cannot operate as intended;
2) they have a level of immunity to the electromagnetic disturbance to be expected in their intended use which allows them to operate without unacceptable degradation of their intended use.
(2) Having regard to the requirements set out in subsection 1 of this Section, electrical installations shall be installed applying good engineering practices and respecting the information on the intended use of their components. Those good engineering practices shall be documented, and the documentation shall be kept available for as long as the installation is in operation.
(3) Electrical equipment and installations that meet the appropriate requirements for electromagnetic compatibility as set out in harmonised standards shall be presumed to be in conformity with the electromagnetic compatibility requirements.
(1) Electrical equipment shall be accompanied by information on any specific precautions that must be taken when the equipment is assembled, installed, maintained or used, in order to ensure that, when put into service, the equipment is in conformity with the electromagnetic compatibility requirements. Such instructions and information, as well as any labelling, must be clear, understandable to the end-user and intelligible. Information that is aimed at the consumer and accompanies electrical equipment to be marketed in Estonia must be in Estonian.
(2) Electrical equipment for which compliance with the electromagnetic compatibility requirements is not ensured in residential areas shall be accompanied by a clear indication of the restriction of use, where appropriate also on the packaging.
(3) The information required to enable electrical equipment to be used in accordance with its intended purpose shall be included in the instructions accompanying the equipment.
(1) The manufacturer shall demonstrate the compliance of electrical equipment with the requirements using either of the following conformity assessment procedures:
1) internal production control as set out in Section 16 of this Regulation;
2) type examination as set out in Section 17 of this Regulation, followed by assessment of conformity to type based on internal production control as set out in Section 18 of this Regulation.
(2) The manufacturer may choose to restrict the application of the procedure referred to in indent 2 of subsection 1 of this Section to some aspects of the essential requirements, provided that for the other aspects of the essential requirements the procedure referred to in indent 1 of subsection 1 of this Section is applied.
(1) The manufacturer shall assess the electromagnetic compatibility of electrical equipment and its conformity with the requirements. The electromagnetic compatibility assessment shall take into account all normal intended operating conditions. Where the electrical equipment is capable of taking different configurations, the electromagnetic compatibility assessment must confirm whether the electrical equipment meets the essential requirements in all the possible configurations identified by the manufacturer as representative of its intended use.
(2) The manufacturer shall draw up the technical documentation and take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the electrical equipment with the technical documentation and the electromagnetic compatibility requirements. The technical documentation must meet the requirements set out in Annex II to Directive 2014/30/EU of the European Parliament and of the Council.
(3) The manufacturer shall draw up a declaration of conformity for each model of electrical equipment that meets the requirements and keep it together with the technical documentation at the disposal of the market surveillance authorities for at least 10 years after the device is placed on the market. The declaration of conformity must follow the model set out in Annex IV to Directive 2014/30/EU of the European Parliament and of the Council.
(4) The manufacturer shall affix the conformity marking to all electrical equipment that meets the requirements. The requirements for the conformity marking and for affixing it are set out in Section 10 of this Regulation.
(5) The declaration of conformity may also be drawn up and the conformity marking affixed by the manufacturer’s authorised representative, if the manufacturer has issued a written mandate to that effect.
(1) Type examination is the assessment, by a conformity assessment body that holds the appropriate right to operate, of the adequacy of the technical design of electrical equipment through examination of the technical documentation, without examination of a specimen (design type). It may be restricted to some aspects of the essential requirements as specified by the manufacturer or the manufacturer’s authorised representative.
(2) The manufacturer shall lodge an application for type examination with a single conformity assessment body of its choice. The application shall specify the aspects of the essential requirements for which examination is requested and shall include:
1) the name and address of the manufacturer and, if the application is lodged by the authorised representative, also the name and address thereof;
2) a written declaration that the same application has not been lodged with any other conformity assessment body;
3) technical documentation that meets the requirements set out in Annex II to Directive 20147/30/EU of the European Parliament and of the Council.
(3) The conformity assessment body shall examine the technical documentation and assess the adequacy of the technical design of the electrical equipment in relation to the aspects of the essential requirements for which examination is requested.
(4) The conformity assessment body shall draw up an evaluation report that records the activities undertaken in accordance with subsection 3 and their outcomes. Without prejudice to the conformity assessment body’s obligations vis-à-vis the authority that granted its right to operate or the market surveillance authority, the conformity assessment body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
(5) Where the type meets the requirements that apply to the electrical equipment concerned, the conformity assessment body shall issue a type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The type examination certificate may have one or more annexes attached. The type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured electrical equipment with the examined type to be evaluated and to allow for in-service control. Where the type does not meet the applicable requirements, the notified body shall refuse to issue a type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
(6) The conformity assessment body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements, and shall determine whether such changes require further investigation. If so, the conformity assessment body shall inform the manufacturer accordingly.
(7) The manufacturer shall inform the conformity assessment body that holds the technical documentation relating to the type examination certificate of all modifications to the approved type that may affect the conformity of the electrical equipment with the essential requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original type examination certificate.
(8) The conformity assessment body shall inform the authority that granted its right to operate concerning the type-examination certificates or any additions thereto which it has issued or withdrawn, and shall, periodically or on request, make available to the authority that granted its right to operate the list of certificates or any additions thereto refused, suspended or otherwise restricted. Each conformity assessment body shall inform the other conformity assessment bodies concerning the type examination certificates or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, on request, concerning such certificates or additions thereto which it has issued. The conformity assessment body shall keep a copy of the type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
(9) The manufacturer shall keep a copy of the type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the electrical equipment is placed on the market.
(10) The manufacturer’s authorised representative may lodge the application referred to in subsection 2 of this Section and fulfil the obligations set out in subsections 7 and 9, if the manufacturer has issued a written mandate to that effect.
(1) Conformity to type based on internal production control is the part of conformity assessment whereby the manufacturer fulfils the obligations laid down in subsections 2, 3 and 4 of this Section, and ensures and declares that the electrical equipment concerned is in conformity with the type described in the type examination certificate and satisfies the applicable requirements.
(2) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured electrical equipment with the approved type described in the type examination certificate and with the applicable requirements.
(3) The manufacturer shall draw up a declaration of conformity for each model of electrical equipment that meets the requirements and keep it together with the technical documentation at the disposal of the market surveillance authorities for at least 10 years after the electrical equipment is placed on the market. The declaration of conformity must follow the model set out in Annex IV to Directive 2014/30/EU of the European Parliament and of the Council.
(4) The manufacturer shall affix the conformity marking to each device that meets the requirements. The requirements for the conformity marking and for affixing it are set out in Section 10 of this Regulation.
(5) The declaration of conformity may also be drawn up and the conformity marking affixed by the manufacturer’s authorised representative, if the manufacturer has issued a written mandate to that effect.
The Technical Regulatory Authority shall carry out supervision of the requirements set out in this Regulation, in accordance with the procedures set out in the Product Conformity Act.
Where the conformity of electrical equipment to the requirements is attested in accordance with Directive 2004/108/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ L 390, 31.12.2004, p. 24) and Directive 2006/95/EC of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (OJ L 374, 27.12.2006, p. 10), that electrical equipment may be placed on the market until 20 April 2016.
1Directive 2014/30/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79); Directive 2014/35/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
Kristen Michal
Minister for Economic Affairs and Infrastructure
Ahti Kuningas
Deputy Secretary-General for Transport (for the Secretary-General)
