Government Regulation No. 118 / 2016 Coll.
Government regulation on conformity assessment of electrical equipment intended for use within certain voltage limits when making them available on the market
Valid
Regulation
Effective from 20.04.2016
118
GOVERNMENT REGULATION
of 30 March 2016
on the conformity assessment of electrical equipment intended for use within certain voltage limits when making them available on the market
The Government mandates, pursuant to Sections 4 and 50 (5) of Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market ("the Act '):
Subject matter
(1) This Regulation implements the relevant European Union1 Regulation and regulates the technical requirements for electrical equipment intended for use within certain voltage limits which they must meet when placing on the market, the conditions and procedures for making them available on the market and the conformity assessment procedure.
(2) This Regulation shall apply to electrical equipment intended for use in the range of rated voltages for AC current from 50 to 1000 V and for DC current from 75 to 1,500 V (hereinafter referred to as "electrical equipment ').
(3) This Regulation shall not apply to equipment and radio and electrical interference listed in Annex 2 to this Regulation.
Technical requirements for electrical equipment
The essential technical requirements for electrical equipment shall be the essential requirements of the safety principles for electrical equipment intended for use within certain voltage limits set out in Annex 1 to this Regulation. Compliance with the essential technical requirements shall be demonstrated by conformity assessment.
Supply on the market
Only electrical equipment which is manufactured in accordance with good technical safety practice may be made available on the market and which, provided that it is correctly installed, maintained and used for the purpose for which it was manufactured, does not endanger the health and safety of persons, domestic animals or property.
Manufacturer
(1) Before placing electrical equipment on the market, the manufacturer shall ensure that such equipment is designed and manufactured in accordance with the essential technical requirements set out in Annex 1 to this Regulation, draw up the technical documentation referred to in Annex 3 to this Regulation and carry out or have carried out the conformity assessment procedure set out in Annex 3 to this Regulation.
(2) Where the conformity of electrical equipment with the essential technical requirements set out in Annex 1 to this Regulation has been demonstrated by a conformity assessment procedure, the EU manufacturer shall draw up a declaration of conformity and place the CE marking in accordance with Article 12.
(3) The manufacturer shall keep the technical documentation and the EU declaration of conformity for a period of 10 years from the placing on the market of electrical equipment.
(4) The manufacturer shall ensure that procedures are in place to ensure that serially manufactured products comply with the requirements laid down in this Regulation, including where changes in design or parameters of electrical equipment or changes in harmonised standards referred to in § 10 (1) (a), international standards referred to in § 10 (1) (b), Czech technical standards referred to in § 10 (1) (c) or other documents prescribing the technical requirements to be met by electrical equipment (hereinafter referred to as "technical specifications') on the basis of which conformity of electrical equipment is declared.
(5) In order to protect the health and safety of end-users, the manufacturer shall carry out tests on samples of electrical equipment made available on the market and other necessary investigations, where necessary in view of the risks posed by the electrical equipment, in view of the manufacturer's intended purpose of use. The manufacturer shall carry out such tests and investigations to the extent necessary to confirm or eliminate the existing risk. The manufacturer shall keep a record of complaints, non-compliant electrical equipment and equipment withdrawn and shall keep distributors informed of such activities.
(6) The manufacturer shall ensure that the electrical equipment which he has placed on the market bears the type or batch number or serial number or other element enabling it to be identified, or in cases where the size or nature of the electrical equipment does not allow the required information to be given on his packaging or on the document accompanying the electrical equipment.
(7) The manufacturer shall also indicate on the electrical equipment or, if this is not possible, on the packaging or in the document accompanying the electrical equipment his name or business name or trade mark, as the case may be, and the address for service at which he can be contacted. The delivery address shall be the address of the place at which the manufacturer can actually be contacted. The contact details shall be given in a language easily understood by end-users and the supervisory authority.
(8) The manufacturer shall ensure that the electrical equipment is accompanied by instructions and safety information in the Czech language. Such instructions, safety information and any markings shall be clear, understandable and easily understandable.
Authorised representative
The authorised representative shall keep the EU declaration of conformity and the technical documentation at the disposal of the supervisory authority for 10 years from the placing on the market of the electrical equipment.
Importer
(1) Before placing electrical equipment on the market, the importer shall ensure that the manufacturer carries out the conformity assessment procedure, draws up the technical documentation, places the CE marking on the electrical equipment, attaches the required documents and complies with the requirements laid down in paragraphs 6 and 7 of Section 4.
(2) The importer shall indicate on the electrical equipment or, if this is not possible, on the packaging or on the document accompanying the electrical equipment his name or business name or trade mark, as the case may be, and the address for service at which he can be contacted. The contact details shall be given in a language easily understood by end-users and the supervisory authority.
(3) The importer shall ensure that the electrical equipment is accompanied by instructions and safety information in the Czech language.
(4) The importer shall, in order to protect the health and safety of end-users, carry out tests on samples of electrical equipment made available on the market and other necessary investigations where appropriate in view of the risks posed by electrical equipment. The importer shall carry out such tests and investigations to the extent necessary to confirm or eliminate the risk. The importer shall keep records of complaints, non-compliant electrical equipment and electrical equipment withdrawn and shall keep distributors informed of such activities.
(5) The importer shall, for a period of 10 years from the placing on the market of electrical equipment, keep a copy of the EU declaration of conformity at the disposal of the supervisory authority and ensure that technical documentation can be submitted to the supervisory authority upon request.
Distributor
Before making electrical equipment available on the market, the distributor shall verify that:
(a) the electrical equipment bears the CE marking;
(b) the electrical equipment is accompanied by the required documentation and instructions and safety information in the Czech language; and
(c) the manufacturers and importers have complied with the relevant requirements set out in Sections 4 (6) and (7) and 6 (2).
Time for identification of operator
The operator shall keep for a period of 10 years after the supply of the electrical equipment on the market the data by which, at the request of the supervisory authority, the operator who supplied the electrical equipment to him or to him may be identified.
Conformity assessment procedure
The conformity assessment procedure for electrical equipment shall be the internal production control (Module A) set out in Annex 3 to this Regulation.
Presumption of conformity
(1) If the electrical equipment conforms to
(a) harmonised standards (2) or parts thereof to which references have been published in the Official Journal of the European Union;
(b) the safety provisions of international standards established by the International Electrotechnical Commission (IEC), where the standards referred to in (a) have not yet been established and published and those safety provisions have been published by the European Commission; or
(c) the safety provisions of the Czech technical standards, in the absence of the technical standards referred to in (a) or (b);
it shall be deemed to comply with the essential technical requirements set out in Annex 1 to this Regulation to which those standards or parts thereof apply.
(2) The Office for Technical Standardisation, Metrology and State Testing shall publish in the Bulletin of the Office for Technical Standardisation, Metrology and State Testing the standards referred to in paragraph 1 (b) and (c).
EU declaration of conformity
(1) The EU declaration of conformity demonstrates compliance with the essential requirements set out in Annex 1 to this Regulation.
(2) The EU declaration of conformity shall be drawn up in accordance with the model set out in Annex 4 to this Regulation. The declaration shall contain the information set out in Module A set out in Annex 3 to this Regulation and shall be kept up to date. The EU declaration of conformity shall also be translated into the language (s) required by the Member State of the European Union in which the electrical equipment is placed or made available on the market.
(3) Where electrical equipment is subject to more than one European Union harmonisation regulation providing for the drawing up of an EU declaration of conformity, a single EU declaration of conformity shall be drawn up with references to all those provisions under which conformity has been assessed, including references to their publication. This single EU declaration of conformity may take the form of a component consisting of declarations of conformity issued for each Regulation.
Placing the CE marking
The CE marking which is placed on the market before the electrical equipment is placed on the market shall be placed on the electrical equipment or its production label. Where this is not possible or justified due to the nature of the electrical equipment, it shall be placed on the packaging and accompanying documents.
Formal deficiencies
A formal deficiency shall be considered to be:
(a) the CE marking has been placed in breach of Article 30 of Regulation (EC) No 765 / 2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93 or Article 12;
(b) the CE marking has not been affixed;
(c) the EU declaration of conformity has not been drawn up;
(d) the EU declaration of conformity has not been drawn up in accordance with this Regulation;
(e) the technical documentation is missing or incomplete;
(f) the information provided for in Article 4 (7) or Article 6 (2) is missing or incorrect or incomplete; or
(g) another administrative requirement referred to in § 4 or § 6 has not been met.
Transitional provision
Electrical equipment complying with the requirements laid down by Decree No. 17 / 2003 Coll. may continue to be made available on the market if it was placed on the market before 20 April 2016.
Repeal
Government Decree No. 17 / 2003 Coll., laying down technical requirements for low voltage electrical equipment, is hereby repealed.
Efficacy
This Regulation shall enter into force on 20 April 2016.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.
Příloha č. 1
Annex No 1 to Government Regulation No 118 / 2016 Coll.
ESSENTIAL SAFETY PRINCIPLES REQUIREMENTS FOR ELECTRIC DEVICES INTENDED FOR USE IN CERTAIN DISTRIBUTIONS
1. General conditions
(a) on the electrical equipment or, where this is not possible, on the accompanying document, the essential particulars and instructions, the knowledge and compliance of which shall ensure that the electrical equipment is used safely and for the purpose for which it was manufactured;
(b) electrical equipment and its components shall be so designed as to be safely and correctly assembled and connected;
(c) electrical equipment shall be designed and constructed in such a way as to ensure protection against the hazards referred to in points 2 and 3 when used for the purposes for which it is intended and properly maintained.
2. Protection against hazards that may be caused by electrical equipment
In accordance with point 1, technical measures shall be provided for in such a way that:
(a) persons and domestic animals are adequately protected from the risk of physical injury or other damage which could be caused by direct contact or indirectly;
(b) there are no temperatures, electrical arches or radiations which could be dangerous;
(c) persons, domestic animals and property have been adequately protected from risks of a non-electrical nature which, according to experience, could be caused by electrical equipment; and
(d) the insulation complies with foreseeable conditions.
3. Protection against hazards that may arise from external effects on electrical equipment
In accordance with point 1, technical measures shall be laid down to ensure that electrical equipment:
(a) comply with the envisaged conditions of mechanical stress in such a way as to avoid endangering persons, domestic animals and property;
(b) be resistant to non-mechanical effects under the foreseeable environmental conditions so as to avoid endangering persons, domestic animals and property; and
(c) under foreseeable conditions of congestion does not endanger persons, pets and property.
Příloha č. 2
Annex No 2 to Government Regulation No 118 / 2016 Coll.
ESTABLISHMENTS AND NOVERS NOT FALLING INTO THE SCOPE OF THIS REGULATION
This Regulation shall not apply to:
1. electrical equipment intended for use in potentially explosive atmospheres;
2. electrical equipment intended for radiology and medical purposes;
3. electrical components for freight and passenger lifts,
4. electrometers;
5. household sockets and forks,
6. equipment for power supply of electrical bays,
7. radio and electrical interference,
8. specialised electrical equipment for use on ships, aircraft and railways which comply with the security rules developed by the international authorities in which the Member States of the European Union are represented,
9. tailor-made assessment kits for professionals exclusively for use in research and development facilities intended for this purpose.
Příloha č. 3
Annex No. 3 to Government Regulation No. 118 / 2016 Coll.
Internal production control (Module A)
1. Internal production control
Internal production control shall be a conformity assessment procedure whereby the manufacturer carries out the activities set out in points 2, 3 and 4 and guarantees and declares, under his responsibility, that the electrical equipment concerned complies with the requirements of this Regulation which apply to it.
2. Technical documentation
The manufacturer shall draw up the technical documentation. The documentation shall allow an assessment of the conformity of electrical equipment with the relevant requirements and shall include an appropriate analysis and risk assessment. The technical documentation shall specify the relevant requirements and, to the extent necessary for the assessment, shall relate to the design, manufacture and operation of the electrical equipment. The technical documentation shall include, where relevant, at least the following elements:
(a) an overall description of the electrical equipment;
(b) conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits and, where appropriate, other design documentation;
(c) descriptions and explanations necessary for understanding the drawings, diagrams and operation of the electrical equipment;
(d) a list of harmonised standards to which the references in the Official Journal of the European Union have been published and which have been applied in full or in part, or of the international standards referred to in Article 10 (1) (b) or of the Czech technical standards referred to in Article 10 (1) (c), and a description of the solutions chosen to meet the essential technical requirements of this Regulation, where such harmonised, international or national standards have not been applied, including a list of other relevant technical specifications which have been used. In the case of partly used harmonised standards or international standards referred to in Section 10 (1) (b) or national standards referred to in Section 10 (1) (c), the technical documentation shall include those parts which have been used,
(e) the results of the design calculations, the examinations carried out and, where appropriate, other results of the calculations or checks;
(f) test reports.
3. Production
The manufacturer shall take all necessary measures to ensure that the production process and its control ensure compliance of the electrical equipment produced with the technical documentation referred to in point 2 and with the requirements laid down in this Regulation which apply to it.
4. CE marking and EU declaration of conformity
4.1 The manufacturer shall place the CE marking on each individual electrical device which complies with the requirements laid down in this Regulation.
4.2 The manufacturer shall draw up a written EU declaration of conformity for the product model and keep it for the supervisory authority for 10 years after the electrical equipment has been placed on the market together with the technical documentation. The EU declaration of conformity shall specify the electrical equipment for which it has been drawn up.
A copy of the EU declaration of conformity shall be provided to the supervisory authority upon request.
5. Compulsory representative
The manufacturer's activities set out in point 4 may be carried out by his authorised representative on his behalf and under his responsibility, provided that the manufacturer has so specified in the authorised representative's mandate.
Příloha č. 4
Annex No. 4 to Government Regulation No. 118 / 2016 Coll.
EU CONFORMITY DECLARATION (No XXXX) 3
1. Product / product model (dose, product or type or serial number):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity shall be issued under the sole responsibility of the manufacturer.
4. Subject matter of the declaration (identification of electrical equipment enabling them to be traced back; may include a sufficiently clear colour representation if necessary to identify the electrical equipment concerned):
5. The subject matter of the declaration described above is in conformity with the relevant European Union harmonisation legislation:
6. References to the relevant harmonised standards which have been applied or to other technical specifications on the basis of which conformity is declared:
7. Other information:
Signed after and on behalf of:
(place and date of issue):
(name, function) (signature):
1) Directive 2014 / 35 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment intended for use within certain voltage limits.
(2) Article 2 (1) (c) of Regulation (EU) No 1025 / 2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89 / 686 / EEC and 93 / 15 / EEC and Directives 94 / 9 / EC, 94 / 25 / EC, 95 / 16 / EC, 97 / 23 / EC, 98 / 34 / EC, 2004 / 22 / EC, 2007 / 23 / EC, 2009 / 23 / EC and 2009 / 105 / EC of the European Parliament and of the Council and repealing Council Decision 87 / 95 / EEC and Decision No 1673 / 2006 / EC of the European Parliament and of the Council.
3) The manufacturer may assign a certificate of conformity number.
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Regulation Information
| Citation | Government Regulation No. 118 / 2016 Coll., on conformity assessment of electrical equipment intended for use within certain voltage limits when making them available on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.04.2016 |
|---|---|
| Effective from | 20.04.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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