118/2016 Sb.
GOVERNMENT REGULATION
of 30 March 2004. March 2016
on conformity assessment of electrical equipment designed for use within
certain voltage limits when they are making available on the market
The Government directs pursuant to § 4 and § 50 para. 5 of law No. 90/2016 Coll.
conformity assessment of specified products when they are making available on the market (hereinafter
"the Act"):
§ 1
The subject of the edit
(1) this regulation incorporates the relevant provision of the European Union ^ 1) and
regulates the technical requirements for electrical equipment for
use within certain voltage limits, which must comply when placing on the
the market, the conditions and procedures for their supply on the market, and the method of assessing
of conformity.
(2) this Regulation applies to electrical equipment designed for use
the voltage rating of the AC from 50 to 1 000 V and for
the direct current from 75 to 1 500 V (hereinafter referred to as "electrical equipment").
(3) this Regulation shall not apply to equipment and radio-electrical
interference referred to in annex 2 to this regulation.
§ 2
Technical requirements for electrical equipment
Basic technical requirements for electrical installations are the basic
the requirements of the safety objectives for electrical equipment designed for
use within certain voltage limits set out in annex 1 to this
of the regulation. Meet the essential technical requirements shall be demonstrated
conformity assessment.
§ 3
Making available on the market
On the market can supply only electrical devices that are built in
accordance with good practice in terms of technical security and which, for the
provided that they are properly installed and maintained and used for its intended
for which it was made, it does not endanger the health and safety of persons, domestic
animals or property.
§ 4
The manufacturer of the
(1) the manufacturer before placing electrical equipment on the market shall ensure that
This device was designed and built in compliance with the essential
technical requirements set out in annex 1 to this regulation,
shall draw up the technical file referred to in annex 3 to this
Regulation and carry out or have carried out the conformity assessment procedure provided for
in annex 3 to this regulation.
(2) if the compliance of electrical equipment with basic technical
the requirements set out in annex 1 to this regulation established
the conformity assessment procedure, manufacturers shall draw up the EU Declaration of conformity and
According to § 12 shall affix the CE marking.
(3) the manufacturer shall keep the technical documentation and the EU Declaration of conformity
for 10 years since the introduction of the electrical equipment on the market.
(4) the manufacturer shall ensure that such procedures were put in place, through the
which mass produced products are in conformity with the requirements laid down
This regulation, even in the cases when there are changes to the design or
the parameters of the electrical equipment or the changes in the harmonised standards
referred to in section 10, paragraph 1. 1 (b). and), international standards referred to in article 10
paragraph. 1 (b). (b)), the Czech technical standards referred to in section 10, paragraph 1. 1
(a). (c)) or other documents that prescribe the technical requirements,
that has the electrical equipment comply with the (hereinafter referred to as "the technical
specification "), on the basis of the conformity of the electrical equipment
declares.
(5) the manufacturer shall carry out in order to protect the health and safety of the final
users sample testing of electrical equipment that came on the market and other
the necessary investigation, if this is necessary due to the risks
electrical equipment represents, relative to the intended use by the manufacturer
the use of the. The manufacturer shall conduct these tests and investigations to the extent necessary for the
the confirmation or refutation of the risks involved. The producer keeps records
complaints, non-conforming electrical equipment and devices that have downloaded
out of circulation, and continually inform distributors of those activities.
(6) the manufacturer shall ensure that the electronic devices, which stated
on the market bear a type, batch or serial number or other element
allowing their identification, or, where the size or
the nature of the electrical equipment does not allow it, that the required information
listed on its packaging or in a document attached to the electrical
device.
(7) the manufacturer shall, on the electrical equipment or, where that is not possible,
on the packaging or in a document accompanying the electrical equipment of your name
or trade name or trademark and the address for
service, at which he can be contacted. Address for service must be
the address of the place in which the manufacturer can be actually reach you. Contact
details are 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 Czech language. These tutorials, security
information and any labelling must be clear, comprehensible and easily
to understand.
§ 5
Authorized representative
Authorized representative shall keep the EU Declaration of conformity and the technical
documentation for the requirements of a supervisory authority for a period of 10 years after the
the electrical equipment on the market.
§ 6
The importer
(1) the importer before placing electrical equipment on the market shall ensure that
the manufacturer has performed the conformity-assessment procedure, developed by the technical
the documentation placed on the electrical equipment of the CE marking, to
It required documents and has complied with the requirements set out in section 4, paragraph 4. 6 and 7.
(2) the importer shall indicate on the electrical equipment or, where that is not possible, to
packaging or in a document accompanying the electrical equipment of your name or
business name or trade mark and the address for service, at
which he can be contacted. Contact details are 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 Czech language.
(4) the importer performs in order to protect the health and safety of the final
users sample testing of electrical equipment placed on the market and other
the necessary investigation, if that is appropriate to the risks which electrical
a device represents. The importer performs these tests and investigations to the extent
required for confirmation or refutation of the risks involved. The importer
keeps records of complaints, of non-conforming electrical equipment and
electrical equipment, which pulled out of circulation, and such
activities inform distributors.
(5) the importer for a period of 10 years following the placing on the market of electrical equipment
stores a copy of the EU Declaration of conformity at the disposal of the supervisory authority and the
ensures that the supervisory authority on request can be submitted to the technical
documentation.
§ 7
Distributor
The distributor prior to delivery of the electrical equipment on the market shall verify that
and) electrical equipment bears the CE marking, the
(b) electrical equipment) are accompanied by the required documents and tutorials and
safety information in Czech language and
(c) manufacturers and importers meet) the requirements set out in section 4, paragraph 4.
6 and 7 and § 6 para. 2.
§ 8
Time to identify the operator
Economic operator for a period of 10 years from the delivery of electrical equipment to the
the market keeps the data that can be used at the request of the supervisory authority to determine
an economic operator who has supplied him with electrical equipment or which
it, he added.
§ 9
The conformity assessment procedure
Procedure for assessment of conformity of the electrical equipment is an internal control
production (module A) laid down in annex 3 to this regulation.
§ 10
Presumption of conformity
(1) where electrical equipment is in conformity with the
a) ^ 2) harmonised standards or parts thereof, for which
published references in the official journal of the European Union,
b) safety standards laid down in the provisions of international
The International Electrotechnical Commission (IEC), if the standards referred to in point (a)
and have not been created yet) and published and if this safety
the provisions of the European Commission published, or
(c) the safety provisions of Czech) technical standards, if
There are no technical standards referred to in point (a)), or (b)),
It is considered that it is in compliance with the technical requirements
set out in annex 1 to this regulation, to which these standards
or parts thereof.
(2) Office for standards, metrology and testing
be published in the journal of the Office for standards, metrology and
information about State testing standards referred to in paragraph 1 (b). (b)), and (c)).
§ 11
EU Declaration of conformity
(1) the EU Declaration of conformity to meet 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 specimen in annex
No 4 to this regulation. The Declaration contains the information specified in the module and
referred to in annex 3 to this regulation and must still be
updated. EU Declaration of conformity is also translated into the language or
languages required by the Member State of the European Union, in which the electric
a device placed or made available on the market.
(3) where electrical equipment is subject to more Community harmonisation
European Union legislation providing for the elaboration of EU Declaration of conformity,
draw up a single EU Declaration of conformity with links to all of these
legislation under which it was considered a match, including links to their
publication. This single EU Declaration of conformity may take the form of a folder
consisting of declarations of conformity issued to individual regulations.
§ 12
Affixing the CE marking
CE mark, which is to be placed before placing electrical equipment on
market, are placed on the electrical equipment or to its data plate. If
due to the nature of the electrical equipment is not possible or not warranted,
placed on the packaging and accompanying documents.
section 13 of the
Formal defects
A formal deficiency is considered when
and) the CE marking was placed in breach of article. 30 of the regulation of the European
Parliament and of the Council (EC) no 765/2008 of 9 June. July 2008 laying
sets out the requirements for accreditation and market surveillance relating to the marketing of
products on the market and repealing Regulation (EEC) No 339/93 or with section
12,
(b)) the CE marking has not been affixed,
c) EU Declaration of conformity has not been drawn up,
d) EU Declaration of conformity has not been drawn up in accordance with this
by regulation,
e) technical documentation is missing or incomplete,
f) information laid down in paragraph 4, paragraph 4. 7 or § 6 para. 2 are missing or
are incorrect or incomplete, or
g) was not fulfilled other administrative requirement referred to in paragraph 4 or in section
6.
§ 14
Transitional provision
Electrical equipment complying with the requirements fixed by regulation of the Government No.
17/2003 Coll. may continue to be supplied to the market, if it has been placed on the market
20. April 2016.
§ 15
Regulation (EEC)
Government Regulation No. 17/2003 Coll. laying down technical requirements for
electrical low voltage equipment, is hereby repealed.
section 16 of the
The effectiveness of the
This Regulation shall enter into force on 20 March 2004. April 2016.
Prime Minister:
Mgr. Sobotka in r.
Minister of industry and trade:
Ing. Mládek, CSc., r.
Č. 1
THE BASIC REQUIREMENTS OF THE SAFETY OBJECTIVES FOR ELECTRICAL EQUIPMENT DESIGNED
FOR USE WITHIN CERTAIN VOLTAGE LIMITS
1. General conditions
and) on the electrical equipment or, where that is not possible, in the attached
the document must be given basic information and instructions of which knowledge and
compliance shall ensure that electrical equipment was used safely and to
the purpose for which it was made,
(b)) the electrical equipment and its components must be carried out so as to
can be safely and properly assembled and connected,
(c)) the electrical equipment must be designed and constructed so that the
guaranteed protection against the hazards set out in points 2 and 3, if the
used for the purposes for which it was made and is adequately maintained.
2. protection against hazards which may be caused by electric
device
In accordance with paragraph 1 shall be the technical measures designed to
and) persons and domestic animals are adequately protected against the danger of
physical injury or other harm which might be caused by
through direct contact or indirectly,
(b)) that temperatures, arcs or radiation which could
be dangerous,
(c)) persons, domestic animals and property are adequately protected against
as examples of the dangers of the character, which, according to experience
be caused by electrical equipment, and
(d)) that the insulation must foreseeable conditions.
3. protection against hazards which can be caused by external
influences on the electrical equipment
In accordance with paragraph 1 shall be made for measures of a technical nature, which
ensure that the electrical equipment
and meets the expected conditions) mechanical stress to
to avoid danger to persons, domestic animals and property,
(b)) was that the anticipated environmental conditions resistant to
other than mechanical factors so as to avoid risks
of persons, domestic animals and property, and
c) foreseeable conditions of overload do not endanger persons, domestic
animals and property.
Č. 2
EQUIPMENT AND PHENOMENA OUTSIDE THE SCOPE OF THIS REGULATION
This Regulation shall not apply to
1. electrical equipment intended for use in potentially
the explosion,
2. electrical equipment for Radiology and medical purposes,
3. electrical parts for goods and passenger lifts
4. electrical energy meters,
5. plugs and socket outlets for household
6. for the power supply of the electric fence,
7. radio-electrical interference,
8. specialized electrical equipment, for use on ships,
airplanes and railways which comply with safety regulations
drawn up by international bodies in which the Member States of the European
the Union represented,
9. the evaluation kits tailor-made for professionals exclusively for the
the purposes of use in the research and development of devices used for such
purposes.
Č. 3
The internal production control (module A)
1. Internal production control
Internal production control is the conformity assessment procedure whereby the manufacturer
performs the activities provided for in paragraphs 2, 3 and 4 and on their own responsibility
ensures and declares that the electrical equipment meets the requirements
This regulation, which applies to them.
2. Technical documentation
The manufacturer shall establish the technical documentation. The documentation must allow
assessment of the conformity of the electrical equipment with the applicable requirements and
contains an adequate analysis and assessment of the risk. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the electrical equipment. Technical
the dossier shall include, if applicable, at least the following
Essentials
and a general description of the electrical equipment),
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
circuit design, design documentation, if any,
c) descriptions and explanations necessary for the understanding of said drawings and
schemes and the operation of the electrical equipment,
(d)) the list of harmonized standards, references to which have been published in the
The official journal of the European Union and which have been applied in full
or in part, or the international standards referred to in section 10, paragraph 1. 1 (b). (b))
or Czech technical standards referred to in section 10, paragraph 1. 1 (b). (c)), and
a description of the solutions adopted to meet the essential technical requirements
of this regulation, where those harmonised, international or
national standards have not been applied, including a list of other relevant
the technical specifications that were used. In the case of partially
applied harmonized standards or international standards referred to in section
10, paragraph 1. 1 (b). (b)) or the national standards referred to in section 10, paragraph 1. 1
(a). (c)) in the technical documentation shall specify the parts which have been applied,
e) results of design calculations, examinations carried out, where appropriate,
For more results of the calculations or checks,
f) test reports.
3. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured electrical equipment with the
the technical documentation referred to in point 2 and with the requirements laid down in this
Regulation that apply to them.
4. CE marking and EU Declaration of conformity
4.1. The manufacturer shall affix the CE marking to each individual electrical device
which meets the requirements laid down in this regulation.
4.2. the manufacturer shall draw up a written EU Declaration of conformity for a product model and
After a period of 10 years following the placing on the market of the electrical equipment, together with
the technical documentation at the disposal of the supervisory authority. IN THE EU
Declaration of conformity shall identify the electrical equipment, for which it has been
drawn up.
A copy of the EU Declaration of conformity shall on request provide the supervisory authority.
5. Authorized Representative
The activities of the manufacturer referred to in point 4 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if the manufacturer in
authorised representative established the credentials.
Č. 4
EU Declaration of conformity (# XXXX) ^ 3)
1. Product Model/product (batch number, the product or the type or serial number):
2. the name and address of the manufacturer or his authorised representative:
3. this Declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the Declaration (identification of electrical equipment to allow backward
trace; may include a sufficiently clear representation of the color, if it is
for the identification of the necessary electrical equipment):
5. object of the Declaration described above is in conformity with the relevant Community harmonisation
the legislation of the European Union:
6. references to the relevant harmonised standards which have been applied, or to other
technical specifications by reference to which conformity is declared:
7. Additional information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
1) directive of the European Parliament and of the Council/35/EU of 26 March. February
2014 on the harmonisation of the laws of the Member States relating to the
the delivery of electrical equipment designed for use within certain limits
the tension on the market.
2) article 2, point 1. (a). (c)) the European Parliament and of the Council (EU)
No 1025/2012 of 25 June. October 2012 on European standardisation, change
Council Directives 89/686/EEC and 93/15/EEC and the directives of the European Parliament and of the
Council Directive 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 and repealing Council decision
87/95/EEC and European Parliament and Council decision No 1673/2006/EC.
3) the manufacturer may give the number of the Declaration of conformity.
