of 20 December. December 2006
on technical requirements for products in terms of their
Government orders under section 22 of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
Act No. 207/2002 Coll. (hereinafter the "Act") to implement section 7 (2). 7 and 8,
§ 11 (1) 2, § 12 para. 1 and 3 and section 13 of the Act:
(1) this regulation incorporates the relevant provisions of the European
Community ^ 1) and regulates the technical product requirements in terms of
their electromagnetic compatibility.
(2) in this regulation means
the device or device) and fixed installation,
(b)) the appliance the appliance, or complete a combination of apparatus placed on the market
as a single functional unit, intended for the final user, which
can cause electromagnetic interference or whose operation can be
electromagnetic interference effect
(c) a fixed installation report) several types of apparatus and, where applicable,
the funds, which are assembled, installed and intended to be permanent
use on a given site in advance,
d) electromagnetic compatibility the ability of equipment to satisfactorily
to operate in its electromagnetic environment without causing itself
electromagnetic disturbances to other equipment in that environment,
e) electromagnetic disturbance electromagnetic phenomenon which may degrade the
the function of the device; an electromagnetic disturbance may be electromagnetic
noise, an unwanted signal or a change in the propagation environment,
f) resistance the ability of equipment to function correctly without degradation
in the presence of electromagnetic interference,
g) security to ensure protection of human health, life or
h) electromagnetic environment all electromagnetic phenomena
observable in a given location.
(3) the device referred to in paragraph 2 (a). (b)) means also
component or subassembly) designed for installation in devices
the end user, which may be a source of electromagnetic interference
or whose functioning can be affected by such disturbance,
(b)) mobile installations are defined as a combination of apparatus or
devices, intended to be moved and operated in different locations.
(4) laid down under this regulation are products within the meaning of § 12 para.
1 (b). and all devices) of the Act, with the exception of devices referred to in
(5) this Regulation shall not apply to
and radio and on) telecommunications terminal equipment, which are covered by
a special law ^ 2)
(b)) products, parts and appliances referred to in regulation of aviation technology
The European Parliament and of the Council (EC) No 1592/2002 of 15 July 2002 July 2002
on common rules in the field of civil aviation and establishing a
The European Aviation Safety Agency,
c) radio equipment used by radio amateurs within the meaning of the radio communication
the regulations adopted in the framework of the Constitution and Convention of the International Telecommunication
EU ^ 3), if the device is not available on the market; for available on the market is
not a kit with parts intended for radio amateurs and Assembly
on the market of the said equipment suitable radio amateurs for their own use,
(d)), which are by their very nature of the physical characteristics that
1. cannot cause the electromagnetic radiation in excess of the level of
to enable the radio, telecommunications, and other devices operating in
accordance with that purpose, or to contribute to such radiation and
2. without acceptable deterioration of function in the presence of
electromagnetic interference that is common due to the purpose of their
the use of the.
The basic requirements
(1) the basic requirements that must be met are specified products
listed in annex 1 to this regulation.
(2) shall be deemed to have satisfied the basic requirement to which it relates
and harmonised European standard), which is published in the official
Journal of the European Union,
b) harmonised Czech technical standard, which incorporates the standard
c) foreign technical standard in the Member State of the European Union, which
adopts the standard under (a)),
and the relevant provisions of these devices of harmonised technical
It meets the standards. This presumption does not apply, if the link from the official
Journal of the European Union is withdrawn.
(3) the requirements laid down in specific laws for the device
^ 4) rules are not, as far as the essential requirements referred to in paragraph 1,
without prejudice to this regulation.
Placing on the market and/or put into service
(1) the device may be placed on the market or put into service only if it is
done so that, provided that it is properly installed, maintained and
used for the purposes for which it is intended, conforms to the requirements of this
of the regulation.
(2) if the device that corresponds to the paragraph 1, for the purpose of
and overcoming existing or anticipated) issue with
electromagnetic compatibility in a particular place, or
(b) protection of public telecommunications networks) or receivers and transmitters,
If they are in clearly defined situations, used for safety purposes,
to limit the commissioning according to special legal regulation, must
be this restriction without undue delay, notified the Office of technical
Standardization, metrology and testing, which shall inform the
The Commission of the European communities and the other Member States of the European Union.
This is without prejudice to the procedures under a special legal regulation ^ 5).
(3) devices that do not meet the requirements of this regulation, may be
exposed to or presented at trade fairs, exhibitions and similar
events, provided that a visible sign clearly, not
be placed on the market or put into service until they match
with the requirements of this regulation; demonstrations may be held, provided
that the appropriate measures are taken to prevent electromagnetic
Procedures for assessing the conformity of the instrument
(1) the assessment of conformity with the essential requirements referred to in § 2 (2). 1, the
executes the procedure laid down in Appendix 2 to this regulation. The manufacturer of the
or his authorised representative may enjoy also the procedure according to annex
# 3, to this regulation. The conformity of the apparatus shall certify the manufacturer or his
the authorized representative of issuing an EC declaration of conformity and the measures
the device bearing the CE mark according to § 5 para. 1 and 2.
(2) the evidence of conformity assessment (section 13 paragraph 7 of the Act) include EC
Declaration of conformity (article 13, paragraph 2, of the Act) and the technical documentation referred to in
of paragraph 4.
(3) the EC declaration of conformity must contain the
and reference to the relevant regulation) of the European Community),
(b)) information pursuant to § 5 para. 3 (b). and about the device on) that applies,
(c) information on the manufacturer or) authorized representative-in the name of natural persons
full name or business name and the address of the place of residence or
place of residence or place of business in the legal entity name or business
the company, its registered office or the location of the branch (hereinafter referred to as
"personally identifiable information"),
d) details of the technical standards or other documents that the appliance
meets and is declared inadmissible on the basis of compliance with provisions
of this regulation, indicating the date of issue of these standards or documents,
(e) the date of the Declaration,)
(f) the identification data of the person) authorized to act on behalf of the manufacturer or
authorised representative and its signature.
(4) the technical documentation must enable the conformity of the instruments with the
the essential requirements which apply to it. Must include the
design and manufacture of the device, and must contain
and a general description of the device),
(b)) evidence of compliance with the harmonised technical standards used
either completely or partially,
(c)) if the manufacturer has not applied harmonised technical standards, or is
applied only in part, the description and explanation of the procedure, which is the
ensure that the essential requirements including a description of the assessment
electromagnetic compatibility pursuant to point 1 of annex 2 to this
Regulation, the results of the design calculations, the reports on
the tests, or other appropriate documents,
(d)) of the notified body, if the expression has been used procedure according to annex
# 3, to this regulation.
The CE marking and other labelling and information
(1) the CE marking (section 13, paragraph 3, of the Act), the graphic design is
fixed special legislation ^ 6), is to be placed on the device or the
data plate. If this is not possible or it cannot be with regard to the
the nature of the instrument to secure, must be affixed to the packaging,
If the appliance is delivered, and on the accompanying documents. The appliance
It must not be marked, which might mislead anyone,
with regard to the CE marking. On the product, its packaging or the instructions for use
can be placed, other than the CE marking, the marking must not be
reduced the visibility and legibility of the CE marking.
(2) if the legislation, that the product is subject and that
CE marking set or allow for a transitional period permits the
the manufacturer has chosen, the provisions will govern, then the CE marking
shall indicate conformity solely with those provisions or the provisions of that
manufacturer. In this case, it must be in the documents, notices
or instructions required by applicable law, and the accompanying
for the relevant product, the particulars of the relevant legal
the regulations of the European Community or their provisions, which
(3) for each apparatus shall be identified
and) type, batch, serial number or any other information allowing for the
(b)) the identification of the manufacturer and, if the manufacturer is not established in the Member
State of the European Community, the identification details of the authorised
representative or other person responsible for bringing in the European Community
apparatus on the market.
(4) the manufacturer shall draw attention to the specific measures that must be taken when
Assembly, installation, maintenance or use of the appliance, in order to
ensure that after putting into operation the unit will meet the requirements for
the protection referred to in point 1 of annex 1 to this Regulation (hereinafter referred to as
"the protection requirements").
(5) on the device that is not in its use in residential areas
guarantee compliance with the requirements for protection, such restrictions must be
the use of clearly marked to the device or its packaging.
(6) the information needed for use of the device in accordance with the purpose to
which is intended, it must be listed in the instructions accompanying the apparatus.
Notice of the imposition of a safeguard measure
In the event that the appliance has been stored for protective measures pursuant to
special legal regulation ^ 7), it shall be indicated in the notification referred to in § 7 para. 8
the law, whether non-compliance with the requirements pursuant to § 3 (2). 1 was caused by
failure to satisfy the requirements of §) 2 (2). 1, where the apparatus does not
harmonised technical standards according to § 2 (2). 2,
b) incorrect application of harmonised technical standards in accordance with § 2
paragraph. 2, or
c) shortcomings in the harmonised technical standards under section 2 (2). 2.
The conditions of the authorization
When you authorize legal entities to the activities under this Regulation shall
apply the conditions laid down in annex 4 to this regulation.
Legal entities which meet the assessment criteria laid down in
relevant harmonised European standards, the references of which are
published in the official journal of the European Union, are considered
meeting the criteria laid down in annex 4 to this regulation, on which these
(1) a device that is intended to be incorporated into a fixed
installation and is not otherwise separately placed on the market may not satisfy the
the essential requirements referred to in § 2 (2). 1 and the conditions referred to in sections 4 and 5, if the
in the documentation supplied with the apparatus shall
and) data identifying the fixed installation, for which the device is intended,
the characteristics of the electromagnetic compatibility and the measures
to be taken with regard to the incorporation of the apparatus into the fixed installation
in order not to compromise the conformity of the installation with the requirements for protection, and
(b)) information pursuant to § 5 para. 3.
(2) an assessment of the conformity of a fixed installation with the requirements for protection provides
the operator of an installation or a person authorized by the case that
for fixed installation) reflected signs of non-compliance with the requirements for protection,
in particular, when reference to interference, and
(b) the Czech Telecommunication Office) finds the procedure under the Special
^ Law 8) the operator of an installation or a person designated by him
the documents submitted (accompanying documentation, the documentation referred to in point 2
Annex 1 to this regulation, where appropriate, other documents) sufficient
evidence of proof of conformity.
(3) the compliance of the fixed installation with the requirements for protection provides
Equipment meeting the requirements of Government Regulation No. 18/2003 Coll., amending
laying down technical requirements for the products in terms of their
electromagnetic compatibility, can be placed on the market before 20.
July, 2009. To the operation of such devices can be placed after this
Government Regulation No. 18/2003 Coll., laying down technical requirements for
products in terms of their electromagnetic compatibility, is hereby repealed.
The effectiveness of the
This Regulation shall enter into force on 20 March 2004. July 2007.
Ing. Topolanek in r.
Minister of industry and trade:
Ing. Roman v. r.
THE BASIC REQUIREMENTS
1. the requirements for the protection of
Devices must be designed and constructed so that, taking into account
achieved State of technology ensures that
a) electromagnetic interference that causes, shall not exceed the level at which
radio and telecommunication equipment, or other device is not capable of
work as it should,
(b)) the level of its resistance to electromagnetic interference
the anticipated when using for that purpose allows him to function without
unacceptable degradation of specified functions.
2. specific requirements for fixed installation and use of components for the
the purpose of the
Fixed installation must be installed with the use of the correct technical
procedures and respecting the information about how to use components for a particular purpose,
in order to meet the protection requirements referred to in point 1. These correct
technical procedures must be documented and the documentation
the operator for the operation of fixed installations for inspection
by the competent authorities.
CONFORMITY ASSESSMENT PROCEDURE according to § 4, paragraph 4. 1
(Internal production control)
1. the manufacturer shall assess the electromagnetic compatibility of equipment on
the basis of the relevant phenomena in order to fulfil the requirements for protection. The correct
the use of all relevant harmonised standards, the references of which have been
published in the official journal of the European Union, is equivalent to
2. in assessing the electromagnetic compatibility shall be taken into account
all normal intended operating conditions. If the device can have a different
configuration, you must assess the electromagnetic compatibility, confirm
whether the device meets the requirements for protection in all possible
configurations, specified by the manufacturer as an example use for a particular purpose.
3. the manufacturer processes the technical documentation as provided for in section 4, paragraph 4.
4 proving the conformity of the instrument with the essential requirements of this regulation.
4. the manufacturer or his authorised representative shall keep the technical
documentation at the disposal of the competent authorities for at least ten years
from the cessation of production of the unit.
5. the manufacturer or his authorised representative shall confirm the release
EC declaration of conformity in compliance with all the relevant essential requirements.
6. the manufacturer or his authorised representative shall keep the EC declaration of
conformity at the disposal of the competent authorities for a period of ten years from the end of
production of the unit.
7. If the manufacturer is not established in the European Community or does not exist
its authorised representative shall be responsible for the retention of the EC declaration of
conformity and the technical documentation for the competent authority, the person
that in the European Community lists the device on the market.
8. The manufacturer shall take all measures necessary to ensure that
the products were made in accordance with the technical documentation referred to in point
3 and with the provisions of this regulation, that the product is subject.
9. Ec Declaration of conformity shall be drawn up according to the provisions in section 4, paragraph 4. 3.
CONFORMITY ASSESSMENT PROCEDURE according to § 4, paragraph 4. 1
This procedure consists of a procedure in accordance with Annex 2, which is supplemented by
1. the manufacturer or his authorised representative shall provide technical
documentation the notified person and ask it for assessment. The manufacturer, or
his authorised representative, the notified person shall communicate that aspect of the
essential requirements required to assess.
2. the notified body shall examine the technical documentation and assess whether the
properly demonstrates that the requirements of this regulation, which is to be assessed, the
met. When they confirm that the appliance is in conformity with them, it shall issue
notified to the manufacturer or to his authorised representative observations
attesting such compliance. This representation shall be limited to the aspects of the
the basic requirements which the notified body has assessed.
3. The manufacturer shall obtain from the representation to technical
THE CONDITIONS OF THE AUTHORIZATION
The terms of the authorization under section 11 (1) 2 of the Act are:
1. the required staffing resources and the necessary means and equipment.
2. The competence and professional integrity of personnel.
3. the independence and performance of the message handling functions under this
of the regulation.
4. the independence of the staff and technical staff with respect to all
interested entities, groups or persons directly or indirectly
interested on the product concerned.
1) European Parliament and Council Directive 2004/108/EC of 15 December 1999.
December 2004 on the approximation of the laws of the Member States on
to electromagnetic compatibility and repealing Directive 89/336/EEC.
2) of Decree-Law No. 426/2000 Coll., laying down technical
requirements for radio and telecommunications terminal equipment, as amended by
Government Regulation No. 484/2002 Coll. and regulation of the Government No. 251/2003 Coll.
3) Constitution and the Convention adopted by the International Telecommunication Union
additional Conference of Plenipotentiaries (Geneva, 1992), as amended by
the Conference of Plenipotentiaries (Kyoto, 1994).
4), for example, Government Regulation No. 464/2005 Coll., laying down
technical requirements for measuring instruments, Decree-Law No 336/2004 Coll.
laying down technical requirements for medical devices and fixing
amending Government Decree No. 251/2003 Coll., amending certain regulations
the Government issued for the implementation of Act No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
5) of Decree-Law No 339/2002 Coll., on the procedures for the provision of
information in the field of technical regulations, technical documents and
technical standards, as amended by Government Decree No. 178/2004 Sb.
6) Government Regulation No. 291/2000 Coll., laying down graphic design
the CE marking.
7 for example, § 7a) paragraph. 1 (b). a) and b) of Act No. 64/1986 Coll., on Czech
commercial inspection, as amended by Act No. 22/1997 Coll. and Act No. 204/2002
8) Act No. 127/2005 Coll., on electronic communications and amending
some related laws (Act on electronic communications),
in the wording of later regulations.