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The Assessment Of Conformity Of Products In Terms Of The Solenoid. Compatibility

Original Language Title: posuzování shody výrobků z hlediska elektromagn. kompatibility

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117/2016 Sb.



GOVERNMENT REGULATION



of 30 March 2004. March 2016



on the assessment of conformity of products in terms of electromagnetic compatibility

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 product requirements in terms of their

electromagnetic compatibility, which must comply when placing on the market

and/or put into service, the conditions and procedures for their making available on the market and

methods of conformity assessment.



(2) this Regulation shall not apply to



a) radio and telecommunications terminal equipment, which are covered by other

Law ^ 2)



(b)) products, parts and appliances referred to in aviation technology directly

applicable legislation the European Union ^ 3),



c) radio equipment used by radio amateurs within the meaning of the radio

regulations adopted in the framework of the Constitution and Convention of the International Telecommunication

Union ^ 4), if the devices are not supplied on the market; as supplied, the

not a kit with parts intended for radio amateurs and Assembly

on the market, the modified ham radio equipment for its own use and



(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 to operate in

accordance with the intended use, or contribute to such radiation and



2. operate without unacceptable degradation in the presence of

electromagnetic interference that is common when their operation in accordance with the

the intended use,



(e)) the assessment kits tailor-made for professionals designed exclusively

for use in research and development facilities for such purposes.



§ 2



Definition of terms



(1) for the purposes of this regulation, means a



the device or device) and fixed installation,



(b) the finished appliance or appliance) combination supplied on the market

as a single functional unit, intended for the final user, which

can be a source of electromagnetic interference or whose operation can

be affected by such disturbance,



(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

assets,



h) electromagnetic environment all electromagnetic phenomena

observable in a given location.



(2) the device referred to in paragraph 1 (b). (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.



§ 3



Technical requirements



(1) the device must meet the basic technical requirements, which are

listed in annex 1 to this regulation.



(2) if the basic technical requirements for the equipment referred to in annex

No. 1 laid down in another regulation of the ^ 5), essential requirements referred

in annex 1 to this regulation, shall not apply.



(3) meet the essential technical requirements shall be demonstrated by assessing

of conformity.



§ 4



The delivery of equipment on the market and putting into service



(1) the device may be supplied 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, shall meet

the requirements of this regulation.



(2) if there is a device which meets the requirements referred to in paragraph 1,

to limit the entry into service or use in accordance with other legal

Regulation in order to



and overcoming existing or anticipated) issue with

electromagnetic compatibility in a particular place, or



(b) protection of public telecommunications networks) or receivers and transmitters,

that are used for safety purposes in well-defined

in the spectrum of situations,



This restriction must be, without undue delay notified to the Office for

standards, metrology and testing (hereinafter referred to as

"The Office"), who inform the European Commission and the other Member States

Of the European Union. This is without prejudice to the procedures under another legal

prescription ^ 6).



(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 supplied on the market or put into service until it is secured

their conformity with the requirements of this regulation. Demonstrations may be held in

provided that appropriate measures are taken to prevent

electromagnetic interference.



§ 5



The manufacturer of the



(1) the manufacturer when placing on the market shall ensure that these instruments

have been designed and manufactured in accordance with § 3 (1). 1, shall establish the technical

the documentation referred to in annex No. 2 or 3 to this regulation, and performs

or have carried out the conformity assessment procedure referred to in article 10.



(2) if the conformity of the instrument with the essential technical requirements

the conformity assessment procedure, manufacturers shall draw up the EU demonstrated

Declaration of conformity and affix the CE marking.



(3) the manufacturer shall keep the technical documentation and the EU Declaration of conformity

period of 10 years from placing the apparatus on the market.



(4) the manufacturer shall ensure that such procedures were put in place, through the

which mass produced products remain in conformity with the requirements of

laid down in this regulation and in cases where there are changes to the design

or parameters of the device, or to the changes in the harmonised standards or

other technical specifications, on the basis of the conformity of apparatus

declares.



(5) the manufacturer shall ensure that the equipment, which it placed on the market,

the type or the number of the batch or serial number or other element

allowing their identification, or, where the size or

the nature of the instrument does not allow, that the required information is provided on

packaging or in a document accompanying the product. They shall further ensure that the

the device is accompanied by instructions and the information specified in § 13 para. 2 to 4 in

the Czech language. These tutorials, information and any markings shall be

clear, comprehensible and easy to understand.



(6) the manufacturer shall indicate on the product, or, if this is not possible, on its packaging or in

a document accompanying the device your name or business name, if applicable

the trade mark and the address for service, at which he can be contacted.

Delivery address 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.



§ 6



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

apparatus on the market.



§ 7



The importer



(1) the importer before placing the apparatus on the market shall ensure that the manufacturer has made

one of the conformity assessment procedures referred to in section 10, has drawn up a technical

the documentation placed on the machine the CE marking, it set out to

papers and has complied with the requirements set out in § 5 para. 5 and 6.



(2) the importer shall indicate on the product, or, if this is not possible, on its packaging or in

a document accompanying the device your name or business name, if applicable

the trade mark and the address for service, at which he can be contacted.

Contact details are given in language that is easy to understand for the

the final user and the supervisory authority.



(3) the importer shall ensure that the appliance is accompanied by instructions and information

referred to in § 13 para. 2 to 4 in the Czech language.



(4) the importer for a period of 10 years after the apparatus on the market keeps a copy of

EU Declaration of conformity for the purposes of monitoring the market and ensures that the

the supervisory authorities may on request, be submitted to the technical documentation.



§ 8



Distributor



The Distributor before delivery of the apparatus on the market validates that the device carries the

the CE marking, whether it is accompanied by the required documents and tutorials and

the information referred to in section 13(2). 2 to 4 in the English language and that the manufacturer and the

importer met the relevant requirements set out in § 5 para. 5 and 6 and § 7

paragraph. 2.



§ 9



Time to identify the operator



Economic operator for a period of 10 years from the delivery of the apparatus on the market must keep

data that can be used at the request of the supervisory authority to determine the economic


the body, which the device or it to be added.



§ 10



The conformity assessment procedures



(1) the assessment of conformity with the essential requirements referred to in § 3 (1). 1, the

performs



and internal management of production) (module A) set out in annex 2 to this

Regulation, or



(b)) the EU type-examination (module B), after which conformity to type

based on internal production control (module C) referred to in annex 3 to the

application of this regulation.



(2) the manufacturer may decide that the procedure referred to in paragraph 1

(a). (b)) only on some aspects of essential requirements, if the

other aspects of essential requirements shall follow the procedures referred to in paragraph

1 (b). and).



§ 11



Presumption of conformity



If the appliance is in conformity with the harmonised standards which are

the appliance cover and links which have been published in the official journal

The European Union, or their parts, it is considered that it is in compliance with

essential requirements set out in annex 1 to this regulation, on the

covered by those standards or parts thereof.



§ 12



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 statement contains the information set out in

relevant modules set out in annexes 2 and 3 to this regulation, and

must still be updated. EU Declaration of conformity shall be translated also into

the language or languages required by the Member State of the European Union, in which

the device is put into operation or made available on the market.



(3) If the device is subject to more rules for harmonisation of the European

the Union providing for the elaboration of EU Declaration of conformity,

a single EU Declaration of conformity with links to all of these provisions, in accordance with

which was considered a match, including links to their publication. This

a single EU Declaration of conformity may take the form of a folder consisting of

declarations of conformity issued to individual regulations.



section 13 of the



The CE marking and other labelling and information



(1) the CE marking visibly, legibly and indelibly placed on

the device or data plate. If this is not possible or cannot be

given the nature of the instrument must be affixed to the

the package if the appliance is delivered, and on the accompanying documents.



(2) to the instrument shall be accompanied by a warning to the special measures, which must

be taken when mounting, installation, maintenance or use of the appliance,

in order to ensure that after the commissioning of the unit will meet

the essential requirements laid down in point 1 of annex 1 to this regulation.



(3) in the case of apparatus for which it is not in its use in residential areas

guarantee compliance with the essential requirements laid down in point 1 of Annex No. 1

This Regulation shall be clearly marked restriction of use

on the device, or even on its packaging.



(4) the information required for the use of the appliance in accordance with the purpose to

which is intended, it must be listed in the instructions accompanying the apparatus.



§ 14



Fixed installation



(1) a device that is intended to be incorporated into a fixed

installation and is not otherwise available on the market separately, may not meet the

the essential requirements referred to in § 3 (1). requirements referred to in § 1, 6 and 12 and section

14 and 15 of the Act, including requirements under § 5 to 13, if the accompanying

the documentation shall indicate to the device



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, and



(b)) information pursuant to § 5 para. 5 the first sentence, § 5 para. 6 and § 7 (2). 2.



(2) an assessment of the conformity of the installation operator performs a fixed installation or

in the case of a person authorized by the



and fixed installation), signs of inconsistency, especially when

the reference to interference, and



(b) the Czech Telecommunication Office) the procedure under other legal

prescription ^ 7) finds that the documents submitted by the operator of the installation

or his authorised person, which are, in particular, the accompanying documents,

the documentation provided for in point 2 of annex 1 to this regulation,

other documents, if applicable, to conform to the established requirements sufficiently

demonstrate.



§ 15



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 section 13 of the

paragraph. 1,



(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)), the information specified in § 5 para. 6 or in article 7 para. 2 are missing or

are incorrect or incomplete, or



g) was not fulfilled other administrative requirement referred to in section 6 (1). 5 and

6 or in § 8 para. 3, 6 and 7 of the Act and in section 5, or section 7.



section 16 of the



Transitional provisions



(1) comply with the requirements laid down by regulation of the Government No. 616/2006

Coll. may continue to be supplied on the market and put into service, if the

placed on the market before the date of 20. April 2016.



(2) valid certificates and other documents certifying the detected

fact released persons notified pursuant to Decree-Law No.

616/2006 Coll., shall remain in force and shall be deemed the certificates and other

the documents certifying the facts established under this regulation.



§ 17



Regulation (EEC)



Government Regulation No. 616/2006 Coll. on technical requirements for products from

with regard to their electromagnetic compatibility, is hereby repealed.



section 18



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



BASIC TECHNICAL REQUIREMENTS



1. General requirements



Devices must be designed and constructed so that, taking into account the

achieved the status of the equipment ensure that



a) electromagnetic interference that cause, shall not exceed the level at which

radio and telecommunications equipment or other devices are not capable of

work in accordance with the intended use, and



(b)) are the level of resistance to electromagnetic interference

the expected when their operation in accordance with the intended use, which they

enables you to operate without unacceptable degradation of traffic in accordance with the

the intended use.



2. Specific requirements for fixed installations



Installation and intended use of components



Fixed installation must be installed with the use of codes of good practice

and with regard to the details of the intended use of components in order to meet

the essential requirements laid down in point 1. The rules of practice must be

documented, and the documentation or installation, the operator shall

the designated officer for the operation of the installation to store for the needs of

the supervisory authorities.



Č. 2



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, 4 and 5 of this annex and the

own responsibility, ensures and declares that the instruments concerned satisfy the

the requirements of this regulation which apply to them.



2. assessment of electromagnetic compatibility



The manufacturer of the device on the electromagnetic compatibility

the basis of the relevant phenomena in order to meet the essential requirements laid down in

point 1 of annex 1 to this regulation.



When the electromagnetic compatibility assessment shall be taken into account

all normal operating conditions. If the device can have a different

configuration, you must assess the electromagnetic compatibility, confirm

whether the device meets the essential requirements referred to in point 1 of the annex No. 1 in

all of the possible configurations that the manufacturer designates a representative

for the intended use of the device.



3. the technical documentation



The manufacturer shall establish the technical documentation. The documentation must allow

assessment of the conformity of the instrument with the appropriate requirements, and contain

adequate analysis and risk assessment.



The technical documentation shall specify the applicable requirements and to the extent necessary

for the assessment must cover the design, manufacture and operation of the device.

The technical documentation shall contain, where relevant, at least the following

requirements:



and a general description of the device);



b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,

circuits or any other design documentation;



c) descriptions and explanations necessary for the understanding of those drawings and schemes

and operation of the instrument;



(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, and descriptions of the solutions adopted to meet the essential requirements of the

of this regulation, where those harmonised standards have not been applied, including

list of other relevant technical specifications that were used.

In the event of partly applied harmonised standards, 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 and checks;



f) test reports.



4. production



The manufacturer shall take all measures necessary so that the manufacturing process and its

monitoring ensure conformity of the manufactured instruments with the technical

the documents set out in point 3 and with the essential requirements laid down in

point 1 of annex 1 to this regulation.



5. the CE marking and EU Declaration of conformity



5.1 the manufacturer shall affix the CE marking on each appliance that

complies with the relevant requirements of this regulation.



5.2. the manufacturer shall draw up a written declaration of conformity for the EU model of the device

and for a period of 10 years after the apparatus on the market, together with the technical

documentation at the disposal of the supervisory authority. The EU Declaration of conformity

the device must be provided, for which it has been drawn up.



A copy of the EU Declaration of conformity shall on request provide the supervisory authority.



6. Authorized Representative



The activities of the manufacturer referred to in point 5 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. 3



PART AND



The EU type-examination (module B)



1. the EU type-examination is the part of a conformity assessment procedure in which

the notified body examines the technical design of the device and verifies and attests

the technical design of instruments complies with the essential requirements laid down in

point 1 of annex 1 to this regulation.



2. the EU type-examination shall be made of the technical suitability assessment

the design of the instrument through examination of the technical documentation

in accordance with point 3, without examination of the specimen (design type). May be limited to

some aspects of essential requirements, as determined by the manufacturer or his

authorised representative.



3. the manufacturer lodges an application with a single notified body of his choice, the request

the EU type-examination.



The request must specify the aspects of essential requirements, which

review is required. Furthermore, the request shall contain:



and the name and address of the manufacturer), and if the application is lodged by the authorised representative,

his name and address;



(b)) a written declaration that the same application has not been lodged with any other

the notified body;



(c)) the technical documentation. Technical documentation shall enable

the conformity of the instrument with the appropriate requirements of this regulation and

include an adequate analysis and assessment of risks. The technical documentation

shall specify the applicable requirements and to the extent necessary for the assessment,

cover the design, manufacture and operation of the device. The technical documentation

must contain, if applicable, at least the following information:



I) a general description of the device,



II) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,

circuits, etc.,



III) descriptions and explanations necessary for the understanding of the drawings,

schemes and the operation of the device,



IV) list of the 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, and descriptions of the solutions adopted to meet the essential requirements of the

laid down in this regulation, where those harmonised standards applied

they were not, including a list of other relevant technical specifications,

that were used. In the event of partly applied harmonised standards

the technical documentation shall indicate only the parts which have been applied,



v) results of design calculations, examinations carried out, where appropriate,

For more results of the calculations or the checks and



vi) test reports.



4. the notified body shall examine the technical documentation with a view to assessing

the adequacy of the technical design of the instrument in relation to aspects

the basic requirements to the review is required.



5. the notified body shall draw up an evaluation report that records the

the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to the

obligations of the notified body to the authority, the notified body shall publish

the content of this report, in full or in part, only with the consent of the

manufacturer.



6. Where the type meets the requirements of this regulation which shall apply to the

the instrument, the notified body shall issue the EU type-examination certificate to the manufacturer

type. This certificate must contain the name and address of the manufacturer, conclusions of the

review information about aspects of essential requirements, which are

the review covered, conditions for its validity and the necessary data

to identify the approved type. The EU type-examination certificate may

be accompanied by 1 or more of the annexes.



The EU type-examination certificate and its annexes shall contain all

information to allow evaluation of whether they are produced in conformity with the

přezkoumaným type, and perform a check in operation.



If the type does not satisfy the requirements laid down in this regulation, refuses to

the notified body must issue a type-examination certificate of the EU and shall inform the

applicant accordingly, giving detailed reasons for such denial denial.



7. the notified body shall ensure that it is kept informed of any changes

the generally acknowledged State of the art which indicate that the approved

type may no longer comply with the requirements laid down in this regulation;

If such a situation occurs, shall determine whether such changes require

further investigation and shall inform the manufacturer.



The manufacturer shall inform the notified body that holds the technical

the documentation concerning the EU type-examination certificate of all

modifications to the approved type that may affect the conformity of the instruments with the

the essential requirements of this regulation or the conditions of validity of the

the certificate. The notified body shall approve these adjustments in the form of a supplement to the

the original EU type-examination certificate.



8. each notified body shall inform the authority of the EU type-examination certificates

type or additions thereto which it has issued or withdrawn, and shall, periodically or on

request, make available to the Office a list of the certificates and/or additions thereto,

refused, suspended or otherwise restricted.



Each notified body shall inform the other notified bodies of the

the EU type-examination certificates and/or any additions thereto which it has refused,

withdrawn, suspended or otherwise restricted, and, upon the request of any other notified

subjects also about certificates and/or any additions thereto which it has issued.



The European Commission, European Union Member States and the other notified bodies

the notified body may request a copy of the EU type-examination certificate

or additions to them. The European Commission and the Member States of the European Union

the notified body may ask for a copy of the technical documentation and the results of the

the review carried out by it. The certificate expires, the EU

type-examination, the notified body shall keep a copy of this certificate,

its annexes and additions, as well as the technical file including the

the documentation submitted by the manufacturer.



9. For a period of 10 years after the apparatus on the market, the manufacturer for

the need for the supervisory authority a copy of the EU type-examination certificate, its

annexes and additions together with the technical documentation.



10. the manufacturer's authorised representative may lodge the application referred to in point 3 and

to carry out the activities provided for in paragraphs 7 and 9, where the manufacturer in the mandate

authorised representative established.



PART (B)



Conformity to type based on internal production control (module C)



1. conformity to type based on internal production control is the part of the procedure

conformity assessment, the manufacturer performs the activities provided for in points 2

and 3, and ensures and declares that the appliances are in conformity with the type

as described in the EU type-examination certificate and satisfy the requirements of

laid down in this regulation that apply to them.



2. production



The manufacturer shall take all measures necessary so that the manufacturing process and its

monitoring ensure conformity of the manufactured instruments with the approved type

as described in the EU type-examination certificate and with the requirements of this

the regulation, which applies to them.



3. the CE marking and EU Declaration of conformity



3.1. The manufacturer shall affix the CE marking to each individual unit that is

in conformity with the type as described in the EU type-examination certificate and satisfies the

the relevant requirements of this regulation.



3.2. the manufacturer shall draw up for each machine model written EU Declaration of

conformity and for a period of 10 years after the apparatus on the market is a must, for

the need for the supervisory authority. The manufacturer shall provide, on request, a copy of the EU Declaration of

conformity to the supervisory authority.



4. Authorized Representative



The activities of the manufacturer referred to in point 3 may be on its behalf and on its

responsibility carried out by his authorised representative, if the manufacturer in

authorised representative established the credentials.



Č. 4



EU Declaration of conformity (# XXXX) ^ 8)

1. the Model of the device/product (product number, type or series 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 the device allowing to reverse

trace; If it is necessary for the identification of the instrument, can

include a sufficiently clear colour image):



5. object of the Declaration described above is in conformity with the relevant Community harmonisation

regulations of the European Union:



6. references to the relevant harmonised standards used, including data


standards or other technical specifications, including specifications, data on

which conformity is declared:



7. If necessary, the notified body must: ... (name, number) performed ... (description of intervention) and

issued the certificate:



8. other 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 of 30/EU of 26 March. February

2014 on the harmonisation of the laws of the Member States relating to the

electromagnetic compatibility.



2) Government Regulation No. 426/2000 Coll. laying down technical

requirements for radio and telecommunications terminal equipment, as amended by

amended.



3) European Parliament and Council Regulation (EC) No 216/2008 of 20 October.

February 2008 on common rules in the field of civil aviation and

establishment of the European Aviation Safety Agency, repealing

Council Directive 91/670 EC, Regulation (EC) No 1592/2002 and directive

2004/36/EC, as amended.



4) Constitution and the International Telecommunication Union Convention, adopted at the

additional Conference of Plenipotentiaries (Geneva, 1992), as amended by

Government Plenipotentiaries Conference (Kyoto, 1994).



5) for example, the Government order No. 120/2016 Coll. on the conformity assessment of measuring instruments

When they are making available on the market, Government Regulation No. 54/2015 Coll.

technical requirements for medical devices.



6) Government Regulation 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.



7) Act 127/2005 Coll., on electronic communications and amending

some related laws (Act on electronic communications),

in the wording of later regulations.



8) the manufacturer may give the number of the Declaration of conformity.