426/2000 Coll.
GOVERNMENT REGULATION
of 23 December 2003. October 2000,
laying down technical requirements for radio and telecommunication
terminal equipment
Change: 483/2002 Sb.
Change: 251/2003 Coll.
Change: 426/2000 Coll. (part)
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. 71/2000 Coll. (hereinafter the "Act") to implement section 11 para. 1, §
12 paragraph 1. 1 and 4 and § 13 para. 2 and 4 of the Act:
§ 1
(1) in this regulation means
and telecommunications terminal equipment) product, or relevant component thereof,
to facilitate communication, which is intended for connection to the public interface
telecommunication networks, ^ 1)
b) radio equipment product or its important part of enabling
communication on the basis of the transmission or reception of radio waves ^ 2) using
the frequency spectrum allocated to terrestrial or space
radio communications, ^ 3)
c) device a device that is
1. the components or separate technical unit, of a motor vehicle
intended for use on the road, with or without bodywork
body, with at least four wheels and a maximum design speed
in excess of 25 km/h, including trailers, with the exception of railway
vehicles and agricultural or forestry tractors and machinery
self-propelled work machines and carried, or
2. parts or a separate technical unit of two or
three-wheel motor vehicles intended for use on the road
communications and components or technical units of such
vehicles with the exception of
2.1. vehicles with a max. design speed not exceeding 6 km/h,
2.2. vehicles on the pedal-powered,
2.3. vehicles intended for use by the physically handicapped,
2.4. vehicles designed for use in road or off-road
races,
2.5. vehicles in service before the entry into force of this regulation,
2.6. tractors and machines, used for agricultural or similar purposes,
2.7. vehicles designed for operation outside the road
in his spare time, having wheels arranged symmetrically with one wheel at the front
and two in the rear,
2.8. the components or technical units referred to vehicles other than those
which are intended for use on two-or three-wheel
motor vehicles intended for use on the road,
3. the components or separate technical unit of motor vehicles
four wheels having the following characteristics:
3.1. unladen mass is not more than 350 kg (in the case of
electric vehicles in this weight does not count the weight of the batteries),
maximum design speed not exceeding 45 URkm.hod-1 and the contents of the cylinders
does not exceed 50 cc for positive-ignition engines, spark plug or
maximum net power shall not exceed 4kW for other types of engines, or
3.2. unladen mass does not exceed 400 kg or 550 kg
vehicles intended for the transport of goods (in case of electric vehicles with the
the maximum net engine power not exceeding 15 kW in this
weight does not count the weight of the batteries),
(hereinafter referred to as "equipment").
(2) in this regulation, further means
and interference interference) side, that endangers the functioning of
a radionavigation service or of other safety services or which
otherwise seriously degrades, frustrates, or repeatedly interrupts a radiocommunication
the service operated in accordance with the applicable rules,
(b)) laid down under section 12 paragraph 1 products. 1 of law apparatus and equipment
referred to in paragraph 1,
(c) class that identifies the device class) types of devices and equipment and
the interface for that device or the device is intended. Device classes
establishes the Czech Telecommunication Office (hereinafter referred to as "the authority") measures. ^ 8)
Instruments and devices can be inserted simultaneously or in succession to a more
than one class of the device.
§ 1a
This regulation is in accordance with the law of the European communities ^ 3a) and with
International Treaty ^ 3b) provides technical requirements for radio and
telecommunications terminal equipment.
§ 2
(1) this Regulation applies to instruments and equipment, with the exception of
devices and equipment referred to in annex 1 to this regulation.
(2) if the device and the device incorporates, as an integral part, or as a
Accessories
and) medical devices established by special legislation, ^ 4)
(b) active implantable medical devices) laid down special
legislation, ^ 5)
This is covered by the Government order.
(3) the prescribed products must meet the following basic requirements:
and) health and safety of the user and any other person,
including the objectives stipulated by special legislation, ^ 6) but without
considerations on the value of the voltage,
(b)) concerning electromagnetic compatibility protection provided for
special legislation, ^ 7)
c) radio equipment shall be so constructed that it effectively uses the
frequency spectrum allocated to terrestrial or space
radio communication and resources that reside on the raceways, and so that the
prevent unwanted interference.
(4) the instruments and equipment in certain classes or apparatus and equipment
certain types of Authority shall be published in the telecommunications journal
the form of notice, which shall be in accordance with the relevant international
the Treaty, ^ 8) and these instruments and equipment must be so designed as to
and worked through) public telecommunications network with other
equipment and devices, and that it can be connected to the public
telecommunication network in the territory of the Czech Republic and on the territory of the Member
State of the European Union,
(b)) does not affect adversely the public telecommunications network, do not cause
an unacceptable deterioration in the quality of the services or their operation nezneužívala
the capacity and capabilities of the public telecommunications network,
(c) security elements ensuring) include the protection of personal data and
the privacy of the user and of the Subscriber,
(d) to prevent fraud) support function,
e) support feature that enables access to emergency services,
f) support features to facilitate their use for the disabled
users.
(5) If the equipment is subject to other regulations of the Government,
laying down technical requirements for products, devices and must
to meet the requirements set forth in these regulations.
(6) if the requirements for the equipment specified in
the harmonized standards under section 4A(1). 1 of law or foreign
technical standards adopted pursuant to the harmonised European standard and
the properties of the devices and equipment are consistent with them, it is considered that the
These are the essential requirements referred to in paragraph 3 are met.
§ 3
cancelled
§ 4
(1) prior to the placing on the market of equipment and devices of the manufacturer or his authorised
representative established in the Member State of the European Union or the person in charge
for the placing on the market of devices and equipment ensures conformity assessment pursuant to
§ 12 para. 4 of the Act is the basic requirements according to your choice of any of the
the following procedures:
and) telecommunications terminal equipment, which do not use frequencies or
the frequency bands allocated to terrestrial or space radio communication
and receiving parts of radio equipment shall be subjected to one of the procedures
described in annex No. 2, 4 or 5,
b) if harmonized standards have been applied, subject to the radio
the device is not covered by point (a)), to one of the procedures
described in annex No. 3, 4 or 5,
(c)) If you have not applied the harmonized standards or was used only
their part, radio equipment, is not covered by
paragraph (a)), one of the methods described in annex No 4 or 5 under
choice of the manufacturer.
(2) in addition to the procedures provided for in paragraph 1 may be the conformity of equipment and
device with the essential requirements referred to in § 2 (2). 3 proven by
the procedures provided for by specific legislation, ^ 6) ^ 7) if
These devices and equipment concerned specific legal provisions apply.
(3) the records and correspondence relating to conformity assessment procedures referred to in
paragraph 1 shall be in an official language of the Member State of the European Union, in
where the conformity assessment procedure is conducted, or in a language
agreed appropriate certification under section 11 and 11a of the Act.
(4) to each device, and the device will issue the manufacturer or by his authorized
representative established in the Member State of the European Union or the person in charge
for placing on the market of devices and equipment Declaration of conformity with the essential
the requirements that apply to it, and placed it of the CE marking referred to in
Annex # 7 to indicate the year in which compliance has been assessed. To
identify the manufacturer of the device or device type number, the number
production of the series or the serial number and the name of the manufacturer or the person responsible
for placing the apparatus on the market. If the procedures are in accordance with
Annex No. 3, 4 or 5, is accompanied by the identification
the number of the notified body referred to in annex 6. Radio equipment is
In addition, the identification of the device class according to the character of annex 7. To
the device can be connected to any other designation under the condition that the
This will not reduce the visibility and legibility of the CE marking. Any appliance and
the device, regardless of whether it meets or does not meet the relevant
the essential requirements, may bear any other marking which could indicate
third parties as to the meaning or form of the CE marking referred to in
Annex No. 7.
(5) the manufacturer or his authorized representative is established in the Member State
The European Union or the person responsible for placing the equipment on the
the market must provide users with information about the intended use of
together with a declaration of conformity with the essential requirements laid down in this
Regulation, which is applicable to it. Radio equipment must be
Meanwhile, on the packaging and in the instructions for use of the device listed insufficient data
on the manner and conditions of use of the device and the markings on the device according to the
point 5 of annex # 7 must notify the user on any restrictions or
the permission to use the radio equipment. For telecommunications
terminal equipment shall include sufficient information to
identify the interfaces of public telecommunications networks to which it is to be
device is connected. For all devices, this information must be bold
manner listed.
(6) in the case of radio equipment using frequency bands,
whose use is not in any of the Member States of the European Union
harmonised, the manufacturer or his authorised representative established in the
The European Community or the person responsible for placing the device on the market
shall notify the authority, which is responsible for the management of the frequency spectrum in the Czech
Republic, ^ 10) intention to place such equipment on the market of the Czech Republic. This
notification shall be given no later than 4 weeks before placing the device on the
market and shall contain the information about the radio characteristics of the
the device, in particular frequency bands, channel, kind of distance
modulation and high-frequency performance, and the identification number of the notified
a person in a Member State of the European Union according to annex No 4 or 5.
(7) if the equipment is subject to other directives
Of the European Communities before the directive on radio equipment and Terminal
telecommunications equipment and the mutual recognition of their conformity
include other aspects and also provide for means of identification mark of conformity
CE marking, the latter shall indicate that the appliances and equipment meet also
the provisions of those other directives. In this case, must be in
documents, reports or instructions required by those directives and
accompanying the relevant product, reference to the directive in the
accordance with their publication in the official journal of the European
the community.
§ 5
(1) the instruments and equipment that do not meet the requirements laid down in this
Regulation may not be placed on the market.
(2) in the case of radio equipment, including types of radio equipment, which
cause undesirable interference, including interference with existing or
planned services on nationally allocated frequency bands, or
for which these effects can reasonably be expected, will make the supervisory authorities in the
cooperation with the Office of all appropriate measures, according to a special legal
^ 11) Regulation to ensure that prohibited or restricted their marketing
the market or ensure their withdrawal from the market.
(3) against a person who has affixed a marking not in conformity to section
3 (2). 4 or § 4 paragraph 2. 4 or Annex No. 7, the supervisory authorities shall take
measures under special legislation. ^ 11) If a person cannot be
that this marking will be joined, to determine appropriate action
taken against the person who had the devices and the equipment for yourself at a time when
the mismatch in the first sentence was discovered.
(4) the instruments and equipment that do not meet the requirements laid down in this
Regulation, can publicly exhibiting at trade fairs, exhibitions,
demonstrations and other events only on condition that they are visibly
marked with the caveat that they cannot be marketed and operated
before their match will be ensured with the requirements laid down in this
by regulation.
Section 5a
If it has been saved for equipment and protective measures referred to in
a special law ^ 11a) as a result of non-compliance with the requirements of this regulation, in
notice pursuant to § 7 para. 8 of the Act shall indicate whether the reason for the imposition of
safeguard measure was caused by
and) incorrect application of the harmonised standards,
b) shortcomings in the harmonised standards,
(c) failure to satisfy the requirements referred to in §) 2 (2). 3 where the apparatus and
devices do not meet the harmonised standards.
§ 6
(1) the provisions of government regulation, laying down technical requirements for
products in terms of their electromagnetic compatibility, ^ 7)
not apply to appliances and devices to which this Regulation applies,
with the exception of the protection requirements according to § 3 (2). 1 and 3, § 4, paragraph 4. 1 and 2,
§ 5, 6, 7 and the annex to the decree-law, laying down technical
product requirements in terms of their electromagnetic
compatibility. ^ 7)
(2) the provisions of government regulation, laying down technical requirements for
electrical low voltage equipment, ^ 6) shall not apply to apparatus and
equipment covered by this regulation, with the exception of the objectives
relating to security requirements under section 3, paragraph 3. 1, § 4, 5 and
Annex 2 to the regulation of the Government laying down technical requirements for
electrical low voltage equipment. ^ 6)
§ 7
Evidence of the method of assessment of conformity according to § 13 para. 4 of the law
contain
and) the technical documentation referred in each of the annexes to this
Regulation,
(b)) documents and findings released in the conformity assessment by a notified body.
§ 8
For the assessment of conformity of equipment and facilities may be granted authorization
pursuant to section 11 of the Act, only legal persons that meet the minimum
the conditions laid down in annex 6.
§ 9
cancelled
§ 10
(1) the instruments and equipment, approved by 30. June 2000 under the
The Ministry of economy no. 26/1996 Coll., on the way, conditions and
verification process and approval of telecommunications terminal
the device can be placed on the market by 30. June 2002.
(2) an authorized person shall carry out Tasks until the date of entry into force of
Treaty of accession of the Czech Republic to the European Union, the Office. ^ 12)
§ 11
(1) this Regulation shall enter into force on 1 January 2000. in May 2001, with the exception of
the provisions of paragraph 4, which shall take effect on the date of the entry of the Treaty on
accession of the Czech Republic to the European Union enters into force.
(2) the date of entry of the Treaty of accession of the Czech Republic to the European Union in
force shall expire, section 3, and 9.
Prime Minister:
Ing. Zeman in r.
Minister of transport and communications:
Ing. Schling in r.
Č. 1
APPLIANCES AND DEVICES TO WHICH THIS REGULATION DOES NOT APPLY
1. Radio equipment used by radio amateurs within article 1, definition 53, according to
the radio regulations of the International Telecommunications Union (ITU),
If these devices are not commercially available. For commercially available is
not a kit with parts intended for radio amateurs and Assembly
commercial equipment modified by radio amateurs for their own use.
2. Equipment covered by the ship's equipment, when
2.1. device means any items that must be placed on board
for use in order to meet international regulations or are freely
located on the Board for the use for which it is required by
international regulations, the approval of the Government of the State where the vessel is
registered (flag)
2.2. radiocommunications equipment means the equipment referred to in chapter
IV. International Convention for the safety of life at sea (SOLAS
1974, as amended by regulations),
2.3. for equipment intended for use on
and the new vessel registered in the) European Union Member State without
the difference of whether at the time of construction or not located in the territory of
the Member State of the European Union,
(b) registered in the existing Board) Member State of the European Union,
-where such equipment was not previously placed on board the vessel, or
-If the device that was previously placed on the vessel is replaced,
except when otherwise permitted by international treaty to do without
regardless of whether the ship is at the time when the device is placed on a
the vessel, located or not in the territory of a Member State of the European
Union.
3. Cables & wires.
4. radio equipment intended solely for the reception of sound and tv
the broadcast.
5. Products, appliances and components in the field of civil aviation:
and) products (civil aircraft, engines, motors or equipment),
(b)) equipment (Tools, devices, mechanisms, apparatus or
accessory used or intended for use for the purpose of control of the aircraft for
the flight, which are installed or intended to install or mount
for civil aircraft, but does not form part of the airframe, engine or power),
c) component [component parts or materials not included in (a) subsoučásti
and) or (b)), intended for use in civil aircraft, their engines,
drives or devices].
6. Equipment and systems for air traffic control, in particular
-connection systems
-systems for tracking aircraft,
-systems providing automatic support for air traffic control,
-navigation systems.
7. The apparatus or equipment exclusively used for
and intelligence tasks) ^ 13)
(b)), the police of the Czech Republic in the area of security, ^ 14) or
(c)) services of the Customs Office, ^ 15)
(d)) the tasks of the armed forces of the Czech Republic. ^ 16)
Č. 2
CONFORMITY ASSESSMENT PROCEDURE according to § 3 (2). 1 (b). and section 4, paragraph 4) or. 1
(a). and) (internal production control)
1. The conformity assessment procedure applies to cases in which the
the manufacturer or importer when the procedure under section 3 or the manufacturer or his
authorized representative when the procedure according to § 3 (2). 8 and § 4 filling
the obligations laid down in point 2, ensures and issued a declaration that the
the products meet the requirements of this regulation, the
apply. The manufacturer or importer when the procedure under section 3 and the manufacturer or
his authorised representative in the procedure according to § 3 (2). 8 and section 4 connects to the
every device of the CE marking and draws up a written declaration of conformity
the essential requirements.
2. the manufacturer shall establish the technical documentation described in point 4. The manufacturer, or
the importer of the procedure under section 3 or the manufacturer or his authorised representative
When the procedure according to § 3 (2). 8 and section 4 shall keep this documentation at the time
at least 10 years after the last product has been manufactured, make available to the
the supervisory authorities for control purposes.
3. If the manufacturer of the procedure under section 3 or the manufacturer or his authorised
the representative of the procedure under section 3 (1). 8 and § 4 do not have a seat in the Czech
Republic, the obligation to keep the technical documentation at the
available to the person who places the products on the market of the Czech Republic.
4. the technical documentation must enable the conformity of the product with
the essential requirements. It must cover the design, manufacture and operation
product, in particular
-a general description of the product,
-drawings of the conceptual design and manufacturing drawings and
diagrams of components, sub-assemblies, circuits, etc.,
-descriptions and explanations necessary for the understanding of said drawings and
schemes, as well as the function of the product,
-list of technical standards according to § 2 (2). 6, that were used in the
full or in part. Descriptions and explanations of the solutions adopted to
compliance with the essential requirements of this regulation if the standards referred to in
§ 2 (2). 6 were not used or no such standards exist,
-results of design calculations, examinations, etc.,
-test reports.
5. the manufacturer or importer when the procedure under section 3 or the manufacturer or his
authorized representative when the procedure according to § 3 (2). 8 and 4 keeps, together with
the technical documentation a copy of the Declaration of conformity, if it has been
released.
6. the manufacturer shall take all measures necessary in order that the manufacturing process
ensures compliance of the manufactured products with the technical documentation referred to in point
2 and with the requirements of this regulation which apply to it.
Č. 3
CONFORMITY ASSESSMENT PROCEDURE according to § 3 (2). 1 (b). (b)) or under section 4 (4).
1 (b). (b)) (internal production control plus specific apparatus tests)
For this procedure applies Annex No. 2, and the following additional requirements:
1. for each device type and device manufacturer shall carry out or have carried out the
all essential radio test suites series. For the determination of the series
the tests, which are considered to be essential, it is the responsible authorized person
(notified body in the Member State of the European Union, hereinafter referred to as
"notified body") adopted by the manufacturer, if these are not series
laid down in harmonised standards. Authorized person (notified body
duly taking into account the person) an earlier decision that authorized
persons (notified body) have jointly adopted.
2. the manufacturer or importer when the procedure under section 3 or the manufacturer or his
authorized representative when the procedure according to § 3 (2). 8 and 4 or the person
responsible for placing the apparatus on the market and will issue a declaration that the
These tests have been performed and the device, and the device meets all the
the basic requirements of and in the course of the manufacturing process to it connects
identification number of the notified body (notified body).
3. the obligations referred to in points 1 and 2 in relation to the notified persons is
necessary to perform up to the date of entry of the Treaty of accession of the Czech Republic
The European Union enters into force.
Č. 4
CONFORMITY ASSESSMENT PROCEDURE according to § 3 (2). 1 (b). a) to (c)) or under section 4 of the
paragraph. 1 (b). a) to (c)) (technical construction File)
For this procedure applies Annex No 3 and the following additional requirements:
1. the technical documentation referred to in point 4 of annex 2, together with a declaration
of conformity applicable to specific series radio test suites
According to the annex No. 3 consists of a technical construction file.
2. the manufacturer or importer when the procedure under section 3 or the manufacturer or his
authorized representative when the procedure according to § 3 (2). 8 and 4 or the person
responsible for placing the apparatus and equipment on the market shall submit this file
supporting documents to one or more authorized persons (one or several
notified persons), each of which must be informed of the other,
that the file received.
3. The notified body (notified body) shall review the file, and
If it comes to the conclusion that compliance with the requirements of this directive has not been properly
proven, may announce its opinion on the manufacturers or importers in the
pursuant to section 3 or the manufacturer or his authorised representatives when the procedure pursuant to §
3 (2). 8 and 4 or the person responsible for placing the apparatus and equipment
the market and report to the appropriate message to the other authorized persons
(the parties) that have received the file. The opinion must
be issued within 4 weeks of handout file transfer to the notified body
(notified). After receipt of this opinion or at the end of the period
4 weeks can be the appliance or equipment put on the market without
without prejudice to the provisions of § 3 para. 6 and § 5 para. 1.
4. the manufacturer or importer when the procedure under section 3 or the manufacturer or his
authorized representative when the procedure according to § 3 (2). 8 and 4 or the person
responsible for placing the apparatus on the market must keep or file
supporting documents for a period of at least 10 years after the last product has been manufactured so that the
was available to the supervisory authorities for control purposes.
5. the obligations laid down in points 2 and 3, in relation to the notified persons is
necessary to perform up to the date of entry of the Treaty of accession of the Czech Republic
The European Union enters into force.
Č. 5
CONFORMITY ASSESSMENT PROCEDURE according to § 3 (2). 1 (b). a) to (c)) or section 4, paragraph 4.
1 (b). a) to (c)) (full quality assurance)
1. Full quality assurance is the procedure when a manufacturer that
satisfies the obligations of point 2 ensures and issued a declaration that the
the products meet the requirements of this regulation, the
apply. The manufacturer must affix on each product designation in accordance with § 3 (1). 4
When the procedure under section 3 or placed on a product for the CE marking when the procedure
According to § 3 (2). 8 and section 4 and shall provide a written declaration of conformity.
2. the manufacturer applies the approved quality system for design,
manufacture and final product inspection and testing as specified in point 3 and subject yourself to
the surveillance as specified in point 4.
3. Quality System
3.1. The manufacturer shall provide the authorized person (the notified person) on request
an assessment of their quality system. The request contains
and) all relevant information on the foreseen products,
(b)) the documentation concerning the quality system.
3.2. The quality system must ensure compliance of the products with the requirements of this
the regulation, which applies to them. All the basic principles, the requirements of
and measures adopted by the manufacturer must be systematically and properly
documented in the form of written measures, procedures and instructions. This
the quality system documentation must ensure a uniform interpretation of the concepts and
quality assurance procedures such as quality programmes, plans,
quality, quality manuals and quality records. In particular, it must be suitable
the manner described
a) the quality objectives and the organisational structure, responsibilities and powers of the
of the management with regard to design and quality of production,
(b)) the technical specifications, including the harmonised standards and technical
regulations as well as relevant test specifications that will be applied, and
If the standards referred to in section 2 (2). 6 applied in full,
resources to ensure compliance with the essential requirements of this
the regulation, which apply to the products,
(c)) work on the management methods of the design and its verification, as well as
processes and systematic measures that will be used when designing the
products belonging to that category,
(d) the corresponding factory methods), quality management and quality assurance,
processes and systematic measures that will be used,
e) examinations and tests that will be carried out before the start of production,
during and after its completion, with an indication of the frequency with which they will be
to perform, including where appropriate the results of tests that have been carried out before
the start of production,
f) means by which will be provided to test and control equipment
match the appropriate requirements for carrying out the necessary tests,
g) records relating to the quality, such as control protocols, the results
and test data, calibration data, qualification of the relevant records
workers, etc.,
(h) the means to monitor the achievement of) the required quality
structural design and products, as well as the effective functioning of the system
the quality.
3.3. The notified body (notified body) shall assess the quality system,
in order to determine whether it satisfies the requirements referred to in 3.2. Compliance with these
the quality systems requirements, which apply the relevant
harmonised standards. Authorized person (notified body) in particular
examine whether the quality management system ensures conformity of the products with the requirements of
in terms of this regulation, the relevant documentation submitted pursuant to points
3.1. and 3.2., including the results of the tests submitted by the manufacturer.
At least one member of the Panel must have experience with
evaluation technology of the product. The evaluation process includes
also visit the device manufacturer. The decision must be notified to the manufacturer.
The notification must contain the conclusions of the examination and the reasoned assessment decision on its
the result.
3.4. the manufacturer shall undertake to fulfil the obligations arising from the system
quality in the form in which it was approved, and to maintain, so that
He remained an effective and appropriate to its mission.
The manufacturer or his authorised representative in the Czech Republic are obliged to
to inform an authorized person (by person) that the system
quality approved of any of its intended update.
Authorized person (notified body) will examine the proposed changes and
decide whether the modified quality system will still satisfy the requirements referred
3.2. or whether a re-assessment is required.
Shall notify the manufacturer of its decision. The notification must contain the conclusions of the evaluation
and the reasoned assessment decision.
4. surveillance under the responsibility of the European Community is authorised
persons (notified body)
4.1. The purpose of surveillance is to ensure that a manufacturer correctly fulfils the obligations,
arising out of the approved quality system.
4.2. the manufacturer shall allow the notified body (the notified person) for the purpose of
inspection access to objects where the design of the product is carried out,
its manufacture, inspection and testing, and storage and shall provide it with all
the necessary information, in particular
and) the quality system documentation,
(b)) quality records provided for in part of the quality system relating to
the design, such as results of analyses, calculations, tests,
etc.,
c) quality records provided for in part of the quality system relating to
production, inspection protocols, test results, information about
calibration records of the qualifications of the personnel concerned, etc.
4.3. The notified body (notified body) performs the appropriate
intervals of the screening to make sure that the manufacturer maintains and applies the
quality system and serves them to the report.
4.4. Additionally, the notified body (notified body)
unexpected visits to the manufacturer. During such visits authorized
person (notified body) may, if necessary, carry out or have
carried out tests to verify the proper functioning of the quality system.
Authorized person (notified body) passes to the manufacturer with a visit report
and in the case of carry out tests with a test report.
5. The manufacturer must, for a period of at least 10 years after the manufacture of the last
product
and documentation described in section 3.1). (a). (b)),
b) data on the update according to the second paragraph of point 3. 4.,
(c)), the decisions and reports of the notified body (notified body) according to the
the last paragraph of point 3.4. and 4.3. 4.4. to be available
the supervisory authorities.
6. each notified body (notified) shall make available to the other
authorized persons (the notified persons) relevant information on the
quality system approvals issued or odejmula, referring to the
the product (s).
7. obligations in relation to the persons to be notified to perform up to the date of
the Treaty of accession of the Czech Republic to the European Union in
force.
Č. 6
THE CONDITIONS OF THE AUTHORIZATION
1. the notified body, its Director and the staff responsible for
implementation of tasks for which the notified body has been entrusted with, cannot be
Designer of radio equipment and telecommunications terminal equipment
their manufacturer, vendor, or organization or a worker carrying out
or a network operator or a service provider, nor
the authorised representative of any of those parties. Authorized personnel
the person must be independent and must not be directly involved in the design
design, manufacture, marketing or maintenance of radio equipment and
telecommunications terminal equipment, nor represent the parties
engaged in these activities. This does not preclude the possibility of exchanges
technical information between the manufacturer and the notified body
(notified body).
2. The notified body and its staff must carry out the tasks
the notified body (notified body) responsible for, on
the highest professional level and technical competence and must be
exposed to any pressure and inducements, particularly financial, which might
influence their judgement or the results of the inspection, especially from persons
or groups of persons with an interest in such results.
3. The notified body must have at its disposal the necessary staff and
the device, in order to enable it to perform properly the administrative and technical work
related to entrusted tasks.
4. The staff responsible for inspections must have
-sound technical and vocational training,
-satisfactory knowledge of the requirements relating to the tests carried out and
inspections and adequate experience of such tests and inspections,
-the ability to issue certificates, records and reports required to
proof of inspections carried out.
5. the impartiality of inspection staff must be guaranteed for workers. Their
remuneration must not depend on the number of tests carried out or on the inspections and
the results of such inspections.
6. The notified body shall have liability insurance, if the
its liability is not covered by a Member State of the European Union in accordance with
national regulations or, if not, the Member State itself is directly responsible.
7. the staff of the authorized persons are required to maintain the business
the secret, with regard to all information gained in carrying out
its tasks under this regulation.
Č. 7
The MARKING of the EQUIPMENT according to § 3 (2). 8 and 4
1. the graphic form of the CE marking is established by a special legal
Regulation. ^ 17) Government Regulation No. 291/2000 Coll., laying down
graphic form of the CE marking.
In the case of enlargement or reduction of the CE marking must be retained
the proportions of the cable grid.
2. the CE marking must have a height of at least 5 mm except where this
does not allow for the nature of the instrument.
3. the CE marking is attached to the product or to its identification
the label. Additionally connects to the package (if it exists) and to the accompanying
the documentation.
4. The CE marking shall be affixed visibly, legibly and indelibly.
5. the equipment class identifier with any additional
the indication informs the user of radio equipment stating that the device is
applied in the context of the United States or the European Community restrictions
regarding its entry into service. Identifying character has the same height
as the initials "CE" and this video has the form:
Selected provisions of the novel
Article. XVI Act No. 251/2003 Coll.
(1) in the case of products which are not intended for placing on the market of the European
community and which are subject to Government Regulation referred to
and in the article). XI to XIV, you can follow the existing legislation
the entry of the Treaty of accession of the Czech Republic to the European Union in
entry into force,
(b)) in the article. I to X, you can follow the existing legislation to
the publication of the agreement amending the Protocol to the Europe agreement
establishing an association between the European communities and their
Member States, of the one part, and the Czech Republic, on the other
conformity assessment and acceptance of industrial products, in the collection of
international treaties.
(2) in cases where the conformity assessment procedures involved in the authorized
a person can be followed under this regulation to the date of publication
Agreement amending the Protocol to the Europe Agreement establishing an
Association between the European communities and their Member States, of the
one part, and the Czech Republic, of the other part, on conformity assessment and
acceptance of industrial products, in the collection of international treaties.
1) § 2 (2). 4 Act No. 151/2000 Coll. on telecommunications and amending
other laws.
2) § 2 (2). 12 Act No. 151/2000 Sb.
3) § 94 (a). g) and section 95 paragraph 1 (b). (b)) Law No 151/2000 Sb.
3A) directive of the European Parliament and of the Council No. 1999/5/EC on radio and
telecommunications terminal equipment and the mutual recognition of their
of conformity.
3B) for example, the Protocol to the Europe Agreement establishing an association between the
The Czech Republic on the one hand, and the European communities and their
Member States, of the other part, on conformity assessment and acceptance of
of industrial products (PECA), promulgated under Act No. 56/2001 Coll., m. s.
4) Government Regulation No. 179/1998 Coll., laying down technical
resource requirements for medical devices, as amended
regulations.
5) of Decree-Law No 198/1999 Coll., laying down technical
requirements for active implantable medical devices.
6) of Decree-Law No 168/1997 Coll., laying down technical
requirements for electrical low voltage equipment.
7) Government Decree No. 169/1997 Coll., laying down technical
product requirements in terms of their electromagnetic compatibility.
8) § 4 paragraph 2. 4 Act No. 151/2000 Sb.
Europe Agreement establishing an association between the Czech Republic, of the other
one part, and the European communities and their Member States, of the
Second, under the famous No. 7/1995 Sb.
10) § 56 para. 1 and § 95 paragraph 5 (b). and) of the Act No 151/2000 Sb.
10A) § 46 et seq. Act No. 151/2000 Coll. on telecommunications and amending
other laws.
11) Act No. 64/1986 Coll., on Czech commercial inspection, as amended by
amended.
for example, § 7a 11A) of Act No. 64/1986 Coll., on Czech commercial inspection,
in the wording of later regulations.
12) § 95 paragraph 2 (a). and) of the Act No 151/2000 Sb.
13) Act No. 67/1992 Coll., on the Military Counterintelligence, as amended by
amended. Act No. 154/1994 Coll. on security information
the service, as amended by Act No. 160/1995 Sb.
14) Act No. 283/1991 Coll., on the police of the Czech Republic, as amended by
amended.
15) § 37 c (a). (b)) of the Act No. 13/1993 Coll., the Customs Act, as amended by law
No 113/1997.
16) Act No. 219/1999 Coll., on the armed forces of the United States.
17) Government Regulation No. 291/2000 Coll., laying down graphic design
the CE marking.