88/2009 Sb.
GOVERNMENT REGULATION
of 15 November 2004. February 2012,
amending Government Decree No. 133/2005 Coll., on technical
requirements for operational and technical interconnection of the European
the rail system, as amended
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. and Act No. 34/2006:
Article. (I)
Government Decree No. 133/2005 Coll., on technical requirements for operational and
technical interconnection of the European railway system, as amended by
Government Decree No. 371/2007 Coll. and Decree-Law No 289/2010 Sb..,
be amended as follows:
1. Footnote 1 is added:
"1) European Parliament and Council Directive 2008/57/EC of 17 May 1999. June
2008 on the interoperability of the rail system within the community.
Commission directive 2011/18/EU of 1. March 2011, amending
annexes II, V and VI of the directive of the European Parliament and Council Directive 2008/57/EC on the
interoperability of the rail system within the community. ".
2. In paragraph 1 (b). (b)), the words "and the appropriateness of using established products"
shall be replaced by "provided for the products and their suitability for use."
3. in article 2, paragraphs 2 and 5 shall be deleted.
Paragraphs 3, 4 and 6 shall be renumbered 2, 3 and 4.
4. In article 2 (2). 3, the word "which" shall be replaced by the word "the" and the words
"in the regulations of the European communities" shall be replaced by the words "in a special
the law of the ^ 5) ".
5. In section 3, paragraph 3. 2 (a). a) after the word "meet" the words
"the technical specifications of interoperability and".
6. section 4, including footnote # 13:
"§ 4
(1) components of the interoperability pursuant to this regulation are laid down in
products within the meaning of § 12 para. 1 (b). and) of the Act.
(2) compliance with the requirements pursuant to § 3 (2). 2 (a). and part of the)
verifies the conformity assessment procedure of interoperability. If provided for by
technical specification of interoperability, the part of a conformity assessment
component interoperability is also an assessment of its suitability for
use the appropriate subsystems.
(3) conformity assessment of interoperability constituents or components of its suitability for
use is made according to the technical specifications of interoperability
governing component interoperability and further by
and) the decision on a common framework for the marketing of products ^ 12), if
appropriate technical specifications for interoperability entered into force
no later than 31 March 2004. December 2010, or
(b)) the decision on the modules for the conformity assessment procedures, fitness for
use and the EC verification in the field of railway transport ^ 13), if
appropriate technical specifications for interoperability entered into force
After the date referred to in point (a))
.
(4) the assessment of conformity and/or suitability for use conducted by notified body
person. If the component complies with the interoperability and related activities
its production, using, where appropriate, the requirements of § 3 para. 2 (a). and)
notified body shall issue a type-examination certificate, the certificate of
conformity, suitability for use certificate, or other document provided for by
in the regulations referred to in paragraph 3. Other than the notified body may
to carry out the assessment of conformity or suitability for use, only if it
allow the provisions referred to in paragraph 3.
(5) on the basis of the type-examination certificate, the certificate of conformity,
certificate of suitability for use, or another document issued by the
certification, where appropriate, on the basis of internal control log
the manufacturer on the conformity of the product with the technical specifications of interoperability
demonstrated by the manufacturer or his authorised representative to the conformity of the components
interoperability issuing an EC declaration of conformity with the technical
specifications of interoperability, of conformity with European specifications, or
of compliance with the přezkoumaným type (hereinafter referred to as "EC" Declaration of conformity ") and in
designated part of the interoperability pursuant to paragraph 2 shall demonstrate their
suitability for use by issuing an EC declaration of suitability for use.
The content of these declarations is reproduced in annex 1 to this regulation.
A condition of any such declaration is an application of the provisions of the technical
interoperability in the production specifications, where appropriate, when verifying the conformity of
component.
(6) the components of the interoperability constituent for which it was issued the EC declaration of
the EC declaration of conformity or suitability for use shall be deemed to
components that meet the basic requirements and conditions laid down in
relevant technical specifications of interoperability. Users and
of the notified body are not entitled to impede the placing of these components on the
the market or limit their use of the orbit, which form part of the
conventional or high-speed European railway system;
If the avoidance of new serious circumstances, that the use of those
part of prevent, and users are not notified of the person entitled to
should perform the same checks that have already been carried out as
part of the procedure preceding the issue of the EC declaration of conformity or an EC
Declaration of suitability for use.
(7) For spare parts to the subsystems that are in the time of the entry
the technical specifications of interoperability in force no longer listed
in operation, the assessment of conformity and suitability for use is not required.
13) Commission decision 2010/713/EU of 9. November 2010 about modules
for conformity assessment procedures, suitability for use and the EC verification
to be used in the technical specifications for interoperability
adopted pursuant to the directive of the European Parliament and of the Council
2008/57/EC ".
7. In article 5, paragraphs 2 and 3 shall be deleted.
Paragraphs 4 and 5 shall be renumbered as paragraph 2 and 3.
8. in § 5 para. 2, the first sentence is replaced by the phrase "conformity assessment procedure
part of the interoperability certification performed in stages
the overall project, and the implementation of a subsystem shall be in accordance with the
the conditions laid down in the technical specifications of interoperability. ".
9. in § 5 para. 2 the third sentence, the word "certificate" shall be replaced by the words "EC
Declaration of conformity or an EC declaration of suitability for use ".
10. section 6 including title and footnote No 14:
"section 6
Verification of the subsystem
(1) before placing the subsystem into service must be issued a certificate of
the type-examination certificate for the subsystem verification of a subsystem, or other
the document set out in the relevant technical specification for interoperability,
decision on a common framework for the marketing of products on the market) or in the 12 ^ ^
decision concerning the modules for the conformity assessment procedures, fitness for
use and the EC verification in the field of railway transport ^ 13) (hereinafter referred to as
"certificate of verification of the subsystem"). Certificate of verification of the subsystem
issued by notified body at the request of a subsystem or
authorised representative. The operator of a subsystem or his authorised
the representative of the issues on the basis of the issued certificate of EC verification of the subsystem
Declaration of verification of the subsystem, which it shall forward to the Office of the railway or railway
the registration of.
(2) the notified body when drawing up the certificate of verification of the subsystem
assessing the project and its respect for during and after production
acceptance test, and before a subsystem is put into service, and is responsible for
the accuracy and reliability of the subsystem. It also verifies the interface of the
the subsystem is running, into which it is incorporated, based on the
the information available in the relevant technical specification for interoperability
and in the registers of a part of the European rail system. Verification of the
interoperability of the structural subsystem, which in accordance with the
the essential requirements constitute the European rail system, must be
made on the basis of the reference to the technical specifications of interoperability
they are set up; If there are technical specifications for interoperability
subsystem must be issued, in accordance with European specifications.
(3) structural subsystems, which are part of the European
rail system have been assessed according to the directly applicable legislation
The European Union ^ 11) and the corresponding technical specifications
interoperability, and has been issued to them in the EC declaration of verification
the subsystem, are considered to be interoperable and the basic requirements
satisfactory.
(4) if it satisfies the technical requirements of the subsystem notified to the European Commission
under the law on rail systems ^ 2), the notified body shall issue, at the request
operator of the subsystem or of his authorised representative certificate
verify compliance with national requirements.
(5) the procedure for verification of the subsystem in accordance with paragraphs 1 and 4, and the content of the EC
Declaration of verification of the subsystem are listed in Appendix 2 of this
of the regulation.
14) § 49e para. 5 of the Act No. 266/1994 Coll., on rail, as amended by Act No.
134/2011 Sb. ".
11. the footnote No. 10 shall be deleted.
12. in section 6a, paragraphs 1 and 2 shall be added:
"(1) the operator of a subsystem or his authorized representative may
stage of the overall project or in the stage of implementation of the subsystem request
by the person for the issue of provisional opinion on the review of
the subsystem or the provisional opinion of the verification of the subsystem.
The operator of a subsystem or his authorized representative so requests
by the person for the issue of provisional opinion always provides
technical specifications of interoperability.
(2) the notified body performs a preliminary verification of the subsystem for those
elements of the subsystem whose properties can be checked in the stage before
placing the subsystem into service. Notified body when drawing up the
the provisional opinion on the review of the subsystem or of the provisional
opinions on the verification of a subsystem shall examine project subsystem, its
compliance during production and the quality of its own production. Pre-validation
the subsystem shall follow the procedure referred to in annex 2 of this regulation. ".
13. Annexes 1 and 2 shall be added:
' Annex 1 to the Decree-Law No. 133/2005 Coll.
CONTENTS OF THE EC DECLARATION OF CONFORMITY AND EC DECLARATION OF SUITABILITY FOR USE
EC declaration of conformity and EC declaration of suitability for use contains
description of components) interoperability (model, type, etc.),
(b)) trade name or first and last name, or the name and address of the manufacturer
or his authorised representative in the European Union (enter business name
or the name and surname or the name and full address of the registered office and, where
authorised representative, is also the trade name or name and last name or
the name of the manufacturer or constructor),
(c) a description of the procedure used in) type examination, assessment of the conformity or
suitability for use
d) links to European Union regulations and laws, according to which the
conformity or suitability for use and any reference to the
European specifications,
(e) all of the relevant descriptions of use), to which part of the interoperability
suits, and in particular its conditions of use,
f) name and address of notified body or a notified persons
participating in the procedure used with respect to the assessment of conformity or
suitability for use
(g) the date of certification of the components), together with the duration and
conditions of validity of the certificate,
h) the signature of the person authorized to act for the manufacturer, indicating name, surname
and features and release date EC declaration of conformity or an EC declaration of
suitability for use.
Annex 2 to the regulation of the Government No. 133/2005 Coll.
THE PROCEDURE FOR VERIFICATION OF THE SUBSYSTEMS, AND THE CONTENTS OF THE EC DECLARATION OF VERIFICATION OF THE SUBSYSTEM
I. procedure for verification of the subsystems
1. introduction
The subsystem verification is the procedure whereby a notified body assesses the
compliance and confirms that the subsystem meets the requirements of the technical
specifications for the operation of the subsystem and interoperability requirements
under special legislation ^ 5) and can be put into operation.
2. STAGE
Verification of the subsystem is carried out at each of these stages
and total project)
(b) the design of the subsystem, mainly) of building and civil engineering works,
production processes, Assembly parts and overall adjustments,
(c)) the final examination of the subsystem.
When the authentication subsystem forwarded to persons involved in the design, manufacture,
Assembly and testing of the subsystem according to the technical specifications
interoperability of governing the subsystem and then by
and) the decision on a common framework for the marketing of products ^ 12), if
appropriate technical specifications for interoperability entered into force
no later than 31 March 2004. December 2010 or
(b)) the decision on the modules for the conformity assessment procedures, fitness for
use and the EC verification in the field of railway transport ^ 13), if
appropriate technical specifications for interoperability entered into force
After the date referred to in point (a)).
3. CERTIFICATE
3.1. the notified body shall take into account when issuing the certificate of verification
the subsystem issued an interim opinion on the review of the subsystem
or an interim opinion on the verification of the subsystem and will check whether
issued provisional opinion correspond to the technical specifications
interoperability, examine the technical requirements specified in the subsystem,
compliance with which is not proven issued provisional opinions and
performs a check of the final examination of the subsystem. If the subsystem
has not been considered in conformity with technical specifications of interoperability
the certificate of verification of the subsystem reference to technical
interoperablity specification, or portions thereof, that have not been assessed.
3.2. Certificate of verification of the fulfilment of national requirements must
include precise references to national requirements, with which the authorized
the person explores the consistency during the verification process, including the requirements
relating to the parts which are the subject of derogations from the technical
specifications of interoperability, upgrade or renewal of the subsystem. In
the case of the use of the national requirements for the subsystems constituting the rail
the vehicle splits the verification certificate, the notified body in two parts. In
the first part must be contained references to national requirements which
applies solely to the technical compatibility of the vehicle and the
network, while the second part relates to all other national
requirements.
4. TECHNICAL FILE
4.1. The technical file accompanying the EC declaration of verification
the subsystem must contain
and in particular) for infrastructure: plans of construction of objects,
approval of the excavations and reinforcement, testing and inspection records for concrete,
(b)) for the other subsystems: General and detailed drawings in line with
execution, electrical and hydraulic diagrams, control diagrams
circuits, description of data-processing and automatic systems, operating and
maintenance manuals, etc.,
(c)) list of components interoperability constituents that are included into the subsystem,
(d)) a copy of the EC declaration of conformity or an EC declaration of suitability for
use, which must be equipped with these components and, where appropriate,
accompanied by the corresponding calculation notes and a copy of the log of the tests and
tests carried out on the basis of the notified persons technical
the specifications of the interoperability constituent,
(e) certificate for verification of the subsystem) issued by the certification
responsible for verification, accompanied by corresponding calculation this
a person certified; in the certificate must state that the project is in
accordance with the legislation and technical documentation, and provide all the
withdrawn reservations notified body registered during the implementation of the activities
When the authentication subsystem; Annex to the certificate are inspection reports
and an audit completed by the person in the context of its
tasks,
(f) provisional opinion on examination) of the subsystem or provisional
opinions on the verification of the subsystem, if they are available, including EC
Declaration on the provisional verification of the subsystem and control results
their validity, made by the person,
g) documents relating to the subsystem under consideration issued pursuant to
other rules, including a report on the safety assessment by directly
of the applicable legislation of the European Union ^ 11).
4.2. The technical file accompanying the certificate of verification
meet national requirements must be included in the technical file
documentation accompanying the EC declaration of verification and shall contain
technical details of authentication subsystem with the national
requirements.
5. REVIEW
5.1. The aim of the inspections is to ensure that in the course of manufacture, Assembly or
How to install subsystem the fulfilment of the obligations of the odvozované of the technical
documentation.
5.2. the notified body responsible for checking production must have permanent
access to building sites, production workshops, storage areas and
where appropriate, the equipment for the production of prefabricated parts and to the test
equipment, and in General to all objects, which considers it necessary to visit
in carrying out its tasks. The operator of a subsystem or his authorised
the agent must send the notified person or shipped to them all
the documents needed for that purpose and in particular the implementation plans and
the technical documentation concerning the subsystem.
5.3. the notified body responsible for the assessment of the subsystem shall
perform audits on a regular basis in the design or construction, production and
installation of the subsystem in order to confirm compliance with the law and
the technical documentation. Must provide an audit report to the operator
the subsystem, which is responsible for drawing up the EC declaration of verification
the subsystem. The operator of a subsystem can in certain stages of the construction
activities require the presence of a notified body at a construction site.
5.4. the notified body must perform random site visits or
production workshops. For these visits, the notified body may lead
complete or partial audits. The operators of the subsystem must provide
a report on the inspection and, where appropriate, audit report.
6. TRANSMISSION of DOCUMENTS
6.1. Complete technical file subsystem must be deposited with the
operator of the subsystem, as an annex to the EC declaration of verification
the subsystem. The technical file must be attached to a copy of the EC
Declaration of verification of the subsystem, the subsystem will send the operator
The railway or railway Office to register.
6.2. The EC declaration of verification of the subsystem, including the complete file
the technical documentation must be kept by the operator after the subsystem
for the operational life of the subsystem. A copy of the annexes to the EC declaration of
verification of a subsystem shall be sent to the authority of each Member State
The European Union on its cargo, if it so requests.
7. The PUBLICATION of the
Each notified body must periodically manner allowing remote
access on a quarterly basis publish relevant information about
and requirements) received the conformity assessment components
the suitability for use of interoperability constituents of interoperability,
type examination and verification of the subsystem,
(b)) issued certificates,
c) denials of issue of the certificate,
(d) issued the provisional opinions about) verification of the subsystem,
e) rejected requests for extradition of provisional opinions about verification
the subsystem.
8. language
The file of technical documentation and correspondence relating to the procedures
authentication must be drawn up in the English language or in the official language of the
State in which the provider is established of the subsystem.
II. contents of the EC declaration of verification of the subsystem
The EC declaration of verification of a subsystem shall be written in the same language
as the technical file and must contain the following:
a) trade name or first and last name, or the name and address of the
subsystem operator established in the European Union, which has a legal
interest in verification of the subsystem (enter the business name or name and
the last name or the name and full address of the registered office, and in the case of the authorised
the representative also give the trade name or name and last name or
the name and full address of the registered office of the contracting entity),
(b)) a brief description of the subsystem,
c) name and address of notified body that issued the certificate,
d) links to the reference legislation, legislation of the European Union and
the international treaty,
e) references to the documents contained in the technical file
(f)) all of the relevant temporary or final provisions, which have
the subsystems of the suit, and in particular any operating restrictions or any
conditions,
g) in the case of limited validity of the EC declaration of verification of the subsystem-
the duration of its validity,
h) the signature of the person authorized to act for the manufacturer, indicating name, surname
and features and release date EC declaration of subsystem verification. ".
Article. (II)
Transitional provision
Conformity assessment of interoperability constituents or components of its suitability for
the use or verification of the subsystems, which commenced before the date of application
the effectiveness of this regulation, shall be completed according to the existing legislation.
Article. (III)
The effectiveness of the
This Regulation shall enter into force on the fifteenth day following the date of its publication.
Prime Minister:
RNDr. Nečas in r.
Minister of transport:
Mgr. Katja in r.
