natgillin/translations-raw huggingface dataset:
moduly B (konstrukční typ) + D, B (konstrukční typ) + F, B (výrobní typ) + E, B (výrobní typ) + C2, H
verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the elements which have been designed using other relevant technical specifications without applying the relevant provisions of those standards.
moduly B (výrobní typ) + D, B (výrobní typ) + F, G, H1
carry out appropriate examinations and necessary tests to check whether when the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly.
Bezpečnostní výstroj definovaná v čl.
carry out appropriate examinations and necessary tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of this Directive.
2 bodě 4 a uvedená v čl.
agree with the manufacturer on a location where the examinations and tests will be carried out.
4 odst.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes.
1 písm. d) je zařazena do kategorie IV.
Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
Na základě výjimky však může být bezpečnostní výstroj vyrobená pro zvláštní zařízení zařazena do stejné kategorie jako zařízení, které chrání.
Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate – production type to the manufacturer.
Tlaková výstroj definovaná v čl.
Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type.
2 bodě 5 a uvedená v čl.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
4 odst.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined type to be evaluated and to allow for in-service control.
1 písm. d) se zařazuje do klasifikace podle:
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate – production type and shall inform the applicant accordingly, giving detailed reasons for its refusal.
svého nejvyššího dovoleného tlaku PS,
Provision shall be made for an appeals procedure.
svého objemu V, případně jmenovité světlosti DN,
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation.
skupiny tekutin, pro které je určena.
If so, the notified body shall inform the manufacturer accordingly.
Pro stanovení kategorie posuzování shody se použije příslušný graf pro nádoby nebo potrubí.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate – production type of all modifications to the approved type that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate.
Jestliže podle prvního pododstavce druhé odrážky přichází v úvahu jak objem, tak jmenovitá světlost, musí být tlaková výstroj zařazena do kategorie, která je vyšší.
Such modifications shall require additional approval in the form of an addition to the original EU- type examination certificate – production type.
V následujících grafech pro posuzování shody vyznačují oddělovací čáry horní mez pro každou kategorii.
Each notified body shall inform its notifying authority concerning the EU-type examination certificates – production type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Graf 1
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates – production type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
Nádoby podle čl.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates – production type and/or additions thereto.
4 odst.
On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.
1 písm. a) bodu i) první odrážky
The notified body shall keep a copy of the EU-type examination certificate – production type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Čl.
The manufacturer shall keep a copy of the EU-type examination certificate – production type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
4 odst.
The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
3
EU-Type examination – design type
Výjimkou jsou nádoby určené pro nestabilní plyny a náležející podle grafu 1 do kategorie I nebo II, které musí být zařazeny do kategorie III.
EU-type examination – design type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.
Graf 2
The EU-type examination – design type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen.
Nádoby podle čl.
The experimental design method provided for in point 2.2.4 of Annex I shall not be used in the context of this module.
4 odst.
The manufacturer shall lodge an application for EU-type examination — design type with a single notified body of his choice.
1 písm. a) bodu i) druhé odrážky
The technical documentation shall make it possible to assess the conformity of the pressure equipment with the applicable requirements of the Directive and shall include an adequate analysis and assessment of the risk(s).
Výjimkou jsou přenosné hasicí přístroje a láhve k dýchacím přístrojům, které musí být zařazeny přinejmenším do kategorie III.
information regarding the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,
Graf 3
This supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.
Nádoby podle čl.
The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.
4 odst.
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.
1 písm. a) bodu ii) první odrážky
assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials,
Graf 4
approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with point 3.1.2 of Annex I.
Nádoby podle čl.
carry out appropriate examinations to check whether where the manufacturer has chosen to apply the solutions in the relevant harmonised standards these have been applied correctly.
4 odst.
carry out appropriate examinations to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer meet the corresponding essential safety requirements of this Directive.
1 písm. a) bodu ii) druhé odrážky
Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
Výjimkou jsou sestavy určené pro výrobu teplé vody podle čl.
Where the design meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate — design type to the manufacturer.
4 odst.
Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved design.
2 druhého pododstavce, které musí být podrobeny buď EU přezkoušení typu (modul B – konstrukční typ), pokud se týká jejich shody se základními požadavky podle bodů 2.10, 2.11 a 3.4 a bodu 5 písm. a) a d) přílohy I, nebo úplnému zabezpečování kvality (modul H).
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined design to be evaluated and to allow for in-service control.
Graf 5
Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate — design type and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Tlaková zařízení podle čl.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation.
4 odst.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate — design type of all modifications to the approved design that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate.
1 písm. b)
Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate — design type.
Výjimkou jsou tlakové hrnce, jejichž návrh musí být podroben postupu posuzování shody rovnocennému přinejmenším jednomu z modulů kategorie III.
Each notified body shall inform its notifying authorities concerning the EU-type examination certificates — design type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Graf 6
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates — design type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
Potrubí podle čl.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates — design type and/or additions thereto.
4 odst.
The notified body shall keep a copy of the EU-type examination certificate — design type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
1 písm. c) bodu i) první odrážky
The manufacturer shall keep a copy of the EU-type examination certificate — design type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
Výjimkou je potrubí určené pro nestabilní plyny a náležející podle grafu 6 do kategorie I nebo II, které musí být zařazeno do kategorie III.
MODULE C2:
Graf 7
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS
Potrubí podle čl.
Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to it.
4 odst.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
1 písm. c) bodu i) druhé odrážky
A notified body, chosen by the manufacturer, shall carry out checks or have them carried out at random intervals determined by the body, in order to verify the quality of the final assessment and of the internal checks on the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production.
Výjimkou je potrubí obsahující tekutiny o teplotách vyšších než 350 °C a náležející podle grafu 7 do kategorie II, které musí být zařazeno do kategorie III.
The notified body shall establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I.
Graf 8
An adequate sample of the final pressure equipment, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests applying other technical specifications, shall be carried out to check the conformity of the pressure equipment with the relevant requirements of this Directive.
Potrubí podle čl.
The notified body shall assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples.
4 odst.
Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.
1 písm. c) bodu ii) první odrážky
Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
Graf 9
The manufacturer shall affix the CE marking to each individual pressure equipment or assembly that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Potrubí podle čl.
The manufacturer shall draw up a written EU declaration of conformity for a pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
4 odst.
The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.
1 písm. c) bodu ii) druhé odrážky
MODULE D:
PŘÍLOHA III
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
POSTUPY POSUZOVÁNÍ SHODY
Conformity to type based on quality assurance of the production process is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment or assembly concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it.
Povinnosti vyplývající z ustanovení pro tlaková zařízení uvedených v této příloze se rovněž vztahují na sestavy.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
MODUL A:
Quality system
INTERNÍ ŘÍZENÍ VÝROBY
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned.
Interní řízení výroby je postupem posuzování shody, kterým výrobce plní povinnosti stanovené v bodech 2, 3 a 4 a na svou výhradní odpovědnost zaručuje a prohlašuje, že dané tlakové zařízení splňuje požadavky této směrnice.
all relevant information on the pressure equipment type envisaged,
Technická dokumentace
the documentation concerning the quality system,
Výrobce vypracuje technickou dokumentaci.
the technical documentation of the approved type and a copy of the EU-type examination certificate.
Technická dokumentace musí umožňovat posouzení shody tlakového zařízení s příslušnými požadavky a obsahuje odpovídající analýzu a posouzení rizik.
The quality system shall ensure that the pressure equipment is in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to it.
Technická dokumentace musí uvádět příslušné požadavky a v míře nutné pro posouzení se musí vztahovat na návrh, výrobu a fungování tlakového zařízení.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.
Technická dokumentace musí obsahovat, je-li to relevantní, alespoň tyto prvky:
This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
všeobecný popis tlakového zařízení,
It shall, in particular, contain an adequate description of:
koncepční návrh a výrobní výkresy a schémata součástí, podsestav, obvodů atd.,
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
popisy a vysvětlivky potřebné pro pochopení těchto výkresů a schémat a fungování tlakového zařízení,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
seznam harmonizovaných norem, na něž byly zveřejněny odkazy v Úředním věstníku Evropské unie a které byly použity v celém rozsahu nebo zčásti, a popis řešení zvolených ke splnění základních bezpečnostních požadavků této směrnice, pokud tyto harmonizované normy použity nebyly;
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
v případě částečně použitých harmonizovaných norem se v technické dokumentaci uvedou ty části, jež byly použity,
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc., and
výsledky provedených konstrukčních výpočtů, provedených přezkoušení atd.,
the means of monitoring the achievement of the required quality and the effective operation of the quality system.
protokoly o zkouškách.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
Výroba
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
Výrobce přijme veškerá nezbytná opatření, aby výrobní proces a jeho kontrola zajišťovaly shodu vyráběného tlakového zařízení s technickou dokumentací podle bodu 2 a s požadavky této směrnice.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive.
Označení CE a EU prohlášení o shodě
The audit shall include an inspection visit to the manufacturer’s premises.
Výrobce umístí označení CE na každé jednotlivé tlakové zařízení, které splňuje příslušné požadavky této směrnice.
The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
Výrobce vypracuje pro daný model tlakového zařízení písemné EU prohlášení o shodě a po dobu deseti let od uvedení tlakového zařízení na trh je společně s technickou dokumentací uchovává pro potřebu vnitrostátních orgánů.
The decision shall be notified to the manufacturer.
V EU prohlášení o shodě je uvedeno tlakové zařízení, pro nějž bylo vypracováno.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Kopie EU prohlášení o shodě se na požádání poskytne příslušným orgánům.
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
Zplnomocněný zástupce
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
Povinnosti výrobce stanovené v bodě 4 mohou být jeho jménem a na jeho odpovědnost splněny jeho zplnomocněným zástupcem, pokud jsou uvedeny v pověření.
The notified body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
MODUL A2:
It shall notify the manufacturer of its decision.
INTERNÍ ŘÍZENÍ VÝROBY S KONTROLAMI TLAKOVÝCH ZAŘÍZENÍ POD DOHLEDEM V NÁHODNĚ ZVOLENÝCH INTERVALECH
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Interní řízení výroby s kontrolami tlakových zařízení pod dohledem v náhodně zvolených intervalech je postupem posuzování shody, kterým výrobce plní povinnosti stanovené v bodech 2, 3, 4 a 5 a na svou výhradní odpovědnost zaručuje a prohlašuje, že dané tlakové zařízení splňuje požadavky této směrnice.
Surveillance under the responsibility of the notified body
Dokumentace musí umožňovat posouzení shody tlakového zařízení s příslušnými požadavky a obsahuje odpovídající analýzu a posouzení rizik.
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
Technická dokumentace musí obsahovat, je-li to relevantní, alespoň tyto prvky:
The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
popisy a vysvětlivky potřebné pro pochopení těchto výkresů a schémat a fungování tlakového zařízení,
the quality system documentation,