natgillin/translations-raw huggingface dataset:
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedene tlačne opreme z zahtevami iz te direktive, ki veljajo zanjo.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the pressure equipment has been placed on the market.
Priglašeni organ, ki ga izbere proizvajalec, izvede ustrezne preglede in preskuse, predpisane v ustreznih harmoniziranih standardih, ali enakovredne preskuse, da preveri skladnost tlačne opreme z zahtevami iz te direktive, ki veljajo zanjo, ali poskrbijo za izvedbo takšnih pregledov in preskusov.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual item of pressure equipment that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Kadar harmonizirani standard ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov z uporabo drugih tehničnih specifikacij.
The manufacturer shall draw up a written EU declaration of conformity for each 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.
Priglašeni organ zlasti:
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the pressure equipment.
pregleda tehnično dokumentacijo z vidika načrtovanja in proizvodnih postopkov,
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the pressure equipment during the manufacturing process.
presodi uporabljene materiale, ki niso v skladu z ustreznimi harmoniziranimi standardi ali z evropsko odobritvijo materialov za tlačno opremo, ter preveri certifikat, ki ga je izdal proizvajalec materialov v skladu s Prilogo I, točka 4.3,
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
odobri postopke za izvedbo stalnih spojev delov tlačne opreme ali pa preveri, ali so bili že odobreni v skladu s Prilogo I, točka 3.1.2,
An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.
preveri usposobljenost ali odobritve, zahtevane v Prilogi I, točki 3.1.2 in 3.1.3,
MODULE G:
opravi končni pregled, naveden v Prilogi I, točka 3.2.1, izvede ali da izvesti preskus trdnosti, naveden v Prilogi I, točka 3.2.2, in pregleda varnostne naprave, če so vgrajene.
CONFORMITY BASED ON UNIT VERIFICATION
Priglašeni organ izda certifikat o skladnosti glede na opravljene preglede in preskuse ter na lastno odgovornost namesti ali poskrbi za namestitev svoje identifikacijske številke na odobreno tlačno opremo.
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.
Proizvajalec nacionalnim organom omogoča dostop do certifikatov o skladnosti za obdobje 10 let po tem, ko je bila tlačna oprema dana na trg.
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4.
Proizvajalec namesti oznako CE in na odgovornost priglašenega organa iz točke 4 identifikacijsko številko tega organa na vsako enoto tlačne opreme, ki izpolnjuje veljavne zahteve iz te direktive.
a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards, have not been applied.
Proizvajalec za vzorčno tlačno opremo pripravi pisno izjavo EU o skladnosti in jo hrani skupaj s tehnično dokumentacijo, ki je nacionalnim organom na voljo še 10 let po tem, ko je bila tlačna oprema dana na trg.
appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with points 3.1.2 and 3.1.3 of Annex I.
Obveznosti proizvajalca iz točk 2 in 5 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the applicable requirements of this Directive.
MODUL H:
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standard(s) and/or equivalent tests, to check the conformity of the pressure equipment with the applicable requirements of this Directive, or have them carried out.
SKLADNOST NA PODLAGI CELOVITEGA ZAGOTAVLJANJA KAKOVOSTI
In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out applying other technical specifications.
Skladnost na podlagi celovitega zagotavljanja kakovosti je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da zadevna tlačna oprema izpolnjuje zahteve iz te direktive, ki veljajo zanjo.
In particular the notified body shall:
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za načrtovanje, proizvodnjo, končni pregled proizvoda in preskušanje tlačne opreme, kakor je določeno v točki 3, in zanj velja nadzor, kakor je določeno v točki 4.
examine the technical documentation with respect to the design and the manufacturing procedures,
tehnično dokumentacijo za en model iz vsakega tipa tlačne opreme, ki bo proizveden.
assess the materials used where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,
pisno izjavo, da enak zahtevek ni bil vložen pri nobenem drugem priglašenem organu.
approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with point 3.1.2 of Annex I,
Dokumentacija sistema kakovosti omogoča dosledno razlago programov kakovosti, načrtov, priročnikov in evidenc.
verify the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,
ciljev kakovosti in organizacijske strukture, odgovornosti in pooblastil uprave glede načrtovanja in kakovosti izdelkov,
carry out the final inspection referred to in point 3.2.1 of Annex I, perform or have performed the proof test referred to in point 3.2.2 of Annex I, and examine the safety devices, if applicable.
tehničnih specifikacij za načrtovanje, vključno s standardi, ki se bodo uporabili, in kadar se ustrezni harmonizirani standardi ne bodo uporabili v celoti, načinov, kako se bo zagotovila izpolnitev bistvenih varnostnih zahtev iz te direktive, ki veljajo za tlačno opremo,
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved pressure equipment, or have it affixed under its responsibility.
tehnik nadzora in preverjanja načrtov, procesov in sistemskih ukrepov, ki se bodo uporabljali pri načrtovanju tlačne opreme za zadevni tip proizvoda, predvsem glede materialov v skladu s Prilogo I, točka 4,
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
primernih tehnik, procesov in sistemskih ukrepov v proizvodnji, obvladovanju kakovosti in zagotavljanju kakovosti, ki se bodo uporabljali, predvsem postopkov, uporabljenih v zvezi s stalnim spajanjem delov, odobrenih v skladu s Prilogo I, točka 3.1.2,
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each item of pressure equipment that satisfies the applicable requirements of this Directive.
pregledov in preskusov, ki bodo opravljeni pred proizvodnjo, med njo in po njej, in pogostost njihovega opravljanja,
The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
evidenc kakovosti, na primer poročil o pregledih, podatkov preskušanja, podatkov umerjanja, poročil o kvalifikacijah ali odobritvi zadevnega osebja, posebej za osebje, ki izvaja stalno spajanje delov in neporušitvene preskuse v skladu Prilogo I, točki 3.1.2 in 3.1.3 itd.,
The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
načinov nadzora doseganja zahtevanega načrta in kakovosti tlačne opreme ter učinkovitega delovanja sistema kakovosti.
MODULE H:
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri ocenjevanju na ustreznem področju zadevne tlačne opreme in tehnologije ter znanjem o veljavnih zahtevah iz te direktive.
CONFORMITY BASED ON FULL QUALITY ASSURANCE
Skupina za presojo pregleda tehnično dokumentacijo iz druge alinee točke 3.1, da ugotovi, ali je proizvajalec zmožen opredeliti veljavne zahteve iz te direktive, in izvede potrebne preglede za zagotovitev skladnosti tlačne opreme s temi zahtevami.
Conformity based on full quality assurance is the 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 concerned satisfies the requirements of this Directive that apply to it.
Proizvajalec ali pooblaščeni zastopnik je obveščen o odločitvi.
The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the pressure equipment as specified in point 3 and shall be subject to surveillance as specified in point 4.
Proizvajalec priglašenemu organu za namene ocene omogoči dostop do načrtovanja, proizvodnje, pregledovanja, preskušanja in skladiščenja ter mu zagotovi vse potrebne informacije, zlasti:
the technical documentation for one model of each type of pressure equipment intended to be manufactured.
evidence kakovosti, predvidene v delu sistema kakovosti, ki so povezane z načrtovanjem, na primer rezultate analiz, izračunov, preskusov itd.,
a written declaration that the same application has not been lodged with any other notified body.
evidence kakovosti, predvidene v delu sistema kakovosti, ki je povezan s proizvodnjo, na primer poročila o pregledih in podatke preskušanja, podatke umerjanja, kvalifikacijska poročila zadevnega osebja itd.
That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Priglašeni organ opravlja redne preglede, s čimer zagotovi, da proizvajalec vzdržuje in izvaja sistem kakovosti, poročilo o teh pregledih pa pošilja proizvajalcu.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
Poleg tega lahko priglašeni organ nepričakovano obišče proizvajalca.
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the pressure equipment will be met,
Med takšnimi obiski lahko priglašeni organ po potrebi izvede preskuse proizvodov ali da takšne preskuse opraviti, da preveri pravilno delovanje sistema kakovosti.
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point 4 of Annex I,
Priglašeni organ proizvajalcu pošlje poročilo o obisku, če so bili izvedeni preskusi, pa tudi poročilo o njih.
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
Proizvajalec namesti oznako CE in na odgovornost priglašenega organa iz točke 3.1 identifikacijsko številko tega organa na vsako posamezno enoto tlačne opreme, ki izpolnjuje veljavne zahteve iz te direktive.
the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,
tehnične dokumentacije, navedene v točki 3.1,
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.,
dokumentacije v zvezi s sistemom kakovosti iz točke 3.1,
the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.
odobrenih sprememb, navedenih v točki 3.4,
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive.
odločitev in poročil priglašenih organov, navedenih v točkah 3.3, 3.4, 4.3 in 4.4.
The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.
Vsak priglašeni organ svoje priglasitvene organe obvesti o izdanih ali preklicanih odobritvah sistema kakovosti in redno ali na zahtevo svojim priglasitvenim organom omogoča dostop do seznama zavrnjenih, začasno preklicanih ali drugače omejenih odobritev sistema kakovosti.
The manufacturer or his authorised representative shall be notified of the decision.
MODUL H1:
The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
SKLADNOST NA PODLAGI CELOVITEGA ZAGOTAVLJANJA KAKOVOSTI IN PREGLEDOVANJA NAČRTOVANJA
the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
Skladnost na podlagi celovitega zagotavljanja kakovosti in pregledovanja načrtovanja ter posebnega nadzora končne presoje je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2 in 6 ter zagotovi in na lastno odgovornost izjavi, da zadevna tlačna oprema izpolnjuje zahteve iz te direktive, ki veljajo zanjo.
the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za načrtovanje, proizvodnjo ter končni pregled in preskušanje zadevnih proizvodov, kakor je določeno v točki 3, in zanj velja nadzor, kakor je določeno v točki 5.
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
Ustreznost tehničnega načrtovanja tlačne opreme se pregleda v skladu z določbami iz točke 4.
In addition, the notified body may pay unexpected visits to the manufacturer.
tehničnih specifikacij za načrtovanje, vključno s standardi, ki se bodo uporabili, in kadar se ustrezni harmonizirani standardi ne bodo uporabili v celoti, načinov, kako se bo zagotovila izpolnitev bistvenih varnostnih zahtev iz te direktive, ki veljajo za tlačno opremo,
During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system.
tehnik nadzora in preverjanja načrtov, procesov in sistemskih ukrepov, ki se bodo uporabljali pri načrtovanju tlačne opreme za zadevni tip tlačne opreme, predvsem glede materialov v skladu s Prilogo I, točka 4,
It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri ocenjevanju na ustreznem področju zadevne tlačne opreme in tehnologije ter znanjem o veljavnih zahtevah iz te direktive.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual item of pressure equipment that satisfies the applicable requirements of this Directive.
Priglašeni organ presodi vse predlagane spremembe in odloči, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve, navedene v točki 3.2, ali pa je potrebna vnovična presoja.
the technical documentation referred to in point 3.1,
Pregled načrtovanja
the documentation concerning the quality system referred to in point 3.1,
Proizvajalec priglašenemu organu predloži zahtevek za pregled načrtovanja vsake enote tlačne opreme, ki ga ne zajema predhodni pregled, kakor je navedeno v točki 3.1.
the change referred to point 3.4, as approved,
Zahtevek omogoča razumevanje načrtovanja, proizvodnje in delovanja tlačne opreme ter oceno skladnosti proizvodov z zahtevami iz te direktive, ki veljajo zanjo.
the decisions and reports of the notified body referred to in points 3.3, 3.4, 4.3 and 4.4.
Ta zahtevek vključuje:
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.
ime in naslov proizvajalca,
MODULE H1:
Tehnična dokumentacija opredeljuje veljavne zahteve in v obsegu, ki je pomemben za tako oceno, zajema načrtovanje in delovanje tlačne opreme.
CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
seznam harmoniziranih standardov, katerih navedbe so bile objavljene v Uradnem listu Evropske unije in ki so bili uporabljeni v celoti ali deloma, ter opise rešitev za izpolnitev bistvenih varnostnih zahtev te direktive, če navedeni harmonizirani standardi niso bili uporabljeni.
Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive that apply to it.
dodatna dokazila o ustreznosti tehnične zasnove.
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.
V teh dokazilih se navedejo vsi uporabljeni dokumenti, zlasti če se ustrezni harmonizirani standardi niso uporabljali v celoti, po potrebi pa vključujejo rezultate preskusov, opravljenih v ustreznih laboratorijih proizvajalca ali drugih preskuševalnih laboratorijih v njegovem imenu in na njegovo odgovornost.
The adequacy of the technical design of the pressure equipment shall have been examined in accordance with point 4.
Priglašeni organ pregleda zahtevek in, če načrt izpolnjuje zahteve iz te direktive, ki veljajo za tlačno opremo, proizvajalcu izda certifikat o EU-pregledu načrta.
the technical design specifications, including standards, that will be applied and, where relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential safety requirements of the Directive that apply to the pressure equipment will be met,
Certifikat vsebuje ime in naslov proizvajalca, ugotovitve pregleda, pogoje (če obstajajo) njegove veljavnosti in podatke, potrebne za identifikacijo odobrenega načrta.
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment pertaining to the pressure equipment type covered, particularly with regard to materials in accordance with point 4 of Annex I,
Certifikatu je lahko priložena ena ali več prilog.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive.
Certifikat in priloge vsebujejo vse potrebne informacije, da se lahko oceni skladnost proizvedenih proizvodov s preskušenim načrtom ter po potrebi omogoči nadzor med uporabo.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary.
Če načrt ne izpolnjuje veljavnih zahtev iz te direktive, priglašeni organ zavrne izdajo certifikata o pregledu načrta, vlagatelja pa o tem ustrezno obvesti in mu poda podrobno utemeljitev zavrnitve.
Design examination
Proizvajalec priglašeni organ, ki je izdal certifikat o EU-pregledu načrta, obvesti o kakršnih koli spremembah odobrenega načrta, ki bi lahko vplivale na skladnost z bistvenimi varnostnimi zahtevami te direktive in s pogoji veljavnosti certifikata.
The manufacturer shall lodge an application for examination of the design of each item of pressure equipment not covered by a previous design examination with the notified body referred to in point 3.1.
Priglašeni organ, ki je izdal certifikat o EU-pregledu načrta, mora te spremembe dodatno odobriti v obliki dodatka k izvirnemu certifikatu o EU-pregledu načrta.
The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, and to assess the conformity with the requirements of this Directive that apply to it.
Vsak priglašeni organ svoje priglasitvene organe obvesti o izdanih ali preklicanih certifikatih o EU-pregledu načrta in/ali dodatkih k certifikatom, redno ali na zahtevo pa jim omogoča tudi dostop do seznama zavrnjenih, začasno preklicanih ali drugače omejenih certifikatov in/ali dodatkov.
It shall include:
Vsak priglašeni organ druge priglašene organe obvesti o certifikatih o EU-pregledu načrta in/ali dodatkih k certifikatom, ki jih je zavrnil, preklical, začasno preklical ali drugače omejil, in, na zahtevo, o certifikatih in/ali dodatkih, ki jih je izdal.
the name and address of the manufacturer,
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvode certifikatov o EU-pregledu načrta in/ali njihovih dodatkov.
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the pressure equipment.
Komisija in države članice lahko na zahtevo dobijo izvod tehnične dokumentacije in rezultatov pregledov, ki jih je izvedel priglašeni organ.