natgillin/translations-raw huggingface dataset:
The application shall in addition contain, wherever applicable:
ustrezna dokazila o ustreznosti rešitve tehničnega načrta.
the specimens, representative of the production envisaged.
V teh ustreznih dokazilih so navedeni vsi uporabljeni dokumenti, zlasti če se ustrezni harmonizirani standardi in/ali normativni dokumenti niso uporabljali v celoti.
The notified body may request further specimens if needed for carrying out the test programme;
Ustrezna dokazila po potrebi vsebujejo rezultate preskusov, ki jih je v skladu z drugimi ustreznimi tehničnimi specifikacijami izvedel ustrezni laboratorij proizvajalca ali drug preskuševalni laboratorij v njegovem imenu in na njegovo odgovornost.
the supporting evidence for the adequacy of the technical design solution.
Priglašeni organ:
This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards, and/or normative documents have not been applied in full.
Za instrument:
The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
pregleda tehnično dokumentacijo in ustrezna dokazila, da ugotovi ustreznost tehničnega načrta instrumenta;
The notified body shall:
za vzorce:
For the instrument:
preveri, ali je bil vzorec izdelan v skladu s tehnično dokumentacijo, ter določi elemente, ki so bili načrtovani v skladu z veljavnimi določbami ustreznih harmoniziranih standardov in/ali normativnih dokumentov, in elemente, ki so bili načrtovani v skladu z drugimi ustreznimi tehničnimi specifikacijami;
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument;
izvede ustrezne preglede in preskuse ali jih da izvesti, da preveri, ali so bile v primeru, da se je proizvajalec odločil uporabiti rešitve iz ustreznih harmoniziranih standardov in normativnih dokumentov, ti uporabljeni pravilno;
For the specimen(s):
izvede ustrezne preglede in preskuse ali jih da izvesti, da bi v primeru neuporabe rešitve za ustrezne harmonizirane standarde in/ali normativne dokumente preveril, ali rešitve, ki jih je sprejel proizvajalec, ki uporablja druge ustrezne tehnične specifikacije, izpolnjujejo ustrezne bistvene zahteve iz te direktive;
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 and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications;
se sporazume s proizvajalcem o kraju, v katerem se bodo opravljali pregledi in preskusi.
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and normative documents, these have been applied correctly;
V zvezi z drugimi deli merilnega instrumenta:
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards, and/or normative documents have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Directive;
pregleda tehnično dokumentacijo in ustrezna dokazila, da ugotovi ustreznost tehničnega načrta drugih delov merilnega instrumenta;
agree with the manufacturer on the location where the examinations and tests will be carried out.
Priglašeni organ sestavi poročilo o vrednotenju, ki navaja ukrepe, izvedene v skladu s točko 4, in njihove rezultate.
For the other parts of the measuring instrument:
Brez poseganja v obveznosti do priglasitvenih organov lahko priglašeni organ objavi vsebino navedenega poročila v celoti ali delno le, če se proizvajalec strinja.
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the measuring instrument.
Kadar tip izpolnjuje zahteve iz te direktive, priglašeni organ proizvajalcu izda certifikat o EU-pregledu tipa.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes.
Ta certifikat vsebuje ime in naslov proizvajalca, ugotovitve pregleda, pogoje (če ti obstajajo) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega tipa.
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.
Certifikatu o EU-pregledu tipa je lahko priložena ena ali več prilog.
Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate to the manufacturer.
Certifikat o EU-pregledu tipa in njegove priloge vsebujejo vse potrebne informacije, da se lahko ovrednoti skladnost proizvedenih merilnih instrumentov s preskušenim tipom ter omogoči nadzor med uporabo.
That certificate 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.
Zaradi omogočanja ocenjevanja skladnosti izdelanih instrumentov s pregledanim tipom glede obnovljivosti njihovega meroslovnega delovanja, kadar so pravilno naravnani ob uporabi ustreznih sredstev, certifikat zlasti vključuje:
The EU-type examination certificate may have one or more annexes attached.
meroslovne lastnosti tipa instrumenta,
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured measuring instruments with the examined type to be evaluated and to allow for in-service control.
ukrepe, ki so potrebni za zagotovitev neoporečnosti instrumenta (namestitev zaščitnih oznak, prepoznavanje programske opreme itd.);
In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include:
informacije o drugih elementih, ki so potrebni za prepoznavanje instrumenta in za vizualno kontrolo skladnosti njihove zunanjosti s tipom,
the metrological characteristics of the type of instrument;
če je to primerno, vsako informacijo, ki je potrebna za preverjanje lastnosti izdelanega instrumenta, in
measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.);
v primeru podsestava, vse potrebne informacije za zagotovitev skladnosti z drugimi podsestavi ali merilnimi instrumenti.
information on other elements necessary for the identification of the instruments and to check their visual external conformity to type;
Certifikat o EU-pregledu tipa je veljaven deset let od datuma izdaje in se lahko vsakokrat ponovno podaljša za deset let.
if appropriate, any specific information necessary to verify the characteristics of manufactured instruments;
Kadar tip ne izpolnjuje veljavnih zahtev iz te direktive, priglašeni organ zavrne izdajo certifikata o EU-pregledu tipa in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments.
Priglašeni organ oceni kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev iz te direktive, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The EU-type examination certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
V tem primeru priglašeni organ ustrezno obvesti proizvajalca.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Proizvajalec obvesti priglašeni organ, ki ima tehnično dokumentacijo o certifikatu o EU-pregledu tipa, o vseh spremembah odobrenega tipa, ki bi lahko vplivale na skladnost instrumenta z bistvenimi zahtevami iz te direktive ali pogoji veljavnosti tega certifikata.
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.
Take spremembe zahtevajo dodatno odobritev v obliki dodatka izvirnemu certifikatu o EU-pregledu tipa.
If so, the notified body shall inform the manufacturer accordingly.
Vsak priglašeni organ obvesti svoj priglasitveni organ o certifikatih o EU-pregledu tipa in/ali katerih koli njihovih dodatkih, ki jih je izdal ali preklical ter redno ali na zahtevo da na voljo priglasitvenemu organu seznam zavrnjenih, začasno preklicanih ali drugače omejenih takih certifikatov in/ali kakršnih koli dodatkov.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the instrument with the essential requirements of this Directive or the conditions for validity of that certificate Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvode certifikatov o EU-pregledu tipa in/ali njihovih dodatkov.
Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
Komisija in države članice lahko na zahtevo dobijo izvod tehnične dokumentacije in rezultate pregledov, ki jih je izvedel priglašeni organ.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto.
Priglašeni organ ima izvod certifikata o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti tega certifikata.
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.
Proizvajalec ima izvod certifikata o EU-pregledu tipa, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo, na voljo za nacionalne organe še 10 let po tem, ko je bil instrument dan na trg.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of that certificate.
Pooblaščeni zastopnik proizvajalca lahko predloži zahtevek iz točke 3 in izpolni obveznosti iz točk 8 in 10, če so navedene v pooblastilu.
The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
MODUL C SKLADNOST S TIPOM NA PODLAGI NOTRANJEGA NADZORA PROIZVODNJE
The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 8 and 10, provided that they are specified in the mandate.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje je del postopka ugotavljanja skladnosti, s katerimi proizvajalec izpolni obveznosti iz točk 2 in 3 ter zagotovi in izjavi, da so zadevni merilni instrumenti skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
MODULE C: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih merilnih instrumentov z odobrenim tipom, kot je opisan v certifikatu o EU-pregledu tipa, in z zahtevami te direktive, ki veljajo zanje.
Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive na vsak posamezen instrument, ki je skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te direktive.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Proizvajalec za vsak model instrumenta sestavi pisno izjavo EU o skladnosti in nacionalnim organom omogoči dostop do nje še 10 let po tem, ko je bil instrument dan na trg.
The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive to each individual instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Izjava EU o skladnosti opredeljuje vzorčni instrument, za katerega je bila sestavljena.
The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
Pooblaščeni zastopnik proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni obveznosti iz točke 3, če so navedene v pooblastilu.
The EU declaration of conformity shall identify the instrument model for which it was drawn up.
MODUL C2: SKLADNOST S TIPOM NA PODLAGI NOTRANJEGA NADZORA PROIZVODNJE IN NADZOROVANI PRESKUSI INSTRUMENTOV V NAKLJUČNIH ČASOVNIH PRESLEDKIH
The manufacturer’s obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi instrumentov v naključno izbranih časovnih presledkih so del postopka ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 3 in 4 ter zagotovi in na lastno odgovornost izjavi, da so zadevni merilni instrumenti skladni s tipom, ki je opisan v certifikatu o EU-pregledu tipa, in izpolnjujejo zahteve te direktive, ki veljajo zanje.
MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih merilnih instrumentov s tipom, kot je opisan v certifikatu o EU-pregledu tipa, in z zahtevami te direktive, ki veljajo zanje.
Conformity to type based on internal production control plus supervised instrument 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 measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Po proizvajalčevi izbiri akreditirani interni organ ali priglašeni organ, ki ga izbere proizvajalec, izvaja ali da izvesti preskuse proizvoda v naključno izbranih časovnih presledkih, ki jih določi organ, da bi preveril kakovost notranje kontrole instrumenta, upoštevajoč med drugim tehnološko zapletenost merilnih instrumentov in količino proizvodnje.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Akreditirani interni organ ali priglašeni organ na ustreznem vzorcu končnih merilnih instrumentov, odvzetih na sami lokaciji, pred dajanjem na trg izvede pregled in primerne preskuse, kakor so opredeljeni v ustreznih delih harmoniziranega standarda in/ali normativnih dokumentov, in/ali enakovredne preskuse, ki so določeni v drugih ustreznih tehničnih specifikacijah, s katerimi preveri skladnost instrumenta s tipom, opisanim v certifikatu o EU-pregledu tipa, ter z ustreznimi zahtevami iz te direktive.
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks on the instrument, taking into account, inter alia, the technological complexity of the measuring instruments and the quantity of production.
V primerih, ko vzorec ne dosega sprejemljive ravni kakovosti, akreditirani interni organ ali priglašeni organ sprejme ustrezne ukrepe.
An adequate sample of the final measuring instrument, taken on site by the accredited in-house body or 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 normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instrument with the type described in the EU-type examination certificate and with the relevant requirements of this Directive.
Postopek vzorčenja za sprejemljivost, ki se uporablja, je načrtovan za presojo, ali se proizvodni proces instrumenta izvaja v sprejemljivih mejah s ciljem zagotavljanja skladnosti instrumenta.
Where a sample does not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive na vsak posamezni merilni instrument, ki je skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te direktive.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the instrument performs within acceptable limits, with a view to ensuring conformity of the instrument.
Izjava EU o skladnosti opredeljuje model instrumenta, za katerega je bila sestavljena.
The manufacturer shall affix the CE marking, and the supplementary metrology marking set out in this Directive to each individual measuring instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
MODUL D: SKLADNOST S TIPOM NA PODLAGI ZAGOTAVLJANJA KAKOVOSTI PROIZVODNJE
The EU declaration of conformity shall identify the instrument model for which it has been drawn up.
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje je del postopka ugotavljanja skladnosti, s katerimi proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da so zadevni merilni instrumenti skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za proizvodnjo, končno kontrolo proizvoda in preskušanje zadevnih merilnih instrumentov, kakor je določeno v točki 3, in zanj velja nadzor iz točke 4.
Conformity to type based on quality assurance of the production process is the 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 measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Sistem kakovosti
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
Proizvajalec vloži vlogo za ocenitev svojega sistema kakovosti v zvezi z zadevnimi merilnimi instrumenti pri priglašenem organu, ki ga sam izbere.
Quality system
ime in naslov proizvajalca in, če je zahtevek vložil pooblaščeni zastopnik, tudi njegovo ime in naslov;
The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned.
pisno izjavo, da enaka vloga ni bila vložena pri nobenem drugem priglašenem organu;
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
vse ustrezne informacije za predvideno kategorijo instrumenta;
a written declaration that the same application has not been lodged with any other notified body,
dokumentacijo, ki se nanaša na sistem kakovosti;
all relevant information for the instrument category envisaged;
tehnično dokumentacijo odobrenega tipa in izvod certifikata o EU-pregledu tipa.
the documentation concerning the quality system;
Sistem kakovosti zagotovi skladnost merilnih instrumentov s tipom, ki je opisan v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
the technical documentation of the approved type and a copy of the EU-type examination certificate.
Vsi elementi, zahteve in določbe, ki jih je sprejel proizvajalec, se sistematično in metodično dokumentirajo v obliki pisnih ukrepov, postopkov in navodil.
The quality system shall ensure that the measuring instruments are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them.
Dokumentacija sistema kakovosti mora omogočati dosledno razlago programov, načrtov, priročnikov in zapiskov.
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.
Vsebujejo zlasti ustrezen opis:
This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva v zvezi s kakovostjo proizvodov;
It shall, in particular, contain an adequate description of:
uporabljenih tehnik za ustrezno izdelavo, nadzor in zagotavljanje kakovosti, postopkov in sistematičnih ukrepov, ki se bodo uporabljali;
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
pregledov in preskusov, ki bodo opravljeni pred proizvodnjo, med njo in po njej, ter pogostnost njihovega izvajanja;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
zapisov kakovosti, kot so poročila o kontrolah in podatki o preskusu, podatki o umerjanjih, poročila o strokovni usposobljenosti zadevnega osebja;