natgillin/translations-raw huggingface dataset:
In the absence of such harmonised standard or normative document, the notified body concerned shall decide on the appropriate tests to be carried out.
raven kakovosti, ki ustreza 95 % verjetnosti sprejetja, z neskladnostjo, ki je manjša od 1 %;
The statistical procedure shall meet the following requirements:
mejno kakovost, ki ustreza 5 % verjetnosti sprejetja, z neskladnostjo, ki je manjša od 7 %.
The statistical control will be based on attributes.
Če je partija sprejeta, se šteje, da so odobreni vsi merilni instrumenti, razen tistih iz vzorca, za katere je ugotovljeno, da imajo nezadovoljive rezultate preskusa.
The sampling system shall ensure:
Proizvajalec nacionalnim organom omogoči dostop do certifikatov o skladnosti še 10 let po tem, ko je bil instrument dan na trg.
a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %;
Če se partija zavrne, priglašeni organ sprejme ustrezne ukrepe za preprečitev, da se ta partija da na trg.
a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %.
Če prihaja do pogostih zavrnitev partij, lahko priglašeni organ začasno prekine statistično overjanje in sprejme ustrezne ukrepe.
If a lot is accepted, all measuring instruments of the lot shall be considered approved, except for those measuring instruments from the sample that have been found not to satisfy the tests.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive ter na odgovornost priglašenega organa iz točke 3 svojo identifikacijsko številko na vsak posamezen instrument, ki je skladen z odobrenim tipom iz certifikata o EU-pregledu tipa in izpolnjuje veljavne zahteve iz te direktive.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
Če priglašeni organ iz točke 3 soglaša, lahko proizvajalec na merilne instrumente na odgovornosti priglašenega organa namesti tudi identifikacijsko številko tega organa.
If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that lot.
Če priglašeni organ soglaša, lahko proizvajalec med proizvodnim postopkom na odgovornost priglašenega organa na merilne instrumente namesti identifikacijsko številko tega organa.
In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.
Pooblaščeni zastopnik proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni njegove obveznosti, če so navedene v pooblastilu.
The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual instrument that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Pooblaščenemu zastopniku ni treba izpolniti obveznosti proizvajalca iz točk 2 in 5.1.
If y 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 measuring instruments.
MODUL F1: SKLADNOST NA PODLAGI OVERITVE PROIZVODOV
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the measuring instruments during the manufacturing process.
Skladnost na podlagi overitve proizvodov je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 3, 6.1 in 7 ter na lastno odgovornost zagotovi in izjavi, da so zadevni merilni instrumenti, ki so predmet določb iz točke 4, skladni z zahtevami iz te direktive, ki veljajo zanje.
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.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih merilnih instrumentov z veljavnimi zahtevami iz te direktive.
An authorised representative may not fulfil the manufacturer’s obligations set out in points 2 and 5.1.
Priglašeni organ, ki ga je izbral proizvajalec, izvaja ali da izvesti ustrezne preglede in preskuse, da preveri skladnost merilnih instrumentov z ustreznimi zahtevami iz te direktive.
MODULE F1: CONFORMITY BASED ON PRODUCT VERIFICATION
Pregledi in preskusi za preverjanje skladnosti z zahtevami se po izbiri proizvajalca izvedejo bodisi s pregledom in preskusom vsakega instrumenta v skladu s točko 5 ali s pregledom in preskusom merilnih instrumentov na statistični podlagi v skladu s točko 6.
Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the measuring instruments concerned which have been subject to the provisions of point 4, are in conformity with the requirements of this Directive that apply to them.
Vsak merilni instrument se posamezno pregleda in izvedejo se ustrezni preskusi, ki so navedeni v ustreznih harmoniziranih standardih in/ali normativnih dokumentih, in/ali enakovredni preskusi, ki so določeni v drugih ustreznih tehničnih specifikacijah, da se preveri skladnost z odobrenim tipom, opisanim v certifikatu o EU-pregledu tipa, in ustreznimi zahtevami 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 applicable requirements of this Directive.
Kadar takšen harmonizirani standard ali normativni dokument ni na voljo, zadevni priglašeni organ odloči o primernih preskusih, ki jih je treba opraviti.
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the measuring instruments with the applicable requirements of this Directive.
Proizvajalec sprejme vse potrebne ukrepe, da se v proizvodnem procesu zagotovi homogenost vsake proizvedene partije, in da svoje merilne instrumente preveriti v obliki homogenih partij.
The examinations and tests to verify the conformity with the requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in point 5, or by examination and testing of the measuring instruments on a statistical basis as specified in point 6.
Naključno izbrani vzorec se odvzame iz vsake partije v skladu z zahtevami iz točke 6.4.
All measuring instruments shall be individually examined and appropriate tests, set out in the relevant harmonized standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify their conformity with the requirements that apply to them.
Vsak merilni instrument v vzorcu se posamezno pregleda in izvedejo se ustrezni preskusi, ki so navedeni v ustreznih harmoniziranih standardih in/ali normativnih dokumentih, in/ali enakovredni preskusi, ki so določeni v drugih ustreznih tehničnih specifikacijah, da se preveri skladnost z zahtevami te direktive, ki veljajo za te instrumente, ter določi, ali se partija sprejme ali zavrne.
In the absence of such a harmonised standard, or normative document, the notified body concerned shall decide on the appropriate tests to be carried out.
Kadar harmoniziranega standarda ali normativnega dokumenta ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of each lot produced, and shall present his measuring instruments for verification in the form of homogeneous lots.
Če se partija zavrne, priglašeni organ sprejme ustrezne ukrepe za preprečitev, da se ta partija da na trg.
A random sample shall be taken from each lot according to the requirements of point 6.4.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive ter na odgovornost priglašenega organa iz točke 4 identifikacijsko številko tega organa na vsak posamezen merilni instrument, ki izpolnjuje veljavne zahteve iz te direktive.
All measuring instruments in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of this Directive and to determine whether the lot is accepted or rejected.
Če se veliko število instrumentov dostavlja enemu uporabniku, se lahko ta zahteva razlaga tako, kot da se nanaša na serijo ali pošiljko in ne na posamezne merilne instrumente.
In the absence of such harmonised standard, or normative document, the notified body concerned shall decide on the appropriate tests to be carried out.
Če priglašeni organ iz točke 5 soglaša, proizvajalec lahko na merilne instrumente na odgovornosti priglašenega organa namesti tudi identifikacijsko številko tega organa.
If a lot is rejected, the notified body shall take appropriate measures to prevent that lot from being placed on the market.
Pooblaščenemu zastopniku ni treba izpolniti obveznosti proizvajalca iz prvega odstavka točke 2, točke 3 in točke 6.1.
The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and under the responsibility of the notified body referred to in point 4, the latter’s identification number to each individual measuring instrument that satisfies the applicable requirements of this Directive.
MODUL G: SKLADNOST NA PODLAGI NEPOSREDNE OVERITVE POSAMIČNEGA MERILA
However, this requirement may be interpreted as applying to a batch or consignment rather than individual measuring instruments in those cases where a large number of instruments is delivered to a single user.
Skladnost na podlagi neposredne overitve posamičnega merila je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 3 in 5 ter na lastno odgovornost zagotovi in izjavi, da je zadevni instrument, ki je predmet določb iz točke 4, skladen z zahtevami iz te direktive, ki veljajo zanj.
If the notified body referred to in point 5 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the measuring instruments.
Proizvajalec pripravi tehnično dokumentacijo iz člena 18 in jo da na voljo priglašenemu organu iz točke 4.
An authorised representative may not fulfil the manufacturer’s obligations set out in point 2, first paragraph, point 3 and point 6.1.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost izdelanega instrumenta z veljavnimi zahtevami iz te direktive.
MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
Priglašeni organ, ki ga je izbral proizvajalec, izvede ali da izvesti ustrezne preglede in preskuse, določene v ustreznih harmoniziranih standardih in/ali normativnih dokumentih, ali enakovredne preskuse, določene v drugih ustreznih tehničnih specifikacijah, s čimer overi skladnost instrumenta z veljavnimi zahtevami iz te direktive.
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 instrument concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na odobren instrument ali jo da namestiti na svojo odgovornost.
The manufacturer shall establish the technical documentation as described in Article 18 and make it available to the notified body referred to in point 4.
Proizvajalec na vsak instrument, ki izpolnjuje veljavne zahteve iz te direktive, namesti oznako CE in dodatno meroslovno oznako iz te direktive ter v okviru odgovornosti priglašenega organa iz točke 4 identifikacijsko številko le-tega.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instrument with the applicable requirements of this Directive.
Proizvajalec 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.
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests set out in the relevant harmonised standards, and/or normative documents, or equivalent tests set out in other relevant technical specifications, to verify the conformity of the instrument with the applicable requirements of this Directive, or have them carried out.
Izjava EU o skladnosti opredeljuje model instrumenta, za katerega je bila sestavljena.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and affix its identification number to the approved instrument, or have it affixed under its responsibility.
Izvod izjave EU o skladnosti spremlja merilni instrument.
The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each instrument that satisfies the applicable requirements of this Directive.
Pooblaščeni zastopnik lahko v imenu proizvajalca in na njegovo odgovornost izpolni obveznosti iz točk 2 in 5, če so navedene v pooblastilu.
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 instrument has been placed on the market.
MODUL H: SKLADNOST NA PODLAGI CELOVITEGA ZAGOTAVLJANJA KAKOVOSTI
The EU declaration of conformity shall identify the instrument for which it has been drawn up.
Skladnost na podlagi celovitega zagotavljanja kakovosti je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni svoje obveznosti iz točk 2 in 5 ter na lastno odgovornost zagotovi in izjavi, da so zadevni merilni instrumenti skladni z zahtevami iz te direktive, ki veljajo zanje.
A copy of the EU declaration of conformity shall be supplied with the measuring instrument.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za načrtovanje, izdelavo, končno kontrolo proizvoda in preskušanje zadevnega instrumenta, kakor je določeno v točki 3, in zanj velja nadzor iz točke 4.
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.
tehnično dokumentacijo iz člena 18 za en model iz vsake kategorije merilnih instrumentov, ki bodo izdelani.
MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE
Tehnična dokumentacija opredeljuje veljavne zahteve in v obsegu, ki je pomemben za tako ugotavljanje, zajema načrtovanje, izdelavo in delovanje instrumenta;
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 measuring instruments concerned satisfy the requirements of this Directive that apply to them.
dokumentacijo, ki se nanaša na sistem kakovosti, in
The manufacturer shall operate an approved quality system for design, manufacture and 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.
pisno izjavo, da enaka vloga ni bila vložena pri nobenem drugem priglašenem organu.
the technical documentation, as described in Article 18, for one model of each category of measuring instruments intended to be manufactured.
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva v zvezi z načrtovanjem in kakovostjo proizvodov;
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument,
tehničnih specifikacij načrtovanja, vključno s standardi, ki se bodo uporabili, ter, kadar se zadevni harmonizirani standardi in/ali normativni dokumenti ne bodo uporabljali v celoti, opis sredstev, ki bodo ob uporabi drugih ustreznih tehničnih specifikacij uporabljena za zagotovitev, da bodo bistvene zahteve iz te direktive, ki se nanašajo na merilne instrumente, izpolnjene;
the documentation concerning the quality system, and
tehnik nadzora in preverjanja načrtovanja, postopkov in sistematičnih ukrepov, ki se bodo uporabljali pri načrtovanju merilnih instrumentov, ki spadajo v zadevno kategorijo instrumentov;
a written declaration that the same application has not been lodged with any other notified body.
pregledov in preskusov, ki bodo opravljeni pred izdelavo, med njo in po njej, ter pogostnost njihovega izvajanja;
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
sredstev za nadzor, ki omogočajo kontrolo zahtevane kakovosti načrtovanja in proizvodov ter učinkovitega delovanja sistema kakovosti.
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards, and/or normative documents 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 measuring instruments will be met applying other relevant technical specifications;
Skupina za presojo ima poleg izkušenj s sistemi vodenja kakovosti vsaj enega člana v vlogi ocenjevalca z izkušnjami na ustreznem zadevnem področju instrumentov in tehnologije instrumentov ter poznavanjem veljavnih zahtev iz te direktive.
the design control and design verification techniques, processes and systematic actions that will be used when designing the measuring instruments pertaining to the instrument category covered;
Skupina za presojo pregleda tehnično dokumentacijo iz točke (b) točke 3.1, da ugotovi, ali je proizvajalec zmožen opredeliti veljavne zahteve iz te direktive, in izvede potrebne preglede za zagotovitev skladnosti instrumenta s temi zahtevami.
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
O tej odločitvi je treba uradno obvestiti proizvajalca ali njegovega pooblaščenega zastopnika.
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
Proizvajalec priglašenemu organu za namene ocenjevanja omogoči dostop do prostorov za načrtovanje, izdelavo, kontrolo, preskušanje in skladiščenje ter mu zagotovi vse potrebne informacije, še zlasti:
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive.
dokumentacijo o kakovosti, predvideno v načrtovalnem delu sistema kakovosti, kot so rezultati analiz, izračuni, preskusi;
The auditing team shall review the technical documentation referred to in point (b) of point 3.1 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 instrument with those requirements.
dokumentacijo o kakovosti, predvideno v proizvodnem delu sistema kakovosti, kot so poročila o kontrolah in podatki o preskusu, podatki o umerjanju, poročila o strokovni usposobljenosti zadevnega osebja itd.
The manufacturer or his authorised representative shall be notified of the decision.
Priglašeni organ lahko med takšnimi obiski, če je potrebno, opravi ali da opraviti preskuse proizvodov, da preveri pravilno delovanje sistema kakovosti.
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:
Priglašeni organ proizvajalcu zagotovi poročilo o obisku in, če so bili preskusi izvedeni, poročilo o preskusu.
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests.;
Proizvajalec na vsak posamezni instrument, ki izpolnjuje veljavne zahteve iz te direktive, namesti oznako CE in dodatno meroslovno oznako iz te direktive ter v okviru odgovornosti priglašenega organa iz točke 3.1 identifikacijsko številko le-tega.
the quality records as 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.
tehnično dokumentacijo iz točke 3.1;
During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system.
dokumentacijo v zvezi s sistemom kakovosti iz točke 3.1;
It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
MODUL H1: SKLADNOST NA PODLAGI CELOVITEGA ZAGOTAVLJANJA KAKOVOSTI IN PREGLEDA NAČRTA
The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual instrument that satisfies the applicable requirements of this Directive.
Skladnost na podlagi celovitega zagotavljanja kakovosti in pregleda načrta je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni svoje obveznosti iz točk 2 in 6 ter na lastno odgovornost zagotovi in izjavi, da so zadevni merilni instrumenti skladni z zahtevami iz te direktive, ki veljajo zanje.
the technical documentation referred to in point 3.1,
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za načrtovanje, izdelavo, končno kontrolo proizvoda in preskušanje zadevnih instrumentov, kakor je določeno v točki 3, in zanj velja nadzor iz točke 5.
the documentation concerning the quality system referred to in point 3.1,
Ustreznost tehničnega načrta za merilni instrument mora biti preverjena v skladu s točko 4.
MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
Proizvajalec vloži vlogo za oceno sistema kakovosti v zvezi z zadevnimi merilnimi instrumenti pri priglašenem organu, ki ga sam izbere.
Conformity based on full quality assurance plus design examination 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 measuring instruments concerned satisfy the requirements of this Directive that apply to them.
tehničnih specifikacij načrtovanja, vključno s standardi, ki se bodo uporabili, ter, kadar se zadevni harmonizirani standardi in/ali normativni dokumenti ne bodo uporabljali v celoti, opis sredstev, ki bodo ob uporabi drugih ustreznih tehničnih specifikacij uporabljena za zagotovitev, da bodo bistvene zahteve iz te direktive, ki se nanašajo na merilne instrumente, izpolnjene;
The manufacturer shall operate an approved quality system for design, manufacture and 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 5.
O svoji odločitvi obvesti proizvajalca ali njegovega pooblaščenega predstavnika.