natgillin/translations-raw huggingface dataset:
Modifications to the approved type must receive additional approval from the notified body that issued the EC type-approval certificate where such changes influence conformity with the essential requirements of this Directive or the prescribed conditions for use of the instrument.
Za spremembe na odobrenem tipu mora vložnik dobiti dodatno odobritev priglašenega organa, ki je izdal certifikat o ES-homologaciji, če take spremembe vplivajo na skladnost z bistvenimi zahtevami te direktive ali s predpisanimi pogoji za uporabo te tehtnice.
This additional approval is given in the form of an addition to the original EC type-approval certificate.
Ta dodatna odobritev se izda v obliki priloge k originalnemu certifikatu o ES-homologaciji.
EC declaration of type conformity (guarantee of production quality)
Izjava ES o skladnosti tipa (garancija kakovosti proizvodnje)
The EC declaration of type conformity (guarantee of production quality) is the procedure whereby the manufacturer who satisfies the obligations of point 2.2 declares that the instruments concerned are, where applicable, in conformity with the type as described in the EC type-approval certificate and that they satisfy the requirements of this Directive.
Izjava ES o skladnosti tipa (garancija kakovosti proizvodnje) je postopek, s katerim proizvajalec, ki izpolnjuje obveznosti odstavka 2.2 izjavi, da so zadevne tehtnice, kjer je ustrezno, v skladu s tipom, opisanim v certifikatu o ES-homologaciji in da izpolnjujejo zahteve te direktive.
The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and the inscriptions provided for in Annex IV and shall draw up a written declaration of conformity.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti na vsako tehtnico pritrdi znak skladnosti „CE“ in napise iz Priloge IV, ter sestavi pisno izjavo o skladnosti.
The ‘CE’ conformity marking shall be accompanied by the identification number of the notified body responsible for the EC surveillance referred to in point 2.4.
Znak skladnosti „CE“ spremlja identifikacijska številka priglašenega organa, ki je odgovoren za nadzor ES iz točke 2.4.
The manufacturer shall have adequately implemented a quality system as specified in point 2.3 and shall be subject to EC surveillance as specified in point 2.4.
Proizvajalec mora ustrezno izvajati sistem kakovosti iz odstavka 2.3, ki mora biti predmet nadzora ES iz točke 2.4.
The manufacturer shall lodge an application for approval of his quality system with a notified body.
Proizvajalec pri priglašenem organu vloži zahtevo za odobritev sistema kakovosti.
an undertaking to carry out the obligations arising from the approved quality system,
izjavo, da bo izvajal obveznosti, ki izhajajo iz odobrenega sistema kakovosti,
an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
izjavo, da bo vzdrževal odobreni sistem kakovosti in zagotavljal njegovo nenehno primernost in učinkovitost.
The manufacturer shall make available to the notified body all relevant information, in particular the quality system’s documentation and the design documentation of the instrument.
Proizvajalec mora dati priglašenemu organu na voljo vse ustrezne informacije, zlasti pa dokumentacijo o sistemu kakovosti in tehnično dokumentacijo tehtnice.
The quality system shall ensure conformity of the instruments with the type as described in the EC type-approval certificate and with the requirement(s) of this Directive.
Sistem kakovosti mora zagotavljati skladnost tehtnic s tipom, opisanim v certifikatu o ES-homologaciji, in z zahtevami te direktive.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written rules, procedures and instructions.
Vsi elementi, zahteve in ukrepi, ki jih sprejme proizvajalec, morajo biti dokumentirani sistematično in urejeno v obliki pisnih pravil, postopkov in navodil.
This quality system documentation shall ensure a proper understanding of the quality programmes, plans, manuals and records.
Taka dokumentacija sistema kakovosti mora zagotavljati pravilno razumevanje programov, načrtov, priročnikov in zapisov o kakovosti.
It shall contain in particular an adequate description of:
Vsebovati mora zlasti ustrezen opis:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
ciljev kakovosti in organizacijske strukture, odgovornosti in pooblastil vodstva v zvezi s kakovostjo izdelkov,
the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,
proizvodnega procesa, tehnik obvladovanja in zagotavljanja kakovosti ter sistematičnih ukrepov, ki jih bo uporabljal,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
pregledov in preskusov, ki jih bo izvedel pred, med in po proizvodnji, in kako pogosto jih bo izvedel,
the means to monitor the achievement of the required product quality and the effective operation of the quality system.
načinov za spremljanje doseganja zahtevane kakovosti izdelkov in učinkovitega delovanja sistema kakovosti.
The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 2.3.2.
Priglašeni organ pregleda in ovrednoti sistem kakovosti, da ugotovi, ali zadovoljuje zahteve iz odstavka 2.3.2.
It shall presume conformity with these requirements in respect of quality systems that implement the corresponding harmonised standard.
Za sisteme kakovosti, ki uvajajo ustrezni usklajeni standard, se skladnost s temi zahtevami predpostavlja.
It shall notify its decision to the manufacturer and inform the other notified bodies thereof.
Svojo odločitev sporoči proizvajalcu in o tem obvesti druge priglašene organe.
The notification to the manufacturer shall contain the conclusions of the examination and, in the event of refusal, the justification for the decision.
Obvestilo proizvajalcu mora vsebovati zaključke pregleda in v primeru zavrnitve obrazložitev za tako odločitev.
The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any updating of the quality assurance system in relation to changes brought about by, e.g. new technologies and new quality concepts.
Proizvajalec ali njegov pooblaščeni zastopnik morata priglašeni organ, ki je odobril sistem kakovosti, sproti obveščati o vsaki posodobitvi sistema zagotavljanja kakovosti na podlagi sprememb, ki so jih na primer povzročile nove tehnologije in novi koncepti kakovosti.
Any notified body that withdraws approval of a quality system shall so inform the other notified bodies.
Vsak priglašeni organ, ki umakne odobritev sistema kakovosti, mora o tem obvestiti druge priglašene organe.
EC surveillance
Nadzor ES
The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
Namen nadzora ES je zagotovitev, da proizvajalec pravilno izpolnjuje obveznosti, ki izhajajo iz odobrenega sistema kakovosti.
The manufacturer shall grant the notified body access for inspection purposes to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular:
Proizvajalec priglašenemu organu za kontrolne namene odobri dostop do proizvodnih, kontrolnih, preskusnih in skladiščnih prostorov in mu priskrbi vse potrebne informacije, zlasti:
the design documentation,
tehnično dokumentacijo,
the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
evidence o kakovosti, npr. poročila o kontroli, podatke o preskusih in kalibraciji, poročila o usposobljenosti odgovornega osebja itd.
The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.
Priglašeni organ periodično izvaja revizije, da se prepriča, da proizvajalec vzdržuje in uporablja sistem kakovosti; proizvajalcu poda poročilo o reviziji.
In addition, the notified body may carry out unscheduled visits to the manufacturer.
Poleg tega lahko priglašeni organ izvaja nenačrtovane obiske pri proizvajalcu.
During such visits, the notified body may carry out full or partial audits.
Med takimi obiski lahko priglašeni organ izvaja popolne ali delne revizije.
It shall provide the manufacturer with a report on the visit, and, where appropriate, an audit report.
Proizvajalcu poda poročilo o obisku in kjer je ustrezno, tudi poročilo o reviziji.
The notified body shall ensure that the manufacturer maintains and applies the approved quality system.
Priglašeni organ se mora prepričati, da proizvajalec vzdržuje in uporablja odobreni sistem kakovosti.
EC verification
Overjanje ES
EC verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instruments which have been checked in accordance with point 3.3 are, where applicable, in conformity with the type described in the EC type-examination certificate and that they satisfy the requirements of this Directive.
Overjanje ES je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotovi in izjavi, da so tehtnice, ki so bile preverjene v skladu z odstavkom 3.3, kadar je primerno, skladne s tipom, opisanim v potrdilu o ES pregledu tipa in ustrezajo zahtevam direktive.
The manufacturer shall take all necessary measures in order that the manufacturing process ensures conformity of the instruments, where applicable, with the type as described in the EC type-examination certificate and with the requirements of this Directive which apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces zagotovi skladnost instrumentov, kadar je primerno, s tipom opisanim v potrdilu o ES pregledu tipa in z zahtevami te direktive, ki veljajo zanje.
The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and draw up a written declaration of conformity.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti pritrdi znak skladnosti „CE“ na vsako tehtnico in sestavi pisno izjavo o skladnosti.
The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of every instrument, as specified in point 3.5.
Priglašeni organ opravi ustrezne preglede in preskuse, da preveri skladnost izdelka z zahtevami te direktive s pregledovanjem in preskušanjem vsake tehtnice, kot je določeno v odstavku 3.5.
For instruments not subject to EC type-approval, the documents relating to the design of the instrument, as set out in Annex III, must be accessible to the notified body should the latter so request.
Za tehtnice, ki niso predmet ES homologacije, morajo biti dokumenti v zvezi s tehnično dokumentacijo tehtnice iz Priloge III dostopni priglašenemu organu, če slednji tako zahteva.
Verification by checking and testing of each instrument
Overjanje s preverjanjem in preskušanjem vsake tehtnice
All instruments shall be individually examined and appropriate tests, as set out in the relevant harmonised standards referred to in Article 6(1), or equivalent tests, shall be carried out in order to verify their conformity, where applicable, with the type as described in the EC type-examination certificate and the requirements of this Directive.
Za preverjanje skladnosti tehtnic, kadar je primerno, s tipom, opisanim v potrdilu o ES pregledu tipa in z zahtevami te direktive se vsaka tehtnica individualno pregleda, opravijo pa se tudi ustrezni pregledi iz ustreznih usklajenih standardov iz člena 6(1) ali enakovredni pregledi.
The notified body shall affix, or cause to be affixed, its identification number on each instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity relating to the tests carried out.
Priglašeni organ pritrdi ali da pritrditi svojo identifikacijsko številko na vsako tehtnico, za katero se ugotovi skladnost z zahtevami, in sestavi pisno potrdilo o skladnosti v zvezi z opravljenimi preskusi.
The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
Proizvajalec ali njegov pooblaščeni zastopnik mora biti na zahtevo sposoben predložiti potrdila o skladnosti, ki jih je izdal priglašeni organ.
EC unit verification
ES overjanje enot
EC unit verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instrument, generally designed for a specific application, which has been issued with the certificate referred to in point 4.2 conforms to the requirements of this Directive that apply to it.
ES overjanje enot je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotovi in izjavi, da je tehtnica, ki je običajno oblikovana za posebno uporabo, za katero je bilo izdano potrdilo iz odstavka 4.2, skladna z zahtevami te direktive, ki veljajo zanjo.
The manufacturer or his authorised representative shall affix the ‘CE’ conformity marking to the instrument and shall draw up a written declaration of conformity.
Proizvajalec ali njegov pooblaščeni zastopnik pritrdi znak skladnosti „CE“ na tehtnico in sestavi pisno izjavo o skladnosti.
The notified body shall examine the instrument and carry out the appropriate tests, as set out in the relevant harmonised standard(s) referred to in Article 6(1), or equivalent tests, in order to ensure its conformity with the relevant requirements of this Directive.
Priglašeni organ pregleda tehtnico in opravi ustrezne preskuse iz ustreznih usklajenih standardov iz člena 6(1) ali enakovredne preskuse, da zagotovi njeno skladnost z ustreznimi zahtevami te direktive.
The notified body shall affix, or cause to be affixed, its identification number to the instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity concerning the tests carried out.
Priglašeni organ pritrdi ali da pritrditi svojo identifikacijsko številko na tehtnico, za katero je bila ugotovljena skladnost z zahtevami, in sestavi pisno potrdilo o skladnosti v zvezi z opravljenimi preskusi.
The aim of the technical documentation relating to the design of the instrument, as referred to in Annex III, is to enable conformity with the requirements of this Directive to be assessed and the design, manufacture and operation of the instrument to be understood.
Namen tehnične dokumentacije v zvezi s tehnično dokumentacijo tehtnice iz Priloge III je omogočiti skladnost z zahtevami te direktive ter razumljivost sestave, izdelave in delovanja tehtnice.
It must be accessible to the notified body.
Dokumentacija mora biti dostopna priglašenemu organu.
The EC declaration of type conformity (guarantee of production quality), the EC verification, and the EC unit verification may be carried out at the manufacturer’s works or any other location if transport to the place of use does not require dismantling of the instrument, if the putting into service at the place of use does not require assembly of the instrument or other technical installation work likely to affect the instrument’s performance, and if the gravity value at the place of putting into service is taken into consideration or if the instrument’s performance is insensitive to gravity variations.
Izjava ES o skladnosti tipa (garancija kakovosti proizvodnje), ES overitev in ES overjanje enot se lahko izvedejo v proizvajalčevi tovarni ali na katerikoli drugi lokaciji, če tehtnice za transport na mesto uporabe ni potrebno razstavljati, če tehtnice za začetek obratovanja na mestu uporabe ni potrebno sestavljati ali izvršiti drugih namestitvenih del, ki bi lahko ogrozila delovanje tehtnice, in če se upošteva vrednost težnega pospeška mesta, na katerem bo tehtnica obratovala, oziroma je delovanje tehtnice neobčutljivo na spremembe težnosti.
In all other cases, they shall be carried out at the place of use of the instrument.
V vseh drugih primerih morajo biti izvedeni na mestu uporabe tehtnice.
If the instrument’s performance is sensitive to gravity variations the procedures referred to in point 5.1 may be carried out in two stages, with the second stage comprising all examinations and tests of which the outcome is gravity-dependent, and the first stage all other examinations and tests.
Če je delovanje tehtnice občutljivo na spremembe težnosti, se lahko postopki iz točke 5.1 izvedejo v dveh stopnjah, s tem da druga stopnja zajema vse preglede in preskuse, katerih izid je odvisen od težnosti, prva stopnja pa vse druge preglede in preskuse.
The second stage shall be carried out at the place of use of the instrument.
Druga stopnja se izvede na mestu uporabe tehtnice.
If a Member State has established gravity zones on its territory the expression ‘at the place of use of the instrument’ may be read as ‘in the gravity zone of use of the instrument’.
Če ima država članica na svojem ozemlju opredeljena območja težnosti, lahko izraz „na mestu uporabe tehtnice“ beremo kot „v območju težnosti uporabe tehtnice“.
Where a manufacturer has opted for execution in two stages of one of the procedures mentioned in point 5.1, and where these two stages will be carried out by different parties, an instrument which has undergone the first stage of the procedure shall bear the identification number of the notified body involved in that stage.
Kadar se je proizvajalec odločil za izvedbo enega od postopkov iz 5.1 v dveh fazah in kadar ti dve fazi izvajata dve različni strani, ima tehtnica po opravljeni prvi fazi identifikacijsko številko priglašenega organa, ki je bil vključen v tej fazi.
The party which has carried out the first stage of the procedure shall issue for each of the instruments a certificate containing the data necessary for identification of the instrument and specifying the examinations and tests that have been carried out.
Stran, ki je opravila prvo fazo postopka, za vsako tehtnico izda potrdilo z vsemi potrebnimi podatki za identifikacijo tehtnice in podrobno navaja opravljene preglede in preskuse.
The party which carries out the second stage of the procedure shall carry out those examinations and tests that have not yet been carried out.
Stran, ki opravi drugo fazo postopka, opravi preglede in preskuse, ki še niso bili opravljeni.
A manufacturer who has opted for the EC declaration of type conformity (guarantee of production quality) in the first stage may either use this same procedure in the second stage or decide to continue in the second stage with EC verification.
Proizvajalec, ki se je odločil za izjavo ES o skladnosti tipa (garancijo kakovosti proizvodnje) na prvi stopnji, lahko bodisi uporabi isti postopek na drugi stopnji bodisi se odloči, da bo na drugi stopnji nadaljeval z ES overitvijo.
The ‘CE’ conformity marking shall be affixed to the instrument on completion of the second stage, along with the identification number of the notified body which took part in the second stage.
Znak skladnosti „CE“ se pritrdi na tehtnico po končani drugi fazi, skupaj z identifikacijsko številko priglašenega organa, ki je sodeloval v drugi fazi.
DESIGN TECHNICAL DOCUMENTATION
TEHNIČNA DOKUMENTACIJA
The technical documentation must render the design, manufacture and operation of the product intelligible and enable an assessment to be made of its conformity with the requirements of this Directive.
Tehnična dokumentacija mora na razumljiv način opisati sestavo, izdelavo in delovanje izdelka in omogočiti ugotavljanje njegove skladnosti z zahtevami te direktive.
The documentation shall include in so far as relevant for assessment:
Dokumentacija mora v smiselnem obsegu za ugotavljanje skladnosti vključevati:
a general description of the type,
splošni opis tipa,
conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.,
idejno sestavo in proizvodne skice in načrte elementov, podsestavov, vezij itd.,
descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,
opise in pojasnila, potrebne za razumevanje zgornjega, vključno z delovanjem tehtnice,
a list of the harmonised standards referred to in Article 6(1), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied,
seznam usklajenih standardov iz člena 6(1), ki so upoštevani v celoti ali delno, ter opis rešitev, ki so bile sprejete, da bi izpolnili bistvene zahteve, če usklajeni standardi niso bili upoštevani,
results of design calculations made and of examinations, etc.,
rezultate konstrukcijskih izračunov in pregledov, itd.,
the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.
certifikate o ES-homologaciji in rezultate ustreznih preskusov na tehtnicah, ki vsebujejo dele, ki so identični tistim v načrtu.
Instruments subject to the EC conformity assessment procedure
Tehtnice, ki so predmet ES postopka ugotavljanja skladnosti
These instruments must bear:
Te tehtnice morajo nositi:
the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,
znak skladnosti „CE“, ki vsebuje simbol „CE“, kot je opisan v Prilogi VI,
the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
identifikacijsko(-e) številko(-e) priglašenega(-ih) organa(-ov), ki je (so) opravil(-i) ES nadzor ali ES overjanje.
The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together;
Naveden znak in napisi so pritrjeni na tehtnico skupaj v ločenih skupinah;
a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;
zeleno nalepko kvadratne oblike, veliko najmanj 12,5 × 12,5 mm z natisnjeno veliko črko „M“ črne barve;
the following inscriptions:
naslednje napise:
the number of the EC type-approval certificate, where appropriate,
številko certifikata o ES-homologaciji, če obstaja,
the manufacturer’s mark or name,
oznako ali ime proizvajalca,
the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,
razred točnosti, obkrožen z ovalno črto ali z dvema horizontalnima črtama, povezanima s polkrogoma,
maximum capacity, in the form Max …,
največjo zmogljivost v obliki Max …,
minimum capacity, in the form Min …,
najmanjšo zmogljivost v obliki Min …,
verification scale interval, in the form e = …,
vrednost preskusnega razdelka v obliki e = …,
the last two digits of the year in which the ‘CE’ conformity marking was affixed,
zadnji dve številki leta, v katerem je bil pritrjen znak skladnosti „CE“,
plus, when applicable:
in, če je potrebno:
serial number,
serijsko številko,
for instruments consisting of separate but associated units: identification mark on each unit,
za tehtnice, ki so sestavljene iz ločenih, vendar med seboj povezanih enot: identifikacijsko oznako na vsaki enoti,
scale interval if it is different from e, in the form d = …,
vrednost razdelka, če je drugačen od e, v obliki d = …,
maximum additive tare effect, in the form T = + …,
največji prištevalni tarirni efekt, v obliki T = + …,
maximum subtractive tare effect if it is different from Max, in the form T = – …,
največji odštevalni tarirni efekt, če je drugačen od Max, v obliki T = – …,
tare interval if it is different from d, in the form dT = …,
vrednost razdelka za taro, če je drugačna od d, v obliki dT = …,
maximum safe load if it is different from Max, in the form Lim …,
največje varno breme, če se razlikuje od Max, v obliki Lim …,
the special temperature limits, in the form … °C/… °C,
posebne mejne temperature, v obliki … °C/… °C,