natgillin/translations-raw huggingface dataset:
Supplementary devices are permitted only if they cannot lead to fraudulent use.
Tehtnice, podobne tistim, ki se običajno uporabljajo za neposredno prodajo javnosti, ki pa ne izpolnjujejo zahtev tega poglavja, morajo blizu prikazovalnika nositi neizbrisno oznako „Ne sme se uporabljati za neposredno prodajo javnosti“.
Instruments similar to those normally used for direct sales to the public which do not satisfy the requirements of this Section must carry near to the display the indelible marking ‘Not to be used for direct sale to the public’.
Tehtnice z izpisom nalepke z zneskom
Price labelling instruments
Tehtnice z izpisom nalepke z zneskom izpolnjujejo zahteve za tehtnice, ki izračunavajo znesek in so namenjene za neposredno prodajo javnosti, kolikor so te zahteve uporabne za zadevne tehtnice.
Price labelling instruments shall meet the requirements of price indicating instruments for direct sale to the public, as far as applicable to the instrument in question.
Izpis nalepke s ceno pod najmanjšo zmogljivostjo ni mogoč.
The printing of a price label shall be impossible below a minimum capacity.
UL L 39, 15.2.1980, str.
OJ L 39, 15.2.1980, p.
40.
40.
Za i = r velja ustrezni stolpec iz tabele 1, s tem da e zamenjamo z er.
For i = r, the corresponding column of Table 1 applies, with e replaced by er.
PRILOGA II
ANNEX II
POSTOPKI UGOTAVLJANJA SKLADNOSTI
CONFORMITY ASSESSMENT PROCEDURES
Modul B: EU-pregled tipa
Module B: EU-type examination
EU-pregled tipa je tisti del postopka ugotavljanja skladnosti, pri katerem priglašeni organ pregleda tehnično zasnovo tehtnice ter preveri in potrdi, da tehnična zasnova tehtnice izpolnjuje zahteve te direktive, ki veljajo zanjo.
EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an instrument and verifies and attests that the technical design of the instrument meets the requirements of this Directive that apply to it.
EU-pregled tipa se lahko izvede na katerega koli od naslednjih načinov:
EU-type examination may be carried out in any of the following manners:
pregled vzorca, reprezentativnega za predvideno proizvodnjo popolne tehtnice (tip proizvodnje);
examination of a specimen, representative of the production envisaged, of the complete instrument (production type);
ocena ustreznosti tehnične zasnove tehtnice s pregledovanjem tehnične dokumentacije in ustreznih dokazil iz točke 1.3 ter pregled vzorcev, reprezentativnih za predvideno proizvodnjo, za enega ali več kritičnih delov tehtnice (kombinacija tipa proizvodnje in tipa zasnove);
assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 1.3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type);
ugotavljanje ustreznosti tehnične zasnove tehtnice s pregledom tehnične dokumentacije in ustreznih dokazil iz točke 1.3 brez pregleda vzorca (tip zasnove).
assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 1.3, without examination of a specimen (design type).
Proizvajalec vloži zahtevo za EU-pregled tipa pri enem samem priglašenem organu, ki ga izbere sam.
The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
Vloga vključuje:
The application shall include:
ime in naslov proizvajalca in, če je vlogo vložil pooblaščeni zastopnik, tudi njegovo ime in naslov;
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
pisno izjavo, da enaka vloga ni bila vložena pri nobenem drugem priglašenem organu;
a written declaration that the same application has not been lodged with any other notified body;
tehnično dokumentacijo.
the technical documentation.
Tehnična dokumentacija omogoča ugotavljanje skladnosti tehtnice z veljavnimi zahtevami iz te direktive ter vključuje ustrezno analizo in oceno tveganja.
The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s).
Tehnična dokumentacija opredeljuje veljavne zahteve in v obsegu, ki je pomemben za tako ocenjevanje, zajema zasnovo, proizvodnjo in delovanje tehtnice.
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.
Tehnična dokumentacija, kadar je to ustrezno, vsebuje vsaj naslednje elemente:
The technical documentation shall contain, wherever applicable, at least the following elements:
splošni opis tehtnice;
a general description of the instrument;
razvojno zasnovo, proizvodne skice in načrte sestavnih delov, podsestavov, tokokrogov itd.;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
opis in pojasnila, potrebna za razumevanje navedenih skic in načrtov ter delovanja tehtnice;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
seznam harmoniziranih standardov, ki se uporabljajo v celoti ali deloma in katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije, in, kadar navedeni harmonizirani standardi niso bili uporabljeni, opis rešitev, sprejetih za izpolnitev bistvenih zahtev iz te direktive, vključno s seznamom drugih ustreznih tehničnih specifikacij, ki so bile uporabljene.
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied.
V primeru delne uporabe harmoniziranih standardov se v tehnični dokumentaciji navedejo deli, ki so bili uporabljeni;
In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
rezultate opravljenih izračunov za zasnovo, pregledov itd.;
results of design calculations made, examinations carried out, etc.;
poročila o preskusih;
test reports;
vzorce, reprezentativne za predvideno proizvodnjo.
the specimens representative of the production envisaged.
Priglašeni organ lahko zahteva dodatne vzorce, če je to potrebno za izvedbo programa preskušanja;
The notified body may request further specimens if needed for carrying out the test programme;
ustrezna dokazila o ustreznosti rešitve tehnične zasnove.
the supporting evidence for the adequacy of the technical design solution.
V teh ustreznih dokazilih so navedeni vsi uporabljeni dokumenti, zlasti če se ustrezni harmonizirani standardi niso uporabljali v celoti.
This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full.
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 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.
Priglašeni organ:
The notified body shall:
za tehtnico:
For the instrument:
pregleda tehnično dokumentacijo in ustrezna dokazila, da ugotovi ustreznost tehnične zasnove tehtnice;
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument;
za vzorce:
For the specimen(s):
preveri, ali je bil vzorec izdelan v skladu s tehnično dokumentacijo, ter prepozna elemente, ki so bili načrtovani v skladu z veljavnimi določbami ustreznih harmoniziranih standardov, in elemente, ki so bili načrtovani v skladu z drugimi ustreznimi tehničnimi specifikacijami;
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;
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, ti uporabljeni pravilno;
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, these have been applied correctly;
izvede ustrezne preglede in preskuse ali jih da izvesti, da bi v primeru neuporabe rešitve za ustrezne harmonizirane standarde preveril, ali rešitve, ki jih je sprejel proizvajalec, uporabljene v drugih ustreznih tehničnih specifikacijah, izpolnjujejo ustrezne bistvene zahteve iz te direktive;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Directive;
se sporazume s proizvajalcem o kraju, na katerem se bodo opravljali pregledi in preskusi.
agree with the manufacturer on a location where the examinations and tests will be carried out.
Priglašeni organ sestavi poročilo o vrednotenju, ki navaja ukrepe, izvedene v skladu s točko 1.4, in njihove rezultate.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 1.4 and their outcomes.
Brez poseganja v obveznosti do priglasitvenih organov lahko priglašeni organ objavi vsebino navedenega poročila v celoti ali delno le, če se proizvajalec strinja.
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.
Kadar tip izpolnjuje zahteve iz te direktive, ki veljajo za zadevno tehtnico, priglašeni organ proizvajalcu izda certifikat o EU-pregledu tipa.
Where the type meets the requirements of this Directive, that apply to the instrument concerned, the notified body shall issue an EU-type examination certificate to the manufacturer.
Ta certifikat vsebuje ime in naslov proizvajalca, ugotovitve pregleda, pogoje (če ti obstajajo) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega tipa.
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.
Certifikatu o EU-pregledu tipa je lahko priložena ena ali več prilog.
The EU-type examination certificate may have one or more annexes attached.
Certifikat o EU-pregledu tipa in njegove priloge vsebujejo vse potrebne informacije, da se lahko ovrednoti skladnost proizvedenih tehtnic s pregledanim tipom ter omogoči nadzor med uporabo.
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured instruments with the examined type to be evaluated and to allow for in-service control.
Certifikat o EU-pregledu tipa je veljaven deset let od datuma izdaje in ga je mogoče obnoviti za zaporedna obdobja desetih let.
The EU-type examination certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
V primeru temeljnih sprememb zasnove tehtnice, ki so na primer posledica uporabe novih tehnik, je lahko veljavnost certifikata o EU-pregledu tipa omejena na dve leti in se podaljšuje za tri leta.
In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of EU-type examination certificate may be limited to two years and extended by three years.
Kadar tip ne izpolnjuje veljavnih zahtev iz te direktive, priglašeni organ zavrne izdajo certifikat o EU-pregledu tipa in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
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.
Priglašeni organ zagotavlja svojo seznanjenost s kakršnimi koli spremembami splošno priznanega stanja tehnike, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev iz te direktive, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
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.
V tem primeru priglašeni organ ustrezno obvesti proizvajalca.
If so, the notified body shall inform the manufacturer accordingly.
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 tehtnice z bistvenimi zahtevami iz te direktive ali pogoji veljavnosti tega potrdila.
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.
Take spremembe zahtevajo dodatno odobritev v obliki dodatka k izvirnemu potrdilu o EU-pregledu tipa.
Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
Vsak priglašeni organ obvesti svoj priglasitveni organ o potrdilih 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 potrdil in/ali kakršnih koli 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.
Vsak priglašeni organ obvesti druge priglašene organe o zavrnjenih, preklicanih, začasno preklicanih ali drugače omejenih potrdilih o EU-pregledu tipa ter jih na zahtevo obvesti o izdanih takih potrdilih in/ali dodatkih.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo prejmejo izvode potrdil o EU-pregledu tipa in/ali njihovih dodatkov.
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.
Komisija in države članice lahko na zahtevo prejmejo izvod tehnične dokumentacije in rezultate pregledov, ki jih je izvedel priglašeni organ.
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.
Priglašeni organ hrani izvod potrdila o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti tega potrdila.
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.
Proizvajalec hrani izvod potrdila o EU-pregledu tipa, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo, na voljo za nacionalne organe 10 let po tem, ko je bila tehtnica dana na trg.
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.
Pooblaščeni zastopnik proizvajalca lahko vloži zahtevek iz točke 1.3 ter izpolni obveznosti iz točk 1.7 in 1.9, če so navedene v pooblastilu.
The manufacturer’s authorised representative may lodge the application referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided that they are specified in the mandate.
Modul D: skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje
Module D: Conformity to type based on quality assurance of the production process
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje je del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2.2 in 2.5 ter zagotovi in na lastno odgovornost izjavi, da so zadevne tehtnice v skladu s tipom, opisanim v potrdilu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
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 2.2 and 2.5, and ensures and declares on his sole responsibility that the 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.
Proizvodnja
Manufacturing
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za proizvodnjo, končno kontrolo proizvoda in preskušanje zadevnih tehtnic, kakor je določeno v točki 2.3, in zanj velja nadzor iz točke 2.4.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the instruments concerned as specified in point 2.3, and shall be subject to surveillance as specified in point 2.4.
Sistem kakovosti
Quality system
Proizvajalec vloži vlogo za oceno svojega sistema kakovosti v zvezi z zadevnimi tehtnicami pri priglašenem organu, ki ga sam izbere.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.
vse ustrezne informacije za predvideno kategorijo tehtnic;
all relevant information for the instrument category envisaged;
dokumentacijo o sistemu kakovosti; in
the documentation concerning the quality system; and
tehnično dokumentacijo odobrenega tipa in izvod potrdila o EU-pregledu tipa.
the technical documentation of the approved type and a copy of the EU-type examination certificate.
Sistem kakovosti zagotovi skladnost tehtnic s tipom, ki je opisan v certifikatu o EU-pregledu tipa, in da tehtnice izpolnjujejo zahteve iz te direktive, ki se uporabljajo zanje.
The quality system shall ensure that the 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.
Vse elemente, zahteve in določbe, ki jih je sprejel proizvajalec, se sistematično in metodično dokumentira v obliki pisnih politik, postopkov in navodil.
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.
Dokumentacija o sistemu kakovosti mora omogočati dosledno razlago programov, načrtov, navodil in zapisov kakovosti.
The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Vsebuje zlasti ustrezen opis:
It shall, in particular, contain an adequate description of:
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva glede kakovosti proizvoda;
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
uporabljenih tehnik za ustrezno proizvodnjo, nadzor in zagotavljanje kakovosti, postopkov in sistematičnih ukrepov, ki se bodo uporabljali;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
pregledov in preskusov, ki bodo opravljeni pred proizvodnjo, med njo in po njej, ter pogostnost njihovega izvajanja;
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
zapisov kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o umerjanju, poročila o strokovni usposobljenosti osebja itd.;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
sredstev za spremljanje doseganja zahtevane kakovosti proizvoda in učinkovitega delovanja sistema kakovosti.
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
Priglašeni organ oceni sistem kakovosti, da določi, ali izpolnjuje zahteve iz točke 2.3.2.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 2.3.2.
Priglašeni organ domneva skladnost s temi zahtevami glede elementov sistema kakovosti, ki so skladni z ustreznimi specifikacijami, ki veljajo za ustrezni harmonizirani standard.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
Skupina za presojo ima poleg izkušenj pri sistemih vodenja kakovosti vsaj enega člana z izkušnjami ocenjevalca na ustreznem področju tehtnic in zadevne tehnologije tehtnice ter poznavanjem veljavnih zahtev iz te direktive.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive.
Presoja vključuje ocenjevalni obisk proizvajalčevih prostorov.
The audit shall include an assessment visit to the manufacturer’s premises.
Skupina za presojo pregleda tehnično dokumentacijo iz točke 2.3.1(e), da preveri sposobnosti proizvajalca, da prepozna ustrezne zahteve iz te direktive in izvede potrebne preglede, da se zagotovi, da tehtnica izpolnjuje te zahteve.
The auditing team shall review the technical documentation referred to in point 2.3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements.
Proizvajalca se obvesti o odločitvi.
The decision shall be notified to the manufacturer.
Obvestilo vsebuje ugotovitve presoje in utemeljeno odločitev o ocenjevanju.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Proizvajalec se zaveže, da bo izpolnjeval obveznosti, ki izhajajo iz sistema kakovosti, kot je bil odobren, ter ga vzdrževal, da ostane ustrezen in učinkovit.
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
Proizvajalec obvešča priglašeni organ, ki je odobril sistem kakovosti, o kakršni koli nameravani spremembi sistema kakovosti.