natgillin/translations-raw huggingface dataset:
Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in [Article R31(5)(b)], the Commission shall inform the relevant European standardisation body or bodies and shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC.
Če se nacionalni ukrep šteje kot upravičen in je neskladnost proizvoda posledica pomanjkljivosti v harmoniziranih standardih iz [člena R31(5)(b)], mora Komisija obvestiti ustrezni evropski organ (organe) za standardizacijo in zadevo predložiti odboru, ustanovljenemu s členom 5 Direktive 98/34/ES.
That Committee shall consult the relevant European standardisation body or bodies and deliver its opinion without delay.
Odbor se mora posvetovati z ustreznim evropskim organom (organi) za standardizacijo in brez odlašanja predložiti mnenje.
Article R33
Člen R33
Compliant products which present a risk to health and safety
Skladni proizvodi, ki vseeno predstavljajo tveganje za zdravje in varnost
Where, having performed an evaluation under Article [R31(1)], a Member State finds that although a product is in compliance with this ... [act], it presents a risk to the health or safety of persons or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.
Če država članica ugotovi, da po izvedbi vrednotenja iz člena [R31(1)] proizvod, čeprav skladen s tem … [akt], predstavlja tveganje za zdravje ali varnost ljudi ali ogroža druge vidike zaščite javnega interesa, od zadevnega gospodarskega subjekta zahteva, da sprejme ustrezne ukrepe, s katerimi zagotovi, da zadevni proizvod takrat, ko je dan v promet, ne predstavlja več navedenega tveganja, ali pa proizvod umakne s trga ali ga odpokliče v obdobju, razumnem glede na naravo tveganja, ki ga lahko predpiše.
The economic operator shall ensure that corrective action is taken in respect of all the products concerned that he has made available on the market throughout the Community.
Gospodarski subjekt zagotavlja izvajanje korektivnih ukrepov glede proizvoda, ki ga je dal na trg po vsej Skupnosti.
The Member State shall immediately inform the Commission and the other Member States.
Država članica nemudoma obvesti Komisijo in druge države članice.
That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
Informacije morajo biti natančne, zlasti morajo biti navedeni podatki za identifikacijo zadevnega proizvoda, poreklo in dobavna veriga proizvoda, vrsta tveganja ter vrsta in trajanje sprejetih nacionalnih ukrepov.
The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken.
Komisija se nemudoma posvetuje z državami članicami in zadevnim(-i) gospodarskim(-i) subjektom(-i) ter nadaljuje z vrednotenjem nacionalnega ukrepa.
On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified or not, and where necessary, propose appropriate measures.
Na podlagi rezultatov vrednotenja, Komisija odloči, l ali je ukrep upravičen ali ne, in, če je to potrebno, predlaga ustrezne ukrepe.
Article R34
Člen R34
Formal non-compliance
Ukrepi v zvezi s formalno neskladnostjo
Without prejudice to Article [R31], where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
Brez poseganja v člen [R31] država članica od gospodarskega subjekta zahteva, da neskladnost odpravi, če ugotovi enega od naslednjih dejstev:
the conformity marking has been affixed in violation of Article [R11] or of Article [R12];
oznake skladnosti so bile nameščene tako, da sta kršena člena [R11] in [R12];
the conformity marking has not been affixed;
oznaka skladnosti ni bila nameščena;
the EC declaration of conformity has not been drawn up;
izjava ES o skladnosti ni bila izdelana;
the EC declaration of conformity has not been drawn up correctly;
izjava ES o skladnosti ni bila pravilno izdelana;
technical documentation is either not available or not complete.
tehnična dokumentacija ni na voljo ali ni popolna.
Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.
Če se neizpolnjevanje iz odstavka 1 nadaljuje, zadevna država članica sprejme vse primerne ukrepe za omejevanje ali prepoved dajanja na trg proizvoda ali pa zagotovi njegov odpoklic ali umik s trga.
CONFORMITY ASSESSMENT PROCEDURES
POSTOPKI UGOTAVLJANJA SKLADNOSTI
Internal production control
Notranji nadzor proizvodnjen
Internal production control is the 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 products concerned satisfy the requirements of the legislative instrument that apply to them.
Notranji nadzor proizvodnje je postopek ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 2, 3 in 4 ter zagotovi in na lastno odgovornost izjavi, da zadevni proizvodi izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall establish the technical documentation.
Proizvajalec mora predložiti tehnično dokumentacijo.
The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
Dokumentacija omogoča ugotavljanje skladnosti proizvoda z ustreznimi zahtevami ter vključuje ustrezno analizo in oceno tveganja.
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product.
Tehnična dokumentacija opredeljuje veljavne zahteve in v obsegu, ki je pomemben za tako ugotavljanje, zajema oblikovanje, proizvodnjo in delovanje proizvoda.
The technical documentation shall, wherever applicable, contain at least the following elements:
Tehnična dokumentacija mora, kjer je to ustrezno, vsebovati vsaj naslednje elemente:
a general description of the product,
splošni opis proizvoda,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
konceptualne, konstrukcijske in proizvodne načrte ter shematski prikaz sestavnih delov, montažnih sklopov, vezij itd.,
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,
opis in potrebne razlage za razumevanje teh načrtov in shematskih prikazov ter delovanje proizvoda,
results of design calculations made, examinations carried out, etc., and
rezultate opravljenih projektnih izračunov, pregledov itd.,
test reports.
poročila o preizkusih.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the legislative instruments that apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da se s proizvodnim procesom in njegovim spremljanjem zagotovi skladnost proizvedenih proizvodov s tehnično dokumentacijo iz točke 2 in zahtevami zakonodajnih instrumentov, ki zanje veljajo.
Conformity marking and declaration of conformity
Znak skladnosti in izjava o skladnosti
The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.
Proizvajalec namesti zahtevani znak skladnosti, kot določa zakonodajni instrument, na vsak proizvod, ki izpolnjuje veljavne zahteve zakonodajnega instrumenta.
The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.
Proizvajalec za vzorčni proizvod sestavi pisno izjavo o skladnosti in jo hrani skupaj s tehnično dokumentacijo, ki je nacionalnim organom na voljo 10 let po tem, ko je bil dan na trg proizvod.
The declaration of conformity shall identify the product for which it has been drawn up.
Izjava o skladnosti opredeljuje proizvod, za katerega je bila sestavljena.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
Na zahtevo pristojnih organov se zagotovi izvod izjave o skladnosti.
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Obveznosti proizvajalca iz točke 4 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
Internal production control plus supervised product testing
Notranji nadzor proizvodnje in nadzorovani preskusi proizvodov
Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.
Notranji nadzor proizvodnje in nadzorovani preskusi proizvodov, ki jih izvede priglašeni organ, so postopki ugotavljanja skladnosti, pri katerih proizvajalec izpolni obveznosti iz točk 2, 3, 4 in 5 ter zagotovi in na lastno odgovornost izjavi, da zadevni proizvodi izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
The documentation shall make it possible to assess the product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
Dokumentacija omogoča ugotavljanje skladnosti proizvoda z ustreznimi zahtevami ter vključuje ustrezno analizo in oceno tveganja.
The technical documentation shall contain, wherever applicable, at least the following elements:
Tehnična dokumentacija mora, kjer je to ustrezno, vsebovati vsaj naslednje elemente:
Product checks
Preskusi proizvodov
For each individual product manufactured, one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements of the legislative instrument.
Za vsak proizveden proizvod proizvajalec sam ali kdo drug v njegovem imenu izvede enega ali več preskusov glede enega ali več posebnih vidikov proizvoda, da preveri skladnost z ustreznimi zahtevami zakonodajnega instrumenta.
At the choice of the manufacturer, the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer.
Na proizvajalčevo izbiro izvaja preskuse pooblaščeni interni organ ali pa je zanje odgovoren priglašeni organ, ki ga izbere proizvajalec.
Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
Če preskuse izvaja priglašeni organ, proizvajalec med proizvodnim procesom na odgovornost priglašenega organa namesti identifikacijsko številko priglašenega organa.
The manufacturer's obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Obveznosti proizvajalca iz točke 5 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
Internal production control plus supervised product checks at random intervals
Notranji nadzor proizvodnje in nadzorovani preskusi proizvodov
Internal production control plus supervised product checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.
Notranji nadzor proizvodnje in nadzorovani preskusi proizvodov, ki jih izvede priglašeni organ, so postopki ugotavljanja skladnosti, pri katerih proizvajalec izpolni obveznosti iz točk 2, 3, 4 in 5 ter zagotovi in na lastno odgovornost izjavi, da zadevni proizvodi izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the product, taking into account, inter alia, the technological complexity of the products and the quantity of production.
Na proizvajalčevo izbiro, pooblaščeni interni organ ali priglašeni organ, ki ga izbere proizvajalec, izvede preskuse proizvodov ali jih da izvesti v naključno izbranih časovnih presledkih, ki jih določi organ, da preveri kakovost notranjega preskušanja proizvodov, pri čemer se med drugim upoštevata tehnološka zahtevnost proizvodov in količina proizvodnje.
An adequate sample of the final products, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the product with the relevant requirements of the legislative instrument.
Organ na ustreznem vzorcu končnih proizvodov, odvzetih na sami lokaciji, pred dajanjem v promet izvede pregled in primerne preskuse, ki so opredeljeni v ustreznih delih harmoniziranega standarda, katerega sklicevanja so bila objavljena v Uradnem listu Evropske unije, ali podobne preskuse, s katerimi preveri skladnost proizvoda z ustreznimi zahtevami zakonodajnega instrumenta.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the product performs within acceptable limits, with a view to ensuring conformity of the product.
Postopek vzorčenja za sprejemljivost, ki se uporablja, je zasnovan za presojo, ali se proizvodni proces zadevnega proizvoda izvaja v sprejemljivih mejah s ciljem zagotavljanja skladnosti proizvoda.
EC-type examination
ES-pregled tipa
EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the legislative instrument that apply to it.
ES-pregled tipa je tisti del postopka ugotavljanja skladnosti, pri katerem priglašeni organ pregleda tehnično oblikovanje proizvoda ter preveri in potrdi, da tehnična oblikovanost proizvoda izpolnjuje zahteve zakonodajnega instrumenta, ki zanj veljajo.
EC-type examination may be carried out in either of the following manners:
ES-pregled tipa se lahko izvede na naslednje načine:
examination of a specimen, representative of the production envisaged, of the complete product (production type),
pregled vzorca, reprezentativnega za predvideno proizvodnjo, popolnega proizvoda (tip proizvodnje),
assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type),
ugotavljanje ustreznosti tehničnega oblikovanja proizvoda s pregledovanjem tehnične dokumentacije in dodatnih dokazil iz točke 3 ter pregled vzorcev, reprezentativnih za predvideno proizvodnjo, za enega ali več kritičnih delov proizvoda (kombinacija tipa proizvodnje in tipa oblikovanosti),
assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).
ugotavljanje ustreznosti tehničnega oblikovanja proizvoda s pregledovanjem tehnične dokumentacije in dodatnih dokazil iz točke 3 brez pregleda vzorca (tip oblikovanosti).
The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.
Proizvajalec vloži vlogo za ES-pregled tipa pri priglašenem organu, ki ga izbere sam.
The application shall include:
Vloga vključuje:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
ime in naslov proizvajalca in, če je vlogo vložil pooblaščeni zastopnik, tudi njegovo ime in naslov,
a written declaration that the same application has not been lodged with any other notified body,
pisno izjavo, da ista vloga ni bila vložena tudi pri kakem drugem priglašenem organu,
the technical documentation.
tehnično dokumentacijo.
The technical documentation shall make it possible to assess the product's conformity with the applicable requirements of the legislative instrument and shall include an adequate analysis and assessment of the risk(s).
Tehnična dokumentacija omogoča ugotavljanje skladnosti proizvoda z veljavnimi zahtevami zakonodajnega instrumenta ter vključuje ustrezno analizo in oceno tveganja.
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
konceptualne, konstrukcijske in proizvodne načrte ter shematski prikaz sestavnih delov, montažnih sklopov, vezij itd.,
test reports,
poročila o preskusih,
the specimens representative of the production envisaged.
vzorce, reprezentativne za predvideno proizvodnjo.
The notified body may request further specimens if needed for carrying out the test programme,
Priglašeni organ lahko zahteva dodatne vzorce, če je to potrebno za izvedbo preskusnega programa,
the supporting evidence for the adequacy of the technical design solution.
dodatna dokazila o ustreznosti rešitve tehničnega oblikovanja.
This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full.
Ta dodatna dokazila navajajo kakršne koli ustrezne dokumente, ki so se uporabljali, zlasti če se ustrezni harmonizirani standardi in/ali tehnične specifikacije niso uporabljali v celoti.
The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
Dodatna dokazila po potrebi vsebujejo rezultate preskusov, ki jih je izvedel ustrezni laboratorij proizvajalca ali drug preskuševalni laboratorij v njegovem imenu in na njegovo odgovornost.
For the product:
za proizvod:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product;
pregleda tehnično dokumentacijo in dodatna dokazila, da ugotovi ustreznost tehničnega oblikovanja proizvoda;
For the specimen(s):
za vzorec(-e):
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 technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;
preveri, ali je (so) bil(-i) vzorec(-i) proizveden(-i) v skladu s tehnično dokumentacijo, ter določi elemente, ki so bili oblikovani v skladu z ustreznimi določbami ustreznih harmoniziranih standardov in/ali tehničnih specifikacij, in tudi elemente, ki so bili oblikovani, ne da bi bile upoštevane ustrezne določbe teh standardov;
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/or technical specifications, these have been applied correctly;
izvede ustrezne preglede in preskuse ali jih da izvesti, s čimer preveri, ali je proizvajalec, kadar se je odločil za upoštevanje rešitev pri ustreznih harmoniziranih standardih in/ali tehničnih specifikacijah, te res upošteval;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;
izvede ustrezne preglede in preskuse ali jih da izvesti, da bi v primeru neuporabe rešitve za ustrezne harmonizirane standarde in/ali tehnične specifikacije preveril, ali rešitve, ki jih je sprejel proizvajalec, izpolnjujejo ustrezne bistvene zahteve zakonodajnega instrumenta;
agree with the manufacturer on a location where the examinations and tests will be carried out.
se dogovori s proizvajalcem za mesto, kjer bodo izvedeni pregledi in preskusi.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes.
Priglašeni organ sestavi poročilo o oceni, ki vsebuje dejavnosti, kot se izvajajo v skladu s točko 4, in njihove rezultate.
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.
Ne glede na obveznosti do priglašenih oblasti lahko priglašeni organ objavi vsebino poročila v celoti ali delno le, če se proizvajalec strinja.
Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the notified body shall issue an EC-type examination certificate to the manufacturer.
Če tip izpolnjuje zahteve posebnega zakonodajnega instrumenta, ki veljajo za zadevni proizvod, priglašeni organ proizvajalcu izda certifikat o ES-pregledu tipa.
The 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.
Certifikat vsebuje ime in naslov proizvajalca, rezultate pregleda, pogoje (če so) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega tipa.
The certificate may have one or more annexes attached.
Certifikatu je lahko priložena ena ali več prilog.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.
Certifikati in priloge vsebujejo vse potrebne informacije, da se lahko oceni skladnost proizvedenih proizvodov s preskušenim tipom ter omogoči nadzor med uporabo.
Where the type does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če tip ne izpolnjuje veljavnih zahtev zakonodajnega instrumenta, priglašeni organ zavrne izdajo certifikata o ES-pregledu tipa in ustrezno obvesti vlagatelja s podrobno utemeljitvijo zavrnitve.