natgillin/translations-raw huggingface dataset:
Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a product.
Kadar proizvod predstavlja tveganje, distributerji o tem takoj obvestijo pristojne nacionalne organe držav članic, v katerih je ta proizvod dostopen na trgu, in jim predložijo informacije, zlasti o neskladnosti in kakršnih koli sprejetih korektivnih ukrepih.
They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have made available on the market.
Distributerji na podlagi utemeljene zahteve pristojnega nacionalnega organa posredujejo vse potrebne informacije in dokumentacijo za dokazovanje skladnosti proizvoda v papirni ali elektronski obliki.
Article 10
S tem organom na njegovo zahtevo sodelujejo pri vseh dejavnostih, katerih cilj je preprečiti tveganje, ki ga povzročajo proizvodi, katerih dostopnost na trgu so omogočili.
Cases in which obligations of manufacturers apply to importers and distributors
Člen 10
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 6, where he places a product on the market under his name or trade mark or modifies a product already placed on the market in such a way that compliance with this Directive may be affected.
Primeri, ko se obveznosti proizvajalcev uporabljajo za uvoznike in distributerje
Article 11
Uvoznik ali distributer se za namene te direktive obravnava kot proizvajalec in zanj veljajo obveznosti proizvajalca iz člena 6, kadar da proizvod na trg pod svojim imenom ali blagovno znamko ali spremeni proizvod, ki je že bil dan na trg, tako, da to lahko vpliva na skladnost s to direktivo.
Identification of economic operators
Člen 11
Economic operators shall, on request, identify the following to the market surveillance authorities:
Identifikacija gospodarskih subjektov
any economic operator who has supplied them with a product;
Gospodarski subjekti organom za nadzor trga na zahtevo sporočijo:
any economic operator to whom they have supplied a product.
vsak gospodarski subjekt, ki jim je dobavil proizvod;
Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the product and for 10 years after they have supplied the product.
vsak gospodarski subjekt, ki so mu dobavili proizvod.
CHAPTER 3
Gospodarski subjekti lahko predložijo informacije iz prvega odstavka 10 let po tem, ko jim je bil proizvod dobavljen, in 10 let po tem, ko so proizvod dobavili.
CONFORMITY OF THE PRODUCT
POGLAVJE 3
Article 12
SKLADNOST PROIZVODA
Presumption of conformity of products
Člen 12
Products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.
Domneva o skladnosti proizvodov
In the absence of harmonised standards, Member States shall take any steps which they deem necessary to bring to the attention of the parties concerned the existing national standards and technical specifications regarded as important or relevant to the proper implementation of the essential health and safety requirements set out in Annex II.
Za proizvode, ki so v skladu s harmoniziranimi standardi ali delom harmoniziranih standardov, katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije, se domneva, da so v skladu z bistvenimi zdravstvenimi in varnostnimi zahtevami iz Priloge II, zajetimi v navedenih standardih ali delih standardov.
Article 13
V odsotnosti harmoniziranih standardov države članice storijo vse, kar se jim zdi potrebno, da udeležene strani opozorijo na obstoječe nacionalne standarde in tehnične specifikacije, ki veljajo za pomembne ali relevantne za ustrezno izvajanje bistvenih zdravstvenih in varnostnih zahtev iz Priloge II.
Conformity assessment procedures
Člen 13
The procedures to be followed for assessing the conformity of equipment and, where necessary, the devices referred to in point (b) of Article 1(1) shall be as follows:
Postopki ugotavljanja skladnosti
for equipment-groups I and II, equipment-categories M 1 and 1, the EU-type examination set out in Annex III, in conjunction with either of the following:
Za ugotavljanje skladnosti opreme in po potrebi naprav iz točke (b) člena 1(1) se uporabljajo naslednji postopki:
conformity to type based on quality assurance of the production process set out in Annex IV,
za skupino opreme I in II, kategorijo opreme M 1 in 1, EU pregled tipa iz Priloge III, skupaj z naslednjim:
conformity to type based on product verification set out in Annex V;
skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnega procesa iz Priloge IV,
for equipment-groups I and II, equipment categories M 2 and 2:
skladnost s tipom na podlagi preverjanja proizvoda iz Priloge V;
in the case of internal combustion engines and electrical equipment in these groups and categories, the EU-type examination set out in Annex III, in conjunction with either of the following:
za skupino opreme I in II, kategorijo opreme M 2 in 2:
conformity to type based on internal production control plus supervised product testing set out in Annex VI,
pri motorjih z notranjim izgorevanjem ter električni opremi v teh skupinah in kategorijah EU pregled tipa iz Priloge III, skupaj z naslednjimi postopki:
conformity to type based on product quality assurance set out in Annex VII;
skladnost s tipom na podlagi notranje kontrole proizvodnje in nadzorovani preskusi proizvodov iz Priloge VI,
in the case of other equipment in these groups and categories, internal production control set out in Annex VIII and the communication of the technical documentation provided for in Annex VIII, point 2, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it;
skladnost s tipom na podlagi zagotavljanja kakovosti proizvoda iz Priloge VII;
for equipment-group II, equipment category 3, internal production control set out in Annex VIII;
pri drugi opremi v teh skupinah in kategorijah, notranjo kontrolo proizvodnje iz Priloge VIII, in predložitev tehnične dokumentacije iz točke 2 Priloge VIII priglašenemu organu, ki mora čim prej potrditi prejem, in jo shraniti;
for equipment-groups I and II, in addition to the procedures referred to in points (a), (b) and (c) of this paragraph, conformity based on unit verification set out in Annex IX may also be followed.
za skupino opreme II, kategorijo opreme 3, z notranjo kontrolo proizvodnje iz Priloge VIII;
The procedure referred to in point (a) or (d) of paragraph 1 shall be used for conformity assessment of protective systems.
za skupino opreme I in II poleg postopkov iz točk (a), (b) in (c) tega odstavka se lahko uporabi skladnost na podlagi preverjanja enote iz Priloge IX.
The procedures referred to in paragraph 1 shall be applied in respect of components with the exception of the affixing of the CE marking and the drawing up of the EU declaration of conformity.
Postopek iz točk (a) ali (d) odstavka 1 se uporablja za ugotavljanje skladnosti zaščitnih sistemov.
A written attestation of conformity shall be issued by the manufacturer, declaring the conformity of the components with the applicable provisions of this Directive and stating their characteristics and how they must be incorporated into equipment or protective systems to assist compliance with the essential health and safety requirements set out in Annex II applicable to finished equipment or protective systems.
Postopki iz odstavka 1 se uporabljajo tudi za komponente razen namestitve oznake CE in priprave izjave EU o skladnosti.
With regard to the safety aspects referred to in point 1.2.7 of Annex II, in addition to the conformity assessment procedures referred to in paragraphs 1 and 2, the procedure referred to in Annex VIII may also be followed.
Proizvajalec izda pisno potrdilo o skladnosti, s katerim izjavlja skladnost komponent z veljavnimi določbami te direktive ter z opisom njihovih lastnosti in zahtev, kako morajo biti vgrajene v opremo ali zaščitne sisteme, da ti izpolnjujejo bistvene zdravstvene in varnostne zahteve iz Priloge II, ki se uporabljajo za dokončano opremo ali zaščitne sisteme;
By derogation from paragraphs 1, 2 and 4, the competent authorities may, on a duly justified request, authorise the placing on the market and putting into service on the territory of the Member State concerned of the products other than components in respect of which the procedures referred to in paragraphs 1, 2 and 4 have not been applied and the use of which is in the interests of protection.
Poleg postopkov ugotavljanja skladnosti iz odstavkov 1 in 2 se lahko izvede postopek iz Priloge VIII glede varnostnih vidikov iz točke 1.2.7 Priloge II.
Documents and correspondence relating to the conformity assessment procedures referred to in paragraphs 1 to 4 shall be drawn up in a language, determined by the Member State concerned.
Z odstopanjem od odstavkov 1, 2 in 4 lahko pristojni organi na podlagi ustrezno upravičene zahteve dovolijo dajanje proizvodov, razen komponent, za katere niso bili uporabljeni postopki iz odstavkov 1, 2 in 4 in je njihova uporaba v interesu zaščite, na trg ter v uporabo na ozemlju države članice.
Article 14
Dokumenti in dopisovanje v zvezi s postopki ugotovitve skladnosti iz odstavkov 1 do 4 se pripravijo v jeziku, kakor ga določi zadevna država članica.
EU declaration of conformity
Člen 14
The EU declaration of conformity shall state that the fulfilment of the essential health and safety requirements set out in Annex II has been demonstrated.
Izjava EU o skladnosti
The EU declaration of conformity shall have the model structure set out in Annex X, shall contain the elements specified in the relevant conformity assessment procedures set out in Annexes III to IX and shall be continuously updated.
V izjavi EU o skladnosti je navedeno, da je bilo dokazano izpolnjevanje bistvenih zdravstvenih in varnostnih zahtev iz Priloge II.
It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market.
Izjava EU o skladnosti ima obliko po vzorcu, določeno v Prilogi X, vsebuje elemente, opredeljene v ustreznih postopkih ugotavljanja skladnosti iz prilog III do IX in se stalno posodablja.
Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts.
Prevede se v jezik ali jezike, ki ga/jih zahteva država članica, v kateri je proizvod dan na trg ali je na njem dostopen.
That declaration shall contain the identification of the Union acts concerned, including their publication references.
Kadar se za proizvod uporablja več kot en akt Unije, ki zahteva izjavo EU o skladnosti, se pripravi enotna izjava EU o skladnosti v zvezi z vsemi temi akti Unije.
By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements laid down in this Directive.
Navedena izjava vsebuje opredelitev zadevnih aktov Unije, vključno z njihovim sklicevanjem na objave.
Article 15
Proizvajalec s pripravo izjave EU o skladnosti prevzame odgovornost za to, da proizvod izpolnjuje zahteve iz te direktive.
General principles of the CE marking
Člen 15
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Splošna načela za oznako CE
Article 16
Za oznako CE veljajo splošna načela iz člena 30 Uredbe (ES) št. 765/2008.
Rules and conditions for affixing the CE marking and other markings
Člen 16
The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate.
Pravila in pogoji za namestitev oznake CE in drugih oznak
Where that is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents.
Oznaka CE se namesti vidno, čitljivo in neizbrisno na proizvod ali na njegovo tablico s podatki.
The CE marking shall be affixed before the product is placed on the market.
Kadar to zaradi narave proizvoda ni mogoče ali upravičeno, se namesti na embalažo in v spremne dokumente.
The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase.
Oznaka CE se namesti, preden je proizvod dan na trg.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
Oznaki CE sledi identifikacijska številka priglašenega organa, kadar ta sodeluje v fazi kontrole proizvodnje.
The CE marking and, where applicable, the identification number of the notified body shall be followed by the specific marking of explosion protection
Identifikacijsko številko priglašenega organa namesti organ sam ali pa jo v skladu z njegovimi navodili namesti proizvajalec ali njegov pooblaščeni zastopnik.
, the symbols of the equipment-group and category and, where applicable, the other markings and information referred to in point 1.0.5 of Annex II.
Oznaki CE in, kadar je primerno, identifikacijski številki priglašenega organa sledijo specifična oznaka protieksplozijske zaščite
The CE marking and the markings, symbols and information referred to in paragraph 4, and, where applicable, the identification number of the notified body, may be followed by any other mark indicating a special risk or use.
, simboli skupine ali kategorije opreme in, kadar je primerno, druge oznake in informacije iz točke 1.0.5 Priloge II.
Products that are designed for a particular explosive atmosphere shall be marked accordingly.
Oznaki CE in oznakam, simbolom in informacijam iz odstavka 4 in po potrebi identifikacijski številki priglašenega organa lahko sledi katera koli druga oznaka, ki označuje posebno tveganje ali uporabo.
Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
Proizvodi, ki so načrtovani za posebne vrste eksplozivnih atmosfer, so ustrezno označeni.
CHAPTER 4
Države članice nadalje razvijajo obstoječe mehanizme, da zagotovijo pravilno izvajanje ureditve, ki ureja oznako CE, in v primeru nepravilne rabe te oznake ustrezno ukrepajo.
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
POGLAVJE 4
Article 17
PRIGLASITEV ORGANOV ZA UGOTAVLJANJE SKLADNOSTI
Notification
Člen 17
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive.
Priglasitev
Article 18
Države članice obvestijo Komisijo in druge države članice o organih, ki so v skladu s to direktivo pristojni za opravljanje nalog ugotavljanja skladnosti tretjih strani.
Notifying authorities
Člen 18
Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 23.
Priglasitveni organi
Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Države članice določijo priglasitveni organ, ki je pristojen za uvedbo in izvajanje potrebnih postopkov za presojo in priglasitev organov za ugotavljanje skladnosti ter monitoring priglašenih organov, vključno s skladnostjo z določbami člena 23.
Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 19.
Države članice lahko določijo, da presojo in monitoring iz odstavka 1 izvaja nacionalni akreditacijski organ v smislu Uredbe (ES) št. 765/2008 in v skladu z njo.
In addition it shall have arrangements to cover liabilities arising out of its activities.
Kadar priglasitveni organ izda pooblastilo ali drugače zaupa presojo, priglasitev ali spremljanje iz odstavka 1 organu, ki ni vladni organ, je navedeni organ pravna oseba in mora smiselno izpolnjevati zahteve iz člena 19.
The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Poleg tega mora imeti takšen organ ureditev, s katero krije obveznosti, ki izhajajo iz njegovih dejavnosti.
Article 19
Priglasitveni organ prevzame celotno odgovornost za naloge, ki jih izvaja organ iz odstavka 3.
Requirements relating to notifying authorities
Člen 19
A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.
Zahteve v zvezi s priglasitvenimi organi
A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
Priglasitveni organ se ustanovi tako, da ne pride do navzkrižja interesov z organi za ugotavljanje skladnosti.
A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.
Priglasitveni organ je organiziran in deluje tako, da zaščiti objektivnost in nepristranskost svojih dejavnosti.
A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis.
Priglasitveni organ je organiziran tako, da vsako odločitev o priglasitvi organa za ugotavljanje skladnosti sprejmejo pristojne osebe, ki niso tiste, ki so izvedle ugotavljanje skladnosti.
A notifying authority shall safeguard the confidentiality of the information it obtains.
Priglasitveni organ ne sme ponujati ali izvajati dejavnosti, ki jih izvajajo organi za ugotavljanje skladnosti, ali svetovanja na komercialni ali konkurenčni osnovi.
A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Priglasitveni organ zagotovi zaupnost pridobljenih podatkov.
Article 20
Priglasitveni organ ima na voljo zadostno število strokovnega osebja za pravilno izvajanje svojih nalog.
Information obligation on notifying authorities
Člen 20
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
Obveznost obveščanja za priglasitvene organe
The Commission shall make that information publicly available.
Države članice Komisijo obvestijo o svojih postopkih za presojo in priglasitev organov za ugotavljanje skladnosti ter monitoring priglašenih organov ter o vseh spremembah v zvezi s tem.
Article 21
Komisija zagotovi, da so navedene informacije javno dostopne.
Requirements relating to notified bodies
Člen 21
For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.
Zahteve v zvezi s priglašenimi organi
A conformity assessment body shall be established under the national law of a Member State and have legal personality.
Za namene priglasitve organ za ugotavljanje skladnosti izpolnjuje zahteve iz odstavkov 2 do 11.
A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.
Organ za ugotavljanje skladnosti se ustanovi v skladu z nacionalnim pravom države članice in ima pravno osebnost.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
Organ za ugotavljanje skladnosti je organ tretje stranke, neodvisen od organizacije ali proizvoda, ki ga ocenjuje.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the representative of any of those parties.
Organ, ki je del poslovne organizacije ali strokovnih zvez, ki zastopajo podjetja, vključena v oblikovanje, proizvodnjo, dobavo, sestavljanje, uporabo ali vzdrževanje proizvodov, ki jih ocenjujejo, se lahko, pod pogojem, da je zagotovljena njegova samostojnost in da ni navzkrižja interesov, šteje kot tak organ.
This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
Organ za ugotavljanje skladnosti, njegovo najvišje vodstvo in osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, niso niti načrtovalci, proizvajalci, dobavitelji, monterji, kupci, lastniki, uporabniki ali vzdrževalci proizvoda, ki ga ocenjujejo, niti zastopniki katere od teh strani.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities.
To ne izključuje uporabe ocenjenih proizvodov, nujnih za delovanje organa za ugotavljanje skladnosti, ali uporabe takšnih proizvodov v zasebne namene.
They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.
Organ za ugotavljanje skladnosti, njegovo najvišje vodstvo in osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, niso neposredno vključeni pri načrtovanju, proizvodnji ali konstrukciji, trženju, vgraditvi, uporabi ali vzdrževanju teh proizvodov niti ne zastopajo strani, ki sodelujejo pri teh dejavnostih.
This shall in particular apply to consultancy services.
Ne sodelujejo pri nobenih dejavnostih, ki bi lahko nasprotovale njihovi neodvisni presoji in integriteti v zvezi z dejavnostmi ugotavljanja skladnosti, za katere so priglašeni.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
To zlasti velja za svetovalne storitve.
Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.
Organi za ugotavljanje skladnosti zagotovijo, da dejavnosti njihovih hčerinskih družb ali podizvajalcev ne vplivajo na zaupnost, objektivnost ali nepristranskost njihovih dejavnosti ugotavljanja skladnosti.