natgillin/translations-raw huggingface dataset:
Furthermore, where the subsystem or the safety component presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the subsystem or the safety component available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
V kolikor podsistem ali varnostni element predstavlja tveganje, distributerji o tem takoj obvestijo pristojne nacionalne organe držav članic, v katerih so omogočili dostopnost podsistema ali varnostnega elementa na trgu, in jim predložijo podrobne informacije, zlasti o neskladnosti in kakršnih koli sprejetih korektivnih ukrepih.
Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a subsystem or a safety component.
Distributerji na podlagi utemeljene zahteve pristojnega nacionalnega organa navedenemu organu predložijo vse potrebne informacije in dokumentacijo za dokazovanje skladnosti podsistema ali varnostnega elementa.
They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have made available on the market.
Z navedenim organom na njegovo zahtevo sodelujejo pri kateri koli dejavnosti, katere cilj je preprečiti tveganja, ki jih povzročajo podsistemi ali varnostni elementi, za katero so omogočili dostopnost na trgu.
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 11, where he places a subsystem or a safety component on the market under his name or trade mark or modifies a subsystem or a safety component already placed on the market in such a way that compliance with the requirements of this Regulation may be affected.
Uvoznik ali distributer se za namene te uredbe obravnava kot proizvajalec in zanj veljajo obveznosti proizvajalca iz člena 11, kadar da podsistem ali varnostni element na trg pod svojim imenom ali svojo blagovno znamko ali spremeni podsistem ali varnostni element, ki je že bil dan na trg, na način, ki lahko vpliva na izpolnjevanje zahtev iz te uredbe.
Economic operators shall, on request, identify the following to the market surveillance authorities:
Gospodarski subjekti na zahtevo organa za nadzor trga navedejo naslednje:
any economic operator who has supplied them with a subsystem or a safety component;
vsak gospodarski subjekt, ki jim je dobavil podsistem ali varnostni element;
any economic operator and any person responsible for a cableway installation to whom they have supplied a subsystem or a safety component.
vsak gospodarski subjekt in vsako osebo, odgovorno za žičniško napravo, ki so ji dobavili podsistem ali varnostni element.
Economic operators shall be able to present the information referred to in the first paragraph for 30 years after they have been supplied with the subsystem or the safety component and for 30 years after they have supplied the subsystem or the safety component.
Gospodarski subjekti morajo biti zmožni predložiti informacije iz prvega odstavka 30 let po tem, ko jim je bil podsistem ali varnostni element dobavljen, in 30 let po tem, ko so podsistem ali varnostni element dobavili.
CONFORMITY OF SUBSYSTEMS AND SAFETY COMPONENTS
SKLADNOST PODSISTEMOV IN VARNOSTNIH ELEMENTOV
Presumption of conformity of subsystems and safety components
Domneva o skladnosti za podsisteme in varnostne elemente
Subsystems and safety components 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 requirements set out in Annex II covered by those standards or parts thereof.
Za podsisteme in varnostne elemente, ki so v skladu s harmoniziranimi standardi ali deli harmoniziranih standardov, katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije, se domneva, da so skladni z bistvenimi zahtevami iz Priloge II, zajetimi v navedenih standardih ali delih teh standardov.
Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with paragraph 2.
Preden se podsistem ali varnostni element da na trg, ga proizvajalec predloži v postopek ugotavljanja skladnosti v skladu z odstavkom 2.
The conformity of subsystems and safety components shall be assessed, at the choice of the manufacturer, by means of any of the following conformity assessment procedures:
Skladnost podsistemov in varnostnih elementov se po izbiri proizvajalca ugotovi z enim od naslednjih postopkov ugotavljanja skladnosti:
EU-type examination (Module B — production type), set out in Annex III combined with one of the following:
EU-pregled tipa (modul B – tip proizvodnje) iz Priloge III, skupaj z enim od naslednjega:
conformity to type based on quality assurance of the production process (Module D), set out in Annex IV;
skladnostjo s tipom na podlagi zagotavljanja kakovosti proizvodnje (modul D) iz Priloge IV;
conformity to type based on subsystem or safety component verification (Module F), set out in Annex V;
skladnostjo s tipom na podlagi preverjanja podsistema ali varnostnega elementa (modul F) iz Priloge V;
conformity based on unit verification (Module G), set out in Annex VI;
skladnost na podlagi preverjanja enote (modul G) iz Priloge VI;
conformity based on full quality assurance plus design examination (Module H 1), set out in Annex VII.
skladnost na podlagi popolnega zagotavljanja kakovosti in pregleda načrta (modul H 1) iz Priloge VII.
Records and correspondence relating to the conformity assessment procedures shall be drawn up in an official language of the Member State where the notified body carrying out the procedures referred to in paragraph 2 is established or in a language accepted by that body.
Zapisi in korespondenca v zvezi s postopki ugotavljanja skladnosti so v uradnem jeziku države članice, kjer ima sedež priglasitveni organ, ki izvaja postopke iz odstavka 2, ali v jeziku, ki je za ta organ sprejemljiv.
The EU declaration of conformity for a subsystem or a safety component shall state that the fulfilment of the essential requirements set out in Annex II has been demonstrated.
V izjavi EU o skladnosti je za podsistem ali varnostni element navedeno, da je bilo dokazano izpolnjevanje bistvenih zahtev iz Priloge II.
The EU declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes III to VII and shall be continuously updated.
Izjava EU o skladnosti ima vzorčno strukturo, določeno v Prilogi IX, vsebuje elemente, opredeljene v ustreznih modulih iz prilog III do VII, ter se redno posodablja.
It shall accompany the subsystem or the safety component and shall be translated into the language or languages required by the Member State in which the subsystem or the safety component is placed or made available on the market.
Priložena je podsistemu ali varnostnemu elementu in se prevede v jezik ali jezike, ki ga/jih zahteva država članica, v kateri se podsistem ali varnostni element da na trg ali je omogočena njegova dostopnost na trgu.
Where a subsystem or a safety component 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.
Kadar se za podsistem ali varnostni element uporablja več kot en akt Unije, ki zahteva izjavo EU o skladnosti, se pripravi enotna izjava EU o skladnosti v zvezi z vsemi takimi akti Unije.
That declaration shall contain the identification of the Union acts concerned, including their publication references.
Navedena izjava vsebuje opredelitev zadevnih aktov Unije, vključno z navedbo njihove objave.
By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the subsystem or the safety component with the requirements laid down in this Regulation.
Proizvajalec s pripravo izjave EU o skladnosti prevzame odgovornost za to, da podsistem ali varnostni element izpolnjuje zahteve iz te uredbe.
The CE marking shall be affixed visibly, legibly and indelibly to the subsystem or the safety component or to its data plate.
Oznaka CE je vidno, čitljivo in neizbrisno nameščena na podsistem ali varnostni element ali njegovo tablico s podatki.
Where that is not possible or not warranted on account of the nature of the subsystem or the safety component, it shall be affixed to the packaging and to the accompanying documents.
Kadar to zaradi značilnosti podsistema ali varnostnega elementa ni mogoče ali upravičeno, se oznaka CE namesti na embalažo in spremne dokumente.
The CE marking shall be affixed before the subsystem or the safety component is placed on the market.
Oznaka CE se namesti, preden je podsistem ali varnostni element 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.
Identifikacijsko številko priglašenega organa namesti organ sam ali pa jo po njegovih navodilih namesti proizvajalec ali njegov pooblaščeni zastopnik.
The CE marking and the identification number referred to in paragraph 3 may be followed by any other mark indicating a special risk or use.
Oznaki CE in identifikacijski številki iz odstavka 3 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.
Države članice nadalje razvijajo obstoječe mehanizme, da zagotovijo pravilno uporabo sistema, ki ureja oznako CE, in v primeru nepravilne rabe te oznake sprejmejo ustrezne ukrepe.
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.
Države članice obvestijo Komisijo in druge države članice o organih, ki so na podlagi te uredbe pooblaščeni za opravljanje nalog ugotavljanja skladnosti tretjih strani.
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 Article 28.
Države članice imenujejo priglasitveni organ, ki je pristojen za uvedbo in izvajanje potrebnih postopkov za ocenjevanje in priglasitev organov za ugotavljanje skladnosti ter spremljanje priglašenih organov, vključno s skladnostjo s členom 28.
Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Države članice lahko določijo, da ocenjevanje in spremljanje iz odstavka 1 izvaja nacionalni akreditacijski organ v smislu Uredbe (ES) št. 765/2008 in v skladu z njo.
Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article 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 24.
Kadar priglasitveni organ izda pooblastilo ali drugače zaupa ocenjevanje, priglasitev ali spremljanje iz odstavka 1 tega člena organu, ki ni vladni subjekt, je ta subjekt pravna oseba in smiselno izpolnjuje zahteve iz člena 24.
In addition, it shall have arrangements to cover liabilities arising out of its activities.
Poleg tega ima takšen organ ureditev, s katero krije obveznosti, ki izhajajo iz njegovih dejavnosti.
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 tako, da vsako odločitev o priglasitvi organa za ugotavljanje skladnosti sprejmejo pristojne osebe, ki niso tiste, ki so izvedle ocenjevanje.
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 ne ponuja ali izvaja dejavnosti, ki jih izvajajo organi za ugotavljanje skladnosti, ali svetovanja na komercialni ali konkurenčni osnovi.
Information obligation on notifying authorities
Obveznost obveščanja o priglasitvenih organih
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.
Države članice obvestijo Komisijo o svojih postopkih za ocenjevanje in priglasitev organov za ugotavljanje skladnosti in spremljanje priglašenih organov ter kakršnih koli spremembah v zvezi s tem.
A conformity assessment body shall be established under the national law of a Member State and have legal personality.
Organ za ugotavljanje skladnosti je ustanovljen v skladu z nacionalnim pravom države članice in je pravna oseba.
A conformity assessment body shall be a third-party body independent of the organisation or the subsystem or the safety component it assesses.
Organ za ugotavljanje skladnosti je organ tretje stranke, neodvisen od organizacije ali podsistema ali varnostnega elementa, ki ga ocenjuje.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of subsystems or safety components which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
Organ, ki je del poslovnega združenja ali strokovne zveze, ki zastopajo podjetja, vključena v načrtovanje, izdelavo, montažo, sestavljanje, uporabo ali vzdrževanje podsistemov ali varnostnih elementov, ki jih ocenjujejo, se lahko, pod pogojem, da je zagotovljena njegova samostojnost in da ni nasprotja interesov, šteje kot takšen organ.
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 subsystems or the safety components which they assess, nor the representative of any of those parties.
Organ za ugotavljanje skladnosti, njegovo najvišje vodstvo in osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, niso načrtovalci, proizvajalci, dobavitelji, monterji, kupci, lastniki, uporabniki ali vzdrževalci podsistemov ali varnostnih elementov, katerih skladnost ocenjujejo, niti zastopniki katerega koli izmed navedenih subjektov.
This shall not preclude the use of assessed subsystems or safety components that are necessary for the operations of the conformity assessment body or the use of such subsystems or safety components for personal purposes.
To ne izključuje uporabe ocenjenih podsistemov ali varnostnih elementov, nujnih za postopke organa za ugotavljanje skladnosti, ali uporabe takih podsistemov ali varnostnih elementov v zasebne namene.
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, marketing, installation, use or maintenance of those subsystems or safety components, or represent the parties engaged in those activities.
Organ za ugotavljanje skladnosti, njegovo najvišje vodstvo in osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, ne smejo neposredno sodelovati pri načrtovanju, izdelavi ali izgradnji, trženju, namestitvi, uporabi ali vzdrževanju teh podsistemov ali varnostnih elementov niti zastopati strank, ki sodelujejo pri teh dejavnostih.
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.
Ne sodelujejo pri nobenih dejavnostih, ki bi lahko bile v nasprotju z njihovo neodvisno presojo ali integriteto v zvezi z dejavnostmi ugotavljanja skladnosti, za katere so priglašeni.
A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
Organ za ugotavljanje skladnosti je zmožen izvajati vse naloge ugotavljanja skladnosti, ki so takšnemu organu dodeljene v prilogah III do VII in za katere je bil priglašen, bodisi da navedene naloge izvede sam bodisi da so izvedene v njegovem imenu in v okviru njegove odgovornosti.
At all times, and for each conformity assessment procedure and each kind or category of subsystems or safety components in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
Organ za ugotavljanje skladnosti ima vedno in za vsak postopek ugotavljanja skladnosti ter za vsako vrsto ali kategorijo podsistema ali varnostnega elementa, za katerega je priglašen, na razpolago:
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the subsystem or safety component technology in question and the mass or serial nature of the production process.
postopke za izvajanje dejavnosti, ki ustrezno upoštevajo velikost podjetja, sektor, v katerem deluje, in njegovo strukturo, stopnjo zahtevnosti tehnologije zadevnega podsistema ali varnostnega elementa ter masovno ali serijsko naravo proizvodnega postopka.
The personnel responsible for carrying out conformity assessment tasks shall have the following:
Osebje, odgovorno za izvajanje dejavnosti ugotavljanja skladnosti, ima:
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
dobro tehnično in poklicno usposobljenost, ki zajema vse dejavnosti ugotavljanja skladnosti, za katere je bil organ za ugotavljanje skladnosti priglašen;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
zadovoljivo znanje o zahtevah glede ocenjevanj, ki jih izvaja, in ustrezna pooblastila za izvedbo teh ocenjevanj;
appropriate knowledge and understanding of the essential requirements set out in Annex II, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation;
primerno znanje in razumevanje bistvenih zahtev iz Priloge II, veljavnih harmoniziranih standardov ter ustreznih določb harmonizacijske zakonodaje Unije in nacionalne zakonodaje;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
sposobnost, ki je potrebna za pripravo certifikatov, zapisov in poročil, ki dokazujejo, da so bila ocenjevanja izvedena.
The impartiality of the conformity assessment bodies, their top-level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.
Zagotovljena je nepristranskost organa za ugotavljanje skladnosti, njegovega najvišjega vodstva in osebja, odgovornega za izvajanje nalog ugotavljanja skladnosti.
The remuneration of the top-level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out, nor on the results of those assessments.
Plačilo najvišjega vodstva in osebja, odgovornega za izvajanje nalog ugotavljanja skladnosti organa za ugotavljanje skladnosti, ni odvisno od števila izvedenih ocenjevanj ali rezultatov navedenih ocenjevanj.
The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out.
Osebje organa za ugotavljanje skladnosti je zavezano k poklicni molčečnosti v zvezi z vsemi informacijami, pridobljenimi med izvajanjem nalog v skladu s prilogami III do VII ali katero koli izvedbeno določbo nacionalne zakonodaje, razen pred pristojnimi organi države članice, v kateri izvaja svoje dejavnosti.
Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Organi za ugotavljanje skladnosti sodelujejo pri ustreznih dejavnostih standardizacije in dejavnostih skupine za usklajevanje priglašenega organa, ustanovljene v skladu s to uredbo, ali zagotovijo, da je njihovo osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, obveščeno o teh dejavnostih, upravne odločbe in dokumente, ki izhajajo iz rezultatov dela navedene skupine, pa uporabljajo kot splošne smernice.
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements.
Kadar organ za ugotavljanje skladnosti dokaže skladnost z merili, določenimi v ustreznih harmoniziranih standardih ali njihovih delih, katerih sklicevanja so bila objavljena v Uradnem listu Evropske unije, se domneva, da izpolnjuje zahteve iz člena 26, če veljavni harmonizirani standardi zajemajo navedene zahteve.
Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 26 and shall inform the notifying authority accordingly.
Kadar priglašeni organ za določene naloge, povezane z ugotavljanjem skladnosti, sklene pogodbo s podizvajalci ali jih prenese na odvisno družbo, zagotovi, da podizvajalec ali odvisna družba izpolnjuje zahteve iz člena 26 ter o tem ustrezno obvesti priglasitveni organ.
Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
Priglašeni organi za ugotavljanje skladnosti prevzamejo celotno odgovornost za naloge, ki jih izvajajo podizvajalci ali odvisne družbe ne glede na sedež podjetja.
Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII.
Priglašeni organi omogočajo priglasitvenim organom dostop do zadevnih dokumentov v zvezi z ocenjevanjem kvalifikacij podizvajalca ali odvisne družbe ter delom, ki ga opravijo v skladu s prilogami III do VII.