natgillin/translations-raw huggingface dataset:
Category I: internal production control (module A) set out in Annex IV;
kategorija I: notranji nadzor proizvodnje (modul A) iz Priloge IV;
Category II: EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;
kategorija II: EU-pregled tipa (modul B) iz Priloge V, ki mu sledi skladnost s tipom na podlagi notranjega nadzora proizvodnje (modul C) iz Priloge VI;
Category III: EU type-examination (module B) set out in Annex V, and either of the following:
kategorija III: EU-pregled tipa (modul B) iz Priloge V in kar koli od naslednjega:
conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;
skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovanih preskusov proizvodov v naključno izbranih časovnih presledkih (modul C2) iz Priloge VII;
conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.
skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnega procesa (modul D) iz Priloge VIII.
By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.
Z odstopanjem se lahko za osebno varovalno opremo, proizvedeno kot samostojna enota, ki je namenjena posameznemu uporabniku in razvrščena glede na kategorijo III, uporabi postopek iz točke (b).
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 Komisijo in druge države članice obvestijo o organih, pooblaščenih za ugotavljanje skladnosti tretjih oseb v okviru te uredbe.
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 26.
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 26.
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 in v skladu z Uredbo (ES) št. 765/2008.
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 22.
Kadar priglasitveni organ izda pooblastilo ali drugače zaupa ocenjevanje, priglasitev ali spremljanje iz odstavka 1 tega člena organu, ki ni vladni organ, je ta organ pravni subjekt in smiselno izpolnjuje zahteve iz člena 22.
In addition, that body 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.
The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Priglasitveni organ prevzame polno odgovornost za naloge, ki jih izvaja organ iz odstavka 3.
Information obligation on notifying authorities
Obveznosti 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 kakršne koli spremembe teh informacij.
For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.
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 PPE it assesses.
Organ za ugotavljanje skladnosti je organ tretje stranke, neodvisen od organizacije ali osebne varovalne opreme, ki jo ocenjuje.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of PPE 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 zastopa podjetja, vključena v načrtovanje, proizvodnjo, dobavo, sestavljanje, uporabo ali vzdrževanje osebne varovalne opreme, ki jo ocenjuje, se lahko šteje kot takšen organ, če je zagotovljena njegova samostojnost in ni nasprotja interesov.
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, purchaser, owner, user or maintainer of the PPE 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, kupci, lastniki, uporabniki ali vzdrževalci osebne varovalne opreme, ki jo ocenjujejo, ali zastopniki katere koli od navedenih strani.
This does not preclude the use of assessed PPE that are necessary for the operations of the conformity assessment body or the use of such PPE for personal purposes.
To ne izključuje uporabe ocenjene osebne varovalne opreme, potrebne za postopke organa za ugotavljanje skladnosti, ali uporabe takšne osebne varovalne opreme 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, marketing, use or maintenance of PPE, or represent the parties engaged in those activities.
Organ za ugotavljanje skladnosti, njegovo najvišje vodstvo in osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, ne sodelujejo neposredno pri načrtovanju, proizvodnji, trženju, uporabi ali vzdrževanju osebne varovalne opreme niti ne zastopajo strank, ki sodelujejo pri teh dejavnostih.
A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes V, VII and VIII 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 V, VII in VIII 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 of PPE for 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 vsako vrsto osebne varovalne opreme, za katero je priglašen, na razpolago:
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures.
opise postopkov, v skladu s katerimi se izvaja ugotavljanje skladnosti, ki zagotavljajo preglednost in zmožnost reprodukcije teh postopkov.
It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
Imeti mora ustrezno politiko in postopke, ki razlikujejo med nalogami, ki jih izvaja kot priglašeni organ, in drugimi dejavnostmi;
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 PPE 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 zadevne osebne varovalne opreme ter masovno ali serijsko naravo proizvodnega postopka.
appropriate knowledge and understanding of the essential health and safety 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 zdravstvenih in varnostnih 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 za pripravo certifikatov, zapisov in poročil, ki dokazujejo, da je bilo ocenjevanje izvedeno.
Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
Organi za ugotavljanje skladnosti sklenejo zavarovanje odgovornosti, razen če odgovornost prevzame država članica v skladu z nacionalnim pravom ali če je država članica sama neposredno odgovorna za ugotavljanje skladnosti.
The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes V, VII and VIII 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 svojih nalog v skladu s prilogami V, VII in VIII ali katero koli določbo nacionalnega prava, ki to zakonodajo uveljavlja, 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 Article 36 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 členom 36, 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 24 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 24, 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 24 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 24, ter o tem ustrezno obvesti priglasitveni organ.
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 V, VII and VIII.
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 V, VII in VIII.
The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the kinds of PPE for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 24.
Vlogi za priglasitev je priložen opis dejavnosti ugotavljanja skladnosti, modul ali moduli za ugotavljanje skladnosti in vrste osebne varovalne opreme, za katere navedeni organ trdi, da je pristojen, ter akreditacijska listina, če obstaja, ki jo izda nacionalni akreditacijski organ, ki potrjuje, da organ za ugotavljanje skladnosti izpolnjuje zahteve iz člena 24.
Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 24.
Kadar zadevni organ za ugotavljanje skladnosti ne more predložiti akreditacijske listine, priglasitvenemu organu predloži vso dokumentacijo, potrebno za preverjanje, priznavanje in redno spremljanje njegove skladnosti z zahtevami iz člena 24.
Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 24.
Priglasitveni organi lahko priglasijo samo tiste organe za ugotavljanje skladnosti, ki izpolnjujejo zahteve iz člena 24.
The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the kinds of PPE concerned and the relevant attestation of competence.
Priglasitev vključuje vse podrobnosti o dejavnostih ugotavljanja skladnosti, modul ali module za ugotavljanje skladnosti in zadevne vrste osebne varovalne opreme ter ustrezno potrdilo o usposobljenosti.
Where a notification is not based on an accreditation certificate referred to in Article 27(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 24.
Kadar priglasitev ne temelji na akreditacijski listini iz člena 27(2), priglasitveni organ Komisiji in drugim državam članicam predloži dokumentacijo, ki potrjuje usposobljenost organa za ugotavljanje skladnosti in uvedene ukrepe, s čimer se zagotovi, da bo organ pod rednim nadzorom in da bo še naprej izpolnjeval zahteve iz člena 24.
The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Zadevni organ lahko izvaja dejavnosti priglašenega organa le, kadar Komisija in druge države članice ne vložijo ugovora v dveh tednih od priglasitve v primeru uporabe akreditacijske listine in v dveh mesecih od priglasitve, kadar ni uporabljena akreditacija.
Only such a body shall be considered a notified body for the purposes of this Regulation.
Samo tak organ se šteje za priglašeni organ za namene te uredbe.
Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 24, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.
Kadar priglasitveni organ ugotovi ali je obveščen, da priglašeni organ ne izpolnjuje več zahtev iz člena 24 ali da ne more izpolniti svojih obveznosti, po potrebi omeji, začasno prekliče ali umakne priglasitev v skladu z resnostjo neizpolnjevanja navedenih zahtev ali nespoštovanja navedenih obveznosti.
In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
V primeru omejitve, začasnega preklica ali umika priglasitve ali kadar je priglašeni organ prenehal z dejavnostjo, priglasitvena država članica sprejme ustrezne ukrepe za zagotovitev, da gradiva in dokumente tega organa bodisi obdela drug priglašeni organ bodisi da so na zahtevo na voljo priglasitvenim organom in organom za nadzor trga.
Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including the withdrawal of the notification if necessary.
Kadar Komisija ugotovi, da priglašeni organ ne izpolnjuje ali več ne izpolnjuje zahtev za priglasitev, sprejme izvedbeni akt, s katerim od priglasitvene države članice zahteva, da sprejme potrebne korektivne ukrepe, po potrebi vključno z umikom priglasitve.
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2).
Ta izvedbeni akt se sprejme v skladu s svetovalnim postopkom iz člena 44(2).
Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes V, VII and VIII.
Priglašeni organi izvajajo ugotavljanje skladnosti v skladu s postopki ugotavljanja skladnosti iz prilog V, VII in VIII.
Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the PPE technology in question and the mass or serial nature of the production process.
Organi za ugotavljanje skladnosti pri izvajanju svojih postopkov upoštevajo velikost podjetja, sektor, v katerem deluje, in njegovo strukturo, stopnjo zahtevnosti zadevne tehnologije osebne varovalne opreme ter masovno ali serijsko naravo proizvodnega postopka.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the PPE with the requirements of this Regulation.
Pri tem v vsakem primeru spoštujejo stopnjo strogosti in zaščite, potrebno za to, da osebna varovalna oprema izpolnjuje zahteve iz te uredbe.
Where a notified body finds that the essential health and safety requirements set out in Annex II or the corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.
Kadar priglašeni organ ugotovi, da proizvajalec ne izpolnjuje bistvenih zdravstvenih in varnostnih zahtev iz Priloge II ali ustreznih harmoniziranih standardov ali drugih tehničnih specifikacij, od navedenega proizvajalca zahteva, da sprejme ustrezne korektivne ukrepe, in ne izda certifikata oziroma odločitve o odobritvi.
Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, a notified body finds that a PPE no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary.
Kadar priglašeni organ med spremljanjem skladnosti po izdaji certifikata oziroma odločitve o odobritvi ugotovi, da osebna varovalna oprema ni več skladna, od proizvajalca zahteva, da sprejme ustrezne korektivne ukrepe, in po potrebi začasno prekliče ali umakne certifikat oziroma odločitev o odobritvi.
Notified bodies shall ensure that a transparent and accessible appeal procedure against their decisions is available.
Priglašeni organi zagotovijo, da je na voljo pregleden in dostopen pritožbeni postopek zoper njihove odločitve.
any circumstances affecting the scope of or conditions for notification;
vseh okoliščinah, ki vplivajo na področje uporabe priglasitve ali pogoje zanjo;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
vsaki zahtevi po informacijah v zvezi z dejavnostmi ugotavljanja skladnosti, ki so jo prejeli od organov za nadzor trga;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
na zahtevo priglasitvenega organa, o dejavnostih ugotavljanja skladnosti, izvedenih v okviru njihove priglasitve in o kakršnih koli drugih izvedenih dejavnostih, vključno s čezmejnimi dejavnostmi in sklepanjem pogodb s podizvajalci.
Notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same kinds of PPE with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Priglašeni organi drugim organom, ki so priglašeni v okviru te uredbe ter izvajajo podobne dejavnosti ugotavljanja skladnosti in zajemajo enake vrste osebne varovalne opreme, zagotavljajo zadevne informacije o vprašanjih v zvezi z negativnimi in na zahtevo pozitivnimi rezultati ugotavljanja skladnosti.
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
Komisija zagotovi ustrezno usklajevanje in sodelovanje med organi, priglašenimi na podlagi te uredbe, ter pravilno delovanje v obliki sektorske skupine priglašenih organov.
UNION MARKET SURVEILLANCE, CONTROL OF PPE ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
NADZOR TRGA UNIJE, NADZOR OSEBNE VAROVALNE OPREME, KI VSTOPA NA TRG UNIJE, IN ZAŠČITNI POSTOPEK UNIJE
Union market surveillance and control of PPE entering the Union market
Nadzor trga Unije in nadzor osebne varovalne opreme, ki vstopa na trg Unije
Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to PPE covered by Article 2(1) of this Regulation.
Za osebno varovalno opremo, ki je zajeta v členu 2(1) te uredbe, se uporabljajo člen 15(3) in členi 16 do 29 Uredbe (ES) št. 765/2008.
Procedure at national level for dealing with PPE presenting a risk
Postopek na nacionalni ravni za obravnavo osebne varovalne opreme, ki predstavlja tveganje