natgillin/translations-raw huggingface dataset:
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, če so navedene v pooblastilu.
EU TYPE-EXAMINATION
EU-PREGLED TIPA
(Module B)
(modul B)
EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of this Regulation that apply to it.
EU-pregled tipa je tisti del postopka ugotavljanja skladnosti, pri katerem priglašeni organ pregleda tehnično načrtovanje osebne varovalne opreme ter preveri in potrdi, da tehnično načrtovanje osebne varovalne opreme izpolnjuje zahteve iz te uredbe, ki veljajo zanjo.
EU type-examination shall be carried out by assessment of the adequacy of the technical design of the PPE through examination of the technical documentation, plus examination of a specimen, representative of the production envisaged, of the complete PPE (production type).
EU-pregled tipa se izvaja z oceno ustreznosti tehničnega načrtovanja osebne varovalne opreme s pregledom tehnične dokumentacije in s pregledom vzorca, reprezentativnega za predvideno proizvodnjo celotne osebne varovalne opreme (tip proizvodnje).
Application for EU type-examination
Zahtevek za EU-pregled tipa
The manufacturer shall lodge an application for EU type-examination with a single notified body of his choice.
Proizvajalec vloži zahtevek za EU-pregled tipa pri priglašenem organu, ki ga izbere sam.
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 ter, če je zahtevek vložil pooblaščeni zastopnik, tudi njegovo ime in naslov;
the technical documentation described in Annex III;
tehnično dokumentacijo, opisano v Prilogi III;
the specimen(s) of the PPE representative of the production envisaged.
vzorec osebne varovalne opreme, reprezentativen za predvideno proizvodnjo.
The notified body may request further specimens if needed for carrying out the test programme.
Priglašeni organ lahko zahteva nadaljnje vzorce, če je to potrebno za izvedbo programa preskušanja.
For PPE produced in series where each item is adapted to fit an individual user, specimens shall be provided that are representative of the range of different users, and for PPE produced as a single unit to accommodate the special needs of an individual user, a basic model shall be provided.
Za osebno varovalno opremo, proizvedeno v serijah, pri čemer je vsak kos prilagojen posameznemu uporabniku, se predložijo vzorci, ki so reprezentativni za celo vrsto različnih uporabnikov, medtem ko se za osebno varovalno opremo, proizvedeno kot samostojna enota, ki je namenjena posebnim potrebam posameznih uporabnikov, predloži osnovni model.
EU type-examination
EU-pregled tipa
examine the technical documentation to assess the adequacy of the technical design of the PPE.
pregleda tehnično dokumentacijo, da oceni ustreznost tehničnega načrta osebne varovalne opreme.
In conducting such an examination, point (j) of Annex III need not be taken into account;
Pri takem pregledu mu ni treba upoštevati točke (j) Priloge III;
for PPE produced in series where each item is adapted to fit an individual user, examine the description of the measures to assess their adequacy;
za osebno varovalno opremo, proizvedeno v serijah, pri čemer je vsak kos prilagojen posameznemu uporabniku, pregleda opis ukrepov, da oceni njihovo ustreznost;
for PPE produced as a single unit to fit an individual user, examine the instructions for manufacturing such PPE on the basis of the approved basic model to assess their adequacy;
za osebno varovalno opremo, proizvedeno kot samostojna enota, namenjena posameznemu uporabniku, pregleda navodila za izdelavo takšne osebne varovalne opreme na podlagi odobrenega osnovnega modela, da oceni njihovo ustreznost;
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the elements which have been designed in accordance with other technical specifications;
preveri, ali je bil vzorec izdelan v skladu s tehnično dokumentacijo, ter določi elemente, ki so bili načrtovani v skladu z veljavnimi določbami ustreznih harmoniziranih standardov, in elemente, ki so bili načrtovani v skladu z drugimi ustreznimi tehničnimi specifikacijami;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential health and safety requirements and have been applied correctly.
izvede ali naroči ustrezne preglede in preskuse, da bi, če rešitve iz ustreznih harmoniziranih standardov niso bile uporabljene, preveril, ali rešitve, ki jih je sprejel proizvajalec, vključno s tistimi iz drugih uporabljenih tehničnih specifikacij, izpolnjujejo ustrezne bistvene zdravstvene in varnostne zahteve in ali so bile uporabljene pravilno.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes.
Priglašeni organ pripravi poročilo o oceni, ki navaja ukrepe, sprejete v skladu s točko 4, in njihove rezultate.
EU type-examination certificate
Certifikat o EU-pregledu tipa
Where the type meets the applicable essential health and safety requirements, the notified body shall issue an EU type-examination certificate to the manufacturer.
Kadar tip izpolnjuje veljavne bistvene zdravstvene in varnostne zahteve, priglašeni organ proizvajalcu izda certifikat o EU-pregledu tipa.
The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate shall not exceed five years.
Novo izdani certifikat in, kjer je to ustrezno, podaljšani certifikat veljata največ pet let.
The EU type-examination certificate shall contain at least the following information:
Certifikat o EU-pregledu tipa vsebuje vsaj naslednje informacije:
the name and identification number of the notified body;
ime in identifikacijsko številko priglašenega organa;
the name and address of the manufacturer and, if the application is lodged by the authorised representative, the latter's name and address;
ime in naslov proizvajalca ter, če je zahtevek vložil pooblaščeni zastopnik, ime in naslov pooblaščenega zastopnika;
identification of the PPE covered by the certificate (type number);
opredelitev osebne varovalne opreme, ki jo certifikat zajema (številka tipa);
a statement that the PPE type complies with the applicable essential health and safety requirements;
izjavo, da je tip osebne varovalne opreme skladen z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami;
where harmonised standards have been fully or partially applied, the references of those standards or parts thereof;
kadar so bili harmonizirani standardi uporabljeni v celoti ali delno, sklice na navedene standarde ali njihove dele;
where other technical specifications have been applied, their references;
kadar so bile uporabljene druge tehnične specifikacije, sklice na njih;
where applicable, the performance level(s) or protection class of the PPE;
po potrebi raven učinkovitost ali razred zaščite osebne varovalne opreme;
for PPE produced as a single unit to fit an individual user, the range of permissible variations of relevant parameters based on the approved basic model;
za osebno varovalno opremo, proizvedeno kot samostojna enota, namenjena posameznemu uporabniku, območje dopustnih sprememb ustreznih parametrov na podlagi odobrenega osnovnega modela;
the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;
datum izdaje, datum izteka veljavnosti in po potrebi datume podaljšanja;
any conditions attached to the issue of the certificate;
vse pogoje, povezane z izdajo certifikata;
for category III PPE, a statement that the certificate shall only be used in conjunction with one of the conformity assessment procedures referred to in point (c) of Article 19.
za kategorijo III osebne varovalne opreme izjavo, da se certifikat uporablja le v povezavi z enim od postopkov za ugotavljanje skladnosti iz točke (c) člena 19.
The EU type-examination certificate may have one or more annexes attached.
Certifikatu o EU-pregledu tipa je lahko priložena ena ali več prilog.
Where the type does not satisfy the applicable essential health and safety requirements, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če tip ne izpolnjuje veljavnih bistvenih zdravstvenih in varnostnih zahtev, priglašeni organ zavrne izdajo certifikata o EU-pregledu tipa in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
Review of the EU type-examination certificate
Pregled certifikata o EU-pregledu tipa
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable essential health and safety requirements, and shall determine whether such changes require further investigation.
Priglašeni organ spremlja kakršne koli spremembe splošno sprejetih najnovejših tehničnih dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih bistvenih zdravstvenih in varnostnih zahtev, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type-examination certificate of all modifications to the approved type and of all modifications of the technical documentation that may affect the conformity of the PPE with the applicable essential health and safety requirements or the conditions for validity of that certificate.
Proizvajalec obvesti priglašeni organ, ki hrani tehnično dokumentacijo v zvezi s certifikatom o EU-pregledu tipa, o kakršnih koli spremembah odobrenega tipa in o kakršnih koli spremembah tehnične dokumentacije, ki bi lahko vplivale na skladnost osebne varovalne opreme z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami ali s pogoji veljavnosti certifikata.
Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.
Take spremembe zahtevajo dodatno odobritev v obliki dodatka k izvirnemu certifikatu o EU-pregledu tipa.
The manufacturer shall ensure that the PPE continues to fulfil the applicable essential health and safety requirements in light of the state of the art.
Proizvajalec zagotovi, da osebna varovalna oprema še naprej izpolnjuje veljavne bistvene zdravstvene in varnostne zahteve glede na najnovejše stanje na področju tehnološkega razvoja.
The manufacturer shall ask the notified body to review the EU type-examination certificate either:
Proizvajalec priglašeni organ zaprosi za pregled certifikata o EU-pregledu tipa v enem od naslednjih primerov:
in the case of a modification to the approved type referred to in point 7.2;
v primeru spremembe odobrenega tipa iz točke 7.2;
in the case of a change in the state of the art referred to in point 7.3;
v primeru spremembe stanja na področju tehnološkega razvoja iz točke 7.3;
at the latest, before the date of expiry of the certificate.
najpozneje pred datumom izteka veljavnosti certifikata.
In order to allow the notified body to fulfil its tasks, the manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate.
Da bi lahko priglašeni organ izpolnil svoje naloge, proizvajalec predloži vlogo nič prej kot dvanajst mesecev in nič pozneje kot šest mesecev pred datumom izteka veljavnosti certifikata o EU-pregledu tipa.
The notified body shall examine the PPE type and, where necessary in the light of the changes made, carry out the relevant tests to ensure that the approved type continues to fulfil the applicable essential health and safety requirements.
Priglašeni organ pregleda tip osebne varovalne opreme in, kadar je potrebno glede na opravljene spremembe, izvede ustrezne preskuse za zagotovitev, da odobreni tip še naprej izpolnjuje veljavne bistvene zdravstvene in varnostne zahteve.
If the notified body is satisfied that the approved type continues to fulfil the applicable health and safety requirements, it shall renew the EU type-examination certificate.
Če priglašeni organ ugotovi, da odobreni tip še naprej izpolnjuje veljavne zdravstvene in varnostne zahteve, certifikat o EU-pregledu tipa podaljša.
The notified body shall ensure that the review procedure is finalised before the expiry date of the EU type-examination certificate.
Priglašeni organ zagotovi, da je postopek pregleda opravljen pred datumom izteka veljavnosti certifikata o EU-pregledu tipa.
Where the conditions referred to in points (a) and (b) of point 7.4 are not met, a simplified review procedure shall apply.
Kadar pogoja iz točk (a) in (b) točke 7.4 nista izpolnjena, se uporabi poenostavljeni postopek pregleda.
The manufacturer shall supply the notified body with the following:
Proizvajalec priglašenemu organu predloži naslednje:
his name and address and data identifying the EU type-examination certificate concerned;
svoje ime in naslov ter podatke za identifikacijo zadevnega certifikata o EU-pregledu tipa;
confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant harmonised standards or other technical specifications applied;
certifikat iz točke 7.2, da odobreni tip, vključno z materiali, podkomponentami ali podsestavi, pa tudi uporabljeni ustrezni harmonizirani standardi ali tehnične specifikacije niso bili spremenjeni;
confirmation that there has been no change in the state of the art as referred to in point 7.3;
certifikat, da ni bilo nobene spremembe stanja na področju tehnološkega razvoja iz točke 7.3;
where not already supplied, copies of current product drawings and photographs, product marking and information supplied by the manufacturer; and
izvode skic in fotografij sedanjih proizvodov, oznake proizvodov in informacije, ki jih zagotovi proizvajalec, kadar vse to priglašenemu organu še ni bilo predloženo, in
for category III products, where not already available to the notified body, information on the results of the supervised product checks at random intervals carried out in accordance with Annex VII, or on the results of audits of his quality system carried out in accordance with Annex VIII.
za proizvode iz kategorije III, če priglašeni organ še nima teh informacij, informacije o rezultatih nadzorovanih preskusov proizvodov v naključno izbranih časovnih presledkih, izvedenih v skladu s Prilogo VII, ali o rezultatih pregledov svojega sistema kakovosti, opravljenih v skladu s Prilogo VIII.
Where the notified body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out.
Kadar priglašeni organ potrdi, da ni prišlo do nobene spremembe odobrenega tipa iz točke 7.2 ter do nobene spremembe stanja na področju tehnološkega razvoja iz točke 7.3, se uporabi poenostavljeni postopek pregleda, pregledi in preskusi iz točke 7.5 se ne izvedejo.
In such cases, the notified body shall renew the EU type-examination certificate.
V takih primerih priglašeni organ podaljša certifikat o EU-pregledu tipa.
The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure.
Stroški, povezani z navedenim podaljšanjem, so sorazmerni z upravnim bremenom poenostavljenega postopka.
If the notified body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply.
Če priglašeni organ ugotovi, da je prišlo do spremembe stanja na področju tehnološkega razvoja iz točke 7.3, se uporabi postopek iz točke 7.5.
If, following the review, the notified body concludes that the EU type-examination certificate is no longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the market of the PPE concerned.
Če po pregledu priglašeni organ ugotovi, da certifikat o EU-pregledu tipa ni več veljaven, ta organ certifikat umakne, proizvajalec pa preneha dajati na trg zadevno osebno varovalno opremo.
Each notified body shall inform its notifying authority concerning the EU type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti svoje priglasitvene organe o certifikatih o EU-pregledu tipa in/ali katerih koli njihovih dodatkih, ki jih je izdal ali umaknil, ter redno ali na zahtevo da na voljo priglasitvenim organom seznam zavrnjenih, začasno preklicanih ali drugače omejenih takih certifikatov in/ali kakršnih koli dodatkov.
Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o zavrnjenih, umaknjenih, začasno preklicanih ali drugače omejenih certifikatih o EU-pregledu tipa in/ali kakršnih koli dodatkih ter jih na zahtevo obvesti o izdanih takih certifikatih in/ali dodatkih.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination certificates and/or additions thereto.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvod certifikatov o EU-pregledu tipa in/ali njihovih dodatkov.
On a reasoned request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.
Komisija in države članice lahko na utemeljeno zahtevo dobijo izvod tehnične dokumentacije in rezultatov pregledov, ki jih je izvedel priglašeni organ.
The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.
Priglašeni organ hrani izvod certifikata o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnične dokumentacije, vključno z dokumentacijo, ki jo je predložil proizvajalec, še pet let po izteku veljavnosti navedenega certifikata.
The manufacturer shall keep a copy of the EU type-examination certificate, its annexes and additions, together with the technical documentation at the disposal of the national authorities, for 10 years after the PPE has been placed on the market.
Proizvajalec še deset let po tem, ko je bila osebna varovalna oprema dana na trg, omogoča nacionalnim organom dostop do izvoda certifikata o EU-pregledu tipa, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo.
The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7.2, 7.4 and 9, provided that they are specified in the mandate.
Pooblaščeni zastopnik proizvajalca lahko vloži zahtevek iz točke 3 ter izpolni obveznosti iz točk 7.2, 7.4 in 9, če so navedene v pooblastilu.
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
SKLADNOST S TIPOM NA PODLAGI NOTRANJEGA NADZORA PROIZVODNJE
Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares under his sole responsibility that the PPE concerned is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje je del postopka ugotavljanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2 in 3 ter na lastno odgovornost zagotovi in izjavi, da je zadevna osebna varovalna oprema v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjuje veljavne zahteve iz te uredbe.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured PPE with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation.
Proizvajalec sprejme vse potrebne ukrepe, da se s proizvodnim procesom in njegovim spremljanjem zagotovi skladnost proizvedene osebne varovalne opreme s tipom, opisanim v certifikatu o EU-pregledu tipa, in veljavnimi zahtevami iz te uredbe.
The manufacturer shall affix the CE marking to each individual PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Proizvajalec oznako CE namesti na vsako posamezno osebno varovalno opremo, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te uredbe.
The manufacturer shall draw up a written EU declaration of conformity for a PPE model and keep it at the disposal of the national authorities for 10 years after the PPE has been placed on the market.
Proizvajalec za vsak model osebne varovalne opreme sestavi pisno izjavo EU o skladnosti in še deset let po tem, ko je bila oprema dana na trg, nacionalnim organom omogoča dostop do nje.
The manufacturer's obligations set out in point 3 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 3 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS
SKLADNOST S TIPOM NA PODLAGI NOTRANJEGA NADZORA PROIZVODNJE IN NADZOROVANIH PRESKUSOV PROIZVODOV V NAKLJUČNO IZBRANIH ČASOVNIH PRESLEDKIH
Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 5.2 and 6, and ensures and declares on his sole responsibility that the PPE, which has been subject to the provisions of point 4, is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovanih preskusov proizvodov v naključno izbranih časovnih presledkih je del postopka ugotavljanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2, 3, 5.2 in 6 ter na lastno odgovornost zagotovi in izjavi, da je osebna varovalna oprema, za katero veljajo določbe iz točke 4, v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjuje veljavne zahteve iz te uredbe.