natgillin/translations-raw huggingface dataset:
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of production and 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 homogenost proizvodnje in skladnost proizvedene osebne varovalne opreme s tipom, opisanim v certifikatu o EU-pregledu tipa, in veljavnimi zahtevami iz te uredbe.
Application for supervised product checks at random intervals
Zahtevek za nadzorovane preskuse proizvodov v naključno izbranih časovnih presledkih
Before placing PPE on the market, the manufacturer shall lodge an application for supervised product checks at random intervals with a single notified body of his choice.
Preden proizvajalec da osebno varovalno opremo na trg, vloži zahtevek za nadzorovane preskuse proizvodov v naključno izbranih časovnih presledkih pri enem samem 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;
ime in naslov proizvajalca ter, če je zahtevek vložil pooblaščeni zastopnik, njegovo ime in naslov;
the identification of the PPE concerned.
opredelitev zadevne osebne varovalne opreme.
Where the chosen body is not the body that has carried out the EU type-examination, the application shall also include the following:
Kadar izbrani organ ni organ, ki je opravil EU-pregled tipa, zahtevek vsebuje tudi naslednje:
a copy of the EU type-examination certificate.
izvod certifikata o EU-pregledu tipa.
The notified body shall carry out product checks in order to verify the homogeneity of production and the conformity of the PPE with the type described in the EU type-examination certificate and with the applicable essential health and safety requirements.
Priglašeni organ izvede preskuse proizvodov, da preveri homogenost proizvodnje in skladnost osebne varovalne opreme s tipom, ki je opisan v certifikatu o EU-pregledu tipa, ter z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami.
The product checks shall be carried out at least once a year, at random intervals determined by the notified body.
Preskusi proizvodov se izvedejo najmanj enkrat na leto v naključno izbranih časovnih presledkih, ki jih določi priglašeni organ.
The first product checks shall be carried out no more than one year after the date of issue of the EU type-examination certificate.
Prvi preskusi proizvodov se opravijo največ eno leto po datumu izdaje certifikata o EU-pregledu tipa.
An adequate statistical sample of the manufactured PPE shall be selected by the notified body at a place agreed between the body and the manufacturer.
Priglašeni organ na mestu, dogovorjenem med njim in proizvajalcem, izbere ustrezen statistični vzorec proizvedene osebne varovalne opreme.
All items of PPE of the sample shall be examined, and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify the conformity of the PPE with the type described in the EU type-examination certificate and with the applicable essential health and safety requirements.
Pregledajo se vsi kosi vzorčne osebne varovalne opreme in opravijo se primerni preskusi, ki so določeni v ustreznih harmoniziranih standardih, in/ali enakovredni preskusi iz drugih ustreznih tehničnih specifikacij, da se preveri skladnost osebne varovalne opreme s tipom, opisanim v certifikatu o EU-pregledu tipa, ter z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami.
Where the notified body referred to in point 3 is not the body that issued the relevant EU type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample.
Kadar priglašeni organ iz točke 3 ni organ, ki je izdal certifikat o EU-pregledu tipa, v primeru težav v zvezi z ugotavljanjem skladnosti vzorca stopi v stik s tem organom.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production and performs within acceptable limits, with a view to ensuring conformity of the PPE.
Postopek vzorčenja za sprejemljivost, ki se uporablja, je zasnovan za presojo, ali proizvodni proces zagotavlja homogenost proizvodnje in se izvaja v sprejemljivih mejah s ciljem zagotavljanja skladnosti osebne varovalne opreme.
If the examination and testing reveal that the production is not homogeneous, or that the PPE does not comply with the type described in the EU type-examination certificate or with the applicable essential health and safety requirements, the notified body shall take measures appropriate to the fault(s) recorded and inform the notifying authority thereof.
Če pregled in preskušanje pokažeta, da proizvodnja ni homogena ali da osebna varovalna oprema ni v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, ali z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami, priglašeni organ sprejme ukrepe, primerne za ugotovljene napake, in o tem obvesti priglasitveni organ.
The notified body shall provide the manufacturer with a test report.
Priglašeni organ proizvajalcu pošlje poročilo o preskusu.
The manufacturer shall keep the test report at the disposal of the national authorities for 10 years after the PPE has been placed on the market.
Proizvajalec nacionalnim organom omogoča dostop do poročila o preskusu deset let po tem, ko je bila osebna varovalna oprema dana na trg.
The manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
Proizvajalec med samim proizvodnim postopkom namesti identifikacijsko številko priglašenega organa na odgovornost slednjega.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each individual item of PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Proizvajalec namesti oznako CE in na odgovornost priglašenega organa iz točke 3 identifikacijsko številko tega organa na vsak posamezni kos osebne varovalne opreme, 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 each 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 osebna varovalna oprema dana na trg, nacionalnim organom omogoča dostop do nje.
The EU declaration of conformity shall identify the PPE model for which it has been drawn up.
Izjava EU o skladnosti opredeljuje model osebne varovalne opreme, za katerega je bila sestavljena.
An authorised representative may not fulfil the manufacturer's obligations set out in point 2.
Pooblaščeni zastopnik ne sme izpolniti obveznosti proizvajalca iz točke 2.
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
SKLADNOST S TIPOM NA PODLAGI ZAGOTAVLJANJA KAKOVOSTI PROIZVODNJE
Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5 and 6, and ensures and declares on 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 zagotavljanja kakovosti proizvodnega procesa je del postopka ugotavljanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2, 5 in 6 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 izpolnjuje veljavne zahteve iz te uredbe.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the PPE concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
Proizvajalec upravlja odobren sistem kakovosti za proizvodnjo, pregled končnega proizvoda in preskušanje zadevne osebne varovalne opreme iz točke 3 ter je nadzorovan v skladu s točko 4.
The manufacturer shall lodge an application for assessment of his quality system with a single notified body of his choice.
Zahtevek za oceno sistema kakovosti proizvajalec predloži pri enem samem priglašenem organu, ki ga sam izbere.
the address of the manufacturer's premises where the audits can be carried out;
naslov obratov proizvajalca, v katerih se lahko opravijo pregledi;
the identification of the PPE concerned;
opredelitev zadevne osebne varovalne opreme;
the documentation concerning the quality system.
dokumentacijo o sistemu kakovosti.
the technical documentation of the PPE described in Annex III;
tehnično dokumentacijo osebne varovalne opreme iz Priloge III;
The quality system shall ensure that the PPE is in conformity with the type described in the EU type-examination certificate and complies with the applicable requirements of this Regulation.
Sistem kakovosti zagotavlja, da je osebna varovalna oprema v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in je skladna z veljavnimi zahtevami iz te uredbe.
The quality system documentation shall, in particular, contain an adequate description of:
Dokumentacija sistema kakovosti vsebuje zlasti ustrezen opis:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva v zvezi s kakovostjo proizvodov;
the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and
zapisov o kakovosti, kot so poročila o pregledu in podatki o preskusih, podatki o umerjanju in poročila o strokovni usposobljenosti osebja, ter
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
Priglašeni organ oceni sistem kakovosti, da ugotovi, ali sistem izpolnjuje zahteve, navedene v točki 3.2.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
Priglašeni organ domneva skladnost s tistimi zahtevami glede elementov sistema kakovosti, ki so skladni z ustreznimi specifikacijami ustreznega harmoniziranega standarda.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the field of PPE and technology concerned, and knowledge of the applicable essential health and safety requirements.
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri ocenjevanju na področju zadevne osebne varovalne opreme in njene tehnologije ter znanjem o veljavnih bistvenih zdravstvenih in varnostnih zahtevah.
The auditing team shall review the technical documentation of the PPE referred to in point 3.1 to verify the manufacturer's ability to identify the applicable essential health and safety requirements and to carry out the necessary examinations with a view to ensuring conformity of the PPE with those requirements.
Skupina za presojo pregleda tehnično dokumentacijo iz osebne varovalne opreme iz točke 3.1, da ugotovi, ali je proizvajalec zmožen identificirati veljavne bistvene zdravstvene in varnostne zahteve, in da izvede potrebne preglede za zagotovitev skladnosti osebne varovalne opreme z navedenimi zahtevami.
The result of that assessment shall be notified to the manufacturer.
Proizvajalec je obveščen o rezultatih ocene.
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
Proizvajalec ukrepa tako, da izpolni obveznosti, ki izhajajo iz odobrenega sistema kakovosti, in ohrani njegovo primernost in učinkovitost.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
Priglašeni organ oceni kakršno koli predlagano spremembo in odloči, ali bo spremenjeni sistem kakovosti še vedno izpolnjeval zahteve iz točke 3.2 ali pa je potrebna ponovna ocena.
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Obvestilo vsebuje rezultate pregleda in obrazložitev odločitve.
The notified body shall authorise the manufacturer to affix the notified body's identification number to each individual item of PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Priglašeni organ proizvajalca pooblasti, da namesti njegovo identifikacijsko številko na vsak posamezni kos osebne varovalne opreme, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te uredbe.
The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
Proizvajalec priglašenemu organu za namene ocene omogoči dostop do krajev proizvodnje, pregledovanja, preskušanja in skladiščenja ter mu zagotovi vse potrebne informacije, zlasti:
the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.
zapise kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o umerjanju opreme in poročila o strokovni usposobljenosti osebja.
The notified body shall carry out periodic audits, at least once a year, to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
Priglašeni organ opravlja redne preglede vsaj enkrat letno, s čimer zagotovi, da proizvajalec vzdržuje in izvaja sistem kakovosti, poročila o teh pregledih pa pošilja proizvajalcu.
During such visits the notified body may, if necessary, carry out examinations or tests of the PPE, or have them carried out, in order to verify that the quality system is functioning correctly.
Med takšnimi obiski sme priglašeni organ, če je potrebno, opraviti ali naročiti preskuse osebne varovalne opreme, da preveri pravilno delovanje sistema kakovosti.
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Priglašeni organ proizvajalcu pošlje poročilo o obisku; če so bili izvedeni preskusi, pošlje tudi poročilo o njih.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual item of PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Proizvajalec namesti oznako CE in na odgovornost priglašenega organa iz točke 3.1 identifikacijsko številko tega organa na vsak posamezni kos osebne varovalne opreme, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te uredbe.
The manufacturer shall, for 10 years after the PPE has been placed on the market, keep at the disposal of the national authorities:
Proizvajalec še deset let po tem, ko je bila osebna varovalna oprema dana na trg, omogoča državnim organom dostop do:
the documentation referred to in point 3.1;
dokumentacije iz točke 3.1;
the information related to the change referred to in point 3.5, as approved;
informacij v zvezi s spremembo iz točke 3.5, kakor je bila odobrena;
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
odločitev in poročil priglašenega organa iz točk 3.5, 4.3 in 4.4.
The notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such quality system approvals refused, suspended or otherwise restricted.
Vsak priglašeni organ svoje priglasitvene organe obvesti o izdanih ali umaknjenih odobritvah sistema kakovosti in redno ali na zahtevo svojemu priglasitvenemu organu omogoča dostop do seznama zavrnjenih, začasno preklicanih ali drugače omejenih odobritev sistema kakovosti.
The notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of such quality system approvals which it has issued.
Priglašeni organ druge priglašene organe obvesti o odobritvah sistema kakovosti, ki jih je zavrnil, začasno preklical, umaknil ali drugače omejil, ter jih na zahtevo obvesti o odobritvah sistema kakovosti, ki jih je izdal.
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 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 točk 3.1, 3.5, 5 in 6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
EU DECLARATION OF CONFORMITY No … [1]
IZJAVA EU O SKLADNOSTI št. … [1]
PPE (product, type, batch or serial number):
Osebna varovalna oprema (proizvod, tip, serija ali serijska številka):
Name and address of the manufacturer and, where applicable, his authorised representative:
Ime in naslov proizvajalca in, kadar je ustrezno, njegovega pooblaščenega zastopnika:
This declaration of conformity is issued under the sole responsibility of the manufacturer:
Za izdajo te izjave o skladnosti je odgovoren izključno proizvajalec:
Object of the declaration (identification of PPE allowing traceability; where necessary for the identification of the PPE, a colour image of sufficient clarity may be included):
Predmet izjave (identifikacija osebne varovalne opreme, ki omogoča sledljivost; lahko vključuje dovolj jasno barvno sliko, kadar je to potrebno zaradi identifikacije osebne varovalne opreme):
The object of the declaration described in point 4 is in conformity with the relevant Union harmonisation legislation: …
Predmet izjave iz točke 4 je v skladu z ustrezno harmonizacijsko zakonodajo Unije: …
References to the relevant harmonised standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared:
Sklicevanja na uporabljene relevantne harmonizirane standarde, vključno z datumom standarda, ali sklicevanja na druge tehnične specifikacije, vključno z datumom specifikacije, glede na katere je izdana izjava o skladnosti:
Where applicable, the notified body … (name, number) … performed the EU type-examination (Module B) and issued the EU type-examination certificate … (reference to that certificate).
Kadar je ustrezno, priglašeni organ … (ime, številka) … je izvedel EU-pregled tipa (modul B) ter izdal certifikat o EU-pregledu tipa … (sklic na navedeni certifikat).
Where applicable, the PPE is subject to the conformity assessment procedure … (either conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) or conformity to type based on quality assurance of the production process (Module D)) … under surveillance of the notified body … (name, number).
Kadar je ustrezno, za osebno varovalno opremo velja postopek ugotavljanja skladnosti … (bodisi skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovanih preskusov proizvodov v naključno izbranih časovnih presledkih (modul C2) ali skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnega procesa (modul D)) … pod nadzorom priglašenega organa … (ime, številka).
Signed for and on behalf of: …
Podpisano za in v imenu: …
It is optional for the manufacturer to assign a number to the declaration of conformity.
Proizvajalec lahko sam odloča o tem, ali dodeli izjavi o skladnosti številko.
ANNEX X
PRILOGA X
Directive 89/686/EEC
Direktiva 89/686/EGS
Articles 1 and 2(1)
Člen 1 in člen 2(1)
Article 3 point (1)
Člen 3, točka 1
Article 5(1), (4), (5)
Člen 5(1), (4), (5)
Articles 37-41
Členi 37–41
Article 8(2)-(4)
Člen 8(2)–(4)
Articles 18 and 19 and Annex I
Člena 18 in 19 ter Priloga I
Articles 20, 24(1), 25, and 30(1)
Člen 20, člen 24(1), člen 25 in člen 30(1)
Article 11(A)
Člen 11(A)
Article 11(B)
Člen 11(B)
Articles 12(2) and 13
Člena 12(2) in 13
Article 16(1) first subparagraph and (2)
Člen 16(1), prvi pododstavek, in (2)
Article 16(1) second subparagraph
Člen 16(1), drugi pododstavek
Article 48(2)
Člen 48(2)
Regulation (EU) 2016/426 of the European Parliament and of the Council
Uredba (EU) 2016/426 Evropskega parlamenta in Sveta
on appliances burning gaseous fuels and repealing Directive 2009/142/EC
o napravah, v katerih zgoreva plinasto gorivo, in razveljavitvi Direktive 2009/142/ES
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 114 Pogodbe,
Directive 2009/142/EC of the European Parliament and of the Council [3] lays down rules for the placing on the market and the putting into service of appliances burning gaseous fuels (‘appliances’).
Direktiva 2009/142/ES Evropskega parlamenta in Sveta [3] določa pravila za dajanje na trg in v uporabo naprav, v katerih zgoreva plinasto gorivo (v nadaljnjem besedilu: naprave).
Directive 2009/142/EC is based on the ‘new approach’ principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards [4].
Direktiva 2009/142/ES temelji na načelih novega pristopa v skladu z resolucijo Sveta z dne 7. maja 1985 o novem pristopu k tehnični uskladitvi in standardom [4].
Thus, it sets out only the essential requirements applying to appliances, whereas technical details are adopted by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council [5].
Določa samo bistvene zahteve, ki veljajo za naprave, tehnične podrobnosti pa v skladu z Uredbo (EU) št. 1025/2012 Evropskega parlamenta in Sveta [5] sprejemata Evropski odbor za standardizacijo (CEN) in Evropski odbor za standardizacijo v elektrotehniki (CENELEC).
Conformity with the harmonised standards so set, the reference numbers of which are published in the Official Journal of the European Union, provides a presumption of conformity with the requirements of Directive 2009/142/EC.
Skladnost s tako določenimi harmoniziranimi standardi, katerih referenčne številke so objavljene v Uradnem listu Evropske unije, zagotavlja domnevo o skladnosti z zahtevami Direktive 2009/142/ES.
Experience acquired from the implementation of Directive 2009/142/EC has shown the need to modify some of its provisions in order to clarify and update them and thus ensure legal certainty as regards the definitions relating to its scope, the content of the Member States' communications of the types of gas and corresponding supply pressures used on their territory and certain essential requirements.
Izkušnje, pridobljene iz izvajanja Direktive 2009/142/ES, so pokazale, da je treba spremeniti nekatere njene določbe, da se pojasnijo in posodobijo ter tako zagotovi pravna varnost glede opredelitev, ki se nanašajo na področje uporabe navedene direktive, na vsebino sporočila držav članic o vrstah plinov in ustreznem dovodnem tlaku, ki se uporabljajo na njihovem ozemlju, ter na nekatere bistvene zahteve.