natgillin/translations-raw huggingface dataset:
a list of the essential health and safety requirements applied and fulfilled,
seznamom bistvenih varnostnih in zdravstvenih zahtev, ki so bile uporabljene in izpolnjene;
the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,
opisom varovalnih ukrepov, izvedenih za odpravo ugotovljenih nevarnosti ali zmanjšanje tveganja in, kadar je ustrezno, navedb preostalih tveganj;
a copy of the assembly instructions for the partly completed machinery;
izvod navodil za sestavljanje delno dokončanega stroja;
for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.
pri serijski proizvodnji, interne ukrepe, ki se bodo izvajali za zagotovitev, da bo delno dokončani stroj ostal skladen z uporabljenimi bistvenimi varnostnimi in zdravstvenimi zahtevami.
The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely.
Proizvajalec mora izvajati potrebne raziskave in preskuse komponent, opreme ali delno dokončanih strojev, s katerimi ugotavlja, ali po svoji zasnovi in izdelavi zagotavljajo varno sestavljanje in uporabo.
The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to the competent authorities of the Member States.
Ustrezna tehnična dokumentacija mora biti na voljo vsaj deset let po datumu proizvodnje delno dokončanega stroja ali zadnjega proizvedenega primerka pri serijski proizvodnji in na zahtevo predložena pristojnim organom držav članic.
It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form.
Dokumentacije ni treba hraniti na ozemlju Skupnosti, niti ni nujno, da je trajno na voljo v materialni obliki.
It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation.
Oseba, določena v izjavi za vgradnjo, jo mora biti sposobna sestaviti in predložiti ustreznemu organu.
Failure to present the relevant technical documentation in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.
Če se ustrezna tehnična dokumentacija na obrazloženo zahtevo pristojnih nacionalnih organov ne predloži, je to lahko zadostna podlaga za dvom o skladnosti delno dokončanega stroja z uporabljenimi in preskušenimi bistvenimi varnostnimi in zdravstvenimi zahtevami.
Assessment of conformity with internal checks on the manufacture of machinery
Ugotavljanje skladnosti z notranjim preverjanjem izdelave strojev
This Annex describes the procedure by which the manufacturer or his authorised representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.
V tej prilogi je opisan postopek, po katerem proizvajalec ali njegov pooblaščeni zastopnik, ki izvaja obveznosti, določene v točki 2 in 3, zagotavlja in izjavlja, da zadevni stroji ustrezajo zahtevam te direktive.
For each representative type of the series in question, the manufacturer or his authorised representative shall draw up the technical file referred to in Annex VII, part A.
Proizvajalec ali njegov pooblaščeni zastopnik sestavi tehnično dokumentacijo iz dela A Priloge VII za vsak reprezentativni tip zadevne serije.
The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.
Proizvajalec mora sprejeti vse potrebne ukrepe, da se v proizvodnem procesu zagotovi skladnost proizvedenih strojev s tehnično dokumentacijo iz dela A Priloge VII in z zahtevami te direktive.
EC type-examination
ES-pregled tipa
EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (hereafter named the type) satisfies the provisions of this Directive.
ES-pregled tipa je postopek, v katerem priglašeni organ ugotovi in potrdi, da reprezentativni vzorec stroja iz Priloge IV (v nadaljevanju: „tip“) izpolnjuje določbe te direktive.
The manufacturer or his authorised representative must, for each type, draw up the technical file referred to in Annex VII, part A.
Proizvajalec ali njegov pooblaščeni zastopnik za vsak tip sestavi tehnično dokumentacijo iz dela A Priloge VII.
For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice.
Za vsak tip proizvajalec ali njegov pooblaščeni zastopnik odda vlogo za ES-pregled tipa poljubno izbranemu priglašenemu organu.
The application shall include:
Ta vloga vsebuje:
the name and address of the manufacturer and, where appropriate, his authorised representative,
naziv in naslov proizvajalca in, kadar je potrebno, njegovega pooblaščenega zastopnika,
a written declaration that the application has not been submitted to another notified body,
pisno izjavo, da vloga ni bila oddana drugemu priglašenemu organu,
the technical file.
tehnično dokumentacijo.
Moreover, the applicant shall place at the disposal of the notified body a sample of the type.
Poleg tega da vlagatelj priglašenemu organu na razpolago vzorec tega tipa.
The notified body may ask for further samples if the test programme so requires.
Priglašeni organ lahko zahteva dodatne vzorce, če to zahteva program preskušanja.
examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of the standards referred to in Article 7(2), and those elements whose design is not based on the relevant provisions of those standards;
pregleda tehnično dokumentacijo, preveri, ali je bil tip proizveden v skladu z njo, in ugotovi, kateri elementi so bili načrtovani skladno z ustreznimi določbami standardov iz člena 7(2) in kateri elementi niso bili načrtovani skladno z ustreznimi določbami teh standardov;
carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements of this Directive, where the standards referred to in Article 7(2) were not applied;
izvaja ali da izvesti primerne preglede, meritve in preskuse, s katerimi ugotovi, ali uporabljene rešitve ustrezajo bistvenim varnostnim in zdravstvenim zahtevam te direktive, kadar niso bili uporabljeni standardi iz člena 7(2);
where harmonised standards referred to in Article 7(2) were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied;
kadar so bili uporabljeni harmonizirani standardi iz člena 7(2), izvede ali naroči izvedbo primernih pregledov, meritev in preskusov, s katerimi potrdi, da so bili ti standardi dejansko uporabljeni;
agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.
z vlagateljem se dogovori za kraj izvedbe preskusa, ali je bil tip proizveden skladno s pregledanim tehnično dokumentacijo, ter potrebnih pregledov, meritev in preskusov.
If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate.
Če tip ustreza določbam te direktive, izda priglašeni organ vlagatelju certifikat o ES-pregledu tipa.
The certificate shall include the name and address of the manufacturer and his authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.
Certifikat vsebuje naziv in naslov proizvajalca in njegovega pooblaščenega zastopnika, podatke, ki so potrebni za ugotavljanje istovetnosti odobrenega tipa, ugotovitve pregleda in morebitne pogoje, pod katerimi je bil izdan certifikat.
The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.
Proizvajalec in priglašeni organ hranita izvod tega certifikata, tehnične dokumentacije in vseh ustreznih dokumentov petnajst let po datumu izdaje certifikata.
If the type does not satisfy the provisions of this Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal.
Če tip ne ustreza določbam te direktive, priglašeni organ vlagatelju zavrne izdajo certifikata o ES-pregledu tipa in navede podrobne vzroke za zavrnitev.
It shall inform the applicant, the other notified bodies and the Member State which notified it.
O tem obvesti vlagatelja, druge priglašene organe in državo članico, ki ga je prijavila.
An appeal procedure must be available.
Na voljo mora biti pritožbeni postopek.
The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type.
Vlagatelj mora obvestiti priglašeni organ, ki hrani tehnično dokumentacijo, povezano s certifikatom o ES-pregledu tipa, o vseh spremembah odobrenega tipa.
The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type.
Priglašeni organ te spremembe pregleda in nato bodisi potrdi veljavnost obstoječega certifikata o ES-pregledu tipa, ali pa izda novega, če lahko spremembe vplivajo na skladnost z bistvenimi varnostnimi in zdravstvenimi zahtevami ali na predvidene delovne razmere za tip.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo pridobijo izvod certifikata o ES-pregledu tipa.
On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body.
Na utemeljeno zahtevo lahko Komisija in države članice pridobijo izvod tehnične dokumentacije in rezultate pregledov, ki jih je opravil priglašeni organ.
Files and correspondence referring to the EC type-examination procedures shall be written in the official Community language(s) of the Member State where the notified body is established or in any other official Community language acceptable to the notified body.
Dokumentacija in korespondenca, ki zadevajo postopke ES-pregleda tipa, morajo biti zapisani v uradnem jeziku(-ih) Skupnosti tiste države članice, kjer je ustanovljen priglašeni organ, ali katerem koli drugem jeziku Skupnosti, ki je sprejemljiv za priglašeni organ.
Validity of the EC type-examination certificate
Veljavnost certifikata o ES-pregledu tipa
The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid.
Priglašeni organ je trajno odgovoren za zagotavljanje veljavnosti certifikata o ES-pregledu tipa.
It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate.
Proizvajalca mora obvestiti o vseh večjih spremembah, ki bi lahko vplivale na veljavnost certifikata.
The notified body shall withdraw certificates which are no longer valid.
Priglašeni organ mora preklicati certifikate, ki niso več veljavni.
The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.
Proizvajalec zadevnega stroja je trajno odgovoren za zagotavljanje skladnosti omenjenega stroja z ustreznim stanjem tehnike.
The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.
Proizvajalec mora zahtevati od priglašenega organa pregled veljavnosti certifikata o ES-pregledu tipa na vsakih pet let.
If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years.
Če priglašeni organ ob upoštevanju stanja tehnike ugotovi, da certifikat ostaja veljaven, ta certifikat obnovi za naslednjih pet let.
The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.
Proizvajalec in priglašeni organ morata hraniti izvod tega certifikata, tehnične dokumentacije in vseh ustreznih dokumentov petnajst let po datumu izdaje tega certifikata.
In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned.
Če veljavnost certifikata o ES-pregledu tipa ni podaljšana, mora proizvajalec prenehati dajati na trg zadevne stroje.
Full quality assurance
Popolno zagotavljanje kakovosti
This Annex describes the conformity assessment of machinery referred to in Annex IV, manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.
Ta priloga opisuje ugotavljanje skladnosti strojev iz Priloge IV, proizvedenih z uporabo sistema za popolno zagotavljanje kakovosti in opisuje postopek, po katerem priglašeni organ ocenjuje in odobri sistem kakovosti in spremlja njegovo uporabo.
The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2, and shall be subject to the surveillance referred to in point 3.
Proizvajalec mora pri načrtovanju, proizvodnji, končni kontroli in preskušanju izvajati odobren sistem kakovosti, kakor je opredeljen v točki 2, in biti pod nadzorom iz točke 3.
The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.
Proizvajalec ali njegov pooblaščeni zastopnik vloži vlogo za presojo svojega sistema kakovosti poljubno izbranemu priglašenemu organu.
The application shall contain:
Ta vloga vsebuje:
the places of design, manufacture, inspection, testing and storage of the machinery,
kraje načrtovanja, proizvodnje, kontrole, preskušanja in skladiščenja strojev,
the technical file described in Annex VII, Part A, for one model of each category of machinery referred to in Annex IV which he intends to manufacture,
tehnično dokumentacijo, opisano v delu A Priloge VII, za po en primerek iz vsake vrste strojev iz Priloge IV, ki ga namerava proizvajati,
the documentation on the quality system,
dokumentacijo o sistemu kakovosti,
a written declaration that the application has not been submitted to another notified body.
pisno izjavo, da vloga ni bila oddana drugemu priglašenemu organu.
The quality system must ensure conformity of the machinery with the provisions of this Directive.
Sistem kakovosti mora zagotavljati skladnost strojev z določbami te direktive.
All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions.
Vsi elementi, zahteve in določbe, ki jih je sprejel proizvajalec, morajo biti sistematično in urejeno dokumentirani v obliki ukrepov, postopkov in pisnih navodil.
The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.
Ta dokumentacija o sistemu kakovosti mora dopuščati enotno tolmačenje postopkovnih ukrepov in ukrepov zagotavljanja kakovosti, na primer programov kakovosti, načrtov, priročnikov in zapisnikov.
It must contain, in particular, an adequate description of:
Vsebovati mora zlasti ustrezen opis:
the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,
ciljev kakovosti, organizacijske strukture ter odgovornosti in pooblastil vodstva v zvezi z načrtovanjem in kakovostjo strojev,
the technical design specifications, including standards that will be applied and, where the standards referred to in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety requirements of this Directive are fulfilled,
tehničnih zahtev za načrtovanje, vključno s standardi, ki se bodo uporabljali in, kadar se standardi iz člena 7(2) ne uporabljajo v celoti, sredstva, ki se bodo uporabljala za zagotavljanje izpolnjevanja bistvenih zdravstvenih in varnostnih zahtev te direktive,
the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by this Directive,
pregleda načrtovanja in tehnik potrjevanja načrtovanja, postopkov in sistematičnih dejanj, ki se bodo uporabljali pri načrtovanju strojev, za katere velja ta direktiva,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
ustreznih proizvodnih tehnik, kontrole kakovosti in tehnik zagotavljanja kakovosti, postopkov in sistematičnih dejanj, ki se bodo uporabljali,
the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
pregledov in preskusov, ki se bodo izvajali pred proizvodnjo, med njo in po njej ter pogostost njihovega izvajanja,
the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned,
zapisov o kakovosti, kot so poročila o pregledu in podatki o preskušanju, podatki o kalibriranju in poročila o usposobljenosti udeleženega osebja,
the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.
sredstev za spremljanje doseganja zahtevanega načrtovanja in kakovosti strojev ter učinkovitega delovanja sistema kakovosti.
The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2.
Priglašeni organ presoja sistem kakovosti, da ugotovi, ali izpolnjuje zahteve iz točke 2.2.
The elements of the quality system which conform to the relevant harmonised standard shall be presumed to conform to the corresponding requirements referred to in point 2.2.
Elementi sistema kakovosti, ki so skladni z ustreznim harmoniziranim standardom, štejejo za skladne z ustreznimi zahtevami iz točke 2.2.
The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery.
Vsaj en član ekipe presojevalcev mora imeti izkušnje pri presoji tehnologije strojev.
The assessment procedure shall include an inspection to be carried out at the manufacturer's premises.
Postopek presoje vključuje pregled, ki se opravi v prostorih proizvajalca.
During the assessment, the team of auditors shall carry out a review of the technical files referred to in point 2.1, second paragraph, third indent to ensure their compliance with the relevant health and safety requirements.
Med presojo skupina revizorjev izvede pregled tehnične dokumentacije iz tretje alinee drugega odstavka točke 2.1, da zagotovi njihovo skladnost z ustreznimi zdravstvenimi in varnostnimi zahtevami.
The manufacturer or his authorised representative shall be notified of the decision.
Proizvajalca ali njegovega pooblaščenega zastopnika se obvesti o sklepu.
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Obvestilo vsebuje ugotovitve pregleda in utemeljitev sklepa presoje.
The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.
Proizvajalec izpolni obveznosti, ki izhajajo iz odobrenega sistema kakovosti in zagotoviti, da ta sistem ostane primeren in učinkovit.
The manufacturer or his authorised representative shall inform the notified body which approved the quality system of any planned change to it.
Proizvajalec ali njegov pooblaščeni zastopnik obvesti priglašeni organ, ki je odobril sistem kakovosti, o vseh načrtovanih spremembah sistema.
The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, or whether a re-assessment is necessary.
Priglašeni organ ovrednoti predlagane spremembe in se odloči, ali bo spremenjeni sistem zagotavljanja kakovosti še naprej izpolnjeval zahteve iz točke 2.2, ali pa bo potrebna ponovna presoja.
It shall notify the manufacturer of its decision.
O svoji odločitvi obvesti proizvajalca.
Surveillance under the responsibility of the notified body
Nadzor v pristojnosti priglašenega organa
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
Namen nadzora je zagotoviti, da proizvajalec pravilno izpolnjuje obveznosti, ki izhajajo iz odobrenega sistema kakovosti.
The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:
Zaradi razlogov nadzora proizvajalec omogoči priglašenemu organu dostop do krajev načrtovanja, proizvodnje, pregleda, preskušanja in skladiščenja, in mu preskrbi vse potrebne informacije, kot so:
the documentation concerning the quality system,
dokumentacija, ki zadeva sistem kakovosti,
the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,
zapisi o kakovosti, ki so bili pripravljeni v delu sistema kakovosti, zadevajočem načrtovanje, kot so rezultati analiz, izračunov, preskusov itd.,
the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
zapisov o kakovosti, ki so bili pripravljeni v delu sistema kakovosti, ki zadeva proizvodnjo, kot so poročila o pregledu in podatki o preskušanju, podatki o kalibriranju, poročila o usposobljenosti udeleženega osebja itd.
The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.
Priglašeni organ izvaja redne preglede, da se prepriča, ali proizvajalec vzdržuje in uporablja sistem kakovosti; proizvajalcu zagotovi poročilo o pregledu.
The frequency of the periodic audits shall be such that a full reassessment is carried out every three years.
Pogostost rednih pregledov je takšna, da je popolna ponovna presoja opravljena na vsaka tri leta.
Moreover, the notified body may pay the manufacturer unannounced visits.
Poleg tega lahko priglašeni organ nenapovedano obišče proizvajalca.
The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body.
Potreba po teh dodatnih obiskih in njihovi pogostosti se določi na podlagi sistema za spremljanje obiskov, s katerim upravlja priglašeni organ.