natgillin/translations-raw huggingface dataset:
The manufacturer shall apply an approved quality system for the final inspection of the appliances and the tests, as specified in point 4.3, and is subject to EC surveillance as specified in point 4.4.
Proizvajalec mora uporabljati odobreni sistem kakovosti za končni nadzor naprav in preskusov, kakor je določeno v točki 4.3, in je pod ES-nadzorom, kakor je določeno v točki 4.4.
Under this procedure, the manufacturer must lodge an application for approval of his quality system with a notified body of his choice for the appliances in question.
Po tem postopku mora proizvajalec za odobritev svojega sistema kakovosti za zadevne naprave vložiti vlogo priglašenemu organu po svoji izbiri.
the documentation relating to the approved type and a copy of the EC type-examination certificate.
dokumentacijo, ki se nanaša na odobreni tip, in izvod certifikata ES-pregleda tipa.
As part of the quality system, each appliance must be examined and appropriate tests as laid down in the applicable standard(s) referred to in Article 5 or equivalent tests carried out to check its conformity with the essential requirements relating to it in this Directive.
Kot del sistema kakovosti mora biti vsaka naprava pregledana in opravljeni morajo biti ustrezni preskusi, kakor določa(-jo) veljaven(-vni) standard(-i), naveden(-i) v členu 5, ali enakovredni preskusi, da se preveri njena usklajenost z osnovnimi zahtevami, ki se nanašajo nanjo v tej direktivi.
The quality system documentation shall contain, in particular, an adequate description of:
Dokumentacija sistema kakovosti vsebuje zlasti primeren opis:
the checks and tests to be carried out after manufacture,
preverjanja in preskušanja, ki se opravi po izdelavi,
the method of verifying the effective operation of the quality system.
metode preverjanja učinkovitosti delovanja sistema kakovosti.
The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 4.3.2.
Priglašeni organ preveri in ovrednoti sistem kakovosti, da določi, ali izpolnjuje zahteve, navedene v točki 4.3.2.
It must notify the manufacturer of its decision and inform the other notified bodies thereof.
Svojo odločitev mora uradno sporočiti proizvajalcu in o tem obvestiti druge priglašene organe.
The notification to the manufacturer must contain the conclusions of the examination, the name and address of the notified body and the reasoned assessment decision for the appliances concerned.
Uradno obvestilo proizvajalcu mora vsebovati izide preverjanja, ime in naslov priglašenega organa ter utemeljeno odločitev o oceni zadevnih naprav.
The manufacturer must keep the notified body which approved the quality system informed of any adaptation of the quality system made necessary, e.g. by new technology and quality concepts.
Proizvajalec mora stalno obveščati priglašeni organ, ki je odobril sistem kakovosti, o prilagajanju sistema kakovosti, ki je potrebno na primer zaradi nove tehnologije in novega pojmovanja kakovosti.
The notified body must examine the proposed changes and decide whether the amended quality system satisfies the relevant provisions or whether a reassessment is necessary.
Priglašeni organ mora pregledati predlagane spremembe in se odločiti, ali spremenjeni sistem kakovosti zadošča ustreznim določbam in ali je potrebna vnovična ocena.
The notification must contain the conclusions of the inspection and the reasoned assessment decision.
Uradno obvestilo mora vključevati izide nadzora in utemeljeno odločitev o oceni.
A notified body which withdraws approval of a quality system must inform the other notified bodies that it has done so and give reasons for its decision.
Priglašeni organ, ki odvzame odobritev sistema kakovosti, mora obvestiti druge priglašene organe, da je to storil, in navesti razloge za svojo odločitev.
The manufacturer must allow the notified body access for inspection to the place of inspection, testing and storage and must provide it with all necessary information, in particular:
Proizvajalec mora za nadzor dovoliti priglašenemu organu dostop v nadzorne prostore, v prostore preskušanja in skladiščenja ter mu dati na razpolago vse potrebne podatke, zlasti:
the quality files such as inspection reports and test data, calibration data, report on qualifications of the staff concerned.
zapisnike o kakovosti, kot so poročila o nadzoru in podatki o preskusih, kalibracijski podatki, poročilo o kvalifikacijah zadevnih delavcev.
The notified body must carry out a check at least once every two years to ensure that the manufacturer is maintaining and applying the approved quality system and must supply a report on the check to the manufacturer.
Priglašeni organ mora opraviti preverjanje vsaj enkrat na dve leti, s čimer zagotovi, da proizvajalec upošteva in uporablja odobreni sistem kakovosti, ter mu izročiti poročilo o preverjanju.
During these visits, the body may carry out tests on appliances or have them carried out.
Med temi obiski lahko organ opravi preskuse na napravah ali jih da opraviti.
EC VERIFICATION
ES-OVERJANJE
EC verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the appliances subject to the provisions of point 3 are in conformity to the type as described in the EC type-examination certification and satisfy the requirements of this Directive that apply to them.
ES-overjanje je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotavlja in izjavi, da so naprave po določbah točke 3 skladne s tipom, opisanim v certifikatu o ES-pregledu tipa, in ustrezajo zahtevam te direktive, ki se uporabljajo zanje.
The manufacturer or his authorised representative established within the Community must take all measures necessary in order that the manufacturing process ensures conformity of the appliances to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti mora sprejeti vse potrebne ukrepe, da proizvodni proces zagotavlja skladnost naprav s tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami te direktive, ki se uporabljajo zanje.
The declaration of conformity may cover one or more appliances and must be kept by the manufacturer or his authorised representative established within the Community.
Izjava o skladnosti lahko zajema eno ali več naprav in jo mora hraniti proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti.
The notified body must carry out the appropriate examinations and tests in order to check the conformity of the appliance to the requirements of this Directive by examination and testing of every appliance, as specified in point 5.4, or by examination and testing of appliances on a statistical basis, as specified in point 5.5, at the choice of the manufacturer.
Priglašeni organ mora s pregledovanjem in preskušanjem vsake naprave, kot to določa točka 5.4, opraviti ustrezne preglede in preskuse, da preveri skladnost naprave z zahtevami te direktive, ali s pregledovanjem in preskušanjem naprav na statistični podlagi, kot je določeno v točki 5.5, po izbiri proizvajalca.
Verification by checking and testing of each appliance
Overjanje s preverjanjem in preskušanjem vsake naprave
All appliances must be individually examined and appropriate tests, as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, must be carried out in order to verify their conformity with the type as described in the EC type-examination certificate and the requirements of this Directive that apply to them.
Vse naprave morajo biti pregledane posamič in opravljeni morajo biti ustrezni preskusi, kot je predpisano v ustreznem(ih) standardu(ih) iz člena 5, ali enakovredni preskusi, da bi se preverila njihova skladnost s tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami te direktive, ki se uporabljajo zanje.
The notified body must affix, or cause to be affixed, its identification number on each appliance and draw up a written certificate of conformity relating to the tests carried out.
Priglašeni organ mora pritrditi ali da pritrditi svojo identifikacijsko številko na vsako napravo in sestaviti pisno potrdilo o skladnosti v zvezi z opravljenimi preskusi.
The certificate of conformity may cover one or more appliances.
Potrdilo o skladnosti lahko zajema eno ali več naprav.
The manufacturer or his authorised representative must ensure that he is able to supply the notified body's certificates of conformity on request.
Proizvajalec ali njegov pooblaščeni zastopnik mora zagotoviti, da je sposoben na zahtevo predložiti potrdila o skladnosti, ki jih je izdal priglašeni organ.
Statistical verification
Statistično overjanje
Manufacturers must present the appliances manufactured in the form of uniform batches and must take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.
Proizvajalci morajo predložiti izdelane naprave v obliki enotnih serij in sprejeti vse potrebne ukrepe, da proizvodni proces zagotavlja enotnost vsake izdelane serije.
Statistical control is as follows:
Statistični nadzor je:
Appliances are subject to statistical control by attributes.
Naprave se statistično nadzirajo po lastnostih.
They should be grouped into identifiable batches consisting of units of a single model manufactured under the same conditions.
Razvrščene naj bi bile po skupinah v razpoznavnih serijah, ki jih sestavljajo primerki enega samega tipa, izdelani pod enakimi pogoji.
A batch is examined at random intervals.
Serija se pregleda v naključnih intervalih.
The appliances constituting a sample are examined individually and appropriate tests, as laid down in the respective standard(s) referred to in Article 5, or equivalent tests are carried out to determine whether the batch is to be accepted or rejected.
Naprave, ki tvorijo vzorec, se pregledajo posamič in opravijo se ustrezni preskusi, predpisani v posameznem(ih) standardu(ih) iz člena 5, ali enakovredni preskusi za določitev, ali se serija sprejme ali zavrne.
A sampling system with the following characteristics is applied:
Uporabi se sistem vzorčenja z naslednjimi značilnostmi:
a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,5 and 1,5 %,
raven kakovosti, ki ustreza 95-odstotni verjetnosti sprejemljivosti z od 0,5 do 1,5 odstotka neskladnih,
a limit quality corresponding to a probability of acceptance of 5 %, with a percentage of non-conformity of between 5 and 10 %.
mejna kakovost, ki ustreza 5-odstotni verjetnosti sprejemljivosti z od 5 do 10 odstotki neskladnih.
Where batches are accepted, the notified body must affix, or cause to be affixed, its identification number to each appliance and draw up a written certificate of conformity relating to the tests carried out.
Kadar so serije sprejete, mora priglašeni organ pritrditi ali dati pritrditi svojo identifikacijsko številko na vsako napravo in sestaviti pisno potrdilo o skladnosti v zvezi z opravljenimi preskusi.
All appliances in the batch may be placed on the market except for those products from the sample which were found not to be in conformity.
Vse naprave v seriji se lahko dajo na trg, razen tisti izdelki iz vzorca, za katere se je ugotovilo, da niso skladni.
Where a batch is rejected, the notified body must take appropriate measures to prevent the placing on the market of that batch.
Kadar je serija zavrnjena, mora priglašeni organ ustrezno ukrepati, da prepreči dajanje take serije na trg.
In the event of frequent rejection of batches the notified body may suspend the statistical verification.
Če so serije pogosto zavrnjene, lahko priglašeni organ odloži statistično overjanje.
The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process.
Proizvajalec sme na odgovornost priglašenega organa pritrditi njegovo identifikacijsko številko med proizvodnim procesom.
EC UNIT VERIFICATION
ES-OVERJANJE PO ENOTI
EC unit verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the appliance concerned, which has been issued with the certificate referred to in point 2, conforms to the requirements of this Directive that apply to it.
ES-overjanje po enoti je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotovi in izjavi, da je zadevna naprava, za katero je bilo izdano potrdilo iz točke 2, skladna z zahtevami te direktive, ki veljajo zanjo.
The manufacturer or his authorised representative must affix the CE marking to the appliance and draw up a written declaration of conformity which he must keep.
Proizvajalec ali njegov pooblaščeni zastopnik mora pritrditi znak CE na vsako napravo in sestaviti pisno izjavo o skladnosti, ki jo mora shraniti.
The notified body must examine the appliance and carry out the appropriate tests, taking account of the design documentation in order to ensure its conformity with the essential requirements of this Directive.
Priglašeni organ mora pregledati napravo in opraviti ustrezne preskuse, ob upoštevanju projektne dokumentacije, da zagotovi njeno skladnost z bistvenimi zahtevami te direktive.
The notified body must affix, or cause to be affixed, its identification number to the approved appliance and must draw up a written certificate of conformity concerning the tests carried out.
Priglašeni organ mora pritrditi ali dati pritrditi svojo identifikacijsko številko na odobreno pripravo in sestaviti pisno potrdilo o skladnosti v zvezi z opravljenimi preskusi.
The aim of the technical documentation relating to the design of the instrument, as referred to in Annex IV, is to enable conformity to the requirements of this Directive to be assessed and the design, manufacture and operation of the appliance to be understood.
Namen tehnične dokumentacije v zvezi z zasnovo instrumenta, navedeno v Prilogi IV, je omogočiti ugotavljanje skladnosti z zahtevami te direktive in razumljivost načrta, izdelave in delovanja naprave.
The design documentation referred to in Annex IV must be made available to the notified body.
Projektna dokumentacija, navedena v Prilogi IV, mora biti dostopna priglašenemu organu.
If deemed necessary by the notified body, the examinations and tests may be carried out after installation of the appliance.
Če se zdi priglašenemu organu potrebno, se smejo pregledi in preskusi opraviti po montaži naprave.
CE MARKING AND INSCRIPTIONS
ZNAK CE IN NAPISI
The CE marking consists of the initials ‘CE’ as shown below:
Znak CE sestoji iz začetnic „CE“, kakor je prikazano spodaj:
The CE marking must be followed by the identification number of the notified body involved in the production control phase.
Znaku CE mora slediti identifikacijska številka priglašenega organa, vključenega v fazo nadzora proizvodnje.
The appliance or its data plate must bear the CE marking together with the following inscriptions:
Naprava ali njena podatkovna ploščica mora imeti znak CE skupaj z naslednjimi podatki:
the manufacturer's name or identification symbol,
ime proizvajalca ali identifikacijski znak,
the trade name of the appliance,
trgovsko ime naprave,
the type of electrical supply used, if applicable,
tip uporabljenega električnega napajanja, če je primerno,
the appliance category,
vrsta naprave,
the last two digits of the year in which the CE marking was affixed.
zadnji dve številki leta, v katerem je bila pritrjena znak CE.
Information needed for installation purposes may be added according to the nature of the appliance.
Dodajo se lahko potrebne informacije za montažo v skladu z vrsto naprave.
DESIGN DOCUMENTATION
PROJEKTNA DOKUMENTACIJA
The design documentation must contain the following information, in so far as is required by the notified body for assessment:
Projektna dokumentacija mora vsebovati naslednje podatke, če jih zahteva priglašeni organ za presojo:
a general description of the appliance,
splošen opis naprave,
conceptual designs and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
idejne načrte in načrte za proizvodnjo ter sheme sestavnih delov, podsestavov, tokokrogov itd.,
descriptions and explanations necessary for the understanding of the above, including the operation of the appliances,
opise in razlage, ki so potrebni za njihovo razumevanje, vključno z delovanjem naprav,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 5 have not been applied,
seznam standardov iz člena 5, uporabljenih v celoti ali deloma, in opise rešitev, ki so bile sprejete za izpolnitev bistvenih zahtev, kadar niso bili uporabljeni standardi iz člena 5,
manuals for installation and use.
priročnike za montažo in uporabo.
Where appropriate, the design documentation must contain the following elements:
Kadar je primerno, mora projektna dokumentacija vsebovati še naslednje elemente:
attestations relating to the equipment incorporated in the appliance,
ateste opreme, ki je vgrajena v napravo,
attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance,
ateste in certifikate načinov proizvodnje in/ali pregleda in/ali nadzorovanja naprave,
any other document making it possible for the notified body to improve its assessment.
kateri koli drugi dokument, ki priglašenemu organu olajša presojo.
MINIMUM CRITERIA FOR ASSESSMENT OF NOTIFIED BODIES
MINIMALNA MERILA OCENITVE PRIGLAŠENIH ORGANOV
The notified bodies designated by the Member States must fulfil the following minimum conditions:
Priglašeni organi, ki jih določijo države članice, morajo izpolnjevati naslednje minimalne pogoje:
availability of personnel and of the necessary means and equipment,
razpoložljivost kadrov ter drugih potrebnih sredstev in opreme,
technical competence and professional integrity of personnel,
tehnična usposobljenost in strokovna neoporečnost osebja,
independence in carrying out tests, preparing reports, issuing certificates and performing the surveillance provided for in this Directive, of management and technical staff in relation to all circles, groups or persons directly or indirectly involved in the field of the appliances,
neodvisnost pri opravljanju preskusov, izdelavi poročil, izdaji certifikatov in izvajanju nadzora, predvidenega v tej direktivi, upravljanju ter neodvisnost strokovnega kadra glede na vse kroge, skupine ali osebe, neposredno ali posredno povezane z napravami,
maintenance of professional secrecy by staff,
varovanje poslovnih skrivnosti,
possession of civil liability insurance unless that liability is covered by the State under national law.
zavarovanje civilnopravne odgovornosti, razen če jo po državni zakonodaji prevzema država.
Fulfilment of the conditions in the first two indents must be periodically verified by the competent authorities of the Member States or by bodies designated by the Member States.
Pristojni organi držav članic ali organi, ki jih imenujejo države članice, morajo redno preverjati, ali so izpolnjeni pogoji iz prvih dveh alinej.
Council Directive 90/396/EEC
Direktiva Sveta 90/396/EGS
(OJ L 196, 26.7.1990, p. 15)
(UL L 196, 26.7.1990, str. 15)
only Article 10
Samo člen 10
90/396/EEC
90/396/EGS
30 June 1991
30. junija 1991
1 January 1992
1. januarja 1992
30 June 1994
30. junija 1994
1 January 1995
1. januarja 1995
Directive 90/396/EEC
Direktiva 90/396/EGS
Article 1(1), first and second indents
Člen 1(1), prva in druga alinea
Article 1(2)(a) and (b)
Členi 1(2)(a) in (b)
Article 2(1)
Členi 2(1)
Article 2(2), first and second sentences
Člen 2(2), prvi in drugi stavek
Article 2(2), first subparagraph
Členi 2(2), prvi pododstavek
Article 2(2), third sentence
Člen 2(2), tretji stavek
Article 2(2), second subparagraph
Členi 2(2), drugi pododstavek
Article 5(1)(a), first subparagraph
Člen 5(1)(a), prvi pododstavek
Article 5(1)(a), second subparagraph
Člen 5(1)(a), drugi pododstavek
Article 5(2), first sentence
Člen 5(2), prvi stavek
Article 5(2), third sentence
Člen 5(2), tretji stavek
Article 6(1), first subparagraph, first sentence
Člen 6(1), prvi pododstavek, prvi stavek
Article 6(1), first subparagraph, second sentence
Člen 6(1), prvi pododstavek, drugi stavek
Article 6(2), first sentence
Člen 6(2), prvi stavek
Article 6(2), second sentence
Člen 6(2), drugi stavek
Article 6(2), third sentence
Člen 6(2), tretji stavek
Article 8(1)(b), introductory wording
Člen 8(1)(b), uvodno besedilo
Article 8(1)(b), first to fourth indents
Člen 8(1)(b), prva do četrta alinea
Article 8(1)(b)(i) to (iv)
Člen 8(1)(b)(i) do (iv)
Article 8(4), first subparagraph, first sentence
Člen 8(4), prvi pododstavek, prvi stavek
Article 8(4), first subparagraph, second sentence
Člen 8(4), prvi pododstavek, drugi stavek
Article 8(5)(a)
Člen 8(5)(a)
Article 8(5)(b)
Člen 8(5)(b)
Articles 9 to12
Členi 9 do 12
Articles 9 to 12
Členi 9 do 12
The Commission shall ensure that this information is published in the Official Journal of the European Union.
Komisija zagotovi, da se te informacije objavijo v Uradnem listu Evropske unije.
Upon receipt of the committee’s opinion, the Commission shall, within one month, inform the Member States whether the national standard(s) in question are to enjoy the presumption of conformity.
Po pridobitvi mnenja odbora Komisija v enem mesecu obvesti države članice, ali zadevni državni standard(-i) velja(-jo) za skladne.
If they are, the Member States shall publish the reference numbers of those standards.
Če veljajo, države članice objavijo sklicne številke teh standardov.
The Council has adopted a series of Directives designed to remove technical barriers to trade in accordance with the principles established in Resolution of 7 May 1985 on a new approach to technical harmonisation and standards [7]; each of these Directives provides for the affixing of the CE marking. The Commission, in its Communication of 15 June 1989 on a global approach to certification and testing [8], proposed that common rules be drawn up concerning a CE marking with a single design.
Svet je že sprejel vrsto direktiv, namenjenih odstranitvi tehničnih ovir v trgovini, v skladu z načeli, določenimi v resoluciji z dne 7. maja 1985 o novem pristopu k tehnični uskladitvi in standardom [7]; vsaka od teh direktiv predvideva pritrditev znaka CE; Komisija je v svojem sporočilu z dne 15. junija 1989 o globalnem pristopu v zvezi s certifikacijo in preskušanjem [8] predlagala, da se sestavijo skupna pravila v zvezi z znakom skladnosti CE enotne oblike.
Council Directive 2009/143/EC
Direktiva Sveta 2009/143/ES
amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing
o spremembi Direktive 2000/29/ES v zvezi s prenosom nalog laboratorijskega testiranja
Under Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community [2] the responsible official bodies in the Member States may only delegate the tasks provided for in that Directive, including laboratory testing, to a legal person which under its officially approved constitution is charged exclusively with specific public functions.
V skladu z Direktivo Sveta 2000/29/ES z dne 8. maja 2000 o varstvenih ukrepih proti vnosu organizmov, škodljivih za rastline ali rastlinske proizvode, v Skupnost in proti njihovemu širjenju v Skupnosti [2] lahko pristojni uradni organi v državah članicah naloge iz navedene direktive, vključno z laboratorijskim testiranjem, prenesejo samo na pravno osebo, ki je po svojem uradno potrjenem ustanovitvenem aktu izključno pristojna za posebne javne funkcije.
The laboratory tests which have to be carried out in the framework of Directive 2000/29/EC are of a highly technical nature and concern different scientific fields.
Laboratorijski testi, ki jih je treba opraviti v okviru Direktive 2000/29/ES so zelo tehnične narave in se nanašajo na različna znanstvena področja.