natgillin/translations-raw huggingface dataset:
The technical documentation shall make it possible to assess the conformity of the subsystem or the safety component with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risks.
Tehnična dokumentacija omogoča ugotavljanje skladnosti podsistemov ali varnostnih elementov z veljavnimi zahtevami iz te uredbe ter vključuje ustrezno analizo in oceno tveganj.
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the conformity assessment, the design, manufacture and operation of the subsystem or safety component.
Opredeljuje veljavne zahteve in v obsegu, ki je pomemben za ugotavljanje skladnosti, zajema načrtovanje, proizvodnjo in obratovanje podsistema ali varnostnega elementa.
The technical documentation shall contain, at least the following elements:
Tehnična dokumentacija vsebuje vsaj naslednje elemente:
a general description of the subsystem or the safety component;
splošen opis podsistema ali varnostnega elementa;
design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc. and the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the subsystem or safety component;
skice načrtovanja in izdelave, diagrame sestavnih delov, podsestavov, tokokrogov itd. ter opise in razlage, ki so potrebni za razumevanje teh skic in diagramov ter delovanja podsistema ali varnostnega elementa;
a list of the harmonised standards referred to in Article 17, applied in full or in part, the references of which have been published in the Official Journal of the European Union, and where those harmonised standards have not been applied descriptions of the solutions adopted to meet the essential requirements of this Regulation including a list of other relevant technical specifications applied.
seznam harmoniziranih standardov iz člena 17, ki so uporabljeni v celoti ali deloma, katerih navedbe so bile objavljene v Uradnem listu Evropske unije, če ti harmonizirani standardi niso uporabljeni, pa opis rešitev, sprejetih za izpolnitev bistvenih zahtev iz te uredbe, tudi seznam drugih ustreznih uporabljenih tehničnih specifikacij.
the supporting evidence for the adequacy of the design, including the results of any design calculations, examinations or tests carried out by or for the manufacturer and the related reports;
dokazila o ustreznosti načrtovanja, vključno z rezultati morebitnih izračunov, pregledov ali preskusov načrtovanja, ki jih je izvedel ali naročil proizvajalec, skupaj s povezanimi poročili;
a copy of the instructions for the subsystem or the safety component;
izvod navodil za podsistem ali varnostni element;
for subsystems, copies of the EU declarations of conformity for the safety components incorporated into the subsystem.
pri podsistemih izvode izjav EU o skladnosti za varnostne elemente, vgrajene v podsistem.
EU DECLARATION OF CONFORMITY FOR SUBSYSTEMS AND SAFETY COMPONENTS No … [1]
IZJAVA EU O SKLADNOSTI PODSISTEMOV IN VARNOSTNIH ELEMENTOV št. … [1]
Subsystem/safety component or subsystem/safety component model (product, type, batch, or serial number):
Podsistem/varnostni element ali model podsistema/varnostnega elementa (številka proizvoda, številka tipa, serijska številka ali zaporedna številka):
Name and address of the manufacturer and, where applicable, his authorised representative:
Ime in naslov proizvajalca ter, če je ustrezno, njegovega pooblaščenega zastopnika:
Object of the declaration (identification of the subsystem or safety component allowing traceability.
Predmet izjave (opredelitev podsistema ali varnostnega elementa, ki omogoča sledljivost.
It may, where necessary for the identification of the subsystem or safety component, include an image):
Če je to potrebno za opredelitev podsistema ali varnostnega elementa, lahko vključuje sliko):
description of the subsystem or safety component,
opis podsistema ali varnostnega elementa,
all relevant provisions with which the safety component must comply and, in particular, the conditions of use.
vse ustrezne določbe, ki jih mora izpolnjevati varnostni element, in zlasti pogoje uporabe.
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 or references to the other technical specifications in relation to which conformity is declared:
Sklici na uporabljene relevantne harmonizirane standarde ali sklici na druge tehnične specifikacije, glede na katere je izdana izjava o skladnosti.
The notified body … (name, address, number) … performed … (description of intervention) … and issued the certificate(s): … (details, including its date, and where appropriate, information on the duration and conditions of its validity).
Priglašeni organ … (ime, naslov, številka) je izvedel … (opis posega) in izdal certifikat(-e): … (podrobnosti, ki vključujejo njegov datum in, kjer je to primerno, informacije o trajanju in pogojih njegove veljavnosti).
It is optional for the manufacturer to assign a number to the declaration of conformity.
Proizvajalec lahko sam odloča o tem, ali bo izjave o skladnosti oštevilčil.
Directive 2000/9/EC
Direktiva 2000/9/ES
Article 3, points 7 to 9
Člen 3, točke 7 do 9
Article 1(4) first subparagraph
Člen 1(4), prvi pododstavek
Article 1(4) second subparagraph
Člen 1(4), drugi pododstavek
Article 1(4) third subparagraph
Člen 1(4), tretji pododstavek
Article 3, points 1, 3 to 6
Člen 3, točke 1, 3 do 6
Article 3, points 10 to 27
Člen 3, točke 10 do 27
Article 4 and Article 5(1)
Člen 4 in Člen 5(1)
Articles 18 to 21
Členi 18 do 21
Article 11(6) and (7)
Člen 11(6) in (7)
Articles 11 to 16
Členi 11 do 16
Articles 39 to 43
Členi 39 do 43
Articles 22 to 38
Členi 22 do 38
Annexes III to VII
Priloge III do VII
Regulation (EU) 2016/425 of the European Parliament and of the Council
Uredba (EU) 2016/425 Evropskega parlamenta in Sveta
on personal protective equipment and repealing Council Directive 89/686/EEC
o osebni varovalni opremi in razveljavitvi Direktive Sveta 89/686/EGS
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,
Council Directive 89/686/EEC [3] was adopted in the context of establishing the internal market, in order to harmonise health and safety requirements for personal protective equipment (PPE) in all Member States and to remove obstacles to trade in PPE between Member States.
Direktiva Sveta 89/686/EGS [3] je bila sprejeta v okviru vzpostavitve notranjega trga, da se uskladijo zdravstvene in varnostne zahteve za osebno varovalno opremo v vseh državah članicah ter odstranijo ovire pri trgovanju z osebno varovalno opremo med državami članicami.
Directive 89/686/EEC 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 89/686/EGS temelji na načelih novega pristopa, kakor je določeno v Resoluciji Sveta z dne 7. maja 1985 o novem pristopu k tehnični uskladitvi in standardom [4].
Thus, it sets only the essential requirements applying to PPE, 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 osebno varovalno opremo, 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 89/686/EEC.
Skladnost s tako določenimi harmoniziranimi standardi, katerih referenčne številke so objavljene v Uradnem listu Evropske unije, zagotavlja domnevo o skladnosti z zahtevami Direktive 89/686/EGS.
Experience has shown that those basic principles have worked well in that sector and should be maintained and even further promoted.
Izkušnje kažejo, da so navedena osnovna načela v tem sektorju učinkovita ter da bi jih bilo treba ohraniti in celo še bolj spodbujati.
Experience with the application of Directive 89/686/EEC has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures.
Izkušnje pri izvajanju Direktive 89/686/EGS so pokazale nedoslednosti in pomanjkljivosti glede zajetih proizvodov in postopkov za ugotavljanje skladnosti.
In order to take account of that experience and to provide clarification in relation to the framework within which products covered by this Regulation may be made available on the market, certain aspects of Directive 89/686/EEC should be revised and enhanced.
Da bi upoštevali te izkušnje in pojasnili okvir, znotraj katerega se lahko omogoči dostopnost na trgu proizvodov, ki jih zajema ta uredba, bi bilo treba določene vidike Direktive 89/686/EGS revidirati in izboljšati.
Since the scope, the essential health and safety requirements and conformity assessment procedures have to be identical in all the Member States there is almost no flexibility in transposing a directive based on the new approach principles into national law.
Obseg, bistvene zdravstvene in varnostne zahteve ter postopki ugotavljanja skladnosti morajo biti enaki v vseh državah članicah, zato države članice nimajo skoraj nobene prožnosti pri prenosu direktive, ki temelji na načelih novega pristopa, v nacionalno pravo.
Directive 89/686/EEC should therefore be replaced by a regulation, which is the appropriate legal instrument for imposing clear and detailed rules which do not give room for divergent transposition by Member States.
Direktivo 89/686/EGS bi bilo treba zato nadomestiti z uredbo, ki je ustrezen pravni instrument za uvedbo jasnih in podrobnih pravil, ki državam članicam ne omogočajo različnih prenosov.
Regulation (EC) No 765/2008 of the European Parliament and of the Council [6] lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.
Uredba (ES) št. 765/2008 Evropskega parlamenta in Sveta [6] določa pravila o akreditaciji organov za ugotavljanje skladnosti, zagotavlja okvir za nadzor trga proizvodov in kontrole proizvodov iz tretjih držav ter določa splošna načela glede uporabe oznake CE.
Decision No 768/2008/EC of the European Parliament and of the Council [7] lays down common principles and reference provisions intended to apply across sectoral legislation.
Sklep št. 768/2008/ES Evropskega parlamenta in Sveta [7] določa skupna načela in referenčne določbe, ki naj bi se uporabljale v sektorski zakonodaji.
In order to ensure consistency with other sectoral product legislation, it is appropriate to align certain provisions of this Regulation to that Decision, in so far as sectoral specificities do not require a different solution.
Za zagotavljanje usklajenosti z drugo sektorsko zakonodajo za proizvode je nekatere določbe te uredbe treba ustrezno uskladiti z navedenim sklepom, v kolikor sektorske specifičnosti ne zahtevajo drugačnih rešitev.
Therefore, certain definitions, the general obligations of economic operators, the presumption of conformity, EU declaration of conformity, rules on CE marking, requirements for conformity assessment bodies and notification procedures, the conformity assessment procedures and the provisions concerning procedures to deal with PPE presenting a risk should be adapted to that Decision.
Zato bi bilo treba določene opredelitve pojmov, splošne obveznosti gospodarskih subjektov, domnevo o skladnosti, izjavo EU o skladnosti, pravila za uporabo oznake CE, zahteve glede organov za ugotavljanje skladnosti in priglasitvenih postopkov, postopke za ugotavljanje skladnosti ter določbe o postopkih, ki so povezani z osebno varovalno opremo, ki predstavlja tveganje, prilagoditi navedenemu sklepu.
Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Regulation.
Uredba (EU) št. 1025/2012 določa postopek za pripombe k harmoniziranim standardom, kadar navedeni standardi ne izpolnjujejo zahtev iz te uredbe v celoti.
This Regulation covers PPE which is new to the Union market when it is placed on the market; that is to say it is either new PPE made by a manufacturer established in the Union or PPE, whether new or second-hand, imported from a third country.
V tej uredbi je zajeta osebna varovalna oprema, ki je v trenutku, ko je dana na trg, nova na trgu Unije; to pomeni, da gre bodisi za novo osebno varovalno opremo, ki jo je izdelal proizvajalec s sedežem v Uniji, bodisi za novo ali rabljeno osebno varovalno opremo, uvoženo iz tretje države.
This Regulation should apply to all forms of supply, including distance selling.
To uredbo bi bilo treba uporabljati za vse vrste dobave, vključno s prodajo na daljavo.
Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC.
Nekateri proizvodi na trgu, ki uporabnikom zagotavljajo zaščitno funkcijo, so izvzeti iz področja uporabe Direktive 89/686/EGS.
In order to ensure as high a level of protection for the user of those products as for the user of PPE covered by Directive 89/686/EEC, the scope of this Regulation should include PPE for private use against heat, in line with similar PPE for professional use which is already covered by Directive 89/686/EEC.
Da se za uporabnike navedenih proizvodov zagotovi enako visoka raven zaščite kot za uporabnike osebne varovalne opreme, zajete v Direktivi 89/686/EGS, bi bilo treba v področje uporabe te uredbe vključiti osebno varovalno opremo za zasebno rabo, namenjeno zaščiti pred vročino, v skladu s podobno osebno varovalno opremo za profesionalno rabo, ki je že zajeta v Direktivi 89/686/EGS.
Artisanal decorative products do not claim to fulfil a protective function, are by definition not personal protective equipment and are therefore not concerned by that inclusion.
Na okrasnih obrtniških proizvodih ni navedeno, da izpolnjujejo zaščitno funkcijo, in po definiciji niso osebna varovalna oprema, zato zanje navedena vključitev ne velja.
Clothing intended for private use with reflective or fluorescent elements included for reasons of design or decoration is not personal protective equipment and is therefore not covered by this Regulation.
Oblačila, namenjena za zasebno uporabo, z odsevnimi ali fluorescentnimi elementi, dodanimi zaradi oblikovanja ali okrasa, niso osebna varovalna oprema in zato niso zajeta v tej uredbi.
As for products intended for private use to protect against atmospheric conditions that are not of an extreme nature or to protect against damp and water, including but not limited to seasonal clothing, umbrellas and dishwashing gloves, those should also fall outside of the scope of this Regulation.
Proizvodi, namenjeni za zasebno uporabo za zaščito v atmosferskih pogojih, ki niso ekstremni, ali za zaščito pred vlago in vodo, ki med drugim vključujejo sezonska oblačila, dežnike in rokavice za pomivanje posode, tudi ne bi smeli biti zajeti v področje uporabe te uredbe.
It is also appropriate to clarify the list of excluded PPE set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore excluded from the scope of this Regulation.
Primerno je tudi pojasniti seznam izvzete osebne varovalne opreme iz Priloge I k Direktivi 89/686/EGS, in sicer tako, da se doda sklicevanje na proizvode, ki jih zajema druga zakonodaja in so zato izvzeti iz področja uporabe te uredbe.
Economic operators should be responsible for the compliance of PPE with the requirements of this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of users, and to guarantee fair competition on the Union market.
Gospodarski subjekti bi morali biti v skladu s svojo vlogo v dobavni verigi odgovorni za to, da osebna varovalna oprema izpolnjuje zahteve iz te uredbe, da se zagotovijo visoka raven zaščite javnih interesov, kot sta zdravje in varnost, ter zaščita uporabnikov in poštena konkurenca na trgu Unije.
All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only PPE which is in conformity with this Regulation.
Vsi gospodarski subjekti, ki sodelujejo v dobavni in distribucijski verigi, bi morali sprejeti ustrezne ukrepe, s katerimi se zagotovi, da je na trgu dostopna samo osebna varovalna oprema, ki je skladna s to uredbo.
This Regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.
Ta uredba bi morala določiti jasno in sorazmerno porazdelitev obveznosti glede na vlogo posameznega gospodarskega subjekta v dobavni in distribucijski verigi.
In order to facilitate communication between economic operators, national market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.
Za lažjo komunikacijo med gospodarskimi subjekti, nacionalni organi za nadzor trga in potrošniki bi morale države članice spodbuditi gospodarske subjekte, da poleg poštnega naslova vključijo tudi spletni naslov.
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure.
Proizvajalec, ki podrobno pozna postopek načrtovanja in proizvodnje, je zato najustreznejši za izvedbo postopka ugotavljanja skladnosti.
Conformity assessment should therefore remain solely the obligation of the manufacturer.
Postopek ugotavljanja skladnosti bi moral torej ostati izključno obveznost proizvajalca.
It is necessary to ensure that PPE from third countries entering the Union market complies with the requirements of this Regulation and, in particular, that appropriate conformity assessment procedures have been carried out by manufacturers.
Nujno je treba zagotoviti, da osebna varovalna oprema iz tretjih držav, ki vstopa na trg Unije, izpolnjuje zahteve iz te uredbe, zlasti pa, da so proizvajalci izvedli ustrezne postopke za ugotavljanje skladnosti.
Provision should therefore be made for importers to make sure that PPE they place on the market complies with the requirements of this Regulation and that they do not place on the market PPE which does not comply with such requirements or which present a risk.
Zato bi bilo treba določiti, da morajo uvozniki zagotoviti, da osebna varovalna oprema, ki jo dajejo na trg, izpolnjuje zahteve iz te uredbe, in da na trg ne dajejo osebne varovalne opreme, ki ne izpolnjuje teh zahtev ali pomeni tveganje.
Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities.
Določiti bi bilo treba tudi, da morajo uvozniki zagotoviti, da so bili opravljeni postopki ugotavljanja skladnosti ter da sta oznaka CE in tehnična dokumentacija, ki jo pripravijo proizvajalci, na voljo pristojnim nacionalnim organom za pregled.
The distributor makes PPE available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of PPE does not adversely affect the compliance of the PPE.
Distributer omogoča dostopnost osebne varovalne opreme na trgu, potem ko jo na trg da proizvajalec ali uvoznik, ter mora delovati skrbno in zagotoviti, da njegovo ravnanje z osebno varovalno opremo ne vpliva negativno na skladnost osebne varovalne opreme.
When placing PPE on the market, every importer should indicate on the PPE his name, registered trade name or registered trade mark and the postal address at which he can be contacted.
Pri dajanju osebne varovalne opreme na trg bi moral vsak uvoznik na tej opremi navesti svoje ime, registrirano trgovsko ime ali registrirano blagovno znamko in poštni naslov, na katerem je dosegljiv.
Exceptions should be provided for in cases where the size or nature of the PPE does not allow it.
Izjema bi morali biti primeri, v katerih velikost ali narava osebne varovalne opreme tega ne omogočata.
This includes cases where the importer would have to open the packaging to put his name and address on the PPE.
To vključuje primere, v katerih bi moral uvoznik odpreti embalažo, da bi lahko na osebni varovalni opremi navedel svoje ime in naslov.
Efforts should be made by economic operators to ensure that all relevant documentation, such as the user's instructions, whilst ensuring precise and comprehensible information, are easily understandable, take into account technological developments and changes to end-user behaviour, and are as up to date as possible.
Gospodarski subjekti bi si morali prizadevati za to, da bi bili natančnost in jasnost informacij zagotovljeni v vsej zadevni dokumentaciji, na primer v navodilih za uporabnike, ter da bi bila obenem ta dokumentacija vsem razumljiva, da bi upoštevala tehnološki razvoj in spremembe ravnanja končnega uporabnika in bila kar se da posodobljena.
When PPE is made available on the market in packages containing multiple units, the instructions and information should accompany each smallest commercially available unit.
Ko je osebna varovalna oprema na trgu dostopna v embalaži, ki vsebuje več enot, morajo biti vsaki najmanjši enoti, ki je na voljo na trgu, priložena navodila in informacije.
Any economic operator who either places PPE on the market under his own name or trademark or modifies a product in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
Vsak gospodarski subjekt, ki da osebno varovalno opremo na trg pod svojim imenom ali blagovno znamko ali spremeni izdelek na tak način, da vpliva na izpolnjevanje zahtev iz te uredbe, bi bilo treba šteti za proizvajalca in bi moral prevzeti obveznosti proizvajalca.
Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the PPE concerned.
Distributerji in uvozniki, ki so blizu trga, bi morali biti vključeni v naloge nadzora trga, ki jih izvajajo pristojni nacionalni organi, in bi morali biti pripravljeni na dejavno udeležbo ter zagotoviti tem organom vse potrebne informacije v zvezi z zadevno osebno varovalno opremo.
Ensuring traceability of PPE throughout the whole supply chain helps to make market surveillance simpler and more efficient.
Zagotavljanje sledljivosti osebne varovalne opreme skozi celotno dobavno verigo pomaga pri oblikovanju preprostejšega in učinkovitejšega nadzora trga.
An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant PPE available on the market.
Učinkovit sistem sledljivosti organom za nadzor trga omogoča izsleditev gospodarskega subjekta, ki je omogočil dostopnost neskladne osebne varovalne opreme na trgu.