natgillin/translations-raw huggingface dataset:
Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary.
Organi za ugotavljanje skladnosti za svoje dejavnosti, povezane z ugotavljanjem skladnosti, pogosto najemajo podizvajalce ali te dejavnosti prenesejo na odvisno družbo.
In order to safeguard the level of protection required for the PPE to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks.
Za ohranitev ravni zaščite, ki se zahteva za osebno varovalno opremo, ki bo dana na trg, je za izvajanje nalog ugotavljanja skladnosti bistveno, da podizvajalci in odvisne družbe izpolnjujejo iste zahteve kot priglašeni organi v zvezi z izvajanjem nalog ugotavljanja skladnosti.
Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries.
Zato je pomembno, da ocenjevanje usposobljenosti in delovanja organov, ki bodo priglašeni, ter spremljanje organov, ki so že bili priglašeni, vključuje tudi dejavnosti podizvajalcev in odvisnih družb.
Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body.
Glede na to, da priglašeni organi svoje storitve lahko ponujajo na celotnem ozemlju Unije, je primerno državam članicam in Komisiji dati priložnost, da izrazijo svoje pripombe glede priglašenega organa.
It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.
Zato je treba določiti obdobje, v katerem se lahko razjasnijo vsi dvomi ali pomisleki glede usposobljenosti organov za ugotavljanje skladnosti, preden začnejo delovati kot priglašeni organi.
In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators.
Za namene konkurenčnosti je ključno, da priglašeni organi uporabljajo postopke ugotavljanja skladnosti tako, da s tem gospodarskim subjektom ne ustvarijo nepotrebnega bremena.
That can best be achieved through appropriate coordination and cooperation between notified bodies.
To je mogoče najbolje doseči z ustreznim usklajevanjem in sodelovanjem priglašenih organov.
Interested parties should have the right to appeal against the result of a conformity assessment carried out by a notified body.
Zainteresirane strani bi morale imeti pravico, da se pritožijo zoper rezultate ugotavljanja skladnosti, ki ga opravi priglašeni organ.
For that reason, it is important to ensure that an appeal procedure against decisions taken by notified bodies is available.
Zato je pomembno zagotoviti, da je na voljo pritožbeni postopek zoper odločitve priglašenih organov.
Member States should take all appropriate measures to ensure that PPE covered by this Regulation may be placed on the market only if, when properly stored and used for its intended purpose, or under conditions of use which can be reasonably foreseen, it does not endanger the health or safety of persons.
Države članice bi morale sprejeti vse ustrezne ukrepe, s katerimi zagotovijo, da se lahko osebna varovalna oprema, zajeta v tej uredbi, da na trg le, če pri ustreznem skladiščenju in uporabi za predvideni namen ali v razmerah uporabe, ki jih je mogoče razumno predvideti, ne ogroža zdravja ali varnosti ljudi.
PPE covered by this Regulation should be considered as non-compliant with the essential health and safety requirements laid down in this Regulation only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.
Za osebno varovalno opremo, zajeto v tej uredbi, bi bilo treba šteti, da ne izpolnjuje bistvenih zdravstvenih in varnostnih zahtev iz te uredbe le v razmerah uporabe, ki jih je mogoče razumno predvideti, to je, ko bi njena uporaba lahko sledila iz zakonitega in lahko predvidljivega človekovega ravnanja.
In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to PPE covered by this Regulation.
Za zagotovitev pravne varnosti je treba pojasniti, da se pravila o nadzoru trga Unije in preverjanju proizvodov, ki vstopajo na trg Unije, iz Uredbe (ES) št. 765/2008 uporabljajo za osebno varovalno opremo, zajeto v tej uredbi.
Directive 89/686/EEC already provides for a safeguard procedure which is necessary to allow for the possibility of contesting the conformity of a product.
Direktiva 89/686/EGS že določa zaščitni postopek, ki je potreben, da se omogoči spodbijanje skladnosti proizvoda.
In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States.
Da bi se povečala preglednost in skrajšal čas postopka, je treba obstoječi zaščitni postopek izboljšati v smeri povečanja njegove učinkovitosti in črpanja iz obstoječega strokovnega znanja v državah članicah.
The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to PPE presenting a risk to the health or safety of persons.
Obstoječo ureditev bi bilo treba dopolniti s postopkom, ki zainteresiranim stranem omogoča, da so obveščene o ukrepih, ki se nameravajo izvajati v povezavi z osebno varovalno opremo, ki predstavlja tveganje za zdravje ali varnost ljudi.
It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such PPE.
Organom za nadzor trga bi tudi moral omogočati, da v sodelovanju z ustreznimi gospodarskimi subjekti glede takšne osebne varovalne opreme ukrepajo v zgodnejši fazi.
Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.
Kadar se države članice in Komisija strinjajo glede upravičenosti ukrepa, ki ga sprejme država članica, nadaljnja udeležba Komisije ni potrebna, razen kadar je neskladnost posledica pomanjkljivosti harmoniziranega standarda.
In order to take into account technical progress and knowledge or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the categories of risks against which the PPE is intended to protect users.
Da bi upoštevali tehnični napredek in znanje ali nove znanstvene dokaze, bi bilo treba na Komisijo prenesti pooblastilo za sprejetje aktov v skladu s členom 290 Pogodbe o delovanju Evropske unije v zvezi s spremembo kategorije nevarnosti, pred katerimi naj bi osebna varovalna oprema ščitila uporabnike.
The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Komisija bi morala pri pripravi in oblikovanju delegiranih aktov zagotoviti, da se zadevni dokumenti posredujejo Evropskemu parlamentu in Svetu sočasno, pravočasno in na ustrezen način.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council [9].
Ta pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta [9].
The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.
Za sprejetje izvedbenih aktov, ki od priglasitvene države članice zahtevajo sprejetje potrebnih korektivnih ukrepov v zvezi s priglašenimi organi, ki ne izpolnjujejo ali več ne izpolnjujejo zahtev za svojo priglasitev, bi se moral uporabljati svetovalni postopek.
The examination procedure should be used for the adoption of implementing acts with respect to compliant PPE which presents a risk to the health or safety of persons or to other aspects of public interest protection.
Za sprejetje izvedbenih aktov v zvezi s skladno osebno varovalno opremo, ki predstavlja tveganje za zdravje in varnost ljudi ali za druge vidike varovanja javnega interesa, bi se moral uporabljati postopek pregleda.
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant PPE which presents a risk to the health or safety of persons, imperative grounds of urgency so require.
Komisija bi morala sprejeti izvedbene akte, ki se začnejo uporabljati takoj, kadar je to potrebno iz izredno nujnih razlogov v ustrezno utemeljenih primerih v zvezi s skladno osebno varovalno opremo, ki predstavlja tveganje za zdravje ali varnost ljudi.
In line with established practice, the committee set up by this Regulation can play a useful role in examining matters concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
Odbor, ustanovljen s to uredbo, ima lahko v skladu z uveljavljeno prakso koristno vlogo pri preučitvi vprašanj v zvezi z uporabo te uredbe, ki jih zastavi njegov predsednik ali predstavnik države članice v skladu s poslovnikom odbora.
When matters relating to this Regulation, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.
Kadar skupina strokovnjakov Komisije preučuje vprašanja v zvezi s to uredbo, ki niso njeno izvajanje ali kršitve, bi moral Evropski parlament v skladu z obstoječo prakso prejeti vse informacije in popolno dokumentacijo ter, kadar je to ustrezno, povabilo k udeležbi na takšnih sestankih.
The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant PPE are justified or not.
Komisija bi morala z izvedbenimi akti in glede na njihov poseben značaj brez uporabe Uredbe (EU) št. 182/2011 določiti, ali so ukrepi, ki jih izvajajo države članice v zvezi z neskladnimi proizvodi, upravičeni ali ne.
In order to allow manufacturers and other economic operators sufficient time to adapt to the requirements of this Regulation, it is necessary to provide for a sufficient transitional period after the entry into force of this Regulation during which PPE which complies with Directive 89/686/EEC may still be placed on the market.
Da se proizvajalcem in drugim gospodarskim subjektom zagotovi dovolj časa za prilagoditev zahtevam iz te uredbe, je treba predvideti dovolj dolgo prehodno obdobje po začetku veljavnosti te uredbe, v katerem se osebna varovalna oprema, skladna z Direktivo 89/686/EGS, še vedno lahko da na trg.
Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced.
Države članice bi morale določiti pravila o kaznih, ki se uporabljajo za kršitve te uredbe in zagotoviti, da se ta pravila izvršujejo.
Since the objective of this Regulation, namely to ensure that PPE on the market fulfils the requirements providing for a high level of protection of health and safety of users, whilst guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty on European Union.
Ker cilja te uredbe, in sicer zagotavljanja, da osebna varovalna oprema na trgu izpolnjuje zahteve, ki zagotavljajo visoko raven varovanja zdravja in varnosti uporabnikov ob sočasni ohranitvi delovanja notranjega trga, države članice same ne morejo zadovoljivo doseči, temveč se zaradi njegovega obsega in učinkov lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Directive 89/686/EEC has been amended several times.
Direktiva 89/686/EGS je bila večkrat spremenjena.
Since further substantial amendments are to be made and in order to ensure a uniform implementation throughout the Union, Directive 89/686/EEC should be repealed,
Ker so potrebne nadaljnje bistvene spremembe in da se zagotovi enotno izvajanje po vsej Uniji, bi bilo treba Direktivo 89/686/EGS razveljaviti –
This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.
Ta uredba določa zahteve za načrtovanje in izdelavo osebne varovalne opreme, katere dostopnost se omogoči na trgu, da se zagotovi varovanje zdravja in varnosti uporabnikov ter določijo pravila o prostem pretoku osebne varovalne opreme v Uniji.
This Regulation applies to PPE.
Ta uredba se uporablja za osebno varovalno opremo.
This Regulation does not apply to PPE:
Ta uredba se ne uporablja za osebno varovalno opremo, ki je:
specifically designed for use by the armed forces or in the maintenance of law and order;
posebej načrtovana za uporabo v oboroženih silah ali pri ohranjanju reda in miru;
designed to be used for self-defence, with the exception of PPE intended for sporting activities;
načrtovana za samoobrambo, razen osebne varovalne opreme, namenjene za športne dejavnosti;
designed for private use to protect against:
načrtovana za zasebno uporabo za zaščito pred:
atmospheric conditions that are not of an extreme nature,
atmosferskimi pogoji, ki niso ekstremni;
damp and water during dishwashing;
vlago in vodo med pomivanjem posode;
for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
namenjena izključno za uporabo na morskih ali zračnih plovilih, za katera veljajo ustrezne mednarodne pogodbe, ki se uporabljajo v državah članicah;
for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.
namenjena za zaščito glave, obraza ali oči uporabnikov, ki jo zajema Pravilnik št. 22 Ekonomske komisije Združenih narodov za Evropo o enotnih določbah glede odobritve varovalnih čelad in njihovih vizirjev za voznike motornih koles in koles z motorjem ter njihove sopotnike.
‘personal protective equipment’ (PPE) means:
„osebna varovalna oprema“ pomeni:
equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
opremo, ki je načrtovana in izdelana tako, da jo oseba nosi ali drži zaradi varovanja pred eno ali več nevarnostmi za njeno zdravje ali varnost;
interchangeable components for equipment referred to in point (a) which are essential for its protective function;
zamenljive sestavne dele za opremo iz točke (a), ki so bistveni za njeno varovalno funkcijo;
connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;
priključne sisteme za opremo iz točke (a), ki jih oseba ne nosi ali drži, ki so načrtovani za povezavo te opreme z zunanjo napravo ali z zanesljivo zunanjo točko pritrditve, ki niso načrtovani tako, da bi bili trajno pritrjeni, in ki pred uporabo ne zahtevajo pritrjevanja;
‘making available on the market’ means any supply of PPE for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
„omogočanje dostopnosti na trgu“ pomeni vsako dobavo osebne varovalne opreme za distribucijo ali uporabo na trgu Unije v okviru gospodarske dejavnosti, bodisi v zameno za plačilo bodisi brezplačno;
‘placing on the market’ means the first making available of PPE on the Union market;
„dajanje na trg“ pomeni, da je prvič omogočena dostopnost osebne varovalne opreme na trgu Unije;
‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;
„proizvajalec“ pomeni vsako fizično ali pravno osebo, ki izdeluje osebno varovalno opremo ali za katero se ta oprema načrtuje ali izdeluje in ki jo trži pod svojim imenom ali blagovno znamko;
‘importer’ means any natural or legal person established within the Union who places PPE from a third country on the Union market;
„uvoznik“ pomeni vsako fizično ali pravno osebo s sedežem v Uniji, ki da osebno varovalno opremo iz tretje države na trg Unije;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market;
„distributer“ pomeni vsako fizično ali pravno osebo v dobavni verigi, razen proizvajalca ali uvoznika, ki omogoči dostopnost osebne varovalne opreme na trgu;
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;
„tehnična specifikacija“ pomeni dokument, ki določa tehnične zahteve, ki jih mora izpolnjevati osebna varovalna oprema;
‘harmonised standard’ means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
„harmonizirani standard“ pomeni harmonizirani standard, kakor je opredeljen v točki (c) točke 1 člena 2 Uredbe (EU) št. 1025/2012;
‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
„akreditacija“ pomeni akreditacijo, kakor je opredeljena v točki 10 člena 2 Uredbe (ES) št. 765/2008;
‘national accreditation body’ means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
„nacionalni akreditacijski organ“ pomeni nacionalni akreditacijski organ, kakor je opredeljen v točki 11 člena 2 Uredbe (ES) št. 765/2008;
‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;
„ugotavljanje skladnosti“ pomeni proces ugotavljanja, ali so izpolnjene bistvene zdravstvene in varnostne zahteve iz te uredbe v zvezi z osebno varovalno opremo;
‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;
„odpoklic“ pomeni vsak ukrep za vrnitev osebne varovalne opreme, katere dostopnost je že bila omogočena končnemu uporabniku;
‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;
„umik“ pomeni vsak ukrep za preprečitev, da bi bila na trgu omogočena dostopnost osebne varovalne opreme iz dobavne verige;
‘CE marking’ means a marking by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.
„oznaka CE“ pomeni oznako, s katero proizvajalec izjavlja, da je osebna varovalna oprema skladna z veljavnimi zahtevami iz harmonizacijske zakonodaje Unije, ki določa njeno namestitev.
PPE shall only be made available on the market if, where properly maintained and used for its intended purpose, it complies with this Regulation and does not endanger the health or safety of persons, domestic animals or property.
Dostopnost osebne varovalne opreme na trgu se omogoči le, če je ob pravilnem vzdrževanju ter predvideni uporabi skladna s to uredbo ter ne ogroža zdravja ali varnosti ljudi in domačih živali ali varnosti premoženja.
PPE shall meet the essential health and safety requirements set out in Annex II which apply to it.
Osebna varovalna oprema izpolnjuje bistvene zdravstvene in varnostne zahteve, ki so določene v Prilogi II in se uporabljajo zanjo.
Provisions concerning the use of PPE
Določbe v zvezi z uporabo osebne varovalne opreme
This Regulation shall not affect Member States' entitlement, in particular when implementing Directive 89/656/EEC, to lay down requirements concerning the use of PPE, provided that those requirements do not affect the design of PPE which is placed on the market in accordance with this Regulation.
Ta uredba ne vpliva na pravico držav članic, da zlasti pri izvajanju Direktive 89/656/EGS določijo zahteve glede uporabe osebne varovalne opreme, pod pogojem, da te zahteve ne vplivajo na načrtovanje osebne varovalne opreme, ki se da na trg v skladu s to uredbo.
Member States shall not impede, for the aspects covered by this Regulation, the making available on the market of PPE which complies with this Regulation.
Države članice iz razlogov, povezanih z vidiki iz te uredbe, ne ovirajo omogočanja dostopnosti osebne varovalne opreme, ki je skladna s to uredbo, na trgu.
At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent the showing of PPE which does not comply with this Regulation, provided that a visible sign clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.
Na sejmih, razstavah in predstavitvah ali podobnih dogodkih države članice ne preprečujejo prikazovanja osebne varovalne opreme, ki ni skladna s to uredbo, če oznaka na vidnem mestu jasno kaže na njeno neskladnost s to uredbo in na to, da ne bo dostopna na trgu, dokler ne bo usklajena.
During demonstrations, adequate measures shall be taken to ensure the protection of persons.
Med predstavitvami opreme se sprejmejo ustrezni ukrepi za zagotovitev varnosti ljudi.
When placing PPE on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II.
Proizvajalci pri dajanju osebne varovalne opreme na trg zagotovijo, da je bila načrtovana in izdelana v skladu z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami iz Priloge II.
Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out.
Proizvajalci pripravijo tehnično dokumentacijo iz Priloge III (v nadaljnjem besedilu: tehnična dokumentacija) ter izvedejo ustrezni postopek ugotavljanja skladnosti iz člena 19 ali za njegovo izvedbo pooblastijo tretjo osebo.
Where compliance of PPE with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, manufacturers shall draw up the EU declaration of conformity referred to in Article 15 and affix the CE marking referred to in Article 16.
Kadar je bilo z ustreznim postopkom dokazano, da je osebna varovalna oprema skladna z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami, proizvajalci pripravijo izjavo EU o skladnosti iz člena 15 in namestijo oznako CE iz člena 16.
Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market.
Proizvajalci hranijo tehnično dokumentacijo in izjavo EU o skladnosti še deset let po tem, ko je bila osebna varovalna oprema dana na trg.