natgillin/translations-raw huggingface dataset:
Both the substitution of lead in PVC sensor cards for in-vitro diagnostic medical devices for blood, body fluid and body gas analysis and the elimination of lead via substitution of PVC in these applications are technically impracticable.
Tako nadomestitev svinca v senzorskih karticah PVC za diagnostične medicinske pripomočke in vitro za analize krvi, telesnih tekočin in telesnih plinov kot odstranitev svinca z nadomestitvijo PVC v teh uporabah tehnično nista izvedljiva.
In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.
SPREJELA NASLEDNJO DIREKTIVO:
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje zadnji dan devetega meseca po začetku njene veljavnosti.
Article 2
Besedilo teh določb takoj sporočijo Komisiji.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the last day of the ninth month after entry into force at the latest.
Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.
Države članice sporočijo Komisiji besedila temeljnih določb predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
Article 4
V Bruslju, 30. januarja 2015
OJ L 174, 1.7.2011, p. 88.
V Prilogi IV k Direktivi 2011/65/EU se doda točka 41:
ANNEX
Svinec kot termični stabilizator v polivinilkloridu (PVC), ki se uporablja kot osnovni material v amperometričnih, potenciometričnih in konduktometričnih elektrokemičnih senzorjih za diagnostične in vitro medicinske pripomočke za analize krvi, telesnih tekočin in telesnih plinov.
In Annex IV to Directive 2011/65/EU, the following point 41 is added:
Preneha veljati 31. decembra 2018.“
Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.
Uporabo svinca v senzorjih PVC za analize krvi, telesnih tekočin in telesnih plinov, ki se uporabljajo za diagnostične in vitro medicinske pripomočke bi bilo zato treba izvzeti od prepovedi do 31. decembra 2018.
Expires on 31 December 2018.’
Glede na inovacijske cikle pri medicinskih pripomočkih je to kratko prehodno obdobje, ki zelo verjetno ne bo negativno vplivalo na inovacije.
amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for mercury in intravascular ultrasound imaging systems
o spremembi Priloge IV k Direktivi 2011/65/EU Evropskega parlamenta in Sveta glede izjeme za uporabo živega srebra v sistemih intravaskularnega ultrazvočnega slikanja zaradi prilagoditve tehničnemu napredku
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment [1], and in particular Article 5(1)(a) thereof,
ob upoštevanju Direktive 2011/65/EU Evropskega parlamenta in Sveta z dne 8. junija 2011 o omejevanju uporabe nekaterih nevarnih snovi v električni in elektronski opremi [1] ter zlasti člena 5(1)(a) Direktive,
Mercury is used in electric rotating connectors in medical devices for intravascular ultrasound imaging.
Živo srebro se uporablja v električnih vrtečih se konektorjih v medicinskih pripomočkih za intravaskularno ultrazvočno slikanje.
Substitution of mercury or of the specific component would shorten product life or impair performance significantly.
Nadomestitev živega srebra ali posebnih sestavnih delov bi skrajšalo življenjsko dobo proizvoda ali znatno škodovalo njegovemu delovanju.
Both the substitution of mercury in the connector and the elimination of mercury via substitution of the connector or the device are technically impracticable or have negative overall impacts due to an impact on patients' health.
Nadomestitev živega srebra v konektorjih in odprava živega srebra z zamenjavo priključka ali naprave tehnično ni izvedljiva ali ima splošno negativne učinke zaradi vpliva na zdravje pacientov.
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje zadnji dan devetega meseca po začetku veljavnosti.
For the Commission
UL L 174, 1.7.2011, str. 88.
OJ L 174, 1.7.2011, p. 88.
V Prilogi IV k Direktivi 2011/65/EU se doda točka 42:
ANNEX
Živo srebro v električnih vrtečih se konektorjih v medicinskih pripomočkih za intravaskularno ultrazvočno slikanje, ki se lahko uporabljajo pri visoki delovni frekvenci (> 50 MHz) delovanja
In Annex IV to Directive 2011/65/EU, the following point 42 is added:
Preneha veljati 30. junija 2019“
Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.
Uporabo živega srebra v električnih vrtečih se konektorjih v medicinskih pripomočkih za intravaskularno ultrazvočno slikanje, ki se lahko uporabljajo pri visoki delovni frekvenci delovanja (> 50 MHz), bi bilo zato treba izvzeti od prepovedi do 30. junija 2019.
Expires on 30 June 2019.’
Glede na inovacijske cikle pri medicinskih pripomočkih je to kratko prehodno obdobje, ki zelo verjetno ne bo negativno vplivalo na inovacije.
Council Directive (EU) 2015/637
Direktiva Sveta (EU) 2015/637
on the coordination and cooperation measures to facilitate consular protection for unrepresented citizens of the Union in third countries and repealing Decision 95/553/EC
o ukrepih za usklajevanje in sodelovanje, potrebnih za lažje zagotavljanje konzularne zaščite državljanom Unije brez predstavništva v tretjih državah in o razveljavitvi Sklepa 95/553/ES
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 23 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 23 Pogodbe,
Citizenship of the Union is the fundamental status of nationals of the Member States.
Državljanstvo Unije je temeljni status državljanov držav članic.
The right to enjoy, in the territory of a third country in which the Member State of which they are nationals is not represented, the protection of the diplomatic and consular authorities of another Member State on the same conditions as the nationals of that State is one of the specific rights that point (c) of Article 20(2) of the Treaty on the Functioning of the European Union (TFEU) grants to citizens of the Union.
Pravica državljanov Unije na ozemlju tretje države, v kateri država članica, katere državljani so, nima predstavništva, do zaščite diplomatskih in konzularnih organov druge države članice pod enakimi pogoji, kakršni veljajo za državljane te države, je ena od posebnih pravic, ki jo državljanom Unije zagotavlja točka (c) člena 20(2) Pogodbe o delovanju Evropske unije (PDEU).
The Treaty of Lisbon reinforced the status of citizenship of the Union and strengthened the rights attached to it.
Lizbonska pogodba je okrepila status državljanstva Unije in z njim povezane pravice.
Article 23 TFEU thus provides for the adoption of directives establishing the cooperation and coordination measures necessary to facilitate consular protection for unrepresented citizens of the Union.
Člen 23 PDEU določa sprejetje direktiv o določitvi ukrepov za sodelovanje in usklajevanje, potrebnih za lažje zagotavljanje konzularne zaščite za državljane Unije brez predstavništva.
The values on which the Union is founded include solidarity, non-discrimination and respect for human rights; in its relations with the wider world the Union should uphold its values and contribute to the protection of its citizens.
Med vrednotami, na katerih temelji Unija, so solidarnost, nediskriminacija in spoštovanje človekovih pravic; v odnosih s preostalim svetom bi morala Unija podpirati svoje vrednote in prispevati k zaščiti svojih državljanov.
The fundamental right to consular protection of unrepresented citizens of the Union under the same conditions as nationals, enshrined in Article 46 of the Charter of Fundamental Rights of the European Union (the Charter), is an expression of European solidarity.
Temeljna pravica državljanov Unije brez predstavništva do konzularne zaščite pod enakimi pogoji, kakršni veljajo za državljane držav s predstavništvom, zagotovljena s členom 46 Listine Evropske unije o temeljnih pravicah (v nadaljnjem besedilu: Listina), je izraz evropske solidarnosti.
It provides an external dimension to the concept of citizenship of the Union and strengthens the identity of the Union in third countries.
Konceptu državljanstva Unije zagotavlja zunanjo razsežnost in krepi identiteto Unije v tretjih državah.
The aim of this Directive is to lay down the cooperation and coordination measures necessary to further facilitate consular protection for unrepresented citizens of the Union.
Namen te direktive je določiti ukrepe za sodelovanje in usklajevanje, potrebne za še lažje zagotavljanje konzularne zaščite državljanov Unije brez predstavništva.
Those measures should enhance legal certainty as well as efficient cooperation and solidarity among consular authorities.
Takšni ukrepi bi morali izboljšati pravno varnost ter učinkovito sodelovanje in solidarnost med konzularnimi organi.
In accordance with point (c) of Article 20(2) TFEU and Article 23 TFEU, Member States should provide consular protection to unrepresented citizens on the same conditions as to their own nationals.
V skladu s točko (c) člena 20(2) PDEU in členom 23 PDEU bi morale države članice državljanom brez predstavništva konzularno zaščito zagotoviti pod enakimi pogoji, kakršni veljajo za njihove državljane.
This Directive does not affect Member States' competence to determine the scope of the protection to be provided to their own nationals.
Ta direktiva ne posega v pristojnost držav članic, da določijo obseg zaščite, ki jo zagotavljajo svojim državljanom.
This Directive does not affect consular relations between Member States and third countries, in particular their rights and obligations arising from international customs and agreements, in particular from the Convention of 24 April 1963 on Consular Relations (the Vienna Convention), that Member States apply in compliance with Union law.
Ta direktiva ne vpliva na konzularne odnose med državami članicami in tretjimi državami, še posebej ne na njihove pravice in obveznosti, ki izhajajo iz mednarodnih običajev in pogodb, zlasti Konvencije z dne 24. aprila 1963 o konzularnih odnosih (v nadaljnjem besedilu: Dunajska konvencija), ki jih države članice uporabljajo v skladu s pravom Unije.
Difficulties may occur, in particular, in relation to situations involving citizens who are also nationals of the host country.
Kadar državljani brez predstavništva potrebujejo zaščito v tretjih državah, sta potrebni učinkovito sodelovanje in usklajevanje.
Member States, supported by local consular cooperation, should undertake the necessary measures in relation to third countries to ensure that consular protection can be provided on behalf of other Member States in any given case.
Država članica, ki ima predstavništvo v tretji državi in nudi pomoč državljanu brez predstavništva, ter država članica, katere državljanstvo ima državljan, bi morali tesno sodelovati.
Where unrepresented citizens need protection in third countries, efficient cooperation and coordination is required.
Lokalno konzularno sodelovanje je lahko za državljane brez predstavništva zelo zapleteno, saj zahteva usklajevanje z organi, ki nimajo predstavništva na terenu, po potrebi tudi s pristojnimi diplomatsko-konzularnimi predstavništvi.
The assisting Member State present in a third country and the Member State of nationality of the citizen should cooperate closely.
Za zapolnitev vrzeli, ki nastane za državljana, ker njegova država članica nima diplomatsko-konzularnega predstavništva, bi bilo treba določiti jasna in trdna pravila.
Local consular cooperation in respect of unrepresented citizens can be particularly complex, as it requires coordination with authorities not represented locally, including where relevant with the competent embassies or consulates.
Za zagotovitev učinkovite zaščite je treba veljavne ukrepe tudi pojasniti.
To fill the gap caused by the absence of an embassy or consulate of the citizen's own Member State, a clear and stable set of rules should be laid down.
Za državljane Unije bi moralo veljati, da so brez predstavništva v tretji državi, če država članica, katere državljanstvo imajo, v njej nima diplomatsko-konzularnega predstavništva ali častnega konzula.
Existing measures also need to be clarified to ensure effective protection.
Prav tako bi moralo za državljane veljati, da so brez predstavništva, če lokalno diplomatsko-konzularno predstavništvo ali častni konzul zadevni osebi v določenem primeru iz katerega koli razloga ne more zagotoviti zaščite, do katere je upravičena po nacionalnem pravu ali praksi.
Citizens of the Union should be considered to be unrepresented in a third country if their Member State of nationality has no embassy, consulate or honorary consul established there.
Diplomatsko-konzularna predstavništva bi se morala med seboj obvestiti o vseh izjemnih okoliščinah, ki lahko začasno vplivajo na njihovo sposobnost za zagotavljanje konzularne zaščite.
Citizens should also be considered to be unrepresented if the embassy, consulate or honorary consul established locally is unable for any reason to provide, in a given case, the protection the person concerned would otherwise be entitled to receive according to national law or practice.
Upoštevati bi bilo treba tudi dostopnost in bližino.
Embassies and consulates should inform each other about any exceptional circumstances that may temporarily affect their capacity to provide consular protection.
Državljan, ki zaprosi za pomoč diplomatsko-konzularno predstavništvo druge države članice, denimo ne bi smel biti preusmerjen na diplomatsko-konzularno predstavništvo ali častni konzulat države članice njegovega državljanstva, če zaradi krajevnih okoliščin ali pomanjkanja virov ne more varno priti do svojega diplomatsko-konzularnega predstavništva ali častnega konzula niti oni ne morejo varno priti do njega, tako da bi lahko dobil konzularno zaščito.
Accessibility and proximity should also be taken into consideration.
Neobstoj predstavništva bi bilo treba razlagati tako, da se zagotovi učinkovito uresničevanje pravice državljanov brez predstavništva, da jih na nediskriminatoren način zaščiti diplomatsko-konzularno predstavništvo druge države članice, upoštevajoč okoliščine posameznega primera.
For example, a citizen who seeks consular protection or assistance from the embassy or consulate of another Member State should not be redirected to the embassy, consulate or honorary consul of his or her own Member State of nationality when it is not possible, due to local circumstances or lack of resources, for the citizen safely to reach or be reached by those latter instances in a way allowing him or her to receive consular protection.
Za državljane, ki imajo državljanstvo več kot ene države članice, bi moralo veljati, da so brez predstavništva, če nobena od držav članic, katerih državljani so, nima predstavništva v zadevni tretji državi.
The notion of absence of representation should be interpreted with a view to ensuring the effectiveness of the right of unrepresented citizens to be protected by another Member State's embassy or consulate in a non-discriminatory way, taking into account the circumstances of each particular case.
Da bi zagotovili učinkovito uresničevanje pravice iz točke (c) člena 20(2) PDEU in pravice do spoštovanja zasebnega in družinskega življenja iz člena 7 Listine, upoštevajoč nacionalno pravo in prakso, bo morala morda država članica, ki nudi pomoč državljanu – odvisno od okoliščin posameznega primera –, zagotoviti zaščito tudi družinskim članom državljana Unije, ki imajo državljanstvo tretje države.
Citizens holding the nationality of more than one Member State should be considered unrepresented if none of the Member States of their nationality is represented in the third country concerned.
Ta direktiva ne preprečuje državi članici, ki nudi pomoč državljanu, in državi članici, katere državljanstvo ima državljan brez predstavništva, da se med posvetovanjem, ki bi moralo potekati pred zagotovitvijo zaščite, po potrebi dogovorita o možnosti, da se družinskim članom državljana Unije brez predstavništva, ki imajo državljanstvo tretje države, zagotovi širša pomoč, kot jo določa zakonodaja države članice, ki nudi pomoč, ali kot jo narekuje njena praksa, pri čemer se, kolikor je mogoče, upoštevajo zahteve države članice, katere državljanstvo ima državljan brez zaščite, dogovorjeno pa mora biti skladno s pravom Unije.
With a view to ensuring the effectiveness of the right enshrined in point (c) of Article 20(2) TFEU and of the right to respect for private and family life as recognised in Article 7 of the Charter, and taking into account national law and practice, an assisting Member State might have to provide protection to third-country family members of citizens of the Union, depending on the individual circumstances of each case.
Vendar pa države članice družinskim članom iz tretjih držav morda ne bodo mogle zagotoviti nekaterih oblik konzularne zaščite, kot so na primer potne listine za vrnitev.
This Directive does not preclude that during the consultations which should take place before assistance is provided, the assisting Member State and the unrepresented citizen's Member State of nationality, whenever appropriate, agree on the possibility to extend assistance to third-country family members of the unrepresented Union citizen beyond what is required by the law of the assisting Member State or what is dictated by its practice, taking into account as much as possible requests from the unrepresented citizen's Member State of nationality, and in so far as what is agreed does not fall short of what is required by Union law.
Kadar se zagotavlja pomoč mladoletnikom, bi bilo treba upoštevati predvsem koristi otroka v skladu s členom 24 Listine in kot so določene v Konvenciji Združenih narodov o otrokovih pravicah z dne 20. novembra 1989.
However, Member States might not be in a position to deliver certain types of consular protection, such as emergency travel documents, to third-country family members.
Državljani brez predstavništva bi morali imeti možnost zaprositi za konzularno zaščito na diplomatsko-konzularnem predstavništvu katere koli države članice.
Where assistance for minors is concerned, the best interests of the child should be a primary consideration, in accordance with Article 24 of the Charter, and as provided for in the United Nations Convention on the Rights of the Child of 20 November 1989.
Vendar to ne bi smelo preprečevati državam članicam, da se dogovorijo o praktičnih ureditvah, da bi si porazdelile odgovornost za zagotavljanje konzularne zaščite državljanom brez predstavništva v skladu s to direktivo.
Unrepresented citizens should be able to seek consular protection from the embassy or consulate of any Member State.
Takšne ureditve koristijo državljanom, saj omogočajo boljšo pripravljenost za zagotavljanje učinkovite zaščite.
However, that should not prevent Member States from entering into practical arrangements for the purpose of sharing responsibilities for providing consular protection to unrepresented citizens in accordance with this Directive.
Države članice, ki prejmejo prošnje za zaščito, bi morale oceniti, ali je treba v konkretnem primeru zagotoviti konzularno zaščito ali se zadeva lahko preusmeri na diplomatsko-konzularno predstavništvo, ki je določeno za pristojno v skladu z že obstoječo ureditvijo.
Such arrangements are beneficial to citizens, since they allow for better preparedness to ensure effective protection.
Države članice bi morale uradno obvestiti Komisijo in Evropsko službo za zunanje delovanje (ESZD) o vsaki takšni ureditvi, Unija in države članice pa bi jo morale objaviti, da se zagotovi preglednost za državljane brez predstavništva.
Member States that receive requests for protection should assess whether, in a specific case, it is necessary to provide consular protection or whether the case can be transferred to the embassy or consulate which is designated as competent according to any arrangement already in place.
Ta direktiva ne bi smela preprečevati državi članici, ki nima predstavništva v tretji državi, da zagotovi konzularno zaščito svojemu državljanu, na primer s konzularnimi storitvami prek spleta, če je to primerno.
Member States should notify the Commission and the European External Action Service (EEAS) of any such arrangement, which should be publicised by the Union and Member States to ensure transparency for unrepresented citizens.
Država članica, katere državljanstvo ima državljan brez predstavništva, bi morala imeti možnost, da državo članico, ki jo je državljan zaprosil za konzularno zaščito ali od katere je konzularno zaščito prejel, zaprosi za prenos prošnje ali zadeve, da bi sama zagotovila konzularno zaščito.
This Directive should not prevent the Member State which is not represented in a third country from delivering consular protection to one of its nationals, for example by providing online consular services, where appropriate.
Državljan brez predstavništva zaradi prenosa ne bi smel ostati brez konzularne zaščite.
The Member State of nationality of an unrepresented citizen should be allowed to request the Member State from which that citizen seeks or receives consular protection to transfer the application or case in order itself to deliver consular protection.
Ne glede na različne tradicije držav članic glede pristojnosti častnih konzulov, ti navadno ne zagotavljajo istega obsega storitev kot diplomatsko-konzularna predstavništva.
Such a transfer should not result in the unrepresented citizen being deprived of consular protection.
Ker častni konzuli svojo nalogo pogosto opravljajo prostovoljno, bi se morala vsaka država članica sama odločiti, ali se bo ta direktiva uporabljala za častne konzule.
Notwithstanding the varying traditions of Member States regarding the competences of honorary consuls, they usually do not offer the same range of services as embassies or consulates.
Od častnih konzulov bi se lahko zahtevalo, da zagotovijo konzularno zaščito državljanom brez predstavništva, odvisno od okoliščin posameznega primera.
Considering that honorary consuls often fulfil their mission on a voluntary basis, it should be left to each Member State to decide whether this Directive should apply to its honorary consuls.
Prošnje za zaščito bi bilo treba obravnavati, če prosilci predložijo veljavno potno listino ali osebno izkaznico Unije.
Honorary consuls could be required to provide consular protection to unrepresented citizens, depending on the circumstances of each case.
Toda državljani brez predstavništva, ki potrebujejo konzularno zaščito, morda nimajo več svojih osebnih dokumentov.
Requests for protection should be processed if applicants present a valid Union citizen's passport or identity card.
Temeljni status državljanstva Unije je podeljen neposredno s pravom Unije in osebni dokumenti imajo le deklarativno vrednost.
However, unrepresented citizens in need of consular protection might no longer be in possession of their identity documents.
Če prosilci ne morejo predložiti veljavnih osebnih dokumentov, bi morali biti sposobni dokazati svojo istovetnost na kakršen koli drug način.
The fundamental status of citizenship of the Union is conferred directly by Union law and identity documents are of merely declaratory value.
Če je potrebno, bi se lahko istovetnosti zadevne osebe preverila med posvetovanjem z organi države članice, za katero prosilec trdi, da je njen državljan.