natgillin/translations-raw huggingface dataset:
The product is therefore to be classified under CN code 90183900 as catheters (see also the HSEN to heading 9018, Group (I)).
Izdelek se zato uvrsti pod oznako KN 90183900 kot katetri (glej tudi pojasnjevalne opombe harmoniziranega sistema k tarifni številki 9018, točka I).
A flexible metal wire (so-called ‘guide wire’) with a diameter of 0,35 mm, a length ranging from 180-300 cm, two radiopaque markers and a rounded tip.
Upogljiva kovinska žica (t. i. „vodilna žica“) s premerom 0,35 mm, dolžine od 180 do 300 cm, z dvema radioopačnima označevalcema in zaobljeno konico.
The wire is made of a metal alloy for biomedical use, with a proximal coating of PTFE and a distal coating of silicone or hydrophilic material.
Žica je izdelana iz kovinske zlitine za biomedicinsko uporabo, proksimalni del je prevlečen s PTEE, distalni pa s silikonom ali hidrofilnim materialom.
The radiopaque markers make it possible to locate the exact position of the wire in the body.
Radioopačna označevalca omogočata natančno določitev položaja žice v telesu.
The wire is used for guiding and positioning devices for interventions in the coronary artery.
Žica se uporablja za usmerjanje in nameščanje naprav za posege v koronarni arteriji.
The guide wire is removed from the body and discarded after treatment.
Vodilna žica se odstrani iz telesa in se po uporabi zavrže.
See image 3
Glej sliko 3.
Due to its objective characteristics, namely the combination of the design and the radiopaque markers, the wire can, upon presentation, be identified as an instrument or appliance of Chapter 90, used in medical sciences.
Zaradi svojih značilnosti, in sicer kombinacije oblike in radioopačnih označevalcev, je mogoče žico opredeliti kot instrument ali aparat iz 90. poglavja, ki se uporablja v medicini.
Classification under heading 9021 is excluded as the wire is not implanted in the body to compensate for a defect or disability but it is removed after treatment.
Izdelka ni mogoče uvrstiti pod tarifno številko 9021, ker se žica v telo ne vstavi z namenom, da bi odpravili hibo ali invalidnost, ampak se po posegu odstrani.
The product is therefore to be classified under CN code 90183900 as wire guides (see also the HSEN to heading 9018 Group (I)).
Izdelek se zato uvrsti pod oznako KN 90183900 kot žična vodila (glej tudi pojasnjevalne opombe harmoniziranega sistema k tarifni številki 9018, točka I).
A hand-operated inflation device made of high-strength polycarbonate, equipped with a manometer and a volume scale.
Ročna naprava za napihovanje je izdelana iz polikarbonata visoke trdnosti in opremljena z manometrom in merilcem volumna.
It has a high pressure hose connection (Luer-type) and can inflate, with precise pressure adjustments, up to 20 atmospheres (atm).
Ima nastavek za priključitev visokotlačne cevi (vrste Luer) in lahko napihuje, z natančnimi nastavitvami tlaka, do 20 atmosfer (atm).
The device is to be used in a medical environment for the inflation and deflation of balloon catheters.
Naprava se uporablja v zdravstvu za napihovanje in praznjenje balonskih katetrov.
The manometer is used for monitoring the pressure inside the balloon catheter when inflating or deflating and during surgery.
Manometer se uporablja za spremljanje tlaka znotraj balonskega katetra pri napihovanju ali praznjenju in med posegom.
The volume scale indicates the amount of liquid (maximum 20 ml) that is, by means of pressure, inserted into the catheter and also the amount of liquid that flows back freely as the balloon deflates.
Merilec volumna kaže količino tekočine (največ 20 ml), ki se pod tlakom vbrizga v kateter, in količino tekočine, ki se prosto pretaka v nasprotno smer, ko se balon izprazni.
The Luer connection makes it possible to connect the inflation device to the balloon catheter.
Priključek Luer omogoča priključitev naprave za napihovanje na balonski kateter.
The device is for single patient use only and is discarded after treatment.
Naprava se uporabi samo za enega pacienta in se po posegu zavrže.
See image 4
Glej sliko 4.
Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 9018, 901890 and 90189084.
Uvrstitev opredeljujejo splošni pravili 1 in 6 za razlago kombinirane nomenklature in besedilo oznak KN 9018, 901890 in 90189084.
As a small amount of liquid is inserted into the catheter by means of pressure, but then flows back freely, the device does not raise or otherwise continuously displace volumes of liquids (see the HSEN to heading 8413, first paragraph).
Ker se pod tlakom v kateter vbrizga majhna količina tekočine, ki se lahko nato prosto pretaka nazaj, naprava ne povečuje volumna ali kako drugače spreminja pretoka tekočine (glej tudi pojasnjevalne opombe harmoniziranega sistema k tarifni številki 8413, 1. odstavek).
Consequently, classification under heading 8413 as pumps for liquids is excluded.
Zato izdelka ni mogoče uvrstiti pod tarifno številko 8413 kot črpalke za tekočine.
Due to its objective characteristics, namely the combination of the design, the precise pressure adjustments, the small amount of liquid used and the Luer-type connection, the article can, upon presentation, be identified as an instrument or appliance of Chapter 90, used in medical sciences (see also the HSEN to heading 9018, fifth paragraph).
Zaradi svojih značilnosti, in sicer kombinacije oblike, natančnih nastavitev tlaka, majhnih količin uporabljene tekočine in priključka Luer, se lahko ta izdelek opredeli kot instrument ali aparat iz 90. poglavja, ki se uporablja v medicini (glej tudi pojasnjevalne opombe harmoniziranega sistema k tarifni številki 9018, 5. odstavek).
Classification under heading 9021 is excluded as the article is not worn, carried or implanted in the body to compensate for a defect or disability.
Izdelka ni mogoče uvrstiti pod tarifno številko 9021, ker se izdelek ne nosi na telesu ali vdela v telo z namenom, da bi odpravili hibo ali invalidnost.
The product is therefore to be classified under CN code 90189084 as other instruments and appliances used in medical, surgical, dental or veterinary sciences.
Izdelek se zato uvrsti pod oznako KN 90189084 kot drugi instrumenti in aparati, ki se uporabljajo v medicini, kirurgiji, zobozdravstvu ali veterini.
Commission Implementing Regulation (EU) No 1039/2014
Izvedbena uredba Komisije (EU) št. 1039/2014
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 [1],
ob upoštevanju Uredbe (EU) št. 1308/2013 Evropskega parlamenta in Sveta z dne 17. decembra 2013 o vzpostavitvi skupne ureditve trgov kmetijskih proizvodov in razveljavitvi uredb Sveta (EGS) št. 922/72, (EGS) št. 234/79, (ES) št. 1037/2001 in (ES) št. 1234/2007 [1],
Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.
Izvedbena uredba (EU) št. 543/2011 na podlagi izida večstranskih trgovinskih pogajanj urugvajskega kroga določa merila, po katerih Komisija določi standardne vrednosti za uvoz iz tretjih držav za proizvode in obdobja iz dela A Priloge XVI k tej uredbi.
Commission Delegated Regulation (EU) No 1040/2014
Delegirana uredba Komisije (EU) št. 1040/2014
amending Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption to adapt its Annex I to technical progress
o spremembi Direktive Sveta 2001/112/ES o sadnih sokovih in nekaterih podobnih proizvodih, namenjenih za prehrano ljudi, da se njena Priloga I prilagodi tehničnemu napredku
Directive 2001/112/EC empowers the Commission to adopt delegated acts to amend the Annexes to that Directive, with the exception of Part I of Annex I, and of Annex II, in order to bring them into line with developments in relevant international standards and in order to take into account technical progress.
Direktiva 2001/112/ES pooblašča Komisijo, da sprejme delegirane akte za spremembo prilog k navedeni direktivi, z izjemo dela I Priloge I in Priloge II, da se priloge uskladijo z razvojem ustreznih mednarodnih standardov in da se upošteva tehnični napredek.
Annex I to Directive 2001/112/EC relates to product names, definitions of products and characteristics.
Priloga I k Direktivi 2001/112/ES se nanaša na imena, opredelitve in lastnosti proizvodov.
Point 3 of Part II of that Annex regulates the authorised treatments and substances.
Točka 3 dela II navedene priloge ureja dovoljene obdelave in snovi.
Due to the technical developments new substances for clarification of juices are now available.
Zaradi tehničnega razvoja so zdaj na voljo nove snovi za bistrenje sokov.
Those substances are plant proteins derived from either wheat, peas or potatoes, which can be an alternative to the currently authorized substance gelatine, derived from animal products.
Te snovi so rastlinske beljakovine, pridobljene iz pšenice, graha ali krompirja, ki so lahko alternativa trenutno dovoljeni snovi, tj. želatini, pridobljeni iz živalskih proizvodov.
In order to take into account this technical progress, point 3 of Part II of Annex I to Directive 2001/112/EC should be amended by incorporating those new substances,
Za upoštevanje tega tehničnega napredka bi bilo treba točko 3 dela II Priloge I k Direktivi 2001/112/ES spremeniti, tako da se vključijo te nove snovi –
In point 3 of Part II of Annex I to Directive 2001/112/EC, the following indent is added:
V točki 3 dela II Priloge I k Direktivi 2001/112/ES se doda naslednja alinea:
Plant proteins from wheat, peas or potatoes for clarification’
rastlinske beljakovine iz pšenice, graha ali krompirja za bistrenje“
OJ L 10, 12.1.2002, p. 58.
UL L 10, 12.1.2002, str. 58.
Commission Implementing Regulation (EU) No 1041/2014
Izvedbena uredba Komisije (EU) št. 1041/2014
of 1 October 2014
z dne 1. oktobra 2014
Done at Brussels, 1 October 2014.
V Bruslju, 1. oktobra 2014
Commission Delegated Regulation (EU) No 1042/2014
Delegirana uredba Komisije (EU) št. 1042/2014
supplementing Regulation (EU) No 514/2014 with regard to the designation and management and control responsibilities of Responsible Authorities and with regard to status and obligations of Audit Authorities
o dopolnitvi Uredbe (EU) št. 514/2014 v zvezi z imenovanjem odgovornih organov, njihovimi odgovornostmi glede upravljanja in nadzora ter statusom in obveznostmi revizijskih organov
Having regard to Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management [1], and in particular Articles 26(4) and 29(1) thereof,
ob upoštevanju Uredbe (EU) št. 514/2014 Evropskega parlamenta in Sveta z dne 16. aprila 2014 o splošnih določbah o Skladu za migracije, azil in vključevanje ter o instrumentu za finančno podporo na področju policijskega sodelovanja, preprečevanja kriminala in boja proti njemu ter obvladovanja kriz [1], zlasti členov 26(4) in 29(1) Uredbe,
To ensure the continuity between the implementation of the previous Funds under the General Programme ‘Solidarity and Management of Migrations Flows’ 2007-2013 framework and of the Specific Regulations under the 2014-2020 framework, Regulation (EU) No 514/2014 has largely been modelled on the rules in force for the previous Funds, but taking into account the changes introduced in the shared management by Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council [2].
Da bi se zagotovila kontinuiteta med izvajanjem prejšnjih skladov v okviru splošnega programa „Solidarnost in upravljanje migracijskih tokov“ za obdobje 2007–2013 in posebnimi uredbami v okviru obdobja 2014–2020, Uredba (EU) št. 514/2014 v veliki meri temelji na pravilih, ki so veljala za prejšnje sklade, upošteva pa spremembe, ki so bile uvedene v deljenem upravljanju z Uredbo (EU, Euratom) št. 966/2012 Evropskega parlamenta in Sveta.
To ensure that the bodies implementing the national programmes have the capacity to fulfil their task efficiently and in line with the objectives and priorities set out in the Specific Regulations referred to in Article 2(a) of Regulation (EU) No 514/2014, rules should be laid down for designating them, supervising their designation and ending it where necessary.
[2]
To ensure that the scope of their responsibilities enable them to implement the national programme, it is necessary to lay down rules defining the management and control responsibilities of the Responsible Authorities, in particular the conditions under which they may delegate or outsource some of their tasks.
Da bi lahko organi, ki izvajajo nacionalne programe, svoje naloge izvajali učinkovito in v skladu s cilji in prednostnimi nalogami, določenimi v posebnih uredbah iz člena 2(a) Uredbe (EU) št. 514/2014, bi bilo treba določiti pravila za njihovo imenovanje ter nadzor in po potrebi preklic takega imenovanja.
The selection and award procedure for granting the Union contribution under national programmes should comply with the principles of transparency, non-discrimination and equal treatment.
Da bi odgovornim organom obseg njihovih odgovornosti omogočal izvajanje nacionalnega programa, je treba določiti pravila, ki opredeljujejo njihove obveznosti glede upravljanja in nadzora, zlasti pa pogoje, pod katerimi lahko nekatere svoje naloge prenesejo na pooblaščene organe ali jih zaupajo zunanjim izvajalcem.
It is therefore necessary to lay down the conditions under which Member States should implement the actions under the national programmes, in particular to identify under which circumstances the Responsible Authority may implement projects directly.
Postopek izbire in dodelitve za zagotovitev prispevka Unije prek nacionalnih programov mora biti v skladu z načeli preglednosti, nediskriminacije in enake obravnave.
In all Member States, the audits should be effective, have the appropriate scope and be carried out in accordance with the International Standards on Auditing.
Treba je torej določiti pogoje, pod katerimi bi morale države članice ukrepe izvajati prek nacionalnih programov, zlasti da se opredelijo okoliščine, v katerih lahko odgovorni organ projekte izvaja neposredno.
For this purpose, the status and auditing standards of the Audit Authorities should be clearly defined.
Revizije bi morale biti v vseh državah članicah učinkovite in ustrezno obsežne, izvajati pa bi se morale v skladu z mednarodnimi standardi revidiranja.
To ensure that the audit activities of the Audit Authorities allow them to support their audit opinions, the different types of audit activities should be defined.
Zato bi bilo treba jasno opredeliti status revizijskih organov in revizijske standarde, ki jih morajo uporabljati.
It is important that the results of the Audit Authority's activity are timely and adequately reported to the designating authority as well as to the European Commission.
Da bi se revizijski organi v svojih revizijskih mnenjih lahko opirali na svoje revizijske dejavnosti, bi bilo treba opredeliti različne vrste revizijskih dejavnosti.
In particular, it is important that the management declaration and the annual summary of the final audit reports and of controls carried out transmitted as part of the annual request for payment reflects well the result of the Audit Authority's work and conclusions.
Pomembno je, da revizijski organi o rezultatih svojih dejavnosti pravočasno in ustrezno poročajo tako organu za imenovanje kot Evropski komisiji.
Therefore, the Audit Authority should, as part of its audit work, ensure that information related to its audit activity is adequately reported in these documents.
Zlasti je pomembno, da izjava o upravljanju ter letni povzetek končnih revizijskih poročil in izvedenega nadzora, ki sta predložena v okviru letnega zahtevka za plačilo, primerno odražata rezultat dela revizijskega organa in njegove revizijske zaključke.
In order to allow for the prompt application of the measures provided for in this Regulation and not delay the approval and implementation of the national programmes, the Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.
Zato bi moral revizijski organ v okviru svojega revizijskega dela zagotoviti, da so informacije v zvezi s njegovo revizijsko dejavnostjo v teh dokumentih primerno predstavljene.
Denmark is not bound by Regulation (EU) No 514/2014 nor by this Regulation.
Združeno kraljestvo in Irsko zavezuje Uredba (EU) št. 514/2014, zato ju zavezuje tudi ta uredba.
HAS ADOPTED THIS REGULATION:
Danske ne zavezujeta niti Uredba (EU) št. 514/2014 niti ta uredba –
Definitions
Člen 1
For the purposes of this Regulation, the definitions in Regulation (EU) No 514/2014 shall apply.
Opredelitve pojmov
The following definitions shall also apply:
V tej uredbi se uporabljajo opredelitve iz Uredbe (EU) št. 514/2014.
‘designating authority’ means the ministerial authority of a Member State referred to in Article 26(1) of Regulation (EU) No 514/2014 that designates the Responsible Authority;
Uporabljajo se tudi naslednje opredelitve:
‘competent authorities’ means the Responsible Authority, the Audit Authority and, where appropriate, the Delegated Authority referred to in Article 25(1) of Regulation (EU) No 514/2014;
„organ za imenovanje“ pomeni ministrski organ države članice iz člena 26(1) Uredbe (EU) št. 514/2014, ki imenuje odgovorni organ;
‘SFC2014’ means the electronic information system established by Article 2 of Commission Implementing Regulation (EU) No 802/2014 [3];
„pristojni organi“ pomeni odgovorni organ, revizijski organ in, kjer je ustrezno, pooblaščeni organ iz člena 25(1) Uredbe (EU) št. 514/2014;
‘grant agreement’ means an agreement or an equivalent form of legal instrument on the basis of which the Responsible Authority provides grants to the beneficiary for the purpose of implementing a project under the national programme.
„sistem SFC2014“ pomeni elektronski informacijski sistem, vzpostavljen s členom 2 Izvedbene uredbe Komisije (EU) št. 802/2014; [3]
CHAPTER II
„sporazum o dodelitvi nepovratnih sredstev“ pomeni sporazum ali enakovreden pravni instrument, na podlagi katerega odgovorni organ upravičencu zagotovi nepovratna sredstva za izvajanje projekta v okviru nacionalnega programa.
THE RESPONSIBLE AUTHORITY
POGLAVJE II
SECTION I
ODGOVORNI ORGAN
Designation of the responsible authority
ODDELEK I
Article 2
Naloge odgovornega organa
Criteria and procedure for designating the Responsible Authority
Člen 2
The body to be designated as the Responsible Authority shall have an administrative organisation and a system of internal control that comply with the criteria set out in the Annex to this Regulation (‘the designation criteria’).
Merila in postopek za imenovanje odgovornega organa
The designation criteria concern:
Telo, ki naj bi bilo imenovano za odgovorni organ, ima upravno organizacijo in sistem notranjega nadzora, ki sta v skladu z merili iz Priloge k tej uredbi („merila za imenovanje“).
internal environment,
Merila za imenovanje zadevajo:
control activities;
notranje okolje;
internal information and communication;
nadzorne dejavnosti;
internal monitoring and reporting.
notranje obveščanje in sporočanje;
Member States may lay down further designation criteria to take account of the size, responsibilities and other characteristics of the Responsible Authority.
notranje spremljanje in poročanje.
The audit body referred to in Article 26(3) of Regulation (EU) No 514/2014 shall assess whether the prospective Responsible Authority complies with the designation criteria in the Annex and shall document its audit findings, conclusions and opinion in an audit report addressed to the designating authority.
Države članice lahko določijo dodatna merila za imenovanje, da bi upoštevale velikost, odgovornosti in druge značilnosti odgovornega organa.
If the designating authority is not satisfied that the prospective Responsible Authority complies with the designation criteria, it shall give this body specific instructions to remedy its non-compliances and a deadline for compliance before it may be designated as the Responsible Authority.
Revizijsko telo iz člena 26(3) Uredbe (EU) št. 514/2014 oceni, ali morebitni odgovorni organ izpolnjuje merila za imenovanje iz Priloge, in svoje revizijske ugotovitve, zaključke in mnenje dokumentira v revizijskem poročilu, naslovljenem na organ za imenovanje.
Pending compliance, the body may be granted provisional designation as Responsible Authority for no more than 12 months.
Če organ za imenovanje na podlagi tega meni, da morebitni odgovorni organ ne izpolnjuje meril za imenovanje, mu izda posebna navodila in določi rok za odpravo neskladnosti, preden se ga lahko imenuje za odgovorni organ.
The length of this provisional period shall be proportionate to the non-compliances identified.
Do zagotovitve skladnosti se lahko telo začasno imenuje za odgovorni organ, in sicer za največ 12 mesecev.
Upon designating the Responsible Authority, the Member State shall notify the Commission without delay through SFC 2014.
Dolžina tega začasnega obdobja je sorazmerna z ugotovljenimi neskladnostmi.
With this notification, the Member State shall transmit documentation setting out:
Ko država članica imenuje odgovorni organ, o tem prek sistema SFC2014 nemudoma obvesti Komisijo.
the main division of responsibilities between the organisational units of the Responsible Authority;
Temu obvestilu država članica priloži dokumentacijo, v kateri so navedeni:
a summary of the main procedures for processing financial claims from beneficiaries and for authorising and recording expenditure.
povzetek glavnih postopkov za obdelavo finančnih zahtevkov upravičencev ter za odobritev in evidentiranje odhodkov.
Supervision of the Responsible Authority and review of the designation
Nadzor nad odgovornim organom in ponovni pregled njegovega imenovanja
The designating authority shall supervise the Responsible Authority, in particular on the basis of the information referred to in Article 14(2) of this Regulation, and shall follow up any deficiencies identified.
Organ za imenovanje nadzira odgovorni organ, zlasti na podlagi informacij, določenih v členu 14(2) te uredbe, ter ukrepa na podlagi vseh ugotovljenih pomanjkljivosti.
Member States shall ensure that information indicating that the Responsible Authority no longer complies with the designation criteria is reported to the designating authority without delay.
Država članica zagotovi, da se informacije, ki kažejo, da odgovorni organ ne izpolnjuje več meril za imenovanje, nemudoma sporočijo organu za imenovanje.
When the Responsible Authority no longer fully complies with the designation criteria, or its system of internal control is so deficient as to undermine its ability to fulfil its tasks, the designating authority shall put the Responsible Authority on probation.
Če odgovorni organ meril za imenovanje ne izpolnjuje več v celoti ali če je njegov sistem notranjega nadzora tako pomanjkljiv, da ogroža njegovo zmožnost izpolnjevanja nalog, organ za imenovanje odgovornemu organu spremeni imenovanje v pogojno.
In such cases, the designating authority shall draw up a remedial plan for the Responsible Authority to implement within a period commensurate with the seriousness of the non-compliance or deficiency.
V takih primerih organ za imenovanje pripravi načrt za odpravo neskladnosti, ki ga odgovorni organ izvaja v obdobju, ki je sorazmerno z resnostjo neskladnosti ali pomanjkljivosti.
This period shall not exceed 12 months from the start of the probation period.
To obdobje ne sme biti daljše od 12 mesecev od začetka pogojnega imenovanja.