natgillin/translations-raw huggingface dataset:
Annual notification format for serious adverse events
Obrazec za letno obveščanje o hudih neželenih pojavih
Total number of tissues and cells processed
Skupno število predelanih tkiv in celic
Total number of serious adverse events, which may have affected quality and safety of tissues and cells due to a deviation in:
Skupno število hudih neželenih pojavov, za katere obstaja verjetnost, da so vplivali na kakovost in varnost tkiv in celic zaradi nepravilnosti pri:
Tissues and cells defect (specify)
Napaka tkiv in celic (navedite)
Equipment failure (specify)
Napaka v opremi (navedite)
Human error (specify)
Človeška napaka (navedite)
Information on the minimum donor/recipient data set to be kept as required in Article 9
Informacije o najnujnejših podatkih o darovalcu/prejemniku, ki jih je treba hraniti, kot to določa člen 9
BY TISSUE ESTABLISHMENTS
PODATKI, KI JIH HRANI BANKA TKIV
Donor identification
Identifikacija darovalca
Donation identification that will include at least:
Identifikacija darovanja, ki zajema najmanj naslednje podatke:
Identification of the procurement organisation or Tissue establishment
identifikacija organizacije za pridobivanje ali banke tkiv
Unique Donation ID number
enotna identifikacijska številka darovanja
Date of procurement
datum pridobitve
Place of procurement
kraj pridobitve
Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)
vrsta darovanja (npr. eno- proti večplastnemu tkivu; avtologno proti alogensko; živo proti mrtvemu)
Product identification that will include at least:
Identifikacija izdelka, ki zajema najmanj naslednje podatke:
Identification of the tissue establishment
identifikacija banke tkiv
Type of tissue and cell/product (basic nomenclature)
vrsta tkiva in celice/izdelka (osnovna nomenklatura)
Pool number (if applicable)
številka zbira lotov (če je primerno)
Split number (if applicable)
številka podskupine lotov (če je primerno)
Expiry date
datum izteka
Tissue/cell status (i.e. quarantined, suitable for use etc.)
status tkiva/celice (tj. v karanteni, primerno za uporabo itd.)
Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety.
opis in poreklo izdelkov, uporabljene stopnje predelave, material in dodatki, ki so bili v stiku s tkivi in celicami ter so vplivali na njihovo kakovost in/ali varnost
Identification of the facility issuing the final label
identifikacija ustanove, ki je izdala končno označbo
Human application identification that will include at least:
Identifikacija za zdravljenje ljudi, ki zajema najmanj naslednje podatke:
Date of distribution/disposal
datum razdeljevanja/odstranitve
Identification of the clinician or end user/facility
Identifikacija kliničnega zdravnika ali končnega uporabnika/ustanove
BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION
PODATKI, KI JIH HRANIJO ORGANIZACIJE, PRISTOJNE ZA ZDRAVLJENJE LJUDI
Identification of the supplier tissue establishment
Identifikacija oskrbovalne banke tkiv
Type of tissues and cells
Vrsta tkiv in celic
Identification of the recipient
Podatki o prejemniku
Information contained in the European Coding System
Informacije, ki jih vsebuje evropski kodni sistem
Donation identification:
Identifikacija darovanja:
Unique ID number
enotna identifikacijska številka
Product identification:
Identifikacija izdelka:
Product code (basic nomenclature)
oznaka izdelka (osnovna nomenklatura)
Directive of the European Parliament and of the Council
Direktiva 2006/87/ES Evropskega parlamenta in Sveta
laying down technical requirements for inland waterway vessels and repealing Council Directive 82/714/EEC
o tehničnih predpisih za plovila, namenjena za plovbo po celinskih plovnih poteh, in razveljavitvi Direktive Sveta 82/714/EGS
Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels [3] introduced harmonised conditions for issuing technical certificates for inland waterway vessels in all Member States, albeit excluding operations on the Rhine.
Direktiva Sveta 82/714/EGS z dne 4. oktobra 1982 o tehničnih predpisih za plovila, namenjena za plovbo po celinskih plovnih poteh [3], je uvedla usklajene pogoje za izdajanje tehničnih spričeval za plovila, namenjena plovbi po celinskih plovnih poteh, v vseh državah članicah, izključila pa je plovbo po Renu.
Nevertheless, at European level, various technical requirements for inland waterway vessels have remained in force.
Na evropski ravni kljub temu še vedno veljajo različne tehnične zahteve za plovila, namenjena za plovbo po celinskih plovnih poteh.
Up to now, the coexistence of various international and national regulations has obstructed efforts to ensure mutual recognition of national navigation certificates without the need for an additional inspection of foreign vessels.
Soobstoj različnih mednarodnih in nacionalnih predpisov je doslej oviral prizadevanja za vzajemno priznavanje nacionalnih spričeval za plovbo brez dodatnega pregleda tujih plovil.
Furthermore, the standards contained in Directive 82/714/EEC, in part, no longer reflect current technological developments.
Standardi iz Direktive 82/714/EGS poleg tega deloma ne ustrezajo več sedanjemu tehnološkemu razvoju.
Essentially, the technical requirements set out in the annexes to Directive 82/714/EEC incorporate the provisions laid down in the Rhine Vessel Inspection Regulation, in the version approved by the Central Commission for Navigation on the Rhine (CCNR) in 1982.
Tehnične zahteve iz prilog k Direktivi 82/714/EGS vsebujejo določbe iz Uredbe o inšpekcijskih pregledih plovil, ki plujejo po Renu, in sicer iz različice, ki jo je leta 1982 odobrila Osrednja komisija za plovbo po Renu (CCNR).
The conditions and technical requirements for issuing inland navigation certificates under Article 22 of the Revised Convention for Rhine Navigation have been revised regularly since then and are recognised as reflecting current technological developments.
Pogoji in tehnične zahteve za izdajanje spričeval za plovbo po celinskih plovnih poteh v smislu člena 22 Revidirane konvencije o plovbi po Renu so se od tedaj redno prilagajali, zato velja, da odražajo sedanji tehnološki razvoj.
For competition and safety reasons it is desirable, specifically in the interests of promoting harmonisation at European level, to adopt the scope and content of such technical requirements for the whole of the Community's inland waterway network.
Iz razlogov konkurence in varnosti, posebej zaradi pospeševanja usklajevanja na evropski ravni, je zaželeno, da se področje uporabe in vsebina takšnih tehničnih zahtev sprejmeta za celotno omrežje celinskih plovnih poti Skupnosti.
Account should be taken in this regard of the changes that have occurred in that network.
V zvezi s tem je treba upoštevati spremembe, nastale v tem omrežju.
Community inland navigation certificates attesting the full compliance of vessels with the aforementioned revised technical requirements should be valid on all Community inland waterways.
Spričevala Skupnosti za plovbo po celinskih plovnih poteh, ki potrjujejo, da plovila v celoti izpolnjujejo navedene revidirane tehnične zahteve, morajo veljati na vseh celinskih plovnih poteh Skupnosti.
It is desirable to ensure a greater degree of harmonisation between the conditions for the issuing of supplementary Community inland navigation certificates by Member States for operations on Zone 1 and 2 waterways (estuaries), as well as for operations on Zone 4 waterways.
Zaželeno je zagotoviti višjo stopnjo usklajevanja pogojev držav članic za izdajanje dodatnih spričeval Skupnosti za plovbo po celinskih plovnih poteh con 1 in 2 (izlivi) ter cone 4.
In the interests of passenger transport safety, it is desirable that the scope of Directive 82/714/EEC be extended to include passenger vessels designed to carry more than 12 passengers, along the lines of the Rhine Vessel Inspection Regulation.
Zaradi varnosti potniškega prevoza je zaželeno, da se področje uporabe Direktive 82/714/EGS po zgledu Uredbe o inšpekcijskih pregledih plovil, ki plujejo po Renu, razširi tudi na potniška plovila, namenjena prevozu več kot 12 potnikov.
In the interests of safety, harmonisation of standards should be at a high level and should be achieved in such a way so as not to result in any reduction in safety standards on any Community inland waterway.
Zaradi varnosti je treba doseči usklajenost standardov na visoki ravni, ne da bi se pri tem znižali varnostni standardi na kateri koli celinski plovni poti Skupnosti.
It is appropriate to provide for a transitional regime for vessels in service not yet carrying a Community inland navigation certificate when subjected to a first technical inspection under the revised technical requirements established by this Directive.
Treba je zagotoviti prehodno ureditev za plovila v uporabi, ki ob prvem tehničnem pregledu na podlagi revidiranih tehničnih zahtev, ki jih določa ta direktiva, še nimajo spričevala Skupnosti za plovbo po celinskih plovnih poteh.
It is appropriate, within certain limits and according to the category of vessel concerned, to determine the period of validity of Community inland navigation certificates in each specific case.
Za vsak posamezen primer je treba, v okviru določenih omejitev in glede na kategorijo zadevnega plovila, določiti trajanje veljavnosti spričevala Skupnosti za plovbo po celinskih plovnih poteh.
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [4].
Ukrepe za izvajanje te direktive bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [4].
It is necessary that the measures provided for in Council Directive 76/135/EEC of 20 January 1976 on reciprocal recognition of navigability licenses for inland waterway vessels [5] remain in force for those vessels not covered by this Directive.
Določbe Direktive Sveta 76/135/EGS z dne 20. januarja 1976 o vzajemnem priznavanju dovoljenj za plovbo za plovila, ki plujejo po celinskih plovnih poteh [5], je treba še naprej uporabljati za plovila, ki jih ta direktiva ne zajema.
Given that some vessels fall within the scope of Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft [6] as well as of this Directive, the annexes of the two Directives should be adjusted by the relevant committee procedures as soon as possible if there are any contradictions or inconsistencies between the provisions of those Directives.
Glede na dejstvo, da nekatera plovila spadajo v področje uporabe tako Direktive 94/25/ES Evropskega parlamenta in Sveta z dne 16. junija 1994 o približevanju zakonov in drugih predpisov držav članic v zvezi s plovili za rekreacijo [6], kot te direktive, se z ustreznim postopkom v odboru kar najhitreje prilagodijo priloge k obema direktivama, če se ugotovi, da so določbe obeh direktiv protislovne ali nezdružljive.
In accordance with point 34 of the Interinstitutional Agreement on better law-making [7], Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
V skladu s točko 34 Medinstitucionalnega sporazuma o boljši pripravi zakonodaje [7] se države članice spodbuja, da za svoje potrebe in v interesu Skupnosti izdelajo in objavijo lastne tabele, ki naj, kolikor nazorno je to mogoče, prikažejo korelacijo med to direktivo in ukrepi za prenos v nacionalno pravo.
Directive 82/714/EEC should be repealed,
Direktivo 82/714/EGS je treba razveljaviti —
Classification of waterways
Razvrstitev plovnih poti
For the purposes of this Directive, Community inland waterways shall be classified as follows:
Za namene te direktive se celinske plovne poti Skupnosti razvrstijo na naslednji način:
Zones 1, 2, 3 and 4:
Cone 1, 2, 3 in 4:
Zones 1 and 2: the waterways listed in Chapter 1 of Annex I;
Coni 1 in 2: plovne poti s seznama v Poglavju 1 Priloge I;
Zone 3: the waterways listed in Chapter 2 of Annex I;
Cona 3: plovne poti s seznama v Poglavju 2 Priloge I;
Zone 4: the waterways listed in Chapter 3 of Annex I.
Cona 4: plovne poti s seznama v Poglavju 3 Priloge I.
Zone R: those of the waterways referred to in point (a) for which certificates are to be issued in accordance with Article 22 of the Revised Convention for Rhine Navigation as that Article is worded when this Directive enters into force.
Cona R: tiste plovne poti iz točke (a), za katere se spričevala izdajajo v skladu s členom 22 Revidirane konvencije o plovbi po Renu, kakor to določa omenjeni člen ob začetku veljavnosti te direktive.
Any Member State may, after consulting the Commission, modify the classification of its waterways into the zones listed in Annex I. The Commission shall be notified of these modifications at least six months before their entry into force and shall inform the other Member States.
Vsaka država članica lahko po posvetovanju s Komisijo spremeni razvrstitev svojih plovnih poti v cone iz Priloge I. O teh spremembah se vsaj šest mesecev pred začetkom njihove veljavnosti uradno obvesti Komisijo, ki obvesti ostale države članice.
This Directive shall, in accordance with Article 1.01 of Annex II, apply to the following craft:
Ta direktiva se v skladu s členom 1.01 Priloge II uporablja za naslednje plovne objekte:
vessels having a length (L) of 20 metres or more;
plovila, katerih dolžina (L) je enaka ali presega 20 metrov;
vessels for which the product of length (L), breadth (B) and draught (T) is a volume of 100 m3 or more.
plovila, katerih zmnožek dolžine (L) širine (B) ugreza (T) je enak prostornini 100 m3 ali več.
This Directive shall also apply, in accordance with Article 1.01 of Annex II, to all of the following craft:
Ta direktiva se v skladu s členom 1.01 Priloge II uporablja tudi za vse naslednje plovne objekte:
tugs and pushers intended for towing or pushing craft referred to in paragraph 1 or floating equipment or for moving such craft or floating equipment alongside;
vlačilce in potisna plovila, namenjena za vleko ali potiskanje plovnih objektov iz odstavka 1 ali plavajoče opreme, ali za vzdolžno premikanje takih plovnih objektov ali plavajoče opreme;
vessels intended for passenger transport which carry more than 12 passengers in addition to the crew;
plovila, namenjena potniškemu prevozu, ki poleg posadke prevažajo več kot 12 potnikov;
floating equipment.
plavajočo opremo.
The following craft shall be excluded from this Directive:
Iz te direktive so izključeni naslednji plovni objekti:
ferries;
trajekti;
naval vessels;
plovila vojne mornarice;
sea-going vessels, including sea-going tugs and pusher craft, which:
morska plovila, vključno z morskimi vlačilci in potisnimi plovnimi objekti, ki
operate or are based on tidal waters;
plujejo ali se nahajajo v vodah s plimo in oseko;
operate temporarily on inland waterways, provided that they carry:
začasno plujejo po celinskih plovnih poteh, če imajo:
a certificate proving conformity with the 1974 International Convention for the Safety of Life at Sea (SOLAS), or equivalent, a certificate proving conformity with the 1966 International Convention on Load Lines, or equivalent, and an international oil pollution prevention (IOPP) certificate proving conformity with the 1973 International Convention for the Prevention of Pollution from Ships (MARPOL); or
spričevalo, ki potrjuje skladnost z Mednarodno konvencijo o varstvu človeškega življenja na morju iz leta 1974 (SOLAS) ali enakovredno spričevalo in spričevalo, ki potrjuje skladnost z Mednarodno konvencijo o tovornih črtah iz leta 1966, ali enakovredno spričevalo ter mednarodno spričevalo o preprečevanju onesnaževanja z nafto (IOPP), ki potrjuje skladnost z Mednarodno konvencijo o preprečevanju onesnaževanja morja z ladij iz leta 1973 (MARPOL); ali
in the case of passenger vessels not covered by all of the Conventions referred to in the first indent, a certificate on safety rules and standards for passenger ships issued in conformity with Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships [8]; orin the case of recreational craft not covered by all of the Conventions referred to in the first indent, a certificate of the country of which it carries the flag.
v primeru potniških plovnih objektov, ki jih ne zajemajo vse konvencije iz prve alinee, spričevalo o varnostnih predpisih in standardih za potniške ladje, izdano v skladu z Direktivo Sveta 98/18/ES z dne 17. marca 1998 o varnostnih predpisih in standardih za potniške ladje [8]; aliv primeru plovil za rekreacijo, ki jih ne zajemajo vse konvencije iz prve alinee, spričevalo države, pod katere zastavo plujejo.
Obligation to carry a certificate
Obveznost posedovanja spričevala
Craft operating on the Community inland waterways referred to in Article 1 shall carry:
Plovni objekti, ki plujejo po celinskih plovnih poteh Skupnosti iz člena 1, morajo posedovati:
when operating on a Zone R waterway:
ob plovbi po plovnih poteh cone R:
either a certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation;
spričevalo, izdano na podlagi člena 22 Revidirane konvencije o plovbi po Renu, ali
or a Community inland navigation certificate issued or renewed after 30 December 2008, and attesting full compliance of the craft, without prejudice to the transitional provisions of Chapter 24 of Annex II, with technical requirements as defined in Annex II for which equivalency with the technical requirements laid down in application of the abovementioned Convention has been established according to the applicable rules and procedures;
spričevalo Skupnosti za plovbo po celinskih plovnih poteh, izdano ali obnovljeno po 30. decembru 2008, ki brez poseganja v začasne določbe Poglavja 24 Priloge II potrjuje popolno skladnost plovnega objekta s tehničnimi zahtevami, opredeljenimi v Prilogi II, katerih enakovrednost s tehničnimi zahtevami, določenimi ob uporabljanju zgoraj navedene konvencije, je bila potrjena v skladu s pravili in postopki, ki se uporabljajo;
when operating on other waterways, a Community inland navigation certificate, including, where applicable, the specifications referred to in Article 5.
ob plovbi po drugih plovnih poteh spričevalo Skupnosti za plovbo po celinskih plovnih poteh, ki po potrebi vključuje zahteve iz člena 5.
The Community inland navigation certificate shall be drawn up following the model set out in Part I of Annex V and shall be issued in accordance with this Directive.
Spričevalo Skupnosti za plovbo po celinskih plovnih poteh se oblikuje na podlagi vzorca iz dela I Priloge V in izda v skladu s to direktivo.
Supplementary Community inland navigation certificates
Dodatna spričevala Skupnosti za plovbo po celinskih plovnih poteh
All craft carrying a valid certificate issued pursuant to Article 22 of the Revised Convention for Rhine Navigation may, subject to the provisions of Article 5(5) of this Directive, navigate on Community waterways carrying that certificate only.
Vsi plovni objekti z veljavnim spričevalom, izdanim v skladu s členom 22 Revidirane konvencije o plovbi po Renu, lahko ob upoštevanju določb člena 5(5) te direktive plujejo po plovnih poteh Skupnosti tudi samo s tem spričevalom.
However, all craft carrying the certificate referred to in paragraph 1 shall also be provided with a supplementary Community inland navigation certificate:
Vsi plovni objekti, ki posedujejo spričevalo iz odstavka 1, morajo posedovati tudi dodatno spričevalo Skupnosti za plovbo po celinskih plovnih poteh:
when operating on Zone 3 and 4 waterways, if they wish to take advantage of the reduction in technical requirements on those waterways;
za plovbo po plovnih poteh con 3 in 4, če hočejo na teh plovnih poteh uveljavljati nižje tehnične zahteve;
when operating on Zone 1 and 2 waterways, or, in respect of passenger vessels, when operating on Zone 3 waterways that are not linked to the navigable inland waterways of another Member State, if the Member State concerned has adopted additional technical requirements for those waterways, in accordance with Article 5(1), (2) and (3).
za plovbo po plovnih poteh con 1 in 2 ali, v primeru potniških plovil, za plovbo po plovnih poteh cone 3, ki niso povezane s celinskimi plovnimi potmi druge države članice, če je zadevna država članica za te plovne poti uvedla dodatne tehnične zahteve v skladu s členom 5(1), (2) in (3).
The supplementary Community inland navigation certificate shall be drawn up following the model set out in Part II of Annex V and shall be issued by the competent authorities on production of the certificate referred to in paragraph 1 and under the conditions laid down by the authorities competent for the waterways concerned.
Dodatno spričevalo Skupnosti za plovbo po celinskih plovnih poteh se oblikuje na podlagi vzorca iz dela II Priloge V, izdajajo pa ga pristojni organi na podlagi predložitve spričevala iz odstavka 1 pod pogoji, ki jih določijo organi, pristojni za zadevne plovne poti.
Additional or reduced technical requirements for certain zones
Dodatne ali nižje tehnične zahteve za nekatere cone
Each Member State may, after consulting the Commission, and where applicable subject to the requirements of the Revised Convention for Rhine Navigation, adopt technical requirements additional to those in Annex II for craft operating on Zone 1 and 2 waterways within its territory.
Vsaka država članica lahko po posvetovanju s Komisijo in kadar je to potrebno, ob upoštevanju zahtev Revidirane konvencije o plovbi po Renu, poleg tehničnih zahtev iz Priloge II, sprejme dodatne tehnične zahteve za plovne objekte, ki plujejo po plovnih poteh con 1 in 2 na njenem ozemlju.
In respect of passenger vessels operating on Zone 3 waterways within its territory that are not linked to the navigable inland waterways of another Member State, each Member State may maintain technical requirements additional to those in Annex II.
Posamezna država članica lahko za potniška plovila, ki plujejo po plovnih poteh cone 3 na njenem ozemlju, ki niso povezane s celinskimi plovnimi potmi druge države članice, poleg zahtev iz Priloge II ohrani dodatne tehnične zahteve.
Amendments to such technical requirements shall require the prior approval of the Commission.
Spremembe takšnih tehničnih zahtev mora predhodno odobriti Komisija.
The additional requirements shall be restricted to the subjects listed in Annex III.
Dodatne zahteve so omejene na področja s seznama v Prilogi III.
The Commission shall be notified of these additional requirements at least six months before their entry into force and shall inform the other Member States.
O teh dodatnih zahtevah se vsaj šest mesecev pred datumom začetka njihove veljavnosti uradno obvesti Komisijo, ki obvesti ostale države članice.
Compliance with the additional requirements shall be specified in the Community inland navigation certificate referred to in Article 3 or, where Article 4(2) applies, in the supplementary Community inland navigation certificate.
Izpolnjevanje teh dodatnih zahtev se navede v spričevalu Skupnosti za plovbo po celinskih plovnih poteh iz člena 3 ali, če se uporablja člen 4(2), v dodatnem spričevalu Skupnosti za plovbo po celinskih plovnih poteh.
Such proof of compliance shall be recognised on Community waterways of the corresponding zone.
To potrdilo o skladnosti se priznava na plovnih poteh Skupnosti ustrezne cone.