natgillin/translations-raw huggingface dataset:
Morali bi sprejeti stroga pravila o zaupnosti in varnostne ukrepe za varstvo osebnih podatkov darovalcev in prejemnikov.
Confidentiality rules and security measures should be taken for the protection of the donors' and recipients' personal data.
Na to se sklicujemo v tej uvodni izjavi, ki jasno določa obveznost ravnanja v skladu z zahtevami iz direktive 95/46/ES.
We make the reference under this recital which establishes clearly the obligation to comply with the requirements stated in Directive 95/46/EC.
(19) Pristojni organi držav članic morajo imeti ključno vlogo pri zagotavljanju kakovosti in varnosti organov med celotnim postopkom od darovanja do presaditve.
(19) The competent authorities of the Member States should have a key role to play in ensuring the quality and safety of organs during the entire chain from donation to transplantation.
Kot je bilo poudarjeno v priporočilu Odbora ministrov Sveta Evrope državam članicam o ozadju, funkcijah in pristojnostih nacionalne organizacije za presajanje, je zaželeno, da je uradno priznan le en nepridobitni organ, ki je v celoti pristojen za darovanje, razdeljevanje, sledljivost in določanje odgovornosti.
As emphasised by the Recommendation of the Committee of Ministers to Member States on the background, functions and responsibilities of a National Transplant Organisation (NTO) of the Council of Europe , it is preferable to have a single body which is officially recognised and non-profit making with overall responsibility for donation, allocation, traceability and accountability.
Vendar lahko lokalni, regionalni, nacionalni in/ali mednarodni organi sodelujejo in tako uskladijo darovanje, dodeljevanje in/ali presajanje, kar je odvisno zlasti od porazdelitve pristojnosti med države članice, pod pogojem, da obstoječi okvir zagotavlja določanje odgovornosti, sodelovanje in učinkovitost.
However, depending especially on the repartition of competences within the Member States, a combination of local, regional, national and/or international bodies may work together to co-ordinate donation, allocation and/or transplantation, provided that the framework in place ensures accountability, co-operation and efficiency
(19) Pristojni organi držav članic morajo imeti ključno vlogo pri zagotavljanju kakovosti in varnosti organov med celotnim postopkom od darovanja do presaditve in v času pacientovega okrevanja na podlagi najboljše medicinske prakse in zdravljenja po presaditvi .
(19) The competent authorities of the Member States should have a key role to play in ensuring the quality and safety of organs during the entire chain from donation to transplantation and throughout the patient’s recovery , based on best medical practice in post-transplantation treatment .
Kot je bilo poudarjeno v priporočilu Odbora ministrov Sveta Evrope državam članicam o ozadju, funkcijah in pristojnostih nacionalne organizacije za presajanje, je zaželeno, da je uradno priznan le en nepridobitni organ, ki je v celoti pristojen za darovanje, razdeljevanje, sledljivost in določanje odgovornosti.
As emphasised by the Recommendation of the Committee of Ministers to Member States on the background, functions and responsibilities of a National Transplant Organisation (NTO) of the Council of Europe15, it is preferable to have a single body which is officially recognised and non-profit making with overall responsibility for donation, allocation, traceability and accountability.
Postopek presaditve se ne konča, ko pacient z operacijo prejme organ.
The transplant process does not end when the patient has received an organ in the transplant operation.
Tudi obdobje okrevanja in zdravljenje, ki zmanjšuje možnost zavrnitve organa, imata pomembno vlogo pri tem, ali bo presaditev organa za pacienta uspešna ali ne.
The recovery period, and treatment with anti-rejection therapies, are also imperative to the success, or not, of a transplanted organ for the patient.
Tega ne bi smeli zanemariti, saj je za pacienta pomemben del uspešne presaditve in lahko izboljša njegovo zdravje.
This fact should not be neglected as it is a vital part of whether the patient has undergone a successful transplant and is ultimately able to improve their health.
(21) Ukrepe, potrebne za izvajanje te direktive, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil.
(21) The measures needed to implement 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.
V zvezi s členom 25 se je treba v vseh primerih, v katerih izvedbeni ukrepi vplivajo na varstvo podatkov in varnost, posvetovati z vsemi ustreznimi zainteresiranimi stranmi, tudi z evropskim nadzornikom za varstvo podatkov.
With regard to Article 25, in all cases of implementing measures affecting data protection and security, all relevant stakeholders should be consulted, including the European Data Protection Supervisor .
Zakonodajalec mora zagotoviti, da se je v zvezi s členom 25 treba v vseh primerih, v katerih gre za izvedbene ukrepe, ki vplivajo na varstvo podatkov in varnost, posvetovati z vsemi ustreznimi zainteresiranimi stranmi, tudi z evropskim nadzornikom za varstvo podatkov.
The legislator should ensure that, with regard to Article 25, in all cases where implementing measures affecting data protection and security are considered, all relevant stakeholders are consulted, including the EDPS.
(22) Zlasti je treba Komisijo pooblastiti , da za izmenjave organov med državami članicami določi postopke za prenos informacij o značilnostih organov transplantacijskim centrom, postopke, ki so potrebni za zagotovitev sledljivosti organov, vključno z zahtevami o označevanju, ter postopke za poročanje o hudih neželenih dogodkih ali reakcijah.
(22) In particular, power should be conferred on the Commission to lay down, where the organs concerned are to be exchanged between Member States, the procedures for the transmission to transplantation centres of the information on the characteristics of the organs, the procedures needed to ensure the traceability of the organs, including labelling requirements, and the procedures for the reporting of serious adverse events or reactions.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te direktive ali njenemu dopolnjevanju z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Since these measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(22) Da bi dosegli cilje te direktive, je treba Komisijo pooblastiti za sprejemanje delegiranih aktov v skladu s členom 290 PDEU , da za izmenjave organov med državami članicami določi postopke za prenos informacij o značilnostih darovalcev in organov transplantacijskim centrom, postopke, ki so potrebni za zagotovitev sledljivosti organov, vključno z zahtevami o označevanju, ter postopke za poročanje o hudih neželenih dogodkih ali reakcijah.
(22) In order to achieve the objectives of this Directive, the Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU concerning, where the organs concerned are to be exchanged between Member States, the procedures for the transmission to transplantation centres of the information on the characteristics of the donor and the organs, the procedures needed to ensure the traceability of the organs, including labelling requirements, and the procedures for the reporting of serious adverse events or reactions.
Ta direktiva državam članicam ne preprečuje ohranjanja ali uvajanja strožjih zaščitnih ukrepov pod pogojem, da so ti v skladu z določbami Pogodbe .
This Directive shall not prevent Member State s from maintaining or introducing more stringent protective measures, provided that they comply with the provisions of the Treaty .
(a) „odobritev“ je odobritev, akreditacija, imenovanje in dovoljenje, odvisno od koncepta, ki ga uporablja posamezna država članica ;
(a) ‘authorisation‘ means authorisation , accreditation, designation or licensing, depending of the concepts used in each Member State;
(a) „odobritev“ je akreditacija, odobritev, dovoljenje ali certifikacija , odvisno od zakonodajnih pristopov , ki jih uporablja posamezna država članica;
(a) ‘authorisation‘ means accreditation, authorisation, licensing or certification , depending on the regulatory approaches used in each Member State;
Novo besedilo temelji na konceptu iz direktive o tkivih št. 2004/23/ES in zajema različne nacionalne zakonodajne pristope.
The new wording is based on the concepts in the Tissues Directive 2004/23/EC and covers the various national regulatory approaches.
Člen 3 – točka (a a) (novo)
Article 3 – point a a (new)
(aa) „pristojni organ“ je javni ali zasebni nepridobitni organ, organizacija ali institucija, odgovorna za izvajanje določb te direktive;
aa) ' competent authority ' means a non-profit authority, body, organisation or institution, whether public or private, that is responsible for implementing the provisions of this Directive.
(c) „darovalec“ je kakršen koli človeški vir organov , živ ali mrtev ;
(c) ' donor' means every human source of organs, whether living or deceased;
(c) „darovalec“ je vsaka oseba, ki daruje enega ali več organov, ne glede na to, ali je do darovanja prišlo za časa življenja te osebe ali po njeni smrti ;
(c) 'donor' means a person who donates one or several organs, irrespective of whether the donation occur s during that person's lifetime or after death;
Treba je pojasniti, da je pomemben trenutek darovanja in ne dejstvo, ali je v trenutku pridobitve darovalec živ ali ne.
It is fundamental to clarify that what is essential is the moment of the donation and not whether at the moment of recovery the donor passed away or not.
Živi darovalec lahko umre po darovanju organov, vendar zaradi tega ne postane umrli darovalec.
A living donor might die after organ donation but this does not make him a deceased donor
Člen 3 – točka (d)
Article 3 – point d
(d) „darovanje“ je darovanje človeškega organa za presaditev ;
(d) ‘donation’ means donating human organs for transplantation ;
(d) „darovanje“ je priskrba človeškega organa za uporabo pri človeku ;
(d) ‘donation’ means the provision of human organs intended for human applications ;
Predlagano besedilo opredeljuje izraz „darovanje” brez ponavljanja tega izraza.
The proposed wording defines the term ‘donation’ without repetition.
(e) „določanje značilnosti darovalca“ je zbiranje ustreznih podatkov o značilnostih darovalca, ki so potrebni za ustrezno oceno tveganja , da se zmanjšajo tveganja za prejemnika in doseže čim boljše dodeljevanje organov;
(e) " donor characterisation " means the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation ;
(e) „določanje značilnosti darovalca“ je zbiranje ustreznih podatkov o značilnostih darovalca, ki so potrebni za ustrezno oceno ustreznosti darovalca, tveganja in da se zmanjšajo tveganja za prejemnika in zagotovi učinkovito dodeljevanje organov;
(e) ‘ donor characterisation ’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his or her suitability, to undertake a proper risk assessment and minimise the risks for the recipient , and to ensure effective organ allocation;
Novo besedilo bolje odraža namene določanja značilnosti darovalca.
This new wording better reflects the purposes of the donor characterization.
(f) „evropska organizacija za izmenjavo organov“ je javna ali zasebna nepridobitna organizacija, ki se ukvarja s čezmejno izmenjavo organov; države članice teh organizacij so večinoma države članice Skupnosti;
(f) " European organ exchange organisation " means a non-profit organisation, whether public or private, dedicated especially to cross-border organ exchange; the countries members of such an organisation are in their majority Member States of the Community;
(f) „evropska organizacija za izmenjavo organov“ je javna ali zasebna nepridobitna organizacija, ki se ukvarja z nacionalno ali čezmejno izmenjavo organov; države članice teh organizacij so večinoma države članice Skupnosti;
(f) ' European organ exchange organisation ' means a non-profit organisation, whether public or private, dedicated to national or cross-border organ exchange; the countries members of such an organisation are in their majority Member States of the Community;
Vse evropske organizacije za izmenjavo organov upravljajo z izmenjavo organov na ozemlju svojih držav članic in med državami.
All European Organ Exchange Organisations manage exchanges of organs within the territory of their MS and between countries.
(g) „organ“ je diferenciran in vitalen del človeškega telesa, sestavljen iz različnih tkiv, ki ima lastno strukturo, žilje in sposobnost razvoja fizioloških funkcij s pomembno stopnjo avtonomije;
(g) "organ" means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy;
(g) „organ“ je tako diferenciran kot vitalen del človeškega telesa, sestavljen iz različnih tkiv, ki ima lastno strukturo, žilje in sposobnost razvoja fizioloških funkcij s pomembno stopnjo avtonomije; ta opredelitev vključuje tudi del organa, če je njegova funkcija taka, da se v človeškem telesu uporabi za enak namen kot cel organ in ohrani zahteve glede strukture in žilja;
(g) "organ" means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy ; a part of an organ is also considered to fall within the scope of this definition if its function is to be used for the same purpose as the entire organ in the human body , maintaining the requirements of structure and vascularisation ;
(h) „določanje značilnosti organa“ je zbiranje ustreznih podatkov o značilnostih organa, ki so potrebni za ustrezno oceno tveganja , da se zmanjšajo tveganja za prejemnika in doseže čim boljše dodeljevanje organov;
(h) " organ characterisation " means the collection of the relevant information on the characteristics of the organ needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation;
(h) „določanje značilnosti organa“ je zbiranje ustreznih podatkov o značilnostih organa, ki so potrebni za ustrezno oceno njegove ustreznosti, tveganja in da se zmanjšajo tveganja za prejemnika in zagotovi učinkovito dodeljevanje organov;
(h) ' organ characterisation ' means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, to undertake a proper risk assessment and minimise the risks for the recipient , and to ensure effective organ allocation;
Novo besedilo bolje odraža namene določanja značilnosti organa.
This new wording better reflects the purposes of the organ characterization
(i) „pridobivanje“ je postopek, s katerim darovani organi postanejo razpoložljivi;
(i) ‘procurement’ means a process by which the donated organs become available;
(i) „pridobivanje“ je usklajen postopek, s katerim darovani organi postanejo razpoložljivi;
(i) ‘procurement’ means a coordinated process by which the donated organs become available
Postopek pridobivanja mora biti ustrezno usklajen.
The process of procurement must be appropriately coordinated.
(ia)„dajanje na voljo” je priprava, obdelava, konzerviranje, embaliranje in prevoz človeških organov;
ia)'making available' means the preparation, manipulation, preservation, packaging and transport of human organs;
Medtem ko direktiva o tkivih št. 2004/23/ES opredeljuje izraze „pridobivanje”, „predelava” in „konzerviranje”, pa ta predlog direktive opredeljuje le izraza „pridobivanje” in „konzerviranje”.
While the Tissues Directive 2004/23/EG defines the terms 'procurement', 'processing' and 'preservation', the proposal for a Directive under review only defines the terms 'procurement' and 'preservation'.
Bistvene vmesne faze, kot so priprava, obdelava, konzerviranj, embaliranje in prevoz človeških organov, ostajajo zato opredeljene in se jih zakonsko ne ureja.
This means that essential intermediary stages such as preparation, manipulation, packaging and transport of human organs are not defined and are therefore left unregulated.
Člen 3 – točka (j)
Article 3 –point j
(j) „organizacija za pridobivanje organov“ je zdravstvena ustanova, skupina ali enota bolnišnice ali druga organizacija , ki ji je pristojni organ odobril izvajati dejavnost pridobivanja človeških organov;
(j) "procurement organisation" means a health care establishment, a team or a unit of a hospital or another body which is authorised by the competent authority to undertakes procurement of human organs;
(j) „organizacija za pridobivanje organov“ je javni ali zasebni neprofitni organ, organizacija ali institucija, ki je še zlasti dejavna v usklajenem postopku pridobivanja človeških organov in njihovega dajanja na voljo ;
(j) "procurement organisation" means a public or private non-profit making body , organisation or institution engaged particularly in the coordinated process of procuring and making available human organs;
Pri opredelitvi vsebine direktive je nujno treba upoštevati načelo subsidiarnosti po členu 168(7) PDEU (nekdaj člen 152(5) TES).
In defining the regulatory content of the Directive, it is essential to take into account the principle of subsidiarity in accordance with Article 168(7) TFEU (formerly Article 152(5) TEC).
Prav tako je treba ustrezno spremeniti druge določbe, na primer člen 18.
Other provisions, for instance Article 18, will have to be changed accordingly.
Člen 3 – točka (k)
Article 3 – point k
(k) „konzerviranje“ je uporaba kemičnih snovi, spremenjenih okoljskih razmer ali drugih sredstev pri predelavi , da se prepreči ali upočasni biološko ali fizično propadanje človeških organov v obdobju med pridobivanjem in presaditvijo;
(k) ‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of human organs from the procurement until the transplantation;
(k) „konzerviranje“ je uporaba kemičnih snovi, spremenjenih okoljskih razmer ali drugih sredstev, da se prepreči ali upočasni biološko ali fizično propadanje človeških organov , ki so dani na voljo, v obdobju med njihovim pridobivanjem in presaditvijo;
(k) ‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means , while making available human organs , to prevent or retard the biological or physical deterioration thereof from the procurement until the transplantation;
Predlog spremembe usklajuje besedilo z dodano opredelitvijo „dajanje na voljo” (glej predlog spremembe k členu 3(i)).
This amendment brings the text into line with the added definition of 'making available' (see Amendment to Article 3(i)).
Člen 3 – točka (m)
Article 3 – point m
(m) „hud neželen dogodek“ je kateri koli nepredviden dogodek v zvezi s katero koli stopnjo postopka od darovanja do presaditve, ki lahko povzroči prenos nalezljive bolezni, smrt, ogrozi življenje , povzroči invalidnost ali nezmožnost za delo, katerega posledica je hospitalizacija ali obolevnost ali ki podaljša hospitalizacijo ali obolevnost ;
(m) ‘serious adverse event’ means any unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening , disabling, or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;
(m) „hud neželen dogodek“ je kateri koli neželen in nepredviden dogodek v zvezi s pridobivanjem, konzerviranjem ali dajanjem organov na voljo , ki lahko povzroči prenos nalezljive bolezni, smrt ali ogrozi življenje ali povzroči invalidnost darovalca ali prejemnika, ali bi lahko privedlo do hospitalizacije ali povzročilo drugo bolezen, razen če gre za stranske učinke imunosupresije ;
(m) ‘serious adverse event’ means any undesired and unexpected occurrence associated with the procurement, preservation or making available of organs that might lead to the transmission of an infectious disease, to death or a life-threatening condition or to the disabling of donors or recipients, or that might necessitate hospitalisation or cause another illness, providing it is not a matter of the side-effects of immune suppression;
Opredelitev „hudega neželenega dogodka” je tako široka, da bi nedvomno vodila v izdajo velikega števila poročil, ki ne bi imeli ničesar skupnega s standardi kakovosti in varnosti.
The definition of serious adverse unexpected event is so broad that it would inevitably lead to a large number of reports having nothing to do with quality or safety standards being filed.
Zato jo je treba rahlo omejiti, kot je predlagano.
It should therefore be made slightly more restrictive, as proposed above.
Člen 3 – točka (n)
Article 3 – point n
(n) „huda neželena reakcija“ je nenameren odziv, vključno s pojavom prenosljive bolezni pri darovalcu ali prejemniku, povezan s katero koli stopnjo postopka od darovanja do presaditve, ki je smrten, smrtno nevaren, ki povzroča invalidnost ali nezmožnost za delo, ali katerega posledica je hospitalizacija ali obolevnost , ali ki podaljša hospitalizacijo ali obolevnost ;
(n) ‘serious adverse reaction’ means an unintended response, including a communicable disease, in the donor or in the recipient associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in , or prolongs, hospitalisation or morbidity;
Opredelitev „hude neželene reakcije” je tako široka, da bi nedvomno vodila v izdajo velikega števila poročil, ki ne bi imeli ničesar skupnega s standardi kakovosti in varnosti.
The definition of serous adverse reaction is so broad that it would inevitably lead to a large number of reports having nothing to do with quality or safety standards being filed.
Člen 3 – točka (p)
Article 3 – point p
(p) „presaditev“ pomeni postopek ponovne vzpostavitve nekaterih funkcij človeškega telesa z vnosom odgovarjajočih organov v telo prejemnika;
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring equivalent organs to a recipient;
(p) „presaditev“ pomeni postopek ponovne vzpostavitve nekaterih funkcij človeškega telesa z vnosom človeških organov v telo prejemnika;
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring human organs to a recipient;
Pojasnitev pomena izraza „presaditev”.
Clarification of the meaning of ‘transplantation’.
Poglavje II – naslov
Chapter II - title
KAKOVOST IN VARNOST ORGANOV
THE QUALITY AND SAFETY OF ORGANS
Okvir za kakovost in varnost organov
Framework for the quality and safety of organs
Člen 4 – naslov
Article 4 - title
Nacionalni programi za kakovost
National quality programmes
Okvir za programe za nacionalno kakovost in varnost
Framework for national quality and safety programmes
(Sprememba velja za celotno besedilo.)
(This amendment applies throughout the text).
Člen 4 – odstavek 2 – točka (-a) (novo)
Article 4 - paragraph 2 - point - a (new)
(-a) standardnih operativnih postopkov za identifikacijo in napotitev morebitnih darovalcev;
(-a) standard operating procedure s for the identification and referral of potential donors ;
Identifikacija morebitnih darovalcev na enotah za intenzivno nego in napotitev le-teh je nujen predpogoj za vse dejavnosti darovanja organov.
Identification of potential donors in the intensive care units and their referral is the indispensable prerequisite for all organ donation activities.