natgillin/translations-raw huggingface dataset:
Member States should be able to delegate the performance of activities provided for under the framework for quality and safety to specific bodies deemed appropriate under national provisions, including European organ exchange organisations.
Države članice bi morale imeti možnost, da izvajanje dejavnosti, ki jih predvideva okvir za kakovost in varnost, prenesejo na posebne organe, ki veljajo za primerne v skladu z nacionalnimi določbami, med drugim na evropske organizacije za izmenjavo organov.
Competent authorities should supervise compliance with the conditions of procurement through the authorisation of procurement organisations.
Pristojni organi bi morali nadzorovati izpolnjevanje pogojev pridobivanja z odobritvijo določenih organizacij za pridobivanje organov.
Such organisations should have in place proper organisation, suitably qualified or trained and competent personnel and adequate facilities and material.
Takšne organizacije bi morale zagotavljati dobro organiziranost, primerno kvalificirano ali usposobljeno in kompetentno osebje ter ustrezne prostore in material.
The risk-benefit ratio is a fundamental aspect of organ transplantation.
Razmerje med tveganjem in koristjo je pri presaditvi organov bistveno.
Owing to the shortage of organs and the inherent life-threatening nature of diseases leading to the need for organs for transplantation, the overall benefits of organ transplantation are high and more risks are accepted than with blood or most tissues and cell-based treatments.
Zaradi pomanjkanja organov in zaradi življenjsko nevarnih bolezni, ki narekujejo potrebo po organih za presaditev, je splošna korist presajanja organov velika, sprejme pa se več tveganj kot pri zdravljenju s krvjo ali večini presaditev tkiv in celic.
The clinician plays an important role in this context by deciding whether or not organs are suitable for transplantation.
Klinični zdravniki imajo pri tem pomembno vlogo, saj odločajo o primernosti organov za presajanje.
This Directive sets out the information required to make that assessment.
V tej direktivi so navedeni podatki, ki jih je treba upoštevati pri navedeni oceni.
Pre-transplant evaluation of potential donors is an essential part of organ transplantation.
Vrednotenje morebitnih darovalcev pred presaditvijo je bistven element presaditve organov.
That evaluation has to provide enough information for the transplantation centre to undertake a proper risk-benefit analysis.
To vrednotenje mora vključevati dovolj podatkov, da lahko transplantacijski center naredi ustrezno analizo tveganj in koristi.
It is necessary to identify and document the risks and characteristics of the organ in order to allow its allocation to a suitable recipient.
Da se organ lahko dodeli ustreznemu prejemniku, je treba ugotoviti tveganja in značilnosti organa ter jih zabeležiti.
Information from a potential donor's medical history, physical examination and complementary tests should be collected for the adequate characterisation of the organ and the donor.
Zbrati bi bilo treba informacije iz zdravstvene anamneze potencialnega darovalca in s telesnim pregledom ter dodatnimi preiskavami za popoln opis značilnosti organa in darovalca.
To obtain an accurate, reliable and objective history, the medical team should perform an interview with the living donor or, where necessary and appropriate, with the relatives of the deceased donor, during which the team should properly inform them about the potential risks and consequences of donation and transplantation.
Da se pridobijo natančni, zanesljivi in objektivni podatki o predhodnem zdravstvenem stanju, bi morala medicinska ekipa, kadar je to potrebno in ustrezno, opraviti razgovor z živim darovalcem ali sorodniki umrlega darovalca, pri čemer bi jih ta ekipa morala ustrezno seznaniti z možnimi tveganji in posledicami darovanja in presaditve.
Such an interview is particularly important due to the time constraints in the process of deceased donation which reduce the ability to rule out potentially serious transmissible diseases.
Naveden razgovor je zlasti potreben zaradi časovnih omejitev pri postopku darovanja organov umrlih darovalcev, ki zmanjšajo možnosti za izključitev morebitnih hudih nalezljivih bolezni.
The shortage of organs available for transplantation and the time constraints in the process of organ donation and transplantation make it necessary to take into account those situations in which the transplantation team lacks some of the information required for organ and donor characterisation as set out in Part A of the Annex, which specifies a mandatory minimum data set.
Zaradi pomanjkanja organov za presaditev in časovnih omejitev v postopku darovanja in presajanja organov je treba upoštevati primere, ko ekipa za presaditev nima vseh potrebnih informacij o značilnostih darovalca in organa, kot je določeno v delu A Priloge, ki določa obvezen najmanjši podatkovni sklop.
In those particular cases, the medical team should assess the particular risk posed to the potential recipient by the lack of information and by not proceeding with transplantation of the organ in question.
V teh posebnih primerih bi medicinska ekipa morala oceniti, kakšna bi bila konkretna nevarnost za morebitnega prejemnika zaradi pomanjkljivih informacij in v primeru neizvedbe presaditve zadevnega organa.
Where a complete characterisation of an organ, according to Part A of the Annex, is not possible in time or due to particular circumstances, the organ may be considered for transplantation where non-transplantation might pose a greater risk to the potential recipient.
Kadar zaradi časovnih razlogov ali posebnih razmer ni mogoče pravočasno določiti vseh značilnosti organa v skladu z delom A Priloge, se ta organ vseeno sme uporabiti za presaditev, kadar bi bil brez nje morebitni prejemnik v večji nevarnosti.
Part B of the Annex, referring to a complementary data set, should allow a more detailed organ and donor characterisation to be made.
Na podlagi dela B Priloge, ki obravnava dodaten podatkovni sklop, bi se morale natančneje določiti značilnosti organa in darovalca.
Effective rules for the transportation of organs should be provided that optimise ischaemic times and reduce organ damage.
Zagotoviti bi bilo treba učinkovita pravila za prevoz organov, ki optimalno skrajšajo obdobje, v katerem organ nima dotoka krvi, in zmanjšajo poškodbe organov.
While maintaining medical confidentiality, the organ container should be clearly labelled and accompanied by the necessary documentation.
Upoštevajoč zaupnost medicinskih podatkov bi moral biti vsebnik z organom opremljen z jasno oznako, ki jo spremlja potrebna dokumentacija.
The transplantation system should ensure traceability of organs from donation to reception and should have the capacity to raise the alert if there is any unexpected complication.
Sistem presajanja bi moral zagotavljati sledljivost organa od darovalca do prejemnika. Sistem bi moral imeti tudi funkcijo za opozarjanje v primeru nepredvidenih zapletov.
A system should therefore be put in place to detect and investigate serious adverse events and reactions for the protection of vital interest of the individuals concerned.
Za zaščito življenjskih interesov zadevnih posameznikov bi bilo treba vzpostaviti sistem, ki bo odkrival in raziskoval hude neželene dogodke in reakcije.
An organ donor is also very often a tissue donor.
Darovalec organa je zelo pogosto tudi darovalec tkiva.
Quality and safety requirements for organs should complement and be linked with the existing Union system for tissues and cells laid down in Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [4].
Zahteve glede kakovosti in varnosti organov morajo dopolnjevati obstoječ sistem Unije za tkiva in celice iz Direktive 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic [4] in biti z njim povezane.
This does not mean that systems for organs and for tissues and cells should necessarily be electronically linked.
To ne pomeni, da bi morala biti sistema za organe ter tkiva in celice elektronsko povezana.
An unexpected adverse reaction in an organ donor or recipient should be traced by the competent authority and reported through the notification system for serious adverse events and reactions for tissues and cells as provided for in that Directive.
Pristojni organ bi moral odkriti nepredvideno neželeno reakcijo pri darovalcu ali prejemniku organa in poročati o tem prek sistema za poročanje o hudih neželenih dogodkih in reakcijah tkiv in celic, kakor ga določa navedena direktiva.
Healthcare personnel directly involved in the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs should be suitably qualified or trained and competent.
Zdravstveno osebje, ki neposredno sodeluje pri darovanju, testiranju, določanju značilnosti, pridobivanju, konzerviranju, prevozu in presajanju organov, bi moralo biti ustrezno kvalificirano ali usposobljeno in sposobno.
The importance of donor coordinators, appointed at hospital level, has been acknowledged by the Council of Europe.
Svet Evrope je priznal pomen koordinatorjev za presaditve, imenovanih na ravni bolnišnice.
The role of the donor coordinator or coordination team should be recognised as key to improving not only the effectiveness of the process of donation and transplantation, but also the quality and safety of the organs to be transplanted.
Vlogo koordinatorja za presaditve ali koordinacijske ekipe bi bilo treba priznati kot ključno ne le za izboljšanje učinkovitosti postopka darovanja in presajanja, ampak tudi kakovosti in varnosti organov, ki bodo presajeni.
As a general principle, organ exchange with third countries should be supervised by the competent authority.
Načeloma bi moral izmenjavo organov s tretjimi državami nadzorovati pristojni organ.
Organ exchange with third countries should be allowed only where standards equivalent to those provided for in this Directive are met.
Izmenjava organov s tretjimi državami bi se morala dovoliti samo, kadar so izpolnjeni enaki standardi, kakor jih predvideva ta direktiva.
However, the important role played by existing European organ exchange organisations in the exchange of organs between the Member States and third countries participating in such organisations should be taken into account.
Vendar bi bilo treba upoštevati pomembno vlogo, ki jo imajo evropske organizacije za izmenjavo organov pri izmenjavi organov med državami članicami in tretjimi državami, ki sodelujejo pri teh organizacijah.
Altruism is an important factor in organ donations.
Altruizem je pomemben dejavnik pri darovanju organov.
To ensure the quality and safety of organs, organ transplantation programmes should be founded on the principles of voluntary and unpaid donation.
Da bi zagotovili kakovost in varnost organov, bi morali programi presajanja organov temeljiti na načelih prostovoljnega in brezplačnega darovanja.
This is essential because the violation of these principles might be associated with unacceptable risks.
To je bistveno, ker bi lahko kršitev teh načel pomenila nesprejemljivo tveganje.
Where donation is not voluntary and/or is undertaken with a view to financial gain, the quality of the process of donation could be jeopardised because improving the quality of life or saving the life of a person is not the main and/or the unique objective.
Kadar darovanje ni prostovoljno in/ali se izvaja z namenom finančne koristi, bi lahko bila ogrožena kakovost postopka darovanja, ker izboljšanje kakovosti življenja ali reševanje človeškega življenja ni glavni in/ali edini cilj.
Even if the process is developed in accordance with appropriate quality standards, a clinical history obtained from either a potential living donor or the relatives of a potential deceased donor who are seeking financial gain or are subjected to any kind of coercion might not be sufficiently accurate in terms of conditions and/or diseases potentially transmissible from donor to recipient.
Tudi če se postopek razvije v skladu z ustreznimi standardi kakovosti, je možno, da podatki o predhodnem zdravljenju, pridobljeni bodisi od morebitnega živega darovalca bodisi od sorodnikov morebitnega umrlega darovalca, ki zasledujejo finančno korist ali so žrtve kakršne koli prisile, ne bi bili dovolj natančni glede stanja in/ali bolezni, ki so potencialno prenosljive z darovalca na prejemnika.
This could give rise to a safety problem for potential recipients since the medical team would have a limited capability for performing an appropriate risk assessment.
To bi lahko pomenilo težavo za varnost morebitnih prejemnikov, saj bi medicinska ekipa imela omejene možnosti za izvedbo ustrezne ocene tveganja.
The Charter of Fundamental Rights of the European Union should be recalled, notably the principle set out in Article 3(2)(c) thereof.
Treba bi bilo upoštevati Listino Evropske unije o temeljnih pravicah, zlasti načelo iz člena 3(2)(c) Listine.
That principle is also enshrined in Article 21 of the Convention on Human Rights and Biomedicine of the Council of Europe, which many Member States have ratified.
To načelo je zapisano tudi v členu 21 Konvencije Sveta Evrope o človekovih pravicah in biomedicini, ki je številne države članice še niso ratificirale.
It is also reflected in the World Health Organization Guiding Principles on Human Cell, Tissue and Organ Transplantation, whereby the human body and its parts may not be the subject of commercial transactions.
Poleg tega je to načelo omenjeno v vodilnih načelih Svetovne zdravstvene organizacije o človeških celicah, tkivih in presaditvah organov, pri čemer se s človeškim telesom in njegovimi deli ne sme trgovati.
Other internationally recognised principles guiding practices in organ donation and transplantation include, inter alia, the certification or the confirmation of death in accordance with national provisions before the procurement of organs from deceased persons and the allocation of organs based on transparent, non-discriminatory and scientific criteria.
Druga mednarodno priznana načela, ki določajo prakso pri darovanju in presajanju organov, med drugim vključujejo izdajo mrliškega lista ali potrditev smrti v skladu z nacionalnimi določbami pred pridobitvijo organov od umrlih oseb ali dodelitvijo organov na podlagi preglednih, nediskriminatornih in znanstvenih meril.
They should be recalled and be taken into account in the context of the Commission's Action Plan on Organ Donation and Transplantation.
Nanje bi bilo treba opozoriti in jih upoštevati pri akcijskem načrtu Komisije o darovanju in presajanju organov.
Several models of consent to donation coexist in the Union, including opting-in systems in which consent to organ donation has to be explicitly obtained, and opting-out systems in which donation can take place unless there is evidence of any objection to donation.
Unija ima več vzporednih modelov privolitve v darovanje, med drugim sisteme opredelitve za darovanje, pri katerih je treba izrecno pridobiti soglasje za darovanje organa, in sisteme opredelitve proti darovanju, pri katerih je darovanje možno, razen če ni nobenih dokazov za kakršno koli nasprotovanje darovanju.
In order to enable individuals to express their wishes in this regard, some Member States have developed specific registries where citizens record them.
Da bi posameznikom omogočile izraziti njihove želje v zvezi s tem, so nekatere države članice razvile posebne evidence, v katerih so želje državljanov zabeležene.
This Directive is without prejudice to the broad diversity of the systems of consent already in place in the Member States.
Ta direktiva ne posega v veliko raznolikost sistemov soglasja, ki jih že imajo države članice.
In addition, by means of its Action plan on Organ Donation and Transplantation the Commission aims to increase public awareness of organ donation and in particular to develop mechanisms to facilitate the identification of organ donors across Europe.
Poleg tega namerava Komisija s svojim akcijskim načrtom o darovanju in presajanju povečati ozaveščenost javnosti o darovanju organov ter zlasti razviti mehanizme za lažjo prepoznavanje darovalcev po vsej Evropi.
Article 8 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [5] prohibits in principle the processing of data concerning health, while laying down limited exemptions.
Člen 8 Direktive 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [5] načeloma prepoveduje obdelavo podatkov v zvezi z zdravjem, pri čemer so določene omejene izjeme.
Directive 95/46/EC also requires the controller to implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access and against all other unlawful forms of processing.
Direktiva 95/46/ES poleg tega zahteva, da nadzornik izvaja ustrezne tehnične in organizacijske ukrepe za varovanje osebnih podatkov pred naključnim ali nezakonitim uničenjem ali naključno izgubo, spreminjanjem, nepooblaščenim razkritjem ali dostopom ter pred drugimi nezakonitimi načini obdelave.
It should be ensured that strict confidentiality rules and security measures are in place for the protection of donors' and recipients' personal data, in accordance with Directive 95/46/EC.
Morali bi zagotoviti stroga pravila o zaupnosti in varnostne ukrepe za varstvo osebnih podatkov darovalcev in prejemnikov, v skladu z Direktivo 95/46/ES.
Moreover, the competent authority may also consult the national data protection supervisory authority in relation to developing a framework for the transfer of data on organs to and from third countries.
Poleg tega se pristojni organ lahko posvetuje z nacionalnim organom za varstvo podatkov o razvoju okvira za prenos podatkov v zvezi z organi v tretje države in iz njih.
As a general principle, the identity of the recipient(s) should not be disclosed to the donor or the donor's family or vice versa, without prejudice to legislation in force in Member States which, under specific conditions, might allow such information to be made available to donors or donors' families and organ recipients.
Načeloma se identiteta prejemnika/prejemnikov darovalcu ali njegovi družini in obratno ne razkrije, brez poseganja v veljavno zakonodajo držav članic, ki lahko pod posebnimi pogoji dovoljuje, da se taki podatki dajo na razpolago darovalcu ali njegovi družini ter prejemnikom organov.
Living donation coexists with deceased donation in most Member States.
V večini držav članic vzporedno obstajata darovanje organov živih darovalcev in darovanje organov umrlih darovalcev.
Living donation has evolved over the years in such a way that good results can be obtained even where there is no genetic relationship between donor and recipient.
Darovanje organov živih darovalcev se je skozi leta razvilo do te mere, da je mogoče dobre rezultate dobiti tudi, kadar darovalec in prejemnik nista genetsko povezana.
Living donors should be adequately evaluated to determine their suitability for donation in order to minimise the risk of transmission of diseases to the recipients.
Žive darovalce bi bilo treba ustrezno oceniti, da se določi njihova primernost za darovanje z namenom zmanjšanja tveganja prenosa bolezni na prejemnike.
In addition, living donors face risks linked both to testing to ascertain their suitability as a donor and to the procedure to obtain the organ.
Poleg tega se živi darovalci soočajo s tveganjem pri testiranju, da se oceni, ali so primerni kot darovalci, pa tudi pri postopku odvzema organa.
Complications may be medical, surgical, social, financial or psychological.
Zapleti so lahko zdravstveni, kirurški, socialni, finančni ali psihološki.
The level of risk depends, in particular, on the type of organ to be donated.
Stopnja tveganja je odvisna zlasti od vrste organa, ki bo darovan.
Therefore, living donations need to be performed in a manner that minimises the physical, psychological and social risk to the individual donor and the recipient and does not jeopardise the public's trust in the healthcare community.
Zato je treba darovanje organov živih darovalcev izvajati tako, da so fizična, psihološka in socialna tveganja za posameznega darovalca in prejemnika čim manjša ter da ni ogroženo zaupanje javnosti v zdravstveno oskrbo.
The potential living donor has to be able to take an independent decision on the basis of all the relevant information and should be informed in advance as to the purpose and nature of the donation, the consequences and risks.
Morebitni živi darovalec mora imeti možnost, da se na podlagi vseh ustreznih informacij svobodno odloči ter bi moral biti vnaprej obveščen o namenu in značilnostih darovanja, posledicah in tveganjih.
In this context, and to guarantee respect for the principles governing donation, the highest possible protection of living donors should be ensured.
V tem okviru in za zagotovitev spoštovanja načel o darovanju bi bilo treba poskrbeti za največjo možno zaščito živih darovalcev.
It should also be noted that some Member States are signatories to the Convention on Human Rights and Biomedicine of the Council of Europe, and its additional protocol on Transplantation of Organs and Tissues of Human Origin.
Treba bi bilo tudi omeniti, da so nekatere države članice podpisnice Konvencije Sveta Evrope o človekovih pravicah in biomedicini ter njenega dodatnega protokola o presajanju organov in tkiv človeškega izvora.
Complete information, a proper evaluation and an adequate follow-up are internationally recognised measures aimed at protecting the living donors and also contribute to ensuring the quality and safety of organs.
Popolne informacije, pravilna ocena in ustrezno nadaljnje spremljanje so mednarodno priznani ukrepi za zaščito živih darovalcev, pomagajo pa tudi zagotoviti kakovost in varnost organov.
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 in evaluating their quality and safety throughout patients' recovery and during the subsequent follow-up.
Pristojni organi držav članic bi morali imeti ključno vlogo pri zagotavljanju kakovosti in varnosti organov med celotnim postopkom od darovanja do presaditve ter pri ocenjevanju njihove kakovosti in varnosti v času bolnikovega okrevanja in med nadaljnjim spremljanjem.
For that purpose, besides the system for reporting serious adverse events and reactions, the collection of relevant post-transplantation data is needed for a more comprehensive evaluation of the quality and safety of organs intended for transplantation.
V ta namen bi poleg sistema za poročanje o hudih neželenih dogodkih in reakcijah potrebovali zbirko ustreznih podatkov o stanju po presaditvi, ki bi jih potrebovali za celovitejšo oceno kakovosti in varnosti organov za presaditev.
Sharing such information between Member States would facilitate further improvement of donation and transplantation across the Union.
S skupno uporabo teh informacij med državami članicami bi nadalje izboljšali darovanja in presaditve v Uniji.