natgillin/translations-raw huggingface dataset:
Uporaba človeških organov za presajanje se je v zadnjih dveh desetletjih postopoma povečala.
The use of human organs for transplantation has steadily increased during the last two decades.
Presajanje organov je trenutno stroškovno najučinkovitejše zdravljenje končne ledvične odpovedi, za končne odpovedi organov, kot so jetra, pljuča in srce pa je celo edino razpoložljivo zdravljenje.
Organ transplantation is now the most cost-effective treatment for end-stage renal failure, while for end-stage failure of organs such as the liver, lung and heart it is the only available treatment.
Presajanje organov je glede na razmerje med koristjo in tveganjem trenutno najučinkovitejše zdravljenje končne ledvične odpovedi in odpovedi trebušne slinavke , za končne odpovedi organov, kot so jetra, pljuča, črevo in srce pa je celo edino razpoložljivo zdravljenje.
Organ transplantation is now the treatment with the best risk/benefit ratio for end-stage renal and pancreatic failure, while for end-stage failure of organs such as the liver, lung , intestines and heart it is the only available treatment.
Seznam mora kar najpodrobneje našteti vse organe, ki se jih lahko presaja pri trenutnem medicinskem znanju.
If the organ transplantations which are feasible according to the state of the art are to be listed, it is important to ensure that the list is as exhaustive as possible.
(2) Vendar pa je uporaba organov pri presajanju povezana s tveganji.
(2) Risks however are associated with the use of organs in transplantation.
Razširjena uporaba človeških organov za presajanje pri zdravljenju zahteva takšni kakovost in varnost, da se tveganja, povezana s prenosom bolezni, čim bolj zmanjšajo.
The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases.
Dobro organizirani nacionalni sistemi za presajanje ter uporaba najboljšega razpoložljivega strokovnega znanja in izkušenj na področju zdravstva, tehnologije in inovativnega zdravljenja lahko za paciente znatno zmanjšajo tveganje, povezano s presajenimi organi.
Well-organi s ed national transplant systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients.
Imunološke težave po presaditvi niso najboljši primer za potencialne prednosti direktive.
Immunological problems after transplantation are not the best example of the potential benefits of the Directive
(4) Vsako leto se med državami članicami izmenjajo organi.
(4) Every year organs are exchanged between Member States.
Izmenjava organov je pomemben način za povečevanje števila razpoložljivih organov in zagotavljanje večje skladnosti med darovalcem in prejemnikom, zaradi česar je kakovost presaditve večja.
The exchange of organs is an important way of expanding the pool of organs available and ensuring a better match between donor and recipient and therefore improving the quality of the transplant.
To je še posebno pomembno za optimalno zdravljenje posebnih bolnikov, kot so bolniki, ki potrebujejo nujno zdravljenje, hipersenzibilni in pediatrični bolniki.
This is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatments, hypersensitised patients or paediatric patients.
Razpoložljivim organom mora biti omogočen prehod meje brez nepotrebnih zapletov in zamud.
Available organs should be able to cross borders without unnecessary problems and delays.
Izmenjava organov je pomemben način za zagotavljanje večje skladnosti med darovalcem in prejemnikom, zaradi česar je kakovost presaditve večja.
The exchange of organs is an important way of ensuring a better match between donor and recipient and therefore improving the quality of the transplant.
Poglavitni razlog za ustanovitev evropskih organizacij za izmenjavo organov kot sta Scandinavtransplant ali Eurotransplant je zagotavljanje skladnosti med darovalcem in prejemnikom.
Matching donors and recipients is the prime reason for setting up European organ exchange organisations such as Scandinavtransplant or Eurotransplant.
(6) Zato so na ravni Skupnosti potrebni skupni standardi kakovosti in varnosti pri pridobivanju, prevozu in uporabi človeških organov.
(6) There is therefore a need for common quality and safety standards for the procurement, transport and use of human organs at Community level.
Ti standardi bi olajšali izmenjave organov, kar bi koristilo tisočem evropskih bolnikov, ki vsako leto potrebujejo tovrstno zdravljenje.
These standards would facilitate exchanges of organs to the benefit of thousands of European patients in need of this type of therapy each year.
Zakonodaja Skupnosti mora zagotavljati, da so človeški organi v skladu s sprejemljivimi standardi kakovosti in varnosti.
Community legislation should ensure that human organs comply with acceptable standards of quality and safety.
Zato bodo ti standardi pomagali prepričati javnost, da imajo človeški organi, pridobljeni od darovalca v drugi državi članici, vendarle enaka jamstva glede kakovosti in varnosti kakor tisti, pridobljeni v lastni državi.
Therefore such standards will help to reassure the public that human organs procured in another Member State nonetheless carry the same basic quality and safety guarantees as those obtained in their own country.
(6) Zato so na ravni Skupnosti potrebni skupni standardi kakovosti in varnosti pri pridobivanju, prevozu in uporabi človeških organov , ob spoštovanju načela subsidiarnosti v skladu s členom 168(7) PDEU .
(6) There is therefore a need , while duly respecting the subsidiarity principle pursuant to Article 168(7) TFEU, for common quality and safety standards for the procurement, transport and use of human organs at Community level.
Zakonodaja Skupnosti mora zagotavljati, da so človeški organi v skladu s priznanimi standardi kakovosti in varnosti.
Community legislation should ensure that human organs comply with recognised standards of quality and safety.
(6a) V skladu s členom 168(7) PDEU ukrepi, sprejeti po odstavku 4 tega člena, ne posegajo v nacionalne določbe o medicinski uporabi organov.
(6a) In accordance with Article 168(7) TFEU , the measures adopted under paragraph 4(a) of that Article do not affect national provisions on the medical use of organs.
Zato sam kirurški poseg presaditve ne spada v področje uporabe te direktive.
Therefore the surgical act of transplantation itself does not fall within the scope of this Directive.
Vendar je treba ob upoštevanju cilja zmanjšanja tveganja, povezanega s presajenimi organi, vključiti v to direktivo nekatere določbe, ki zadevajo postopek presaditve, zlasti določbe, ki obravnavajo neželene in nepričakovane situacije, ki nastanejo med presaditvijo in ki lahko vplivajo na kakovost in varnost organov.
However, in view of the objective of reducing the associated risks of the transplanted organs, it is necessary to include in this Directive certain provisions concerning the transplantation process and in particular provisions aimed at addressing those unintended and unexpected situations occurring during the transplantation that might affect the quality and safety of organs.
Te programe je treba izvajati in ohranjati skozi ves postopek od darovanja do presaditve ali odstranitve, zajemati pa morajo vključeno osebje, organizacijo, prostore, opremo, materiale, dokumentacijo in shranjevanje podatkov.
This programme should be implemented and maintained throughout the entire chain from donation to transplantation or disposal, and should cover the personnel and organisation, premises, equipment, materials, documentation and record-keeping involved.
Nacionalni program za kakovost mora po potrebi zajemati tudi revizijo.
The national quality programme should include auditing where necessary.
Države članice morajo imeti možnost s pisnimi sporazumi del pristojnosti za dele tega programa prenesti na evropske organizacije za izmenjavo organov.
Member States should be able to delegate, through written agreements, the responsibility for parts of this programme to European organ exchange organisations.
(10) Vrednotenje morebitnih darovalcev pred presaditvijo je bistven element presajanja organov.
(10) Pre-transplant evaluation of potential donors is an essential part of organ transplantation.
Vključevati mora dovolj podatkov, da lahko transplantacijski center naredi ustrezno analizo tveganj in koristi.
This evaluation must provide enough information for the transplant centre to undertake a proper risk-benefit analysis.
Da se organ lahko dodeli ustreznemu prejemniku, je treba ugotoviti tveganja in značilnosti ter jih zabeležiti.
The risks and characteristics of the organ must be identified and documented to allow allocation to a suitable recipient.
Zbrati je treba informacije za popoln opis značilnosti organa in darovalca.
Information should be collected for complete characterisation of the organ and the donor.
Zbrati je treba informacije iz podatkov o predhodnem zdravstvenem stanju, z telesnim pregledom in dodatnimi preiskavami za popoln opis značilnosti organa in darovalca.
Information from clinical history, physical examination and complementary tests should be collected for complete characterisation of the organ and the donor.
Da se pridobijo natančni, zanesljivi in objektivni podatki o predhodnem zdravstvenem stanju, medicinska ekipa izpraša živega darovalca ali sorodnike umrlega darovalca.
In order t o obtain an accurate, reliable and objective medical history, the medical team should interview the living donor or the relatives of the deceased donor.
To je bistvenega pomena, saj časovne omejitve postopka darovanja organov umrlega darovalca zmanjšajo možnosti za izključitev morebitnih hudih nalezljivih bolezni.
This is essential since the time constraints of the process of deceased donation reduce the ability to rule out potentially serious transmissible diseases.
Med razgovori bi ekipa morala ustrezno seznaniti izprašane osebe o tveganjih in posledicah darovanja in presaditve, da se zavedajo pomena tega, da medicinski ekipi dajo vse potrebne podatke.
During the interviews, the team should properly inform the interviewees of the risks and consequences of donation and transplantation so as to make them aware of the importance of providing the medical team with all relevant information.
Treba bi bilo poudariti pomembnost pridobitve ustreznih podatkov o predhodnem zdravstvenem stanju, saj je to bistvenega pomena za zagotavljanje kakovosti in varnosti organov za presaditev.
The importance of obtaining an appropriate medical history should be stressed as an essential point for ensuring the quality and safety of organs for transplantation.
Zato je treba vključiti pojem ustreznega informiranja darovalcev/sorodnikov, da razumejo potencialno tveganje za prejemnika.
For that purpose the concept of properly informing donors/relatives to make them understand the potential risks for the recipient should be included.
(14) Osebje, ki neposredno sodeluje pri darovanju, pridobivanju, testiranju, konzerviranju, prevozu in presajanju človeških organov, mora biti ustrezno kvalificirano in usposobljeno .
(14) Personnel directly involved in the donation, procurement, testing, preservation, transport and transplantation of human organs should be suitable qualified and trained.
(14) Osebje, ki neposredno sodeluje pri darovanju, testiranju, določanju značilnosti, pridobivanju , konzerviranju, prevozu in presajanju človeških organov, mora biti ustrezno kvalificirano in pristojno.
(14) Personnel directly involved in the donation, testing, characterisation, procurement, preservation, transport and transplantation of human organs should be suitably qualified and competent.
Treba je pojasniti, da se te zahteve nanašajo le na zdravstveno osebje, ki sodeluje v postopku.
It should be clarified that these requirements apply only to healthcare personnel involved in the process.
Zahtevati, da tudi drugo osebje izpolnjuje te zahteve, bi lahko vodilo do nepotrebne izgube organov.
Asking for such strict requirements for other personnel might lead to a necessary loss of organs.
Bolje je, če so koraki našteti v vrstnem redu, ki ustreza klinični praksi, in v skladu s členom 2 direktive.
The steps are suggested to be ordered according to clinical practice and to be consistent with article 2 of the Directive.
Novo besedilo bolje povzema prakso v EU in pojasnjuje, da namen ni povečati upravno breme.
The new wording better captures the EU MS realities and clarifies that it is not intended to increase the administrative burden
(16) Ta direktiva mora spoštovati temeljne pravice in upoštevati načela, ki jih priznava zlasti Listina Evropske unije o temeljnih pravicah.
(16) This Directive should respect the fundamental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union.
V skladu z navedeno listino in da se ustrezno upošteva Konvencija o človekovih pravicah in biomedicini, morajo programi presajanja organov temeljiti na načelih prostovoljnega in brezplačnega darovanja, nesebičnosti darovalca in solidarnosti med darovalcem in prejemnikom, pri čimer mora biti zagotovljena anonimnost umrlega darovalca in prejemnikov .
In line with that charter and to take account of, as appropriate the Convention on human rights and biomedicine , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient(s).
(16) Programi presaditve organov bi morali temeljiti na načelih prostovoljnega in neplačanega darovanja, da se zagotovita kakovost in varnost organov za presaditev.
(16) In order to ensure the quality and safety of organs for transplantation, organ transplantation programmes should be founded on the principles of voluntary and unpaid donation.
To je nujen vidik, saj bi kršitev teh načel lahko pomenila nesprejemljivo tveganje in slabe rezultate za prejemnike in za žive darovalce.
This is an essential aspect, since the violation of these principles might be associated with unacceptable risks and poor outcomes for recipients and living donors.
Če darovanje ni prostovoljno ali daje finančne koristi, se kakovost postopka darovanja ne more zagotoviti v celoti, saj izboljšanje kakovosti življenja ali reševanje človeškega življenja nista glavna ali edina cilja, ki se dosegata.
When donation is not voluntary or provides for financial gain, the quality of the process of donation cannot be fully guaranteed, since improving the quality of life or saving the life of a person is not the main or sole objective to be achieved.
Čeprav se postopek razvije v skladu z ustreznimi standardi kakovosti, podatki o predhodnem zdravstvenem stanju, pridobljeni od potencialnega živega darovalca ali od sorodnikov potencialnega umrlega darovalca, pa lahko niso dovolj natančni, kar zadeva stanja ali bolezni, ki so potencialno prenosljivi z darovalca na prejemnika, če si darovalci prizadevajo za pridobitev finančne koristi ali so žrtve kakršne koli prisile.
Even if the process is developed in accordance with appropriate quality standards, the clinical history obtained either from the potential living donor or the relatives of the potential deceased donor might not be accurate enough in terms of those conditions or diseases which are potentially transmissible from donors to recipients when donors are seeking financial gain or are subjected to any kind of coercion.
To bi povzročilo težavo za varnost potencialnih prejemnikov, saj bi ekipa imela omejene možnosti za izvedbo ustrezne analize tveganja.
This would result in a safety problem for potential recipients since the team would have a limited capability for performing an appropriate risk analysis.
Ta direktiva mora spoštovati temeljne pravice in upoštevati načela, ki jih priznava zlasti Listina Evropske unije o temeljnih pravicah.
This Directive should respect the fundamental rights and observe the principles recognised in particular by the Charter of Fundamental Rights of the European Union .
V skladu z navedeno listino in da se ustrezno upošteva Konvencija o človekovih pravicah in biomedicini, morajo programi presajanja organov temeljiti na načelih prostovoljnega in brezplačnega darovanja, nesebičnosti darovalca in solidarnosti med darovalcem in prejemnikom, pri čimer mora biti zagotovljeno, da se upoštevajo stroga pravila o zaupnosti in varnostni ukrepi za varstvo osebnih podatkov darovalcev in prejemnikov .
In line with that charter and to take account of, as appropriate the Convention on human rights and biomedicine , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring that strict confidentiality rules and security measures are in place for the protection of the donors' and the recipients' personal data.
Koncepta sledljivosti in določljivosti sta močno povezana: kadar je mogoča sledljivost imetnikov bioloških materialov, posredno ali neposredno, ti imetniki lahko štejejo za določljive.
The concepts of 'traceability' and 'identifiability' are strongly connected to each other: whenever traceability of the holders of the biological materials is possible, either in a direct or indirect way, these holders can be considered as identifiable.
Z vidika varstva podatkov sledljivost in anonimnost ne moreta obstajati hkrati, saj sta si nasprotni.
From a data protection perspective, traceability and anonymity of data cannot appear at the same time since they are opposite to each other.
(16a) Pristojni organ se mora posvetovati z nacionalnim organom za varstvo podatkov o razvoju okvira za prenos podatkov v zvezi z organi v tretje države in iz njih.
(1 6 a) The competent authority should consult with the national Data Protection Authority in relation to developing a framework for the transfer to and from third countries of data concerning organs.
Uporabljati je treba posebno ureditev za prenos osebnih podatkov tretjim državam, kot je določeno v členih 25 in 26 Direktive Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov 1 .
The specific regime for the transfer of personal data to third countries as laid down in Articles 25 and 26 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 1 should apply .
V členih 25 in 26 Direktive 95/46/ES je določena posebna ureditev za prenos osebnih podatkov tretjim državam.
A specific regime for transfer of personal data to third countries is laid down in Articles 25 and 26 of Directive 95/46/EC.
V členu 21 ali uvodni izjavi 15 predloga bi bilo lahko navedeno, da se pristojni organ posvetuje z nacionalnim organom za varstvo podatkov, da bi razvili potreben okvir za varen, pa tudi hiter in učinkovit prenos podatkov v zvezi z organi v tretje države in iz njih.
Article 21 or the relevant Recital 15 of the proposal could state that the competent authority will consult with the national Data Protection Authority in order to develop the necessary framework for secure, but also fast and efficient transfer of organs' data to and from the third countries.
(16b) Načeloma se istovetnost prejemnika/prejemnikov ne razkrije darovalcu ali njegovi družini in obratno, kar ne posega v veljavno zakonodajo držav članic, ki lahko pod določenimi pogoji dovoljuje, da se ob soglasju obeh strani taki podatki dajo na razpolago darovalcu ali njegovi družini ter prejemnikom organov.
(16b) 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 donor or donors' families and organ recipients with the consent of both parties.
Bolje je, če se ohranjanje anonimnosti med darovalcem in prejemnikom, ki je bilo sprva vključeno v uvodno izjavo 16 prvotnega predloga, pojasni v novi uvodni izjavi.
The maintenance of anonymity between donor and recipient initially placed in recital 16 of the original proposal is better to be explained in a new specific recital.
To bi pojasnilo, da se načelo anonimnosti ne nanaša na postopek za zagotavljanja varstva podatkov, saj bi to bilo v nasprotju s sledljivostjo.
This would clarify that this principle of anonymity is not referred to a procedure to ensure data protection, since this last one would be in contradiction with the traceability.
(16c) Boj proti trgovini s človeškimi organi ne bi smel ostati samo v pristojnosti Unije.
(16c) Combating organ trafficking should not remain the responsibility of the Union alone.
Tudi države članice bi morale sprejeti temu namenjene ukrepe, vključno z zmanjšanjem povpraševanja, bolj učinkovitim spodbujanjem darovanja organov, ohranjanjem stroge zakonodaje glede živečih darovalcev, zagotavljanjem preglednosti nacionalnih registrov in čakalnih list, določanjem pravne odgovornosti medicinskega osebja v zvezi z odkrivanjem nepravilnosti in z izmenjavo informacij.
Member States should also take measures to that end, including reducing demand, promoting organ donation more effectively, maintaining strict legislation with regard to live donors, guaranteeing transparency of national registers and waiting lists, establishing the legal responsibility of the medical profession for tracking irregularities, and sharing information.
(17) 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 načeloma prepoveduje obdelavo podatkov v zvezi z zdravjem.
(17) 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 13 prohibits in principle the processing of data concerning health.
Določene so omejene izjeme, za katere ta načelna prepoved ne velja.
Limited exemptions to this prohibition principle are laid down.
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.
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.
(17) 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 13 načeloma prepoveduje obdelavo podatkov v zvezi z zdravjem.
(17) 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 13 prohibits in principle the processing of data concerning health.
Določene so omejene izjeme, za katere ta načelna prepoved ne velja.
Limited exemptions to this prohibition are laid down.
V skladu s to direktivo bi morali veljati stroga pravila o zaupnosti in varnostni ukrepi za varstvo osebnih podatkov darovalcev in prejemnikov.
In line with that Directive, strict confidentiality rules and security measures should be in place for the protection of donors’ and recipients’ personal data.
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.
Moreover, the competent authority may also consult the national Data Protection Authority in relation to developing a framework for the transfer to and from third countries of data concerning organs.