natgillin/translations-raw huggingface dataset:
As emphasised by the Recommendation Rec(2006)15 of the Committee of Ministers of the Council of Europe to Member States on the background, functions and responsibilities of a National Transplant Organisation (NTO), it is preferable to have a single non-profit making body which is officially recognised with overall responsibility for donation, allocation, traceability and accountability.
Kot je bilo poudarjeno v priporočilu Rec(2006)15 Odbora ministrov Sveta Evrope državam članicam o ozadju, funkcijah in pristojnostih nacionalne organizacije za presajanje, je zaželeno, da je uradno priznano eno nepridobitno telo, ki je v celoti pristojno za darovanje, razdeljevanje, sledljivost in določanje odgovornosti.
However, depending especially on the division of competences within the Member States, a combination of local, regional, national and/or international bodies may work together to coordinate donation, allocation and/or transplantation, provided that the framework in place ensures accountability, cooperation and efficiency.
Vendar lahko lokalna, regionalna, nacionalna in/ali mednarodna telesa sodelujejo in tako uskladijo darovanje, dodeljevanje in/ali presajanje, kar je odvisno zlasti od delitve pristojnosti v državah članicah, pod pogojem, da obstoječi okvir zagotavlja določanje odgovornosti, sodelovanje in učinkovitost.
Member States should lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and ensure that these penalties are implemented.
Države članice bi morale določiti pravila o kaznih, ki se uporabljajo za kršitve nacionalnih predpisov, sprejetih na podlagi te direktive, in zagotoviti, da se jih izvaja.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to adapt the Annex.
Komisijo bi bilo treba pooblastiti, da v skladu s členom 290 PDEU sprejme delegirane akte v zvezi s prilagoditvijo Priloge.
The Commission should supplement or amend the minimum data set specified in Part A of the Annex only in exceptional situations where it is justified by a serious risk to human health, and supplement or amend the complementary data set specified in Part B of the Annex in order to adapt it to scientific progress and international work carried out in the field of quality and safety of organs intended for transplantation.
Komisija bi morala dopolniti ali spremeniti najnujnejše podatke, določene v delu A Priloge, samo v izrednih primerih, kadar je to upravičeno zaradi hude nevarnosti za človekovo zdravje, ter dopolniti ali spremeniti dodatni sklop podatkov, določen v delu B Priloge, da bi ga prilagodila znanstvenemu napredku in mednarodnemu delu, opravljenemu na področju kakovosti in varnosti organov za presaditev.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Zlasti je pomembno, da Komisija med svojim pripravljalnim delom izvede ustrezna posvetovanja, tudi na ravni strokovnjakov.
The exchange of organs between Member States requires that uniform rules on the procedures for the transmission of information on organs and donor characterisation, as well as for ensuring the traceability of organs and for reporting serious adverse events and reactions, should be adopted by the Commission, in order to ensure the highest standards of quality and safety of the organs exchanged.
Zaradi izmenjave organov med državami članicami bi morala Komisija sprejeti enotna pravila za postopke prenosa informacij o značilnostih organov in darovalcev, pa tudi za zagotovitev sledljivosti organov in za poročanje o hudih neželenih dogodkih in reakcijah, da bi zagotovili najvišje možne standarde kakovosti in varnosti izmenjanih organov.
According to Article 291 TFEU, rules and general principles concerning mechanisms for the control by Member States of the Commission's exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure.
V skladu s členom 291 PDEU je treba pravila in splošna načela, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije, določiti vnaprej, in sicer z uredbo, sprejeto v skladu z rednim zakonodajnim postopkom.
Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [6] continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.
Do sprejetja te nove uredbe se še naprej uporablja Sklep Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [6], razen regulativnega postopka s pregledom, ki se ne uporablja.
Since the objectives of this Directive, namely laying down quality and safety standards for organs intended for transplantation to the human body, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker ciljev te direktive, in sicer določitve standardov kakovosti in varnosti za organe, namenjene za presaditev v človeško telo, države članice ne morejo zadovoljivo doseči in ker te cilje zaradi obsega ukrepa lažje doseže Unija, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,
Skladno z načelom sorazmernosti iz navedenega člena, ta direktiva ne presega okvirov, ki so potrebni za doseganje navedenih ciljev –
Subject Matter
Vsebina
This Directive lays down rules to ensure standards of quality and safety for human organs (hereinafter ‘organs’) intended for transplantation to the human body, in order to ensure a high level of human health protection.
Ta direktiva določa pravila za zagotavljanje standardov kakovosti in varnosti za človeške organe (v nadaljnjem besedilu: organi), ki so namenjeni za presaditev v človeško telo, da se zagotovi visoka raven varovanja zdravja ljudi.
This Directive applies to the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs intended for transplantation.
Ta direktiva se uporablja za darovanje, testiranje, določanje značilnosti, pridobivanje, konzerviranje, prevoz in presajanje organov, ki so namenjeni za presaditev.
Where such organs are used for research purposes, this Directive only applies where they are intended for transplantation into the human body.
Ta direktiva se pri organih, ki so uporabljeni za raziskave, uporablja le za tiste, ki so namenjeni za presaditev v človeško telo.
‘authorisation’ means authorisation, accreditation, designation, licensing or registration, depending on the concepts used and the practices in place in each Member State;
„odobritev“ pomeni odobritev, akreditacijo, imenovanje, dovoljenje ali registracijo, odvisno od pojmov, ki se uporabljajo v posamezni državi članici, in praks v tej državi članici;
‘competent authority’ means an authority, body, organisation and/or institution responsible for implementing the requirements of this Directive;
„pristojni organ“ pomeni organ, organizacijo in/ali ustanovo, odgovorno za izvrševanje zahtev iz te direktive;
‘disposal’ means the final placement of an organ where it is not used for transplantation;
„uničenje“ pomeni končno usodo organa, kadar organ ni bil uporabljen za presaditev;
‘donor’ means a person who donates one or several organs, whether donation occurs during lifetime or after death;
„darovalec“ pomeni osebo, ki daruje enega ali več organov, ne glede na to, ali do darovanja pride za časa življenja te osebe ali po njeni smrti;
‘donation’ means donating organs for transplantation;
„darovanje“ pomeni darovanje organov za presaditev;
‘donor characterisation’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his/her suitability for organ donation, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;
„določanje značilnosti darovalca“ pomeni zbiranje ustreznih podatkov o značilnostih darovalca, ki so potrebni za oceno njegove ustreznosti za darovanje organa, da se opravi pravilna ocena tveganja in da se zmanjšajo tveganja za prejemnika in zagotovi učinkovito dodeljevanje organov;
‘European organ exchange organisation’ means a non-profit organisation, whether public or private, dedicated to national and cross-border organ exchange, in which the majority of its member countries are Member States;
„evropska organizacija za izmenjavo organov“ pomeni javno ali zasebno nepridobitno organizacijo, ki se ukvarja z nacionalno ali čezmejno izmenjavo organov, v kateri so večina njenih članic države članice;
‘organ’ means a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy.
„organ“ pomeni diferenciran del človeškega telesa, sestavljen iz različnih tkiv, ki ima lastno strukturo, žilje in sposobnost razvoja fizioloških funkcij z znatno stopnjo avtonomije.
A part of an organ is also considered to be an organ 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;
Del organa se tudi šteje za organ, če je njegova funkcija taka, da se v človeškem telesu uporabi za enak namen kot cel organ in ohrani zahteve glede strukture in žilja;
‘organ characterisation’ means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;
„določanje značilnosti organa“ pomeni zbiranje ustreznih podatkov o značilnostih organa, ki so potrebni za oceno njegove ustreznosti, da se opravi pravilna ocena tveganja in zmanjšajo tveganja za prejemnika ter doseže čim boljše dodeljevanje organov;
‘procurement’ means a process by which the donated organs become available;
„pridobivanje“ pomeni postopek, s katerim darovani organi postanejo razpoložljivi;
‘procurement organisation’ means a healthcare establishment, a team or a unit of a hospital, a person, or any other body which undertakes or coordinates the procurement of organs, and is authorised to do so by the competent authority under the regulatory framework in the Member State concerned;
„organizacija za pridobivanje organov“ pomeni zdravstveno ustanovo, ekipo ali enoto bolnišnice, osebo ali katero koli drugo organizacijo, ki se ukvarja z ali usklajuje pridobivanje organov in ji je pristojni organ odobril izvajati to dejavnost na podlagi regulativnega okvira v zadevni državi članici;
‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means to prevent or retard biological or physical deterioration of organs from procurement to transplantation;
„konzerviranje“ pomeni uporabo kemičnih snovi, spremenjenih okoljskih razmer ali drugih sredstev, da se prepreči ali upočasni biološko ali fizično propadanje organov v obdobju od pridobivanja do presaditve;
‘recipient’ means a person who receives a transplant of an organ;
„prejemnik“ pomeni osebo, ki prejme organ za presaditev;
‘serious adverse event’ means any undesired and 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;
„hud neželen dogodek“ pomeni kateri koli neželen in 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;
‘serious adverse reaction’ means an unintended response, including a communicable disease, in the living donor or in the recipient that might be 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;
„huda neželena reakcija“ pomeni nenameren odziv, vključno s pojavom prenosljive bolezni pri živem darovalcu ali prejemniku, ki bi lahko bil 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;
‘operating procedures’ means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end outcome;
„operativni postopki“ pomenijo pisna navodila, ki opisujejo korake posebnega postopka, vključno z materiali in metodami, ki se uporabljajo, ter pričakovanim končnim izidom;
‘transplantation’ means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient;
„presaditev“ pomeni postopek, namenjen ponovni vzpostavitvi nekaterih funkcij človeškega telesa s prenosom organa darovalca v telo prejemnika;
‘transplantation centre’ means a healthcare establishment, a team or a unit of a hospital or any other body which undertakes the transplantation of organs and is authorised to do so by the competent authority under the regulatory framework in the Member State concerned;
„transplantacijski center“ pomeni zdravstveno ustanovo, ekipo ali enoto bolnišnice ali kateri koli drug organ, ki se ukvarja s presaditvijo organov, in mu je pristojni organ odobril izvajati to dejavnost na podlagi regulativnega okvira v zadevni državi članici;
‘traceability’ means the ability to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, including the ability to:
„sledljivost“ pomeni možnost, da se najde in identificira organ na vseh stopnjah postopka od darovanja do presaditve ali uničenja, vključno z možnostjo, da se:
identify the donor and the procurement organisation,
identificira darovalca in organizacijo za pridobivanje organov,
identify the recipient(s) at the transplantation centre(s), and
poišče prejemnike pri transplantacijskem centru in
locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ.
identificira vse pomembne neosebne podatke v zvezi s proizvodi in materiali v stiku z organom.
THE QUALITY AND SAFETY OF ORGANS
KAKOVOST IN VARNOST ORGANOV
Framework for quality and safety
Okvir za kakovost in varnost
Member States shall ensure that a framework for quality and safety is established to cover all stages of the chain from donation to transplantation or disposal, in compliance with the rules laid down in this Directive.
Države članice zagotovijo vzpostavitev okvira za kakovost in varnost, ki zajema vse stopnje celotnega postopka od darovanja do presaditve ali uničenja v skladu s pravili iz te direktive.
The framework for quality and safety shall provide for the adoption and implementation of operating procedures for:
Okvir za kakovost in varnost določa sprejetje in izvajanje operativnih postopkov za:
the verification of donor identity;
potrditev identitete darovalca;
the verification of the details of the donor's or the donor's family's consent, authorisation or absence of any objection, in accordance with the national rules that apply where donation and procurement take place;
potrditev podrobnih podatkov o privolitvi darovalca ali darovalčeve družine, dovoljenje ali nenasprotovanje v skladu z nacionalnimi pravili, ki se uporabljajo v kraju darovanja in pridobitve;
the verification of the completion of the organ and donor characterisation in accordance with Article 7 and the Annex;
potrditev, ali je bilo določanje značilnosti organa in darovalca izvedeno v celoti v skladu s členom 7 in Prilogo;
the procurement, preservation, packaging and labelling of organs in accordance with Articles 5, 6 and 8;
pridobivanje, konzerviranje, pakiranje in označevanje organov v skladu s členi 5, 6 in 8;
the transportation of organs in accordance with Article 8;
prevoz organov v skladu s členom 8;
ensuring traceability, in accordance with Article 10, guaranteeing compliance with the Union and national provisions on the protection of personal data and confidentiality;
zagotavljanje sledljivosti v skladu s členom 10, pri čemer se zagotovi skladnost s predpisi Unije in nacionalnimi predpisi v zvezi z varstvom osebnih podatkov in zaupnostjo;
the accurate, rapid and verifiable reporting of serious adverse events and reactions in accordance with Article 11(1);
točno, hitro in preverljivo poročanje o hudih neželenih dogodkih in reakcijah v skladu s členom 11(1);
the management of serious adverse events and reactions in accordance with Article 11(2).
ravnanje v primeru hudih neželenih dogodkov in reakcij v skladu s členom 11(2).
The operating procedures referred to in points (f), (g) and (h) shall specify, inter alia, the responsibilities of procurement organisations, European organ exchange organisations and transplantation centres.
Operativni postopki iz točk (f), (g) in (h) med drugim določajo pristojnosti organizacij za pridobivanje organov, evropskih organizacij za izmenjavo organov in transplantacijskih centrov.
In addition, the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal are suitably qualified or trained and competent, and shall develop specific training programmes for such personnel.
Poleg tega okvir za kakovost in varnost zagotavlja, da je zdravstveno osebje, ki je na vseh stopnjah vključeno v verigo od darovanja do presaditve ali uničenja, ustrezno kvalificirano ali usposobljeno in sposobno, ter omogoča razvoj posebnih programov usposabljanja za to osebje.
Procurement organisations
Organizacije za pridobivanje organov
Member States shall ensure that the procurement takes place in, or is carried out by, procurement organisations that comply with the rules laid down in this Directive.
Države članice zagotovijo, da se pridobivanje izvaja v okviru organizacij za pridobivanje organov, ki izpolnjujejo pravila, določena s to direktivo, ali ga izvajajo te organizacije.
Member States shall, upon the request of the Commission or another Member State, provide information on the national requirements for the authorisation of procurement organisations.
Države članice na zahtevo Komisije ali druge države članice posredujejo informacije o nacionalnih zahtevah za odobritev organizacij za pridobivanje organov.
Organ procurement
Pridobivanje organov
Member States shall ensure that medical activities in procurement organisations, such as donor selection and evaluation, are performed under the advice and the guidance of a doctor of medicine as referred to in Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications [7].
Države članice zagotovijo, da se zdravstvene dejavnosti organizacij za pridobivanje, kot je izbira in ocena darovalca, izvajajo s svetovanjem in pod vodstvom zdravnika, kakor je navedeno v Direktivi 2005/36/ES Evropskega parlamenta in Sveta z dne 7. septembra 2005 o priznavanju poklicnih kvalifikacij [7].
Member States shall ensure that procurement takes place in operating theatres, which are designed, constructed, maintained and operated in accordance with adequate standards and best medical practices so as to ensure the quality and safety of the organs procured.
Države članice zagotovijo, da se pridobivanje organov izvaja v operacijskih dvoranah, ki so oblikovane, zgrajene, vzdrževane in upravljane v skladu z ustreznimi standardi in najboljšo zdravniško prakso, da se zagotovita kakovost in varnost pridobljenih organov.
Member States shall ensure that procurement material and equipment are managed in accordance with relevant Union, international and national legislation, standards and guidelines on the sterilisation of medical devices.
Države članice zagotovijo, da sta material in oprema, ki se uporabljata pri pridobivanju organov, v skladu z ustreznimi mednarodnimi predpisi in nacionalno zakonodajo ter zakonodajo Unije, standardi in smernicami o sterilizaciji medicinskih pripomočkov.
Organ and donor characterisation
Opis značilnosti organa in darovalca
Member States shall ensure that all procured organs and donors thereof are characterised before transplantation through the collection of the information set out in the Annex.
Države članice zagotovijo, da se pred presaditvijo določijo značilnosti vseh pridobljenih organov in njihovih darovalcev z zbiranjem informacij, določenih v Prilogi.
The information specified in Part A of the Annex contains a set of minimum data which has to be collected for each donation.
Informacije, določene v delu A Priloge, vsebujejo sklop najnujnejših podatkov, ki jih je treba zbrati pri vsakem darovanju.
Information specified in Part B of the Annex contains a set of complementary data to be collected in addition, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case.
Informacije, določene v delu B Priloge, vsebujejo sklop dodatnih podatkov, ki jih je treba zbrati dodatno na podlagi odločitve medicinske ekipe ob upoštevanju razpoložljivosti teh informacij in posebnih okoliščin primera.
Notwithstanding paragraph 1, if according to a risk-benefit analysis in a particular case, including in life-threatening emergencies, the expected benefits for the recipient outweigh the risks posed by incomplete data, an organ may be considered for transplantation even where not all of the minimum data specified in Part A of the Annex are available.
Kadar ne glede na odstavek 1 v skladu z analizo tveganj in koristi v posameznem primeru, vključno v življenjsko nevarnih nujnih primerih, pričakovana korist za prejemnika prevlada nad tveganjem, ki ga pomenijo nepopolni podatki, je mogoče organ uporabiti za presaditev tudi, kadar niso na voljo vsi najnujnejši podatki iz dela A Priloge.
In order to meet the quality and safety requirements laid down in this Directive, the medical team shall endeavour to obtain all necessary information from living donors and for that purpose shall provide them with the information they need to understand the consequences of donation.
Da bi medicinska ekipa izpolnila vse zahteve glede kakovosti in varnosti iz te direktive, si prizadeva, da od živih darovalcev pridobi vse potrebne informacije in da jim v ta namen nudi vse informacije, ki jih potrebujejo za razumevanje posledic darovanja.
In the case of deceased donation, where possible and appropriate, the medical team shall endeavour to obtain such information from relatives of the deceased donor or other persons.
Pri darovanju organov umrlih darovalcev si medicinska ekipa vedno, kadar je to možno in ustrezno, prizadeva, da te podatke pridobi od sorodnikov umrlega darovalca ali drugih oseb.
The medical team shall also endeavour to make all parties from whom information is requested aware of the importance of the swift transmission of that information.
Medicinska ekipa si tudi prizadeva, da so vse strani, od katerih se zahtevajo informacije, seznanjene s pomembnostjo hitrega posredovanja navedenih informacij.
The tests required for organ and donor characterisation shall be carried out by laboratories with suitably qualified or trained and competent personnel and adequate facilities and equipment.
Testiranje, zahtevano za določanje značilnosti organa in darovalca, se izvede v laboratoriju, ki ima ustrezno kvalificirano ali usposobljeno in sposobno osebje ter ustrezne prostore in opremo.