natgillin/translations-raw huggingface dataset:
Procurement of tissues and cells from living donors shall take place in an environment that ensures their health, safety and privacy.
Pridobivanje tkiv in celic od živih darovalcev poteka v okolju, ki zagotavlja njihovo zdravje, varnost in zasebnost.
Where appropriate, the staff and equipment necessary for body reconstruction of deceased donors shall be provided.
Po potrebi se zagotovi osebje in oprema, potrebna za rekonstrukcijo telesa umrlih darovalcev.
Such reconstruction shall be completed effectively.
Taka rekonstrukcija se opravi učinkovito.
The procedures for the procurement of tissues and cells shall be carried out in accordance with the requirements specified in Article 5.
Postopki za pridobitev tkiv in celic potekajo v skladu z zahtevami, določenimi v členu 5.
A unique identifying code shall be allocated to the donor and the donated tissues and cells, during procurement or at the tissue establishment, to ensure proper identification of the donor and the traceability of all donated material.
Enotna identifikacijska oznaka se dodeli darovalcu ter darovanim tkivom in celicam med pridobivanjem ali v tkivni ustanovi za zagotovitev ustrezne identifikacije darovalca in sledljivosti darovanega materiala.
The coded data shall be entered in a register maintained for the purpose.
Kodirani podatki se vnesejo v register, ki se hrani v ta namen.
Donor documentation shall be maintained in accordance with section 1.4 of Annex IV.
Dokumentacija o darovalcih se hrani v skladu s točko 1.4 Priloge IV.
Selection criteria for donors of tissues and cells
Merila za izbor darovalcev tkiv in celic
The competent authority or authorities shall ensure that donors comply with the selection criteria set out in:
Pristojni organ ali organi zagotovijo, da darovalci izpolnjujejo merila za izbor, določena v:
Annex I for donors of tissues and cells, except donors of reproductive cells;
Prilogi I za darovalce tkiv in celic, razen za darovalce reproduktivnih celic;
Annex III for donors of reproductive cells.
Prilogi III za darovalce reproduktivnih celic.
Laboratory tests required for donors
Potrebno laboratorijsko testiranje darovalcev
The competent authority or authorities shall ensure that:
Pristojni organ ali organi zagotovijo, da:
donors of tissues and cells, except donors of reproductive cells, undergo the biological tests set out in point 1 of Annex II;
darovalci tkiv in celic, razen darovalcev reproduktivnih celic, opravijo biološke teste, določene v točki 1 Priloge II;
the tests referred to in point (a) are carried out in compliance with the general requirements set out in point 2 of Annex II.
so testi iz točke (a), opravljeni v skladu s splošnimi zahtevami, določenimi v točki 2 Priloge II.
donors of reproductive cells undergo the biological tests set out in points 1, 2 and 3 of Annex III;
darovalci reproduktivnih celic opravijo biološke teste, določene v točkah 1, 2 in 3 Priloge III;
the tests referred to in point (a) above are carried out in compliance with the general requirements set out in point 4 of Annex III.
so testi iz točke (a), opravljeni v skladu s splošnimi zahtevami, določenimi v točki 4 Priloge III.
Tissue and/or cell donation and procurement procedures and reception at the tissue establishment
Darovanje tkiva in/ali celic ter postopki pridobivanja in sprejem v tkivno ustanovo
The competent authority or authorities shall ensure that the tissue and/or cell donation and procurement procedures and the reception of tissues and/or cells at the tissue establishment comply with the requirements set out in Annex IV.
Pristojni organ ali organi zagotovijo, da so pri darovanju tkiva in/ali celic ter postopkih pridobivanja in sprejemu v tkivno ustanovo izpolnjene zahteve, določene v Prilogi IV.
Requirements for direct distribution to the recipient of specific tissues and cells
Zahteve za neposredno razdeljevanje določenih tkiv in celic prejemniku
The competent authority or authorities may authorise the direct distribution of specific tissues and cells from where the procurement is carried out to a health care establishment for immediate transplantation.
Pristojni organ ali organi lahko odobrijo, da so določena tkiva in celice s kraja pridobivanja neposredno razdeljena zdravstveni ustanovi za takojšnjo presaditev.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 November 2006, at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 1. novembra 2006.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Vsebino besedila teh predpisov in korelacijsko tabelo med omenjenimi predpisi in to direktivo takoj sporočijo Komisiji.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedila glavnih določb nacionalne zakonodaje, ki jih sprejmejo na področju, ki ga ureja ta direktiva.
Addressees
Prejemniki
SELECTION CRITERIA FOR DONORS OF TISSUES AND/OR CELLS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 3(a)
MERILA ZA IZBOR DAROVALCEV TKIV IN/ALI CELIC (RAZEN DAROVALCEV REPRODUKTIVNIH CELIC), KAKOR JE NAVEDENO V ČLENU 3(a)
Selection criteria for donors are based on an analysis of the risks related to the application of the specific cells/tissues.
Merila za izbor darovalcev temeljijo na analizi tveganj, povezanih z uporabo posebnih tkiv/celic.
Indicators of these risks must be identified by physical examination, review of the medical and behavioural history, biological testing, post-mortem examination (for deceased donors) and any other appropriate investigation.
Kazalniki teh tveganj so opredeljeni s fizikalnim pregledom, pregledom zdravstvene anamneze in vedenja v preteklosti, biološkim testiranjem, obdukcijo (pri umrlih darovalcih) ter katerim koli drugim ustreznim pregledom.
Unless justified on the basis of a documented risk assessment approved by the responsible person as defined in Article 17 of Directive 2004/23/EC, donors must be excluded from donation if any of the following criteria applies:
Razen če je to upravičeno na podlagi dokumentirane ocene tveganja, ki jo odobri odgovorna oseba, v skladu s členom 17 Direktive 2004/23/ES, so darovalci izključeni iz darovanja, če velja katero od naslednjih meril:
Deceased Donors
Umrli darovalci
General criteria for exclusion
Splošna merila za izključitev
Cause of death unknown, unless autopsy provides information on the cause of death after procurement and none of the general criteria for exclusion set out in the present section applies.
Vzrok smrti je neznan, razen če obdukcija razkrije vzrok smrti po pridobivanju in se ne uporabi nobeno splošno merilo za izključitev iz oddelka 1.1.
History of a disease of unknown aetiology.
Bolezen neznanega vzroka v preteklosti.
Presence, or previous history, of malignant disease, except for primary basal cell carcinoma, carcinoma in situ of the uterine cervix, and some primary tumours of the central nervous system that have to be evaluated according to scientific evidence.
Maligna bolezen v sedanjosti ali preteklosti, razen če gre za primarni karcinom bazalnih celic, rak in situ na materničnem vratu in nekatere primarne tumorje na centralnem živčnem sistemu, ki jih je treba oceniti v skladu z znanstvenimi dokazi.
Donors with malignant diseases can be evaluated and considered for cornea donation, except for those with retinoblastoma, haematological neoplasm, and malignant tumours of the anterior segment of the eye.
Darovalci z malignimi boleznimi se lahko ocenijo in upoštevajo za darovanje roženice, razen če imajo retinoblastom, hematološko neoplazmo in maligne tumorje na notranjem delu očesa.
Risk of transmission of diseases caused by prions.
Tveganje za prenos bolezni, ki jih povzročijo prioni.
This risk applies, for example, to:
To tveganje vključuje:
people diagnosed with Creutzfeldt–Jakob disease, or variant Creutzfeldt-Jacob disease, or having a family history of non-iatrogenic Creutzfeldt-Jakob disease;
posebno izključitev oseb, pri katerih je bila ugotovljena Creutzfeldt-Jakobova bolezen ali varianta Creutzfeldt-Jakobove bolezni ali imajo v družinski anamnezi neiatrogeno Creutzfeldt-Jakobovo bolezen;
people with a history of rapid progressive dementia or degenerative neurological disease, including those of unknown origin;
osebe, ki so v preteklosti imele hitro napredujočo demenco ali degenerativno nevrološko bolezen, vključno z boleznimi neznanega izvora;
recipients of hormones derived from the human pituitary gland (such as growth hormones) and recipients of grafts of cornea, sclera and dura mater, and persons that have undergone undocumented neurosurgery (where dura mater may have been used).
prejemnike hormonov, pridobljenih iz hipofize (npr. rastni hormoni), in prejemnike presadkov roženice, beločnice in dura mater ter osebe, pri katerih je bila opravljena nedokumentirana nevrološka operacija (kjer se lahko uporabi trda možganska ovojnica).
For variant Creutzfeldt-Jakob disease, further precautionary measures may be recommended.
Za varianto Creutzfeldt-Jakobove bolezni se lahko priporočijo nadaljnji previdnostni ukrepi.
Systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated.
Sistemska okužba, ki v času darovanja ni bila nadzorovana, vključno z bakterijskimi boleznimi, sistemskimi virusnimi, glivičnimi ali parazitskimi okužbami ali obsežnejšimi lokalnimi okužbami tkiv in celic, namenjenih za darovanje.
Donors with bacterial septicaemia may be evaluated and considered for eye donation but only where the corneas are to be stored by organ culture to allow detection of any bacterial contamination of the tissue.
Darovalce s sepso se lahko oceni in predvidi za darovanje očesa, vendar samo, če bo roženica shranjena v gojišču za organe, da se lahko odkrije kakršna koli bakterijska okužba tkiva.
History, clinical evidence, or laboratory evidence of HIV, acute or chronic hepatitis B (except in the case of persons with a proven immune status), hepatitis C and HTLV I/II, transmission risk or evidence of risk factors for these infections.
Klinični ali laboratorijski dokaz za virus HIV, akutni ali kronični hepatitis B (razen pri osebah z dokazanim imunskim statusom), hepatitis C in HTLV I/II, tveganje za prenos ali dokaz o dejavnikih tveganja za te okužbe ali prisotnost teh bolezni v preteklosti.
History of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the tissue to be retrieved.
Zgodovina kronične, sistematične avtoimunske bolezni, ki bi lahko imela neželen učinek na kakovost tkiva, ki ga je treba pridobiti.
Indications that test results of donor blood samples will be invalid due to:
Pokazatelji, s katerimi se testirajo rezultati vzorcev krvi darovalca, so neveljavni zaradi:
the occurrence of haemodilution, according to the specifications in Annex II, section 2, where a pre-transfusion sample is not available; or
pojava hemodilucije v skladu s specifikacijami iz Priloge II, oddelek 2, kjer vzorec pred transfuzijo ni na voljo; ali
treatment with immunosuppressive agents.
zdravljenja z imunosupresivnimi snovmi.
Evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration donor travel and exposure history and local infectious disease prevalence.
Dokaz o katerih koli drugih dejavnikih tveganja za nalezljive bolezni na podlagi ocene tveganja, ob upoštevanju preteklih potovanj in izpostavljenosti darovalca ter lokalne razširjenosti nalezljive bolezni.
Presence on the donor’s body of physical signs implying a risk of transmissible disease(s) as described in Annex IV, point 1.2.3.
Prisotnost fizičnih znakov na darovalčevem telesu, ki kažejo na tveganje za nalezljivo bolezen(-ni), kot je opisano v Prilogi IV, točka 1.2.3.
Ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.
Zaužitje ali izpostavljenost snovi (npr. cianid, svinec, živo srebro, zlato), ki se lahko prenese na prejemnika v količinah, ki bi lahko ogrozile njegovo zdravje.
Recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist.
Nedavno cepljenje z živim oslabljenim virusom, kjer obstaja možnost za prenos.
Transplantation with xenografts.
Presaditev s ksenotransplantati.
Additional exclusion criteria for deceased child donors
Dodatna merila za izključitev, če so darovalci umrli otroci.
Any children born from mothers with HIV infection or that meet any of the exclusion criteria described in section 1.1 must be excluded as donors until the risk of transmission of infection can be definitely ruled out.
Vsi otroci, ki se rodijo materam, okuženim s HIV, ali ki izpolnjujejo merila za izključitev, opisana v oddelku 1.1, morajo biti izključeni kot darovalci do dokončne izključitve tveganja za prenos okužbe.
Children aged less than 18 months born from mothers with HIV, hepatitis B, hepatitis C or HTLV infection, or at risk of such infection, and who have been breastfed by their mothers during the previous 12 months, cannot be considered as donors regardless of the results of the analytical tests.
Otroci, stari manj kot 18 mesecev, ki so rojeni materam, okuženim z virusom HIV, hepatitisom B, hepatitisom C ali virusom HTLV ali so v nevarnosti pred tako okužbo in so jih v zadnjih 12 mesecih dojile njihove matere, ne morejo biti obravnavani kot darovalci, ne glede na rezultate analiz testiranj ali preskusov;
Children of mothers with HIV, hepatitis B, hepatitis C or HTLV infection, or at risk of such infection, and who have not been breastfed by their mothers during the previous 12 months and for whom analytical tests, physical examinations, and reviews of medical records do not provide evidence of HIV, hepatitis B, hepatitis C or HTLV infection, can be accepted as donors.
otroci mater, okuženih z virusom HIV, hepatitisom B, hepatitisom C ali virusa HTLV ali otroci, ki so v nevarnosti pred tako okužbo in ki jih v zadnjih 12 mesecih niso dojile matere ter pri katerih analizno preskušanje, fizikalni pregledi in pregledi zdravniških kartotek ne dokazujejo prisotnosti virusa HIV, hepatitisa B, hepatitisa C ali virusa HTLV, se lahko sprejmejo kot darovalci.
Living donors
Živi darovalci
Autologous living donor
Avtologni živi darovalci
If the removed tissues and cells are to be stored or cultured, the same minimum set of biological testing requirements must apply as for an allogeneic living donor.
Če so odstranjeno tkivo in celice namenjene za shranjevanje ali gojenje, je treba uporabiti enake minimalne zahteve za biološko testiranje kot pri alogenskem živem darovalcu.
Positive test results will not necessarily prevent the tissues or cells or any product derived from them being stored, processed and reimplanted, if appropriate isolated storage facilities are available to ensure no risk of cross-contamination with other grafts and/or no risk of contamination with adventitious agents and/or mix-ups.
Pozitivni rezultati testiranja ne preprečujejo nujno, da so tkiva ali celice ali kateri koli drugi izdelki, pridobljeni iz njih, shranjeni, predelani in ponovno vsajeni, če so na voljo ustrezni pogoji ali razmere skladiščenja za preprečitev tveganja za navzkrižno kontaminacijo drugih presadkov in/ali če ni nobenega tveganja za okužbo z naključnimi dejavniki in/ali za zamenjavo.
Allogeneic living donor
Alogenski živi darovalci
Allogeneic living donors must be selected on the basis of their health and medical history, provided on a questionnaire and through an interview performed by a qualified and trained healthcare professional with the donor, in compliance with point 2.2.2.
Alogenski živi darovalci so izbrani na podlagi njihovega zdravstvenega stanja in zdravstvene anamneze, zbrane z vprašalnikom in v osebnem razgovoru, ki ga opravi kvalificiran in usposobljen zdravstveni delavec z darovalcem v skladu s točko 2.2.2.
This assessment must include relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases or health risks to themselves.
Ta ocena vključuje ustrezne dejavnike, ki lahko pomagajo pri odkrivanju in presejanju oseb, katerih darovanje bi lahko ogrozilo zdravje drugih, kot je možnost za prenos bolezni ali ogroženost lastnega zdravja.
For any donation, the collection process must not interfere with or compromise the health or care of the donor.
Postopek zbiranja ne sme pri nobenem darovanju vplivati na zdravje ali oskrbo darovalca ali ju ogroziti.
In the case of cord blood or amniotic membrane donation, this applies to both mother and baby.
V primeru darovanja krvi iz popkovnice ali amnijske membrane to velja za mater in dojenčka.
Selection criteria for allogeneic living donors must be established and documented by the tissue establishment (and the transplanting clinician in the case of direct distribution to the recipient), based on the specific tissue or cells to be donated, together with the donor’s physical status and medical and behavioural history and the results of clinical investigations and laboratory tests establishing the donor’s state of health.
Merila za izbor alogenskih živih darovalcev določi in dokumentira tkivna ustanova (in zdravnik, ki opravi presaditev, v primeru neposrednega prenosa na prejemnika) na podlagi posebnih tkiv in celic, namenjenih za darovanje, skupaj z darovalčevim fizičnim stanjem, zdravstveno anamnezo in vedenjem v preteklosti, rezultati kliničnih preiskav in laboratorijskih testov, ki določajo darovalčevo zdravstveno stanje.
The same exclusion criteria must be applied as for deceased donors with the exception of point 1.1.1.
Uporabljajo se enaka merila za izključitev, kot za umrle darovalce, razen točke 1.1.1.
Depending on the tissue or cell to be donated, other specific exclusion criteria may need to be added, such as:
Odvisno od tkiva ali celic, namenjenih za darovanje, je morda treba dodati še druga posebna merila za izključitev, kot so:
pregnancy (except for donors of umbilical cord blood cells and amniotic membrane and sibling donors of haematopoietic progenitors);
nosečnost (razen za darovalce krvnih celic iz popkovine, amnijske membrane in če je darovalec hematopoetskih progenitornih celic sorojenec);
breastfeeding;
dojenje;
in the case of haematopoietic progenitor cells, the potential for transmission of inherited conditions.
v primeru krvotvornih matičnih celic možnost za prenos dednih stanj.
LABORATORY TESTS REQUIRED FOR DONORS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 4(1)
POTREBNO LABORATORIJSKO TESTIRANJE DAROVALCEV (RAZEN DAROVALCEV REPRODUKTIVNIH CELIC), KAKOR JE NAVEDENO V ČLENU 4(1)
Biological tests required for donors
Potrebno biološko testiranje darovalcev
The following biological tests must be performed for all donors as a minimum requirement:
Minimalna zahteva za vse darovalce so naslednji biološki testi:
HIV 1 and 2
HIV 1 in 2
See 1.4 (below)
Glej 1.4 (spodaj)
HTLV-I antibody testing must be performed for donors living in, or originating from, high-incidence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas.
Testi za protitelesa HTLV-I se opravijo na darovalcih, ki živijo na območjih z visoko pojavnostjo ali izvirajo iz njih, ali darovalcih, katerih spolni partnerji ali starši izvirajo iz teh območij.
When anti-HBc is positive and HBsAg is negative, further investigations are necessary with a risk assessment to determine eligibility for clinical use.
Če je anti-HBc pozitiven in HBsAg negativen, so potrebne nadaljnje preiskave z ocenjevanjem tveganja za določitev primernosti za klinično rabo.
A validated testing algorithm must be applied to exclude the presence of active infection with Treponema pallidum.
Validiran testni algoritem se uporabi za izključitev prisotnosti aktivne okužbe z bakterijo Treponema Pallidum.
A non-reactive test, specific or non-specific, can allow tissues and cells to be released.
Ko je specifičen ali nespecifičen test nereaktiven, se lahko tkiva in celice sprostijo za uporabo.
When a non-specific test is performed, a reactive result will not prevent procurement or release if a specific Treponema confirmatory test is non-reactive.
Kadar je opravljen nespecifičen test, reakcija ne prepreči pridobivanja ali sprostitve, če specifičen test za potrditev bakterije Treponema ne reagira.
A donor whose specimen tests reactive on a Treponema-specific test will require a thorough risk assessment to determine eligibility for clinical use.
Darovalec, pri katerem testiranje vzorca reagira na specifičen test za bakterijo Treponema, zahteva temeljito oceno tveganja za določitev primernosti za klinično rabo.
In certain circumstances, additional testing may be required depending on the donor’s history and the characteristics of the tissue or cells donated (e.g. RhD, HLA, malaria, CMV, toxoplasma, EBV, Trypanosoma cruzi).
V nekaterih okoliščinah je potrebno dodatno testiranje, odvisno od darovalčeve preteklosti in lastnosti darovanega tkiva ali celic (npr. RhD, HLA, malarija, CMV, toksoplazma, EBV, Trypanosoma cruzi).
For autologous donors, Annex I, point 2.1.1, applies.
Za avtologne darovalce velja Priloga I, točka 2.1.1.
General requirements to be met for determining biological markers
Splošne zahteve, ki jih je treba upoštevati pri določanju bioloških označevalcev
The tests must be carried out by a qualified laboratory, authorised as a testing centre by the competent authority in the Member State, using EC-marked testing kits where appropriate.
Teste opravi usposobljen laboratorij, ki je od pristojnega organa v državi članici priznan kot center za testiranje in po potrebi uporablja komplete za testiranje z oznako CE.
The type of test used must be validated for the purpose in accordance with current scientific knowledge.
Vrsto uporabljenega testa je treba validirati v ta namen v skladu z razpoložljivimi znanstvenimi dosežki in znanjem.
The biological tests will be carried out on the donor’s serum or plasma; they must not be performed on other fluids or secretions such as the aqueous or vitreous humour unless specifically justified clinically using a validated test for such a fluid.
Biološki testi se opravijo na darovalčevem serumu ali plazmi; ne opravijo se na drugih tekočinah ali izločkih, kot so prekatna vodica ali očesna steklovina, razen če je to izrecno klinično določeno z validiranim testom za takšno tekočino.
When potential donors have lost blood and have recently received donated blood, blood components, colloids or crystalloids, blood testing may not be valid due to haemodilution of the sample.
Če so morebitni darovalci izgubili kri in so pred kratkim prejeli darovano kri, komponente krvi, koloide ali kristaloide, test krvi morda ni veljaven zaradi hemodilucije vzorca.
An algorithm must be applied to assess the degree of haemodilution in the following circumstances:
Za oceno stopnje hemodilucije se algoritem uporabi v naslednjih okoliščinah:
ante-mortem blood sampling if blood, blood components and/or colloids were infused in the 48 hours preceding blood sampling or if crystalloids were infused in the hour preceding blood sampling;
odvzem vzorca krvi pred smrtjo če so bili kri, komponente krvi in/ali koloidi infundirani v 48 urah pred odvzemom vzorca krvi ali če so bili kristaloidi infundirani v uri pred odvzemom vzorca krvi;
post-mortem blood sampling if blood, blood components and/or colloids were infused in the 48 hours preceding death or if crystalloids were infused in the hour preceding death.
odvzem vzorca krvi po smrti če so bili kri, komponente krvi in/ali koloidi infundirani v 48 urah pred smrtjo ali če so bili kristaloidi infundirani v uri pred smrtjo.