natgillin/translations-raw huggingface dataset:
implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o zahtevah po sledljivosti, obveščanju o hudih in neželenih reakcijah in pojavih ter nekaterih tehničnih zahtevah za kodiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje človeških tkiv in celic
Having regard to 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 [1], and in particular Article 8, Articles 11(4) and 28(a), (c), (g) and (h) thereof,
ob upoštevanju 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 [1] ter zlasti členov 8, 11(4) in 28(a), (c), (g) in (h) Direktive,
Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.
Direktiva 2004/23/ES določa standarde kakovosti in varnosti za darovanje, pridobivanje, testiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje človeških tkiv in celic, namenjenih zdravljenju ljudi, ter industrijskih izdelkov, izdelanih na podlagi človeških tkiv in celic, namenjenih zdravljenju ljudi, da se zagotovi visoka raven varovanja zdravja ljudi.
In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC calls for the establishment of specific technical requirements for each one of the steps in the human tissues and cells application process, including standards and specifications with regard to a quality system for tissue establishments.
Da se prepreči prenos bolezni s človeškimi tkivi in celicami, namenjenimi zdravljenju ljudi, in zagotovi enaka raven kakovosti in varnosti, Direktiva 2004/23/ES predvideva uvedbo posebnih tehničnih zahtev za vsako stopnjo postopka uporabe človeških tkiv in celic, vključno s standardi in specifikacijami, ki zadevajo sistem kakovosti bank tkiv.
An accreditation, designation, authorisation or licensing system for tissue establishments and for the preparation processes at the tissue establishments should be established in Member States in accordance with Directive 2004/23/EC, in order to ensure a high level of protection of human health.
Da bi se zagotovila visoka raven varovanja zdravja ljudi, morajo države članice v skladu z Direktivo 2004/23/ES za banke tkiv in za postopke priprave tkiv v bankah tkiv oblikovati sistem za akreditacijo, imenovanje, odobritev ali dodelitev dovoljenj.
It is necessary to lay down the technical requirements for this system.
Določiti je treba tehnične zahteve za ta sistem.
The requirements for accreditation, designation, authorisation or licensing of tissue establishments should cover the organisation and management, personnel, equipment and materials, facilities/premises, documentation and records and quality review.
Zahteve za akreditacijo, imenovanje, odobritev ali dodelitev dovoljenja bank tkiv morajo zajeti organizacijo in upravljanje, osebje, opremo in material, obrate/poslovne prostore, dokumentacijo in evidenco ter pregled kakovosti.
Accredited, designated, authorised or licensed tissue establishments should comply with additional requirements for the specific activities they carry out.
Akreditirane, imenovane, odobrene banke tkiv ali banke tkiv z dodeljenim dovoljenjem morajo izpolnjevati dodatne zahteve za posebne dejavnosti, ki jih izvajajo.
The air quality standard during the processing of tissues and cells is a key factor that may influence the risk of tissue or cell contamination.
Standard kakovosti zraka v času predelave tkiv in celic je ključni dejavnik, ki lahko vpliva na tveganje kontaminacije tkiv ali celic.
An air quality with particle counts and microbial colony counts equivalent to those of Grade A, as defined in the European Guide to Good Manufacturing Practice, Annex 1 and Commission Directive 2003/94/EC [2], is generally required.
Običajno se zahteva takšna kakovost zraka, kjer število delcev in število mikrobnih kolonij ustreza razredu A, kakor je opredeljen v Prilogi 1, Evropskih smernic dobre proizvodne prakse (European Guide to Good Manufacturing Practice) in Direktivi Komisije 2003/94/ES [2].
However, in certain situations, an air quality with particle counts and microbial colony counts equivalent to those of Grade A standard is not indicated.
Vendar pa v nekaterih primerih kakovost zraka s številom delcev in številom mikrobnih kolonij, ki ustreza standardu razredu A, ni navedena.
In these circumstances it should be demonstrated and documented that the chosen environment achieves the quality and safety required for the type of tissue and cells, process and human application concerned.
V teh okoliščinah je treba dokazati in dokumentirati, da izbrano okolje dosega kakovost in varnost, ki sta potrebni za to vrsto tkiva in celic ter zadevni postopek in zdravljenje ljudi.
The scope of this Directive should embrace the quality and safety of human tissues and cells during coding, processing, preservation, storage and distribution to the healthcare establishment where they will be applied to the human body.
Področje uporabe mora vključevati kakovost in varnost človeških tkiv in celic med kodiranjem, predelavo, konzerviranjem, shranjevanjem in razdeljevanjem zdravstvenim ustanovam, v katerih jih bodo uporabili za zdravljenje ljudi.
However, it should not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos).
Vendar pa ne sme zajemati zdravljenja ljudi s pomočjo teh tkiv in celic (npr. kirurške implantacije, perfuzije, osemenitve ali prenosa zarodka).
The provisions of this Directive concerning traceability and the reporting of serious adverse reactions and events apply also to the donation, procurement and testing of human tissues and cells regulated by Commission Directive 2006/17/EC [3].
Določbe te direktive glede sledljivosti in poročanja o hudih neželenih reakcijah in pojavih se uporabljajo tudi pri darovanju, pridobivanju in testiranju človeških tkiv in celic, kot to ureja Direktiva Komisije 2006/17/ES [3].
The use of tissues and cells for human application carries a risk of disease transmission and other potential adverse effects in recipients.
Pri uporabi tkiv in celic za zdravljenje ljudi obstaja tveganje za prenos bolezni in drugih potencialnih neželenih učinkov pri prejemnikih.
In order to monitor and reduce these effects, specific requirements for traceability and a Community procedure for notifying serious adverse reactions and events should be set out.
Za spremljanje in zmanjšanje teh učinkov je treba določiti posebne zahteve za sledljivost in postopek Skupnosti za obveščanje o hudih neželenih reakcijah in pojavih.
Suspected serious adverse reactions, in the donor or in the recipient, and serious adverse events from donation to distribution of tissues and cells, which may influence the quality and safety of tissues and cells and which may be attributed to procurement (including donor evaluation and selection), testing, processing, preservation, storage and distribution of human tissues and cells should be notified without delay to the competent authority.
Pristojni organ je treba nemudoma obvestiti o sumu resnih neželenih reakcij pri darovalcu ali prejemniku ter sumu resnih neželenih pojavov, do katerih bi prišlo na kateri koli stopnji od darovanja do razdeljevanja tkiv in celic in ki lahko vplivajo na kakovost in varnost tkiv in celic ter se lahko pripišejo pridobivanju (vključno z oceno in izborom darovalca), testiranju, predelavi, konzerviranju, shranjevanju in razdeljevanju človeških tkiv in celic.
Serious adverse reactions may be detected during or following procurement in living donors or during or following human application.
Resne neželene reakcije se lahko odkrijejo med pridobivanjem ali po pridobivanju pri živih darovalcih ali med zdravljenjem ali po zdravljenju ljudi.
They should be reported to the associated tissue establishment for subsequent investigation and notification to the competent authority.
O tem je treba obvestiti ustrezno banko tkiv zaradi poznejše preiskave in obvestila pristojnemu organu.
This should not preclude a procurement organisation or an organisation responsible for human application from also directly notifying the competent authority if it so wishes.
To ne sme onemogočiti organizaciji za pridobivanje ali organizaciji, pristojni za zdravljenje ljudi, da neposredno obvesti tudi pristojni organ, če to želi.
This Directive should define the minimum data needed for notification to the competent authority, without prejudice to the ability of Member States to maintain or introduce in their territory more stringent and protective measures which comply with the requirements of the Treaty.
Ta direktiva mora opredeliti, kakšen je najmanjši obseg podatkov, potrebnih za obvestilo pristojnemu organu, brez poseganja v zmožnost držav članic, da na svojem ozemlju ohranijo ali uvedejo strožje zaščitne ukrepe, ki so v skladu z zahtevami Pogodbe.
In order to minimise transmission costs, avoid overlaps and increase administrative efficiency, modern technologies and e-government solutions should be used to perform the tasks related to the transmission and treatment of information.
Da bi čim bolj zmanjšali stroške prenosa, se izognili podvajanju in izboljšali upravno učinkovitost, je treba za izvajanje nalog, povezanih s prenosom in obdelavo informacij, uporabljati sodobne tehnologije in e-upravo.
These technologies should be based on a standard exchange format using a system suitable for the management of reference data.
Te tehnologije morajo temeljiti na standardni obliki za izmenjavo, ki uporablja sistem, primeren za upravljanje z referenčnimi podatki.
To facilitate traceability and information on the main characteristics and properties of tissues and cells, it is necessary to lay down the basic data to be included in a single European code.
Za lažjo sledljivost in informiranost v zvezi z glavnimi značilnostmi in lastnostmi tkiv in celic je treba določiti osnovne podatke, ki morajo biti vključeni v enoten evropski kodni sistem.
This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union.
Ta direktiva spoštuje temeljne pravice in upošteva sprejeta načela, zlasti načela Listine o temeljnih pravicah Evropske unije.
The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 29 of Directive 2004/23/EC,
Ukrepi, predvideni s to direktivo, so v skladu z mnenjem odbora, ustanovljenega s členom 29 Direktive 2004/23/ES –
This Directive shall apply to the coding, processing, preservation, storage and distribution of:
Ta direktiva se uporablja za kodiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje:
human tissues and cells intended for human applications; and
človeških tkiv in celic, namenjenih zdravljenju ljudi; in
manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other directives.
industrijskih izdelkov, izdelanih na podlagi človeških tkiv in celic, namenjenih zdravljenju ljudi, kadar teh izdelkov ne urejajo že druge direktive.
The provisions of Articles 5 to 9 of this Directive, concerning traceability and the reporting of serious adverse reactions and events shall also apply to the donation, procurement and testing of human tissues and cells.
Določbe členov 5 do 9 Direktive glede sledljivosti in poročanja o hudih neželenih reakcijah in pojavih se uporabljajo tudi za darovanje, pridobivanje in testiranje človeških tkiv in celic.
For the purposes of this Directive, the following definitions apply:
V tej direktivi se uporabljajo naslednje opredelitve pojmov:
‘reproductive cells’ means all tissues and cells intended to be used for the purpose of assisted reproduction;
„reproduktivne celice“ pomenijo vsa tkiva in celice, namenjene za uporabo v asistirani reprodukciji;
‘partner donation’ means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship;
„darovanje med partnerjema“ pomeni darovanje reproduktivnih celic med moškim in žensko, ki izjavita, da imata intimen fizični odnos;
‘quality system’ means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly;
„sistem kakovosti“ pomeni organizacijsko strukturo, določene pristojnosti, postopke, procese in sredstva za upravljanje kakovosti ter vključuje vse dejavnosti, ki neposredno ali posredno prispevajo h kakovosti;
‘quality management’ means the coordinated activities to direct and control an organisation with regard to quality;
„upravljanje kakovosti“ pomeni usklajene dejavnosti z namenom usmerjanja in nadzorovanja organizacije glede kakovosti;
‘Standard Operating Procedures’(SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;
„standardni operativni postopki“ (SOP) pomenijo pisna navodila, ki opisujejo stopnje posebnega postopka, vključno z materiali in metodami, ki se uporabljajo, ter pričakovanim končnim izdelkom;
‘validation’ (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use;
„validacija“ (ali „kvalifikacija“ v primeru opreme ali okolja) pomeni pripravo dokumentiranih dokazov, ki z visoko stopnjo zanesljivosti zagotavljajo, da bo določen postopek, kos opreme ali okolje dosledno omogočal(-o) izdelavo izdelka, ki bo ustrezal vnaprej določenim specifikacijam in kakovosti; postopek se validira z namenom ovrednotenja delovanja sistema glede njegove učinkovitosti za predvideno uporabo;
‘traceability’ means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells;
„sledljivost“ pomeni zmožnost izsleditve in identifikacije tkiva/celice na kateri koli stopnji od pridobivanja, preko predelave, testiranja in shranjevanja do dodelitve prejemniku ali odstranitve, kar vključuje tudi zmožnost identifikacije darovalca ali banke tkiv ali proizvodnega obrata, ki prejme, predela ali shrani tkivo/celice, ter zmožnost identifikacije prejemnika(-ov) v zdravstveni(h) ustanovi(-ah), ki tkivo/celice presadijo na prejemnika(-e); sledljivost zajema tudi zmožnost izsleditve in identifikacije vseh ustreznih podatkov v zvezi z izdelki in materiali, ki pridejo v stik s temi tkivi/celicami;
‘critical’ means potentially having an effect on the quality and/or safety of or having contact with the cells and tissues;
„kritičen“ pomeni tak, ki lahko vpliva na kakovost in/ali varnost ali ki je v stiku s celicami ali tkivi;
‘procurement organisation’ means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment;
„organizacija za pridobivanje“ pomeni zdravstveno ustanovo ali enoto bolnišnice ali drugo telo, ki izvaja dejavnosti pridobivanja človeških tkiv in celic in za katero ni potrebno, da ima akreditacijo, imenovanje, odobritev ali dovoljenje za banko tkiv;
‘organisations responsible for human application’ means a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells.
„organizacija, pristojna za zdravljenje ljudi“ pomeni zdravstveno ustanovo ali enoto bolnišnice ali drugo telo, ki uporablja človeška tkiva in celice za zdravljenje ljudi.
Requirements for the accreditation, designation, authorisation or licensing of tissue establishments
Zahteve za akreditacijo, imenovanje, odobritev ali dodelitev dovoljenja bankam tkiv
A tissue establishment must comply with the requirements set out in Annex I.
Banka tkiv mora izpolnjevati zahteve iz Priloge I.
Requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes
Zahteve za akreditacijo, imenovanje, odobritev ali dodelitev dovoljenja za postopke priprave tkiv in celic
Preparation processes at the tissue establishments must comply with the requirements set out in Annex II.
Postopki priprave v bankah tkiv morajo izpolnjevati zahteve iz Priloge II.
procurement organisations have procedures in place to retain the records of tissues and cells procured and to notify tissue establishments without delay of any serious adverse reactions in the living donor which may influence the quality and safety of tissues and cells;
so v organizacijah za pridobivanje vzpostavljeni postopki za hranjenje evidenc o pridobljenih tkivih in celicah ter za takojšnje obveščanje bank tkiv o vseh resnih neželenih reakcijah pri živem darovalcu, ki lahko vplivajo na kakovost in varnost tkiv in celic;
organisations responsible for human application of tissues and cells have procedures in place to retain the records of tissues and cells applied and to notify tissue establishments without delay of any serious adverse reactions observed during and after clinical application which may be linked to the quality and safety of tissues and cells;
imajo organizacije, pristojne za zdravljenje ljudi s pomočjo tkiv in celic, vzpostavljene postopke za hranjenje evidenc o uporabljenih tkivih in celicah ter za obveščanje bank tkiv o vseh resnih neželenih reakcijah, opaženih med klinično uporabo ali po njej, ki so lahko povezane s kakovostjo in varnostjo tkiv in celic;
tissue establishments that distribute tissue and cells for human application provide information to the organisation responsible for human application of tissues and cells about how that organisation should report serious adverse reactions as referred to in (b).
banke tkiv, ki razdeljujejo tkivo in celice za zdravljenje ljudi, organizacijam, pristojnim za zdravljenje ljudi s pomočjo tkiv in celic, zagotovijo informacije o tem, kako naj ta organizacija obvešča o resnih neželenih reakcijah, kakor je navedeno v točki (b).
Member States shall ensure that tissue establishments:
Države članice zagotovijo, da imajo banke tkiv:
have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse reactions as referred to in paragraph 1(a) and (b);
vzpostavljene postopke, po katerih pristojni organ takoj obvestijo o vseh ustreznih razpoložljivih informacijah glede suma resnih neželenih reakcij, kakor je navedeno v odstavku 1(a) in 1(b);
have procedures in place to communicate to the competent authority without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.
vzpostavljene postopke, po katerih pristojni organ takoj obvestijo o sklepni ugotovitvi preiskave, ki analizira vzrok in posledice.
the responsible person referred to in Article 17 of Directive 2004/23/EC notifies the competent authority of the information included in the notification set out in Part A of Annex III;
pristojna oseba iz člena 17 Direktive 2004/23/ES pristojnemu organu sporoči informacije, vsebovane v obvestilu, določenem v delu A Priloge III;
tissue establishments notify the competent authority of the actions taken with respect to other implicated tissues and cells that have been distributed for human applications;
banke tkiv obvestijo pristojni organ o ukrepih, ki so jih sprejele v zvezi z drugimi zadevnimi tkivi in celicami, ki so bili razdeljeni za zdravljenje ljudi;
tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex III.
banke tkiv obvestijo pristojni organ o sklepni ugotovitvi preiskave in predložijo vsaj tiste informacije, ki so določene v delu B Priloge III.
Notification of serious adverse events
Obveščanje o hudih neželenih pojavih
procurement organisations and tissue establishments have procedures in place to retain the records and to notify tissue establishments without delay of any serious adverse events that occur during procurement which may influence the quality and/or safety of human tissues and cells;
imajo organizacije za pridobivanje in banke tkiv vzpostavljene postopke za hranjenje evidenc in za takojšnje obveščanje bank tkiv o vseh resnih neželenih reakcijah, ki se pojavijo med pridobivanjem in ki lahko vplivajo na kakovost in/ali varnost človeških tkiv in celic;
organisations responsible for human application of tissues and cells have procedures in place to notify tissue establishments without delay of any serious adverse events that may influence the quality and safety of the tissues and cells;
imajo organizacije, pristojne za zdravljenje ljudi s pomočjo tkiv in celic, vzpostavljene postopke za takojšnje obveščanje bank tkiv o vseh resnih neželenih pojavih, ki lahko vplivajo na kakovost in varnost tkiv in celic;
tissue establishments provide to the organisation responsible for human application information about how that organisation should report serious adverse events to them that may influence the quality and safety of the tissues and cells.
banke tkiv zagotovijo organizaciji, pristojni za zdravljenje ljudi, informacije o tem, kako naj jih ta organizacija obvešča o resnih neželenih pojavih, ki lahko vplivajo na kakovost in varnost tkiv in celic.
In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up shall be considered to be a serious adverse event.
V primeru asistirane reprodukcije se bo vsaka napačna identifikacija ali zamenjava gamete ali zarodka štela za resen neželen pojav.
All persons or procurement organisations or organisations responsible for human application performing assisted reproduction shall report such events to the supplying tissue establishments for investigation and notification to the competent authority.
Vse osebe, organizacije za pridobivanje ali organizacije, pristojne za zdravljenje z ljudmi, ki izvajajo asistirano reprodukcijo, obvestijo oskrbovalno banko tkiv o takšnih pojavih za potrebe preiskave in obveščanja pristojnega organa.
have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse events as referred to in paragraph 1(a) and (b);
vzpostavljene postopke, po katerih pristojnemu organu takoj sporočijo vse ustrezne razpoložljive informacije glede suma resnih neželenih pojavov, kakor je navedeno v odstavku 1(a) in 1(b);