natgillin/translations-raw huggingface dataset:
Udtagning af humane væv eller celler må kun foretages, når alle obligatoriske krav til samtykke eller tilladelse, som er gældende i medlemsstaten, er opfyldt.
The procurement of human tissues or cells shall be authorised only after all mandatory consent or authorisation requirements in force in the Member State concerned have been met.
Medlemsstaterne træffer, i overensstemmelse med deres lovgivning, alle nødvendige foranstaltninger til at sikre, at donorerne eller deres nærmeste eller de personer, der giver tilladelsen på donorernes vegne, modtager alle de relevante oplysninger, der er omhandlet i bilaget.
Member States shall, in keeping with their national legislation, take all necessary measures to ensure that donors, their relatives or any persons granting authorisation on behalf of the donors are provided with all appropriate information as referred to in the Annex.
Medlemsstaterne træffer alle nødvendige foranstaltninger til at sikre, at alle oplysninger, herunder genetiske data, der er indsamlet i overensstemmelse med dette direktiv, og som tredjepart har adgang til, er gjort anonyme, således at hverken donorer eller recipienter længere kan identificeres.
Member States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive and to which third parties have access, have been rendered anonymous so that neither donors nor recipients remain identifiable.
Med dette for øje skal medlemsstaterne sikre,
For that purpose, they shall ensure that:
at der er truffet sikkerhedsmæssige forholdsregler vedrørende sådanne oplysninger samt beskyttelsesforanstaltninger mod ubeføjet tilføjelse, sletning eller ændring af oplysninger i donorjournaler eller registre over udelukkede donorer og mod enhver videregivelse af oplysninger
data security measures are in place, as well as safeguards against any unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information;
at der ikke sker ubeføjet videregivelse af oplysninger, samtidig med at det sikres, at donationerne kan spores.
no unauthorised disclosure of information occurs, whilst guaranteeing the traceability of donations.
Medlemsstaterne træffer alle nødvendige foranstaltninger til at sikre, at recipientens/recipienternes identitet ikke videregives til donoren eller dennes familie og omvendt, uden at dette berører gældende bestemmelser i medlemsstaterne om betingelserne for videregivelse af oplysninger, bl.a. i forbindelse med donation af kønsceller.
Member States shall take all necessary measures to ensure that the identity of the recipient(s) is not disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions for disclosure, notably in the case of gametes donation.
Aktiviteter i forbindelse med udtagning af væv skal ske på en sådan måde, at det sikres, at donorevaluering og -udvælgelse sker i overensstemmelse med kravene ifølge artikel 28, litra d) og e), samt at væv og celler udtages, emballeres og transporteres i overensstemmelse med kravene ifølge artikel 28, litra f).
The activities related to tissue procurement shall be carried out in such a way as to ensure that donor evaluation and selection is carried out in accordance with the requirements referred to in Article 28(d) and (e) and that the tissues and cells are procured, packaged and transported in accordance with the requirements referred to in Article 28(f).
I tilfælde af autolog donation fastslås egnethedskriterierne i overensstemmelse med kravene ifølge artikel 28, litra d).
In the case of an autologous donation, the suitability criteria shall be established in accordance with the requirements referred to in Article 28(d).
Resultaterne af donorevalueringen og testprocedurerne dokumenteres, og eventuelle forekomster af væsentlige uregelmæssigheder rapporteres i overensstemmelse med bilaget.
The results of the donor evaluation and testing procedures shall be documented and any major anomalies shall be reported in accordance with the Annex.
Den eller de kompetente myndigheder sikrer, at alle aktiviteter i forbindelse med vævsudtagning udføres i overensstemmelse med kravene ifølge artikel 28, litra f).
The competent authority or authorities shall ensure that all activities related to tissue procurement are carried out in accordance with the requirements referred to in Article 28(f).
Medlemsstaterne træffer alle nødvendige foranstaltninger til at sikre, at de enkelte vævscentre iværksætter og ajourfører et kvalitetssystem, der bygger på principperne om god praksis.
Member States shall take all necessary measures to ensure that each tissue establishment puts in place and updates a quality system based on the principles of good practice.
Kommissionen fastlægger de fællesskabsstandarder og -specifikationer, der er omhandlet i artikel 28, litra c), med hensyn til aktiviteter i forbindelse med kvalitetssystemet.
The Commission shall establish the Community standards and specifications referred to in Article 28(c) for activities relating to a quality system.
Vævscentre træffer alle nødvendige foranstaltninger til at sikre, at kvalitetssystemet som et minimum omfatter følgende elementer:
Tissue establishments shall take all necessary measures to ensure that the quality system includes at least the following documentation:
uddannelses- og referencemanualer
training and reference manuals,
oplysninger om vævenes eller cellernes endelige bestemmelsessted.
information on the final destination of tissues or cells.
Vævscentre træffer alle nødvendige foranstaltninger til at sikre, at disse oplysninger er tilgængelige for den eller de kompetente myndigheders inspektion.
Tissue establishments shall take all necessary measures to ensure that this documentation is available for inspection by the competent authority or authorities.
Vævscentre skal opbevare de oplysninger, der er nødvendige for at sikre sporbarheden i overensstemmelse med artikel 8.
Tissue establishments shall keep the data necessary to ensure traceability in accordance with Article 8.
Alle vævscentre udpeger en ansvarlig person, som skal opfylde følgende minimumskrav og kvalifikationer:
Every tissue establishment shall designate a responsible person who shall at least fulfil the following conditions and have the following qualifications:
personen skal være i besiddelse af et eksamensbevis eller anden dokumentation for, at vedkommende har gennemført en akademisk uddannelse eller en uddannelse, der i den pågældende medlemsstat kan sidestilles hermed, inden for lægevidenskab eller biologi
possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;
personen skal have mindst to års praktisk erfaring inden for de relevante områder.
at least two years' practical experience in the relevant fields.
Den person, der udpeges i medfør af stk. 1, har ansvaret for:
The person designated under paragraph 1 shall be responsible for:
at humane væv og celler beregnet til anvendelse på mennesker i det center, som denne person er ansvarlig for, er blevet udtaget, testet, behandlet, opbevaret og distribueret i overensstemmelse med dette direktiv samt med den gældende lovgivning i medlemsstaten
ensuring that human tissues and cells intended for human applications in the establishment for which that person is responsible are procured, tested, processed, stored and distributed in accordance with this Directive and with the laws in force in the Member State;
at oplysninger indsendes til den eller de ansvarlige myndigheder i henhold til kravene i artikel 6
providing information to the competent authority or authorities as required in Article 6;
at kravene i artikel 7, 10, 11, 15, 16 samt 18-24, for så vidt angår vævscentret er opfyldt.
implementing the requirements of Articles 7, 10, 11, 15, 16 and 18 to 24 within the tissue establishment.
Vævscentrene meddeler den eller de kompetente myndigheder navnet på den ansvarlige person, der er omhandlet i stk. 1.
Tissue establishments shall inform the competent authority or authorities of the name of the responsible person referred to in paragraph 1.
Træder en anden person permanent eller midlertidigt i stedet for den udpegede ansvarlige person, meddeler vævscentret øjeblikkelig den kompetente myndighed navnet på den nye ansvarlige person og datoen for dennes tiltrædelse.
Where the responsible person is permanently or temporarily replaced, the tissue establishment shall immediately inform the competent authority of the name of the new responsible person and the date on which the duties of that person commence.
Personale, der er direkte beskæftiget med udtagning, behandling, præservering, opbevaring og distribution af væv og celler i et vævscenter, skal være kvalificeret til at udføre sådanne opgaver og modtage den uddannelse, der er omhandlet i artikel 28, litra c).
Personnel directly involved in activities relating to the procurement, processing, preservation, storage and distribution of tissues and cells in a tissue establishment shall be qualified to perform such tasks and shall be provided with the training referred to in Article 28(c).
Vævscentre sikrer, at alle donationer af humane væv eller celler testes i overensstemmelse med kravene ifølge artikel 28, litra e), og at udvælgelsen og godkendelsen af væv og celler sker i overensstemmelse med kravene ifølge artikel 28, litra f).
Tissue establishments shall ensure that all donations of human tissues and cells are subjected to tests in accordance with the requirements referred to Article 28(e) and that the selection and acceptance of tissues and cells comply with the requirements referred to in Article 28(f).
Vævscentre sikrer, at humane væv og celler og ledsagende dokumentation opfylder kravene ifølge artikel 28, litra f).
Tissue establishments shall ensure that human tissue and cells and associated documentation comply with the requirements referred to in Article 28(f).
Vævscentret kontrollerer og registrerer, at emballeringen af modtagne humane væv og celler opfylder kravene ifølge artikel 28, litra f).
Tissue establishments shall verify and record the fact that the packaging of human tissue and cells received complies with the requirements referred to in Article 28(f).
Væv og celler, der ikke opfylder disse bestemmelser, kasseres.
All tissues and cells that do not comply with those provisions shall be discarded.
Godkendelse eller afvisning af modtagne væv eller celler dokumenteres.
The acceptance or rejection of received tissues/cells shall be documented.
Vævscentret sikrer, at humane væv og celler til enhver tid kan identificeres korrekt.
Tissue establishments shall ensure that human tissues and cells are correctly identified at all times.
Alle leverancer eller partier af væv eller celler tildeles en identifikationskode i overensstemmelse med artikel 8.
Each delivery or batch of tissues or cells shall be assigned an identifying code, in accordance with Article 8.
Væv og celler holdes i karantæne, indtil kravene til undersøgelse og information af donoren er opfyldt i overensstemmelse med artikel 15.
Tissue and cells shall be held in quarantine until such time as the requirements relating to donor testing and information have been met in accordance with Article 15.
Vævscentrenes standardprocedurer skal omfatte alle processer, der har en virkning på kvalitet og sikkerhed, og centret sikrer, at behandlingen foregår under kontrollerede forhold.
Tissue establishments shall include in their Standard Operating Procedures all processes that affect quality and safety and shall ensure that they are carried out under controlled conditions.
Vævscentret sikrer, at det anvendte udstyr, arbejdsmiljø, procesdesign, validering og kontrolforanstaltninger opfylder kravene ifølge artikel 28, litra h).
Tissue establishments shall ensure that the equipment used, the working environment, and process design, validation and control conditions are in compliance with the requirements referred to in Article 28(h).
Enhver ændring af de processer, som benyttes ved behandlingen af væv og celler, skal opfylde de kriterier, der er fastsat i stk. 1.
Any modifications to the processes used in the preparation of tissues and cells shall also meet the criteria laid down in paragraph 1.
Vævscentre fastsætter særlige bestemmelser i deres standardprocedurer for håndtering af væv og celler, der kasseres, så der ikke sker kontaminering af andre væv eller celler, arbejdsomgivelser eller personale.
Tissue establishments shall include in their Standard Operating Procedures special provisions for the handling of tissues and cells to be discarded, in order to prevent the contamination of other tissues or cells, the processing environment, or personnel.
Vævscentrene sikrer, at alle procedurer i forbindelse med opbevaring af væv og celler dokumenteres i standardprocedurerne, og at vilkårene for opbevaring opfylder kravene ifølge artikel 28, litra h).
Tissue establishments shall ensure that all procedures associated with the storage of tissues and cells are documented in the Standard Operating Procedures and that the storage conditions comply with the requirements referred to in Article 28(h).
Vævscentrene sikrer, at alle opbevaringsprocesser gennemføres under kontrollerede forhold.
Tissue establishments shall ensure that all storage processes are carried out under controlled conditions.
Vævscentrene fastsætter og anvender procedurer for kontrol af emballerings- og opbevaringsstederne for at imødegå alle omstændigheder, som kunne have uheldige indvirkninger på vævenes og cellernes funktion eller integritet.
Tissue establishments shall establish and apply procedures for the control of packaging and storage areas, in order to prevent any situation arising that might adversely affect the functioning or integrity of tissues and cells.
Behandlede væv eller celler må ikke distribueres, før alle krav i dette direktiv er opfyldt.
Processed tissues or cells shall not be distributed until all the requirements laid down in this Directive have been met.
Medlemsstaterne sikrer, at vævscentre råder over aftaler og procedurer, der sikrer, at beholdninger af væv og celler i tilfælde af ophør af virksomhed uanset begrundelse overdrages i overensstemmelse med det hertil knyttede samtykke til andre vævscentre, som er akkrediteret, udpeget, godkendt eller har fået licens i henhold til artikel 6, uden at dette berører medlemsstaternes lovgivning vedrørende bortskaffelse af donerede væv og celler.
Member States shall ensure that tissue establishments have agreements and procedures in place to ensure that, in the event of termination of activities for whatever reason, stored tissues and cells shall be transferred, according to the consent pertaining to them, to other tissue establishment or establishments accredited, designated, authorised or licensed in accordance with Article 6, without prejudice to Member States' legislation concerning the disposal of donated tissues or cells.
Vævscentrene sikrer, at mærkning, dokumentation og emballering er i overensstemmelse med kravene ifølge artikel 28, litra f).
Tissue establishments shall ensure that labelling, documentation and packaging conform to the requirements referred to in Article 28(f).
Vævscentrene drager omsorg for vævenes eller cellernes kvalitet under distributionen.
Tissue establishments shall ensure the quality of tissues and cells during distribution.
Distributionsvilkårene skal opfylde kravene ifølge artikel 28, litra h).
Distribution conditions shall comply with the requirements referred to in Article 28(h).
Vævscentre indgår skriftlige aftaler med tredjepart, hver gang der gennemføres en aktivitet uden for centret, og denne aktivitet har en indvirkning på de behandlede vævs eller cellers kvalitet og sikkerhed, og især i følgende tilfælde:
Tissue establishments shall establish written agreements with a third party each time an external activity takes place which influences the quality and safety of tissues and cells processed in cooperation with a third party, and in particular in the following circumstances:
hvis tredjepart påtager sig ansvaret for en fase af vævs- eller cellebehandlingen på vegne af vævscentret
where a tissue establishment entrusts one of the stages of tissue or cell processing to a third party;
hvis tredjepart leverer varer og tjenester, der har en indvirkning på vævenes eller cellernes kvalitet og sikkerhed, herunder distributionen af disse
where a third party provides goods and services that affect tissue or cell quality and safety assurance, including their distribution;
hvis et vævscenter yder et andet ikke-godkendt vævscenter tjenester
where a tissue establishment provides services to a tissue establishment which is not accredited;
hvis et vævscenter distribuerer væv eller celler, der er behandlet af tredjepart.
where a tissue establishment distributes tissue or cells processed by third parties.
Vævscentre evaluerer og udvælger tredjepart på grundlag af dennes evne til at opfylde de standarder, som er fastsat i dette direktiv.
Tissue establishments shall evaluate and select third parties on the basis of their ability to meet the standards laid down in this Directive.
Vævscentre fører en fuldstændig liste over aftaler som omhandlet i stk. 1, den har indgået med tredjepart.
Tissue establishments shall keep a complete list of the agreements referred to in paragraph 1 that they have established with third parties.
Aftalerne mellem vævscentre og tredjepart skal indeholde oplysninger om tredjeparts ansvar og de nærmere procedurer.
Agreements between tissue establishments and third parties shall specify the responsibilities of the third parties and detailed procedures.
Vævscentre udleverer genparter af aftaler med tredjepart efter anmodning fra den eller de kompetente myndigheder.
Tissue establishments shall provide copies of agreements with third parties at the request of the competent authority or authorities.
Medlemsstaterne indfører et system til identifikation af humane væv og celler, så det bliver muligt at spore alle humane væv og celler, jf. artikel 8.
Member States shall establish a system for the identification of human tissues and cells, in order to ensure the traceability of all human tissues and cells pursuant to Article 8.
Kommissionen udformer i samarbejde med medlemsstaterne et fælles europæisk kodningssystem, som sikrer en grundlæggende beskrivelse af vævenes og cellernes egenskaber.
The Commission, in cooperation with the Member States, shall design a single European coding system to provide information on the main characteristics and properties of tissues and cells.
Senest den ...
Member States shall send the Commission, before .......
forelægger medlemsstaterne og derefter hvert tredje år Kommissionen en rapport om de aktiviteter, der er gennemført i medfør af dette direktiv, herunder en redegørelse for inspektions- og kontrolforanstaltninger.
and every three years thereafter, a report on the activities undertaken in relation to the provisions of this Directive, including an account of the measures taken in relation to inspection and control.
Kommissionen forelægger Europa-Parlamentet, Rådet, Det Europæiske Økonomiske og Sociale Udvalg og Regionsudvalget de rapporter, medlemsstaterne har indsendt om deres erfaringer med gennemførelsen af dette direktiv.
The Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions the reports submitted by the Member States on experience gained in implementing this Directive.
og derefter hvert tredje år forelægger Kommissionen Europa-Parlamentet, Rådet, Det Europæiske Økonomiske og Sociale Udvalg samt Regionsudvalget en rapport om gennemførelsen af kravene i dette direktiv, navnlig kravene vedrørende inspektion og kontrol.
and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of the requirements of this Directive, in particular as regards inspection and monitoring.
Medlemsstaterne meddeler Kommissionen deres bestemmelser om sanktioner senest den ...
Member States shall notify those provisions to the Commission by ......
* og underretter den straks om eventuelle senere ændringer.
* and shall notify it without delay of any subsequent amendments affecting them.
De tekniske krav og deres tilpasning til den tekniske og videnskabelige udvikling fastlægges efter proceduren i artikel 29, stk. 2, for så vidt angår følgende punkter:
The following technical requirements and their adaptation to scientific and technical progress shall be decided in accordance with the procedure referred to in Article 29(2):
Krav til akkreditering, udpegning eller godkendelse af eller licens til vævscentre
Requirements for the accreditation, designation, authorisation or licensing of tissue establishments;
Krav til udtagning af humane væv og celler
Requirements for the procurement of human tissues and cells;
Kvalitetssystem, herunder uddannelse
Quality system, including training;
Udvælgelseskriterier for donorer af væv og/eller celler
Selection criteria for the donor of tissues and/or cells;
Obligatoriske laboratorietest for donorer
Laboratory tests required for donors;
Procedurer for udtagning af celler og/eller væv og for modtagelse i vævscentre
Cell and/or tissue procurement procedures and reception at the tissue establishment;
Krav til fremgangsmåden for forarbejdning af væv og celler
Requirements for the tissue and cell preparation process;
Behandling, opbevaring og distribution af væv og celler
Tissue and cell processing, storage and distribution;
Krav til direkte distribution af specifikke væv og celler til recipienten.
Requirements for the direct distribution to the recipient of specific tissues and cells.
Perioden i artikel 5, stk. 6, i afgørelse 1999/468/EF, fastsættes til tre måneder.
The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Det eller de relevante videnskabelige udvalg høres af Kommissionen i forbindelse med fastlæggelse og tilpasning af de tekniske krav i artikel 28 til den videnskabelige og tekniske udvikling.
The Commission may consult the relevant Scientific Committee(s) when defining or adapting the technical requirements referred to in Article 28 to scientific and technical progress.
Medlemsstaterne sætter senest den ...
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than ….
Disse love og bestemmelser skal ved vedtagelsen indeholde en henvisning til dette direktiv eller skal ved offentliggørelsen ledsages af en sådan henvisning.
When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication.
Medlemsstaterne kan beslutte, at de i op til et år efter den i stk. 1, første afsnit, fastsatte dato ikke anvender dette direktivs krav på vævscentre, som drives i henhold til nationale forskrifter, som var trådt i kraft inden dette direktivs ikrafttrædelse.
Member States may decide for one year after the date laid down in the first subparagraph of paragraph 1 not to apply the requirements of this Directive to tissue establishments bound by national provisions before the entry into force of this Directive.
Medlemsstaterne meddeler Kommissionen teksten til de nationale retsforskrifter, som de udsteder eller allerede har udstedt på det område, der er omfattet af dette direktiv.
Member States shall communicate to the Commission the texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive.
OPLYSNINGER, DER SKAL GIVES I FORBINDELSE MED DONATION AF VÆV OG/ELLER CELLER
INFORMATION TO BE PROVIDED ON THE DONATION OF CELLS AND/OR TISSUES
LEVENDE DONORER
LIVING DONORS