natgillin/translations-raw huggingface dataset:
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 IV;
pristojna oseba iz člena 17 Direktive 2004/23/ES pristojnemu organu sporoči informacije, vsebovane v obvestilu, določenem v delu A Priloge IV;
tissue establishments evaluate serious adverse events to identify preventable causes within the process;
banke tkiv ovrednotijo resne neželene pojave, da identificirajo vzroke, ki se dajo preprečiti v okviru postopka;
tissue establishments notify the competent authority of the conclusion of the investigation, supplying at least the information set out in Part B of Annex IV.
banke tkiv obvestijo pristojni organ o sklepni ugotovitvi preiskave in predložijo vsaj tiste informacije, ki so določene v delu B Priloge IV.
Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority.
Države članice do 30. junija naslednjega leta Komisiji predložijo letno poročilo o obvestilih o resnih neželenih reakcijah in pojavih, ki so jih prejele od pristojnega organa.
The Commission shall submit to the competent authorities of Member States a summary of the reports received.
Komisija pristojnim organom držav članic predloži povzetek prejetih obvestil.
The competent authority shall make this report available to tissue establishments.
Pristojni organ bankam tkiv omogoči vpogled v to poročilo.
Data transmission shall comply with the data exchange format specifications as set out in Annex V, part A and B, and shall provide all the information necessary to identify the sender and maintain its reference data.
Prenos podatkov je v skladu s specifikacijami oblike za izmenjavo podatkov, kakor so določene v delih A in B Priloge V, in zagotavlja vse informacije, potrebne za identifikacijo pošiljatelja in hranjenje referenčnih podatkov o njem.
Communication of information between competent authorities and to the Commission
Posredovanje informacij med pristojnimi organi in Komisijo
Member States shall ensure that their competent authorities communicate to each other and to the Commission such information as is appropriate with regard to serious adverse reactions and events, in order to guarantee that adequate actions are taken.
Države članice zagotovijo, da njihovi pristojni organi eden drugemu in Komisiji posredujejo potrebne informacije glede resnih neželenih reakcij in pojavov, da omogočijo sprejetje ustreznih ukrepov.
Tissue establishments shall have effective and accurate systems to uniquely identify and label cells/tissues received and distributed.
Banke tkiv imajo učinkovite in natančne sisteme za enotno identifikacijo in označevanje prejetih in razdeljenih celic/tkiv.
Tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, in an appropriate and readable storage medium.
Banke tkiv in organizacije, pristojne za zdravljenje ljudi, hranijo podatke iz Priloge VI vsaj 30 let, in sicer na ustreznem in berljivem pomnilniškem mediju.
European coding system
Enoten evropski kodni sistem
A single European identifying code shall be allocated to all donated material at the tissue establishment, to ensure proper identification of the donor and the traceability of all donated material and to provide information on the main characteristics and properties of tissues and cells.
Enoten evropski kodni sistem se uporabi za celoten darovan material v banki tkiv, da se zagotovijo pravilna identifikacija darovalca in sledljivost celotnega darovanega materiala ter informacije o glavnih značilnostih in lastnostih tkiv in celic.
The code shall incorporate at least the information set out in Annex VII.
Kodni sistem vključuje vsaj tiste informacije, ki so določene v Prilogi VII.
Paragraph 1 shall not apply to partner donation of reproductive cells.
Odstavek 1 se ne uporablja za reproduktivne celice pri darovanju med partnerjema.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2007, at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 1. septembra 2007.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Komisiji takoj posredujejo besedila teh predpisov in primerjalno preglednico med navedenimi predpisi in direktivo.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 10 of this Directive, by 1 September 2008.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s členom 10 te direktive, do 1. septembra 2008.
http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm and OJ L 262, 14.10.2003, p. 22.
http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm in UL L 262, 14.10.2003, str. 22.
Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in Article 3
Zahteve za akreditacijo, imenovanje, odobritev ali dodelitev dovoljenja bankam tkiv, kakor je navedeno v členu 3
ORGANISATION AND MANAGEMENT
ORGANIZACIJA IN UPRAVLJANJE
A responsible person must be appointed having qualifications and responsibilities as provided in Article 17 of Directive 2004/23/EC.
Imenovati je treba pristojno osebo z izobrazbo in pristojnostmi, določenimi v členu 17 Direktive 2004/23/ES.
A tissue establishment must have an organisational structure and operational procedures appropriate to the activities for which accreditation/designation/authorisation/licensing is sought; there must be an organisational chart which clearly defines accountability and reporting relationships.
Banke tkiv morajo imeti organizacijsko strukturo in operativne postopke, ki ustrezajo dejavnostim, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja; obstajati mora organigram, ki jasno opredeljuje razmerje med odgovornostjo in obveščanjem.
Every tissue establishment must have access to a nominated medical registered practitioner to advise on and oversee the establishment’s medical activities such as donor selection, review of clinical outcomes of applied tissues and cells or interaction as appropriate with clinical users.
Vsaka banka tkiv mora imeti dostop do imenovanega registriranega zdravnika, ki svetuje pri zdravstvenih dejavnostih banke, npr. pri izboru darovalca, pregledu kliničnih izidov uporabljenih tkiv in celic ali, če je potrebno, pri interakciji s kliničnimi uporabniki, in jih nadzira.
There must be a documented quality management system applied to the activities for which accreditation/designation/authorisation or licensing is sought, in accordance with the standards laid down in this Directive.
Obstajati mora dokumentirani sistem upravljanja kakovosti, ki se uporablja pri dejavnostih, za katere se zahteva akreditacija/imenovanje/odobritev ali dodelitev dovoljenja, v skladu s standardi te direktive.
It must be ensured that the risks inherent in the use and handling of biological material are identified and minimised, consistent with maintaining adequate quality and safety for the intended purpose of the tissues and cells.
Zagotoviti je treba, da se tveganja, lastna uporabi biološkega materiala in ravnanja z njim, identificirajo in čim bolj zmanjšajo, ter da se obenem ohrani ustrezna kakovost in varnost za uporabo, za katero so namenjeni tkiva in celice.
The risks include those relating in particular to the procedures, environment, staff health status specific to the tissue establishment.
Tveganja vključujejo tista tveganja, ki so zlasti povezana s postopki, okoljem, zdravstvenim stanjem osebja, značilnimi za banko tkiv.
Agreements between tissue establishments and third parties must comply with Article 24 of Directive 2004/23/EC.
Sporazumi med bankami tkiv in tretjimi strankami morajo biti v skladu s členom 24 Direktive 2004/23/ES.
Third party agreements must specify the terms of the relationship and responsibilities as well as the protocols to be followed to meet the required performance specification.
Sporazumi s tretjimi strankami morajo določiti pogoje razmerja in pristojnosti ter protokole, ki jim je treba slediti za doseganje zahtev učinkovitosti.
There must be a documented system in place, supervised by the responsible person, for ratifying that tissues and/or cells meet appropriate specifications for safety and quality for release and for their distribution.
Vzpostavljen mora biti dokumentirani sistem, ki ga nadzira pristojna oseba, da se zagotovi, da so tkiva in/ali celice v skladu z ustreznimi specifikacijami za varnost in kakovost, potrebnimi za njihovo sprostitev in razdeljevanje.
In the event of termination of activities the agreements concluded and the procedures adopted in accordance with Article 21(5) of Directive 2004/23/EC shall include traceability data and material concerning the quality and safety of cells and tissues.
V primeru prenehanja dejavnosti sporazumi in postopki, sklenjeni in sprejeti v skladu s členom 21(5) Direktive 2004/23/ES vključujejo podatke o sledljivosti in informacije v zvezi s kakovostjo in varnostjo celic in tkiv.
There must be a documented system in place that ensures the identification of every unit of tissue or cells at all stages of the activities for which accreditation/designation/authorisation/licensing is sought.
Vzpostavljen mora biti dokumentiran sistem, ki zagotavlja identifikacijo vsake enote tkiva ali celic na vseh stopnjah dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja.
The personnel in tissue establishments must be available in sufficient number and be qualified for the tasks they perform.
Osebje v bankah tkiv mora biti številčno zadostno in kvalificirano za naloge, ki jih izvaja.
The competency of the personnel must be evaluated at appropriate intervals specified in the quality system.
Usposobljenost osebja je treba vrednotiti v ustreznih časovnih intervalih, določenih v sistemu kakovosti.
All personnel should have clear, documented and up-to-date job descriptions.
Celotno osebje mora imeti jasne, dokumentirane in posodobljene opise nalog.
Their tasks, responsibilities and accountability must be clearly documented and understood.
Njihove naloge, pristojnosti in odgovornost morajo biti jasno dokumentirane in razumljene.
Personnel must be provided with initial/basic training, updated training as required when procedures change or scientific knowledge develops and adequate opportunities for relevant professional development.
Osebju mora biti zagotovljeno začetno/osnovno usposabljanje in usposabljanje, ki vključuje zadnje novosti, kakor se to zahteva ob spremembi postopkov ali razvoju znanstvenih spoznanj, ter primerne možnosti za ustrezno poklicno izpopolnjevanje.
The training programme must ensure and document that each individual:
Program usposabljanja mora zagotavljati in imeti pisna dokazila, da za vsakega posameznika velja, da:
has demonstrated competence in the performance of their designated tasks;
je dokazal, da je usposobljen za izvajanje dodeljenih nalog;
has an adequate knowledge and understanding of the scientific/technical processes and principles relevant to their designated tasks;
ustrezno pozna in pojmuje znanstvene/tehnične postopke in načela, ki ustrezajo dodeljenim nalogam;
understands the organisational framework, quality system and health and safety rules of the establishment in which they work, and
razume okvir organizacije, sistem kakovosti in predpise o zdravju in varnosti ustanove, v kateri dela; ter
is adequately informed of the broader ethical, legal and regulatory context of their work.
je ustrezno obveščen o širšem etničnem, pravnem in uredbenem ozadju svojega dela.
EQUIPMENT AND MATERIALS
OPREMA IN MATERIAL
All equipment and material must be designed and maintained to suit its intended purpose and must minimise any hazard to recipients and/or staff.
Vsa oprema in material morata biti zasnovana in vzdrževana v skladu s svojim namenom in morata čim bolj zmanjšati vsa tveganja za prejemnike in/ali osebje.
All critical equipment and technical devices must be identified and validated, regularly inspected and preventively maintained in accordance with the manufacturers' instructions.
Vsa kritična oprema in tehnične naprave morajo biti identificirane in validirane, redno pregledane in preventivno vzdrževane v skladu z navodili proizvajalca.
Where equipment or materials affect critical processing or storage parameters (e.g. temperature, pressure, particle counts, microbial contamination levels), they must be identified and must be the subject of appropriate monitoring, alerts, alarms and corrective action, as required, to detect malfunctions and defects and to ensure that the critical parameters are maintained within acceptable limits at all times.
Kadar oprema in material vplivata na kritične parametre predelave in shranjevanja (kot so npr. temperatura, tlak, število delcev, ravni kontaminacije z mikrobi), morata biti identificirana in ju je treba po potrebi ustrezno spremljati ter izvajati opozorilne in popravne ukrepe, da se odkrijejo nepravilnosti in napake ter da se zagotovi, da kritični parametri ves čas ostajajo znotraj sprejemljivih meja.
All equipment with a critical measuring function must be calibrated against a traceable standard if available.
Vso opremo s kritično merilno funkcijo je treba umeriti glede na razpoznaven standard, če je na voljo.
New and repaired equipment must be tested when installed and must be validated before use.
Novo in popravljeno opremo je treba testirati, ko se jo namesti, in jo validirati pred uporabo.
Test results must be documented.
Rezultati testiranja morajo biti dokumentirani.
Maintenance, servicing, cleaning, disinfection and sanitation of all critical equipment must be performed regularly and recorded accordingly.
Redno je treba izvajati in ustrezno beležiti vzdrževanje, servisiranje, čiščenje, dezinfekcijo in sanitacijo vse kritične opreme.
Procedures for the operation of each piece of critical equipment, detailing the action to be taken in the event of malfunctions or failure, must be available.
Na voljo morajo biti postopki za delovanje vseh kosov kritične opreme s podrobnimi navodili za ravnanje v primeru nepravilnosti ali napake.
The procedures for the activities for which accreditation/designation/authorisation/licensing is sought, must detail the specifications for all critical materials and reagents.
Postopki za dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja, morajo podrobno opisati specifikacije za ves kritični material in reagente.
In particular, specifications for additives (e.g. solutions) and packaging materials must be defined.
Zlasti morajo biti opredeljene specifikacije za aditive (npr. raztopine) in embalažni material.
Critical reagents and materials must meet documented requirements and specifications and when applicable the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [1] and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [2].
Kritični reagenti in material morajo izpolnjevati dokumentirane zahteve in specifikacije in po potrebi zahteve Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [1] in Direktive 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih [2].
FACILITIES/PREMISES
OBRATI/POSLOVNI PROSTORI
A tissue establishment must have suitable facilities to carry out the activities for which accreditation/designation/authorisation or licensing is sought, in accordance with the standards laid down in this Directive.
Banka tkiv mora imeti primerne obrate za izvajanje dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev ali dodelitev dovoljenja, v skladu s standardi te direktive.
When these activities include processing of tissues and cells while exposed to the environment, this must take place in an environment with specified air quality and cleanliness in order to minimise the risk of contamination, including cross-contamination between donations.
Kadar te dejavnosti vključujejo predelavo tkiv in celic, ki so izpostavljeni okolju, se morajo odvijati v okolju z določeno kakovostjo zraka in čistosti, da se čim bolj zmanjša tveganje kontaminacije, tudi navzkrižne kontaminacije med darovalci.
The effectiveness of these measures must be validated and monitored.
Učinkovitost teh ukrepov je treba validirati in spremljati.
Unless otherwise specified in point 4, where tissues or cells are exposed to the environment during processing, without a subsequent microbial inactivation process, an air quality with particle counts and microbial colony counts equivalent to those of Grade A as defined in the current European Guide to Good Manufacturing Practice (GMP), Annex 1 and Directive 2003/94/EC is required with a background environment appropriate for the processing of the tissue/cell concerned but at least equivalent to GMP Grade D in terms of particles and microbial counts.
Če ni drugače določeno v točki 4, velja, da se, kadar so tkiva ali celice med predelavo izpostavljene okolju, brez poznejšega postopka inaktivacije mikroorganizmov, zahteva kakovost zraka s številom delcev in številom mikrobnih kolonij, ki ustrezata številu iz razreda A, kakor je opredeljen v Prilogi 1, veljavnih Evropskih smernicah dobre proizvodne prakse (GMP) in Direktivi 2003/94/ES, in sicer z okoljem, primernim za predelavo zadevnih tkiv/celic, ali vsaj skladnim z razredom D GMP-ja v smislu števila delcev in števila mikrobnih kolonij.
A less stringent environment than specified in point 3 may be acceptable where:
Okolje, ki ni tako strogo opredeljeno kot v točki 3, se lahko dovoli, kadar:
a validated microbial inactivation or validated terminal sterilisation process is applied;
se uporablja inaktivacija mikroorganizmov ali validiran postopek sterilizacije;
or, where it is demonstrated that exposure in a Grade A environment has a detrimental effect on the required properties of the tissue or cell concerned;
se izkaže, da izpostavljenost okolju iz razreda A škodljivo vpliva na zahtevane lastnosti zadevnega tkiva ali celic;
or, where it is demonstrated that the mode and route of application of the tissue or cell to the recipient implies a significantly lower risk of transmitting bacterial or fungal infection to the recipient than with cell and tissue transplantation;
se izkaže, da način uporabe tkiva ali celice pri prejemniku vključuje precej nižje tveganje prenosa bakterijske ali glivične okužbe pri prejemniku kot pri presaditvi celice ali tkiva;
or, where it is not technically possible to carry out the required process in a Grade A environment (for example, due to requirements for specific equipment in the processing area that is not fully compatible with Grade A).
je tehnično nemogoče izvajati zahtevani postopek v okolju razreda A (npr. zaradi zahtev po posebni opremi v predelovalnem območju, ki ni popolnoma v skladu z razredom A).
In point 4(a), (b), (c) and (d), an environment must be specified.
V točki 4(a), (b), (c) in (d) je treba okolje določiti.
It must be demonstrated and documented that the chosen environment achieves the quality and safety required, at least taking into account the intended purpose, mode of application and immune status of the recipient.
Treba je dokazati in pisno dokazati, da izbrano okolje dosega zahtevano kakovost in varnost, pri čemer se upošteva vsaj namen uporabe, način uporabe in imunsko stanje prejemnika.
Appropriate garments and equipment for personal protection and hygiene must be provided in each relevant department of the tissue establishment along with written hygiene and gowning instructions.
V vseh ustreznih oddelkih banke tkiv morajo biti zagotovljeni ustrezna oblačila in oprema za osebno zaščito in higieno ter pisna navodila glede higiene in obleke.
When the activities for which accreditation/designation/authorisation or licensing is sought involve storage of tissues and cells, the storage conditions necessary to maintain the required tissue and cell properties, including relevant parameters such as temperature, humidity or air quality must be defined.
Kadar dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev ali dodelitev dovoljenja, vključujejo shranjevanje tkiv in celic, je treba opredeliti pogoje shranjevanja, potrebne za ohranjanje zahtevanih lastnosti tkiva in celic, vključno z ustreznimi parametri, kot so temperatura, vlažnost ali kakovost zraka.
Critical parameters (e.g. temperature, humidity, air quality) must be controlled, monitored, and recorded to demonstrate compliance with the specified storage conditions.
Kritične parametre (npr. temperaturo, vlažnost, kakovost zraka) je treba nadzorovati, spremljati in beležiti, da se potrdi skladnost z zahtevanimi pogoji shranjevanja.
Storage facilities must be provided that clearly separate and distinguish tissues and cells prior to release/in quarantine from those that are released and from those that are rejected, in order to prevent mix-up and cross-contamination between them.
Zagotoviti je treba skladiščne prostore, v katerih so pred sprostitvijo/v karanteni tkiva in celice jasno ločeni od tistih, ki so bili sprejeti in od tistih, ki so bili zavrnjeni, da se prepreči zamenjava in navzkrižna kontaminacija med njimi.
Physically separate areas or storage devices or secured segregation within the device must be allocated in both quarantine and released storage locations for holding certain tissue and cells collected in compliance with special criteria.
Za ločevanje določenih tkiv in celic v skladu s posebnimi merili je treba v skladiščnih prostorih za tkiva in celice, ki so v karanteni ali pripravljena za sprostitev, določiti fizično ločena območja ali naprave za shranjevanje ali zaščiteno ločevanje znotraj naprave.
The tissue establishment must have written policies and procedures for controlled access, cleaning and maintenance, waste disposal and for the re-provision of services in an emergency situation.
Banka tkiv mora imeti zapisana pravila in postopke za kontroliran dostop, čiščenje in vzdrževanje, odstranjevanje odpadkov ter za reorganizacijo storitev v nujnih primerih.
DOCUMENTATION AND RECORDS
DOKUMENTACIJA IN EVIDENCE
There must be a system in place that results in clearly defined and effective documentation, correct records and registers and authorised Standard Operating Procedures (SOPs), for the activities for which accreditation/designation/authorisation/licensing is sought.
Za dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja, mora obstajati sistem, ki ima jasno opredeljeno in učinkovito dokumentacijo, pravilne evidence in registre ter standardne operativne postopke (SOP).
Documents must be regularly reviewed and must conform to the standards laid down in this Directive.
Dokumente je treba redno pregledovati in morajo biti v skladu s standardi te direktive.
The system must ensure that work performed is standardised, and that all steps are traceable; i.e. coding, donor eligibility, procurement, processing, preservation, storage, transport, distribution or disposal, including aspects relating to quality control and quality assurance.
Sistem mora zagotavljati, da je opravljeno delo standardizirano in da je mogoče slediti vsem stopnjam, tj. kodiranju, primernosti darovalcev, pridobivanju, predelavi, konzerviranju, shranjevanju, prevozu, razdeljevanju ali odstranitvi, vključno z vidiki v zvezi z nadzorovanjem kakovosti in zagotavljanjem kakovosti.
For every critical activity, the materials, equipment and personnel involved must be identified and documented.
Za vsako kritično dejavnost morajo biti zadevni material, oprema in osebje identificirani in dokumentirani.
In the tissue establishments all changes to documents must be reviewed, dated, approved, documented and implemented promptly by authorised personnel.
V bankah tkiv mora vse spremembe v dokumentih pregledati, datirati, odobriti, dokumentirati in takoj izvršiti pristojno osebje.