natgillin/translations-raw huggingface dataset:
A document control procedure must be established to provide for the history of document reviews and changes and to ensure that only current versions of documents are in use.
Za nadzor dokumentov mora biti vzpostavljen postopek, s pomočjo katerega se vodi evidenca pregledov in sprememb dokumentov in ki zagotavlja uporabo samo veljavnih različic dokumentov.
Records must be shown to be reliable and a true representation of the results.
Biti mora razvidno, da so evidence zanesljive in da zajemajo resnične rezultate.
Records must be legible and indelible and may be handwritten or transferred to another validated system, such as a computer or microfilm.
Evidence morajo biti berljive in neizbrisne ter so lahko ročno zapisane ali prenesene v drug validiran sistem, npr. v računalnik ali mikrofilm.
Without prejudice to Article 9(2), all records, including raw data, which are critical to the safety and quality of the tissues and cells shall be kept so as to ensure access to these data for at least 10 years after expiry date, clinical use or disposal.
Brez poseganja v člen 9(2) je treba vse evidence, vključno z neobdelanimi podatki, ki so kritične za varnost in kakovost tkiv in celic, hraniti tako, da se zagotovi dostop do teh podatkov še vsaj 10 let po datumu poteka veljavnosti, klinične uporabe ali odstranitve.
Records must meet the confidentiality requirements laid down in Article 14 of Directive 2004/23/EC.
Evidence morajo izpolnjevati zahteve glede zaupnosti iz člena 14 Direktive 2004/23/ES.
Access to registers and data must be restricted to persons authorised by the responsible person, and to the competent authority for the purpose of inspection and control measures.
Dostop do registrov in podatkov mora biti dovoljen samo osebam, ki jih je pooblastila pristojna oseba, ter pristojnemu organu, in sicer za namen preiskovalnih in nadzornih ukrepov.
QUALITY REVIEW
PREGLED KAKOVOSTI
An audit system must be in place for the activities for which accreditation/designation/authorisation/licensing is sought.
Za dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja, je treba vzpostaviti sistem poslovanja.
Trained and competent persons must conduct the audit in an independent way, at least every two years, in order to verify compliance with the approved protocols and the regulatory requirements.
Preglede morajo nepristransko izvajati usposobljene in za to pristojne osebe, in sicer vsaj na dve leti, da se preveri skladnost z odobrenimi protokoli in uredbenimi zahtevami.
Findings and corrective actions must be documented.
Ugotovitve in popravne ukrepe je treba dokumentirati.
Deviations from the required standards of quality and safety must lead to documented investigations, which include a decision on possible corrective and preventive actions.
Odstopanja od zahtevanih standardov kakovosti in varnosti je treba preiskati in dokumentirati, to pa vključuje odločitev o možnih popravnih in preventivnih ukrepih.
The fate of non-conforming tissues and cells must be decided in accordance with written procedures supervised by the responsible person and recorded.
Odločitev o tem, kako ravnati z neustreznimi tkivi in celicami, je treba sprejeti v skladu s pisnimi postopki, ki jih nadzoruje pristojna oseba, in jih je treba evidentirati.
All affected tissues and cells must be identified and accounted for.
Vse prizadete tkiva in celice je treba identificirati in prikazati.
Corrective actions must be documented, initiated and completed in a timely and effective manner.
Popravne ukrepe je treba dokumentirati, uvesti in zaključiti pravočasno in učinkovito.
Preventive and corrective actions should be assessed for effectiveness after implementation.
Oceniti je treba učinkovitost in izvajanje preventivnih in popravnih ukrepov.
The tissue establishment should have processes in place for review of the performance of the quality management system to ensure continuous and systematic improvement.
Banka tkiv mora vzpostaviti postopke za pregled delovanja sistema upravljanja kakovosti, da zagotovi nepretrgano in sistematično izboljšanje.
Requirements for the authorisation of tissue and cell preparation processes at the tissue establishments as referred to in Article 4
Zahteve za odobritev postopkov priprave tkiv in celic v bankah tkiv, kakor je navedeno v členu 4
The competent authority shall authorise each tissue and cell preparation process after evaluation of the donor selection criteria and procurement procedures, the protocols for each step of the process, the quality management criteria, and the final quantitative and qualitative criteria for cells and tissues.
Pristojni organ odobri vse postopke priprave tkiv in celic po oceni meril za izbor darovalcev in postopkov naročil, protokolov za vsako stopnjo postopka, meril za upravljanje kakovosti ter končnih meril za količino in kakovost celic in tkiv.
This evaluation must comply at least with the requirements set out in this Annex.
Ocena mora izpolnjevati vsaj zahteve iz te priloge.
RECEPTION AT THE TISSUE ESTABLISHMENT
PREVZEM V BANKI TKIV
Upon reception of procured tissues and cells at the tissue establishment, the tissues and cells must comply with the requirements defined in Directive 2006/17/EC.
Ob prevzemu pridobljenih tkiv in celic v banki tkiv morajo tkiva in celice izpolnjevati zahteve, določene v Direktivi 2006/17/ES.
PROCESSING
PREDELAVA
When the activities for which the accreditation/designation/authorisation/licensing is sought include processing of tissues and cells, the tissue establishment procedures must comply with the following criteria:
Kadar dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja, vključujejo predelavo tkiv in celic, morajo postopki, ki jih uvedejo banke tkiv, izpolnjevati naslednja merila:
The critical processing procedures must be validated and must not render the tissues or cells clinically ineffective or harmful to the recipient.
Kritični postopki predelave morajo biti validirani in ne smejo spremeniti tkiv in celic v klinično neučinkovite ali škodljive za prejemnika.
This validation may be based on studies performed by the establishment itself, or on data from published studies or, for well established processing procedures, by retrospective evaluation of the clinical results for tissues supplied by the establishment.
Validacija lahko temelji na študijah, ki jih izvede banka tkiv sama, ali na podatkih iz objavljenih študij ali, v primeru dobro utečenih postopkov predelave, na retroaktivni oceni kliničnih izidov glede tkiv, ki jih je priskrbela banka tkiv.
It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff.
Dokazano mora biti, da lahko osebje v banki tkiv dosledno in učinkovito izvaja validirani postopek.
The procedures must be documented in SOPs which must conform to the validated method and to the standards laid down in this Directive, accordingly with Annex I(E), points 1 to 4.
Postopki morajo biti dokumentirani v SOP, ki mora biti v skladu z validirano metodo in standardi iz te direktive, skladno s točko E (1 do 4) Priloge I.
It must be ensured that all processes are conducted in accordance with the approved SOPs.
Zagotoviti je treba, da se vsi postopki izvajajo v skladu z odobrenim SOP.
Where a microbial inactivation procedure is applied to the tissue or cells, it must be specified, documented, and validated.
Kadar se za tkiva in celice uporablja postopek inaktivacije mikroorganizmov, ga je treba posebej navesti, dokumentirati in validirati.
Before implementing any significant change in processing, the modified process must be validated and documented.
Preden se v predelavi uvede kakršna koli pomembna sprememba, je treba spremenjeni postopek validirati in dokumentirati.
The processing procedures must undergo regular critical evaluation to ensure that they continue to achieve the intended results.
Postopke predelave je treba redno kritično ocenjevati, da se zagotovi, da še naprej dosegajo predvidene rezultate.
Procedures for discarding tissue and cells must prevent the contamination of other donations and products, the processing environment or personnel.
Postopki zavržbe tkiv in celic morajo preprečiti kontaminacijo drugih darovanih tkiv in celic ter izdelkov, predelovalnega okolja in osebja.
These procedures must comply with national regulations.
Ti postopki morajo biti v skladu s predpisi posameznih držav.
STORAGE AND RELEASE OF PRODUCTS
SHRANJEVANJE IN SPROSTITEV IZDELKA
When the activities for which the accreditation/designation/authorisation/licensing is sought include storage and release of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria:
Kadar dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja, vključujejo shranjevanje in sprostitev tkiv in celic, morajo odobreni postopki, ki jih uvedejo banke tkiv, izpolnjevati naslednja merila:
Maximum storage time must be specified for each type of storage condition.
Za vsako vrsto pogojev shranjevanja mora biti opredeljen čas shranjevanja.
The selected period must reflect among others possible deterioration of the required tissue and cell properties.
Določeno obdobje mora med drugim upoštevati možnost poslabšanja lastnosti zahtevanih tkiv in celic.
There must be a system of inventory hold for tissues and/or cells to ensure that they cannot be released until all requirements laid down in this Directive have been satisfied.
Obstajati mora sistem za zadrževanje tkiv in/ali celic pred sprostitvijo, ki zagotavlja, da tkiva in/ali celice ne morejo biti sproščeni, dokler niso izpolnjene vse zahteve iz te direktive.
There must be a standard operating procedure that details the circumstances, responsibilities and procedures for the release of tissues and cells for distribution.
Obstajati mora standardni operativni postopek, ki podrobno opisuje okoliščine, pristojnosti in postopke v zvezi s sprostitvijo tkiv in celic za razdeljevanje.
A system for identification of tissues and cells throughout any phase of processing in the tissue establishment must clearly distinguish released from non-released (quarantined) and discarded products.
Sistem identifikacije tkiv in celic na kateri koli stopnji predelave v banki tkiv mora jasno ločevati sproščene izdelke od tistih, ki niso bili sproščeni (v karanteni) in ki so bili zavrženi.
Records must demonstrate that before tissues and cells are released all appropriate specifications are met, in particular all current declaration forms, relevant medical records, processing records and test results have been verified according to a written procedure by a person authorised for this task by the responsible person as specified in Article 17 of Directive 2004/23/EC.
Iz evidenc mora biti razvidno, da so bile pred sprostitvijo tkiv in celic izpolnjene vse ustrezne specifikacije in da so bili v skladu s pisnim postopkom zlasti preverjeni vsi veljavni obrazci deklaracije, ustrezne zdravstvene evidence, evidence o predelavi in rezultati testiranj, in sicer s strani osebe, ki jo je za to nalogo pooblastila pristojna oseba, kakor je opredeljena v členu 17 Direktive 2004/23/ES.
If a computer is used to release results from the laboratory, an audit trail should indicate who was responsible for their release.
Če je za objavo rezultatov iz laboratorija uporabljen računalnik, mora revizijska sled navesti, kdo je bil pristojen za njihovo objavo.
A documented risk assessment approved by the responsible person as defined in Article 17 of Directive 2004/23/EC must be undertaken to determine the fate of all stored tissues and cells following the introduction of any new donor selection or testing criterion or any significantly modified processing step that enhances safety or quality.
Izvesti je treba dokumentirano oceno tveganja, ki jo odobri pristojna oseba, kakor je opredeljena v členu 17 Direktive 2004/23/ES, da se določi, kako se bo ravnalo z vsemi shranjenimi tkivi in celicami po uvedbi kakršnega koli novega izbora darovalca ali merila testiranja ali katerega koli vidno spremenjenega postopka predelave, ki vpliva na varnost ali kakovost.
DISTRIBUTION AND RECALL
RAZDELJEVANJE IN ODPOKLIC
When the activities for which the accreditation/designation/authorisation/licensing is sought include distribution of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria:
Kadar dejavnosti, za katere se zahteva akreditacija/imenovanje/odobritev/dodelitev dovoljenja, vključujejo razdeljevanje tkiv in celic, morajo postopki, ki jih uvedejo banke tkiv, izpolnjevati naslednja merila:
Critical transport conditions, such as temperature and time limit must be defined to maintain the required tissue and cell properties.
Določiti je treba kritične pogoje prevoza, kot so temperaturne in časovne omejitve, da se vzdržujejo zahtevane lastnosti vlaken in celic.
The container/package must be secure and ensure that the tissue and cells are maintained in the specified conditions.
Embalaža/paket mora biti zaščiten(a) in mora zagotavljati, da se tkiva in celice hranijo v določenih pogojih.
All containers and packages need to be validated as fit for purpose.
Vsi paketi in embalaža morajo biti validirani z vidika ustreznosti svojemu namenu.
Where distribution is carried out by a contracted third party, a documented agreement must be in place to ensure that the required conditions are maintained.
Kadar razdeljevanje izvaja pogodbena tretja stranka, mora obstajati dokumentirani sporazum, s katerim se zagotovi vzdrževanje zahtevanih pogojev.
There must be personnel authorised within the tissue establishment to assess the need for recall and to initiate and coordinate the necessary actions.
V banki tkiv mora biti tudi osebje, ki je pooblaščeno za to, da oceni potrebo po odpoklicu, in ki lahko sproži ter koordinira potrebne ukrepe.
An effective recall procedure must be in place, including a description of the responsibilities and actions to be taken.
Vzpostavljen mora biti učinkovit postopek odpoklica, vključno z opisom odgovornosti in ukrepov, ki jih je treba sprejeti.
This must include notification to the competent authority.
Ta mora vključevati tudi obveščanje pristojnih organov.
Actions must be taken within pre-defined periods of time and must include tracing all relevant tissues and cells and, where applicable, must include trace-back.
Ukrepi morajo biti izpeljani v predhodno določenih časovnih rokih in vključevati sledenje vseh zadevnih tkiv in celic ter po potrebi tudi sledenje do darovalca.
The purpose of the investigation is to identify any donor who might have contributed to causing the reaction in the recipient and to retrieve available tissues and cells from that donor, as well as to notify consignees and recipients of tissues and cells procured from the same donor in the event that they might have been put at risk.
Namen preiskovanja je identifikacija darovalcev, ki so morda sopovzročili reakcijo pri prejemniku, pridobitev vseh tkiv in celic tega darovalca ter obveščanje prejemnikov tkiv in celic tega dajalca o njihovi morebitni izpostavljenosti tveganju.
Procedures must be in place for the handling of requests for tissues and cells.
Vzpostavljeni morajo biti postopki za obravnavanje prošenj za tkiva in celice.
The rules for allocation of tissues and cells to certain patients or health care institutions must be documented and made available to these parties upon request.
Pravila za dodelitev tkiv in celic nekaterim pacientom ali zdravstvenim ustanovam morajo biti dokumentirana in na voljo tem osebam, če izrazijo željo.
A documented system must be in place for the handling of returned products including criteria for their acceptance into the inventory, if applicable.
Vzpostavljen mora biti dokumentirani sistem za ravnanje z vrnjenimi izdelki, vključno z merili za njihovo umestitev med inventar, če je to potrebno.
FINAL LABELLING FOR DISTRIBUTION
KONČNO OZNAČEVANJE ZA RAZDELJEVANJE
The primary tissue/cell container must provide:
Prvotna embalaža za vlakna/celice mora vsebovati:
type of tissues and cells, identification number or code of the tissue/cells, and lot or batch number where applicable;
vrsto tkiv in celic, identifikacijsko številko ali kodo tkiva/celice in po potrebi lot ali serijsko številko;
identification of the tissue establishment;
identifikacijo banke tkiv;
expiry date;
datum izteka;
in the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified;
pri avtolognem darovanju je treba to posebej navesti (samo za avtologno uporabo) in darovalec/prejemnik mora biti identificiran;
in the case of directed donations - the label must identify the intended recipient;
pri namenskem darovanju mora označba identificirati predvidenega prejemnika;
when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARD.
kadar se tkiva in celice izkažejo za pozitivne za ustrezni označevalec nalezljive bolezni, morajo biti označene z opombo „BIOLOŠKO TVEGANJE“.
If any of the information under points (d) and (e) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container.
Če kateri koli podatek iz točk (d) in (e) ne more biti vsebovan na prvotni označbi embalaže, jih je treba priložiti na posebnem listu papirja, priloženem prvotni embalaži.
This sheet must be packaged with the primary container in a manner that ensures that they remain together.
Ta list papirja mora biti zapakiran s prvotno embalažo na način, ki zagotavlja, da ostaneta skupaj.
The following information must be provided either on the label or in accompanying documentation:
Označba ali spremna dokumentacija mora vsebovati naslednje podatke:
description (definition) and, if relevant, dimensions of the tissue or cell product;
opis (opredelitev) in po potrebi dimenzije izdelka iz tkiv ali celic;
morphology and functional data where relevant;
zgradbo in podatke o delovanju, kjer je to potrebno;
date of distribution of the tissue/cells;
datum razdeljevanja tkiv/celic;
biological determinations carried out on the donor and results;
biološke odmerke, uporabljene pri darovalcu in rezultate;
storage recommendations;
priporočila za shranjevanje;
instructions for opening the container, package, and any required manipulation/reconstitution;
navodila za odprtje embalaže, paketa in za vse zahtevane spremembe/obnavljanje;
expiry dates after opening/manipulation;
datum poteka veljavnosti po odprtju/spremembi;
instructions for reporting serious adverse reactions and/or events as set out in Articles 5 to 6;
navodila za prijavo/poročanje o resnih neželenih reakcijah in/ali pojavih, kakor so določeni v členih 5 in 6;
presence of potential harmful residues (e.g. antibiotics, ethylene oxide etc).
prisotnost morebitnih škodljivih ostankov (npr. antibiotiki, etilen oksid itd.).
EXTERNAL LABELLING OF THE SHIPPING CONTAINER
ZUNANJE OZNAČEVANJE EMBALAŽE ZA POŠILJANJE
For transport, the primary container must be placed in a shipping container that must be labelled with at least the following information:
Za prevoz mora biti prvotna embalaža nameščena v embalažo za pošiljanje, ki mora biti označena vsaj z naslednjimi podatki:
identification of the originating tissue establishment, including an address and phone number;
identifikacijo izvorne banke tkiv, vključno z naslovom in telefonsko številko;
identification of the organisation responsible for human application of destination, including address and phone number;
identifikacijo namembne organizacije, pristojne za zdravljenje ljudi, vključno z naslovom in telefonsko številko;
a statement that the package contains human tissue/cells and HANDLE WITH CARE;
izjavo, da paket vsebuje človeško tkivo/celice, ter opombo „RAVNAJ PREVIDNO“;
where living cells are required for the function of the graft, such as stem cells gametes and embryos, the following must be added: ‘DO NOT IRRADIATE’;
kadar so za delovanje presadka potrebne žive celice, kot so zarodne celice, gamete in zarodki, je treba dodati opombo „NE OBSEVAJ“;
recommended transport conditions (e.g. keep cool, in upright position, etc.);
priporočene razmere za prevoz (npr. hraniti na hladnem, pokonci itd.);
safety instructions/method of cooling (when applicable).
navodila za varnost/metodo hlajenja (po potrebi).
Rapid notification for suspected serious adverse reactions
Hitro obveščanje o sumu hudih neželenih reakcij
Tissue establishment
Banka tkiv
Individual affected (recipient or donor)
Prizadeta oseba (prejemnik ali darovalec)
Date and place of procurement or human application (year/month/day)
Datum in kraj pridobitve ali uporabe za zdravljenje ljudi (leto, mesec, dan)
Unique Donation identification number
Enotna identifikacijska številka darovanja
Date of suspected serious adverse reaction (year/month/day)
Datum suma hude neželene reakcije (leto, mesec, dan)
Type of tissues and cells involved in the suspected serious adverse reaction
Vrste tkiv in celic, uporabljenih v zvezi s sumom hude neželene reakcije
Type of suspected serious adverse reaction(s)
Vrsta suma hude neželene reakcije/hudih neželenih reakcij
Conclusions of serious adverse reactions investigation
Sklepne ugotovitve preiskave hudih neželenih reakcij
Unique donation identification number
Enotna identifikacijska številka darovanja
If Yes, Specify
Če je odgovor da, obrazložite
Clinical outcome (if known)
Klinični izid (če je znan)
Outcome of the investigation and final conclusions
Rezultat preiskave in končne ugotovitve
Recommendations for preventive and corrective actions
Priporočila za preventivne in popravne ukrepe
NOTIFICATION OF SERIOUS ADVERSE EVENTS
OBVEŠČANJE O HUDIH NEŽELENIH POJAVIH
Rapid notification for suspected serious adverse events
Hitro obveščanje o sumu hudih neželenih pojavov
Date of serious adverse event (year/month/day)
Datum hudega neželenega pojava (leto, mesec, dan)
Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in:
Hud neželeni pojav, ki lahko vpliva na kvaliteto in varnost tkiv in celic zaradi nepravilnosti pri:
Tissues and cells defect
Napaka tkiv in celic
Procurement
Pridobivanju
Transport
Prevozu
Processing
Predelavi
Storage
Shranjevanju
Distribution
Razdeljevanju
Materials
Materialu
Others (specify)
Drugo (navedite)
Conclusions of Serious Adverse Events investigation
Sklepne ugotovitve preiskave resnih neželenih pojavov
Corrective measures taken (details)
Sprejeti ukrepi za izboljšanje stanja (podrobnosti)
ANNUAL NOTIFICATION FORMAT
OBRAZEC ZA LETNO OBVEŠČANJE
Reporting country
Država poročevalka
Reporting date 1 January-31 December (year)
Datum poročila: 1. januar–31. december (leto)
Number of serious adverse reaction(s) per type of tissue and cell (or product in contact with the tissues and cells)
Število hudih neželenih reakcij glede na vrsto tkiva in celice (ali vrsto izdelka v stiku s tkivi in celicami)
Type of tissue/cell (or product in contact with the tissues and cells)
Vrsta tkiva/celice (ali izdelka v stiku s tkivi in celicami)
Number of serious adverse reaction(s)
Število hudih neželenih reakcij
Total number of tissues/cells of this type distributed (if available)
Skupno število razdeljenih tkiv/celic te vrste (če je na voljo)
Total number of tissues and cells distributed (including type of tissue and cell for which no serious adverse reactions were reported):
Skupno število razdeljenih tkiv in celic (vključno z vrsto tkiva in celice, za katero ni bilo predloženo nobeno poročilo o hudih neželenih reakcijah):
Number of recipients affected (total number of recipients):
Število prizadetih prejemnikov (skupno število prejemnikov):
Nature of the serious adverse reactions reported
Vrsta prijavljenih hudih neželenih reakcij
Total number of serious adverse reaction(s)
Skupno število hudih neželenih reakcij
Transmitted bacterial infection
Prenesena bakterijska okužba
Transmitted viral infection
Prenesena virusna okužba
Other (Specify)
Drugo (navedite)
Transmitted parasitical infection
Prenesena okužba zaradi zajedavca
Transmitted malignant diseases
Prenesene maligne bolezni
Other disease transmissions
Drugi prenosi bolezni
Other serious reactions (Specify)
Druge hude reakcije (navedite)