natgillin/translations-raw huggingface dataset:
There shall be clearly defined procedures to resolve discrepant results and ensure that blood and blood components that have a repeatedly reactive result in a serological screening test for infection with the viruses mentioned in Annex IV to Directive 2002/98/EC shall be excluded from therapeutic use and be stored separately in a dedicated environment.
Vzpostavljeni morajo biti jasno opredeljeni postopki za razreševanje neskladnosti rezultatov, ki zagotovijo, da se kri in komponente krvi, katerih rezultati serološkega presejalnega testiranja na okuženost z virusi, navedenimi v Prilogi IV k Direktivi 2002/98/ES, so bili večkrat lažno pozitivni, izloči iz terapevtske uporabe in shrani v ločenem, za to primernem prostoru.
Appropriate confirmatory testing shall take place.
Izvedejo se ustrezni potrditveni testi.
In case of confirmed positive results, appropriate donor management shall take place including the provision of information to the donor and follow-up procedures.
V primeru potrjenega pozitivnega rezultata nastopi ustrezno vodenje dajalcev vključno z informiranjem dajalca in nadaljnjimi postopki sledenja.
There shall be data confirming the suitability of any laboratory reagents used in the testing of donor samples and blood component samples.
Ustreznost katerega koli laboratorijskega reagenta, ki se uporablja pri testiranju odvzetih vzorcev krvi in komponent krvi, mora biti potrjena.
The quality of the laboratory testing shall be regularly assessed by the participation in a formal system of proficiency testing, such as an external quality assurance programme.
Redno je treba ocenjevati kakovost laboratorijskega testiranja, in sicer z udeležbo v formalnem sistemu preverjanja usposobljenosti, kakršen je program za zunanjo oceno kakovosti.
Blood group serology testing shall include procedures for testing specific groups of donors (e.g. first time donors, donors with a history of transfusion).
Serološko testiranje krvne skupine vključuje postopke testiranja določenih skupin dajalcev (npr. dajalcev, ki prvič darujejo kri, dajalcev, ki so že prejeli transfuzijo).
Processing and validation
Predelava in validacija
All equipment and technical devices shall be used in accordance with validated procedures.
Vsa oprema in tehnična sredstva se uporabljajo v skladu z validiranimi postopki.
The processing of blood components shall be carried out using appropriate and validated procedures including measures to avoid the risk of contamination and microbial growth in the prepared blood components.
Predelava komponent krvi se izvaja z uporabo ustreznih in validiranih postopkov, ki vključujejo ukrepe za preprečevanje okužb in rasti mikrobov v pripravljenih komponentah krvi.
At all stages, all containers shall be labelled with relevant information of their identity.
V vseh fazah morajo biti na vseh vrečkah za kri pritrjene nalepke z ustreznimi informacijami o njihovi vsebini.
In the absence of a validated computerised system for status control, the labelling shall clearly distinguish released from non-released units of blood and blood components.
Če validirani računalniški sistem kontrole statusa ni vzpostavljen, označevanje jasno ločuje enote komponent krvi, ki so sproščene, od tistih, ki niso sproščene.
The labelling system for the collected blood, intermediate and finished blood components and samples must unmistakably identify the type of content, and comply with the labelling and traceability requirements referred to in Article 14 of Directive 2002/98/EC and Commission Directive 2005/61/EC [5].
Sistem označevanja zbrane krvi, vmesnih in končnih komponent ter vzorcev krvi mora nedvoumno navajati vrsto vsebine in biti v skladu z zahtevami glede označevanja in sledljivosti iz člena 14 Direktive 2002/98/ES in Direktive Komisije 2005/61/ES [5].
The label for a final blood component shall comply with the requirements of Annex III to Directive 2002/98/EC.
Nalepka za končno komponento krvi mora biti v skladu z zahtevami iz Priloge III k Direktivi 2002/98/ES.
For autologous blood and blood components, the label also shall comply with Article 7 of Directive 2004/33/EC and the additional requirements for autologous donations specified in Annex IV to that Directive.
Pri avtologni krvi in komponentah krvi mora biti nalepka tudi v skladu s členom 7 Direktive 2004/33/ES in dodatnimi zahtevami za avtologne odvzeme, določene v Prilogi IV k tej direktivi.
Release of blood and blood components
Sproščanje krvi in komponent krvi
There shall be a safe and secure system to prevent each single blood and blood component from being released until all mandatory requirements set out in this Directive have been fulfilled.
Vzpostavi se varen in zanesljiv sistem, ki bo preprečil vsako sproščanje krvi ali komponent krvi, dokler niso izpolnjene vse zavezujoče zahteve iz te direktive.
Each blood establishment shall be able to demonstrate that each blood or blood component has been formally released by an authorised person.
Vsaka transfuzijska ustanova mora biti sposobna dokazati, da je vsako sproščanje katerega koli posameznega odvzema krvi ali komponente krvi formalno odobrila pooblaščena oseba.
Records shall demonstrate that before a blood component is released, all current declaration forms, relevant medical records and test results meet all acceptance criteria.
Zapisi morajo dokazovati, da pred vsakim sproščanjem komponente krvi vsi obstoječi obrazci deklaracij, ustrezne zdravstvene kartoteke in rezultati testiranj izpolnjujejo vsa merila sprejemljivosti.
Before release, blood and blood components shall be kept administratively and physically segregated from released blood and blood components.
Pred sproščanjem se kri in komponente krvi organizacijsko in fizično hranijo ločeno od sproščene krvi in komponent krvi.
In the absence of a validated computerised system for status control the label of a unit of blood or blood component shall identify the release status in accordance with 6.5.1.
Če validirani računalniški sistem kontrole statusa ni vzpostavljen, mora biti na nalepki za enoto krvi ali komponento krvi v skladu s točko 6.5.1 naveden njen status glede sproščanja.
In the event that the final component fails release due to a confirmed positive infection test result, in conformity with the requirements set out in Section 6.3.2 and 6.3.3, a check shall be made to ensure that other components from the same donation and components prepared from previous donations given by the donor are identified.
V primeru, da končne komponente krvi, v skladu z zahtevami v oddelku 6.3.2 in 6.3.3, ni mogoče sprostiti, ker je bil potrjen pozitivni rezultat testiranja s krvjo prenosljivih bolezni, je treba opraviti preverjanje, ki naj zagotovi izločitev preostalih komponent, ki izhajajo iz istega odvzema, in komponent, pripravljenih iz prejšnjih odvzemov krvi istega dajalca.
There shall be an immediate update of the donor record.
Nemudoma se tudi ustrezno dopolnijo zapisi o dajalcu.
STORAGE AND DISTRIBUTION
SHRANJEVANJE IN RAZDELJEVANJE
The quality system of the blood establishment shall ensure that, for blood and blood components intended for the manufacture of medicinal products, the storage and distribution requirements shall comply with Directive 2003/94/EC.
Sistem kakovosti za transfuzijske ustanove zagotovi, da so zahteve glede shranjevanja ter razdeljevanja krvi in komponent krvi, namenjenih izdelavi zdravil, v skladu z Direktivo 2003/94/ES.
Procedures for storage and distribution shall be validated to ensure blood and blood component quality during the entire storage period and to exclude mix-ups of blood components.
Postopki shranjevanja in razdeljevanja se validirajo, da bi bila zagotovljena kakovost krvi in komponent krvi med celotnim obdobjem shranjevanja in da ne bi prišlo do zamenjav komponent krvi.
All transportation and storage actions, including receipt and distribution, shall be defined by written procedures and specifications.
Vse dejavnosti prevoza in shranjevanja, vključno s prejemom in razdeljevanjem, se opredelijo v pisnih postopkih in specifikacijah.
Autologous blood and blood components as well as blood components collected and prepared for specific purposes shall be stored separately.
Avtologna kri in komponente krvi ter komponente krvi, ki se zbirajo in pripravljajo za posebne namene, se shranjujejo ločeno.
Appropriate records of inventory and distribution shall be kept.
Vodijo se ustrezni zapisi o zalogah in razdeljevanju.
Packaging shall maintain the integrity and storage temperature of blood or blood components during distribution and transportation.
Primerna embalaža mora ohranjati neokrnjenost in temperaturo shranjene krvi ali komponent krvi med njenim razdeljevanjem in prevozom.
Return of blood and blood components into inventory for subsequent reissue shall only be accepted when all quality requirements and procedures laid down by the blood establishment to ensure blood component integrity are fulfilled.
Vračanje krvi in komponent krvi v zalogo za njihovo kasnejšo ponovno izdajo je sprejemljiva samo pod pogojem, če so izpolnjene vse zahteve in postopki glede zagotavljanja kakovosti, ki jih je določila transfuzijska ustanova zaradi zagotavljanja neokrnjenosti komponent krvi.
CONTRACT MANAGEMENT
POGODBENO DELO
Tasks that are performed externally shall be defined in a specific written contract.
Naloge, ki jih opravlja zunanji izvajalec, morajo biti opredeljene v posebni pisni pogodbi.
NON-CONFORMANCE
NESKLADNOST
Deviations
Odstopanja
Blood components deviating from required standards set out in Annex V to Directive 2004/33/EC shall be released for transfusion only in exceptional circumstances and with the recorded agreement of the prescribing physician and the blood establishment physician.
Komponente krvi, ki odstopajo od zahtevanih standardov iz Priloge V k Direktivi 2004/33/ES se lahko sprostijo za transfuzijo samo v izjemnih okoliščinah in ob zabeleženem pristanku lečečega zdravnika in zdravnika transfuzijske ustanove.
Complaints
Pritožbe
All complaints and other information, including serious adverse reactions and serious adverse events, which may suggest that defective blood components have been issued, shall be documented, carefully investigated for causative factors of the defect and, where necessary, followed by recall and the implementation of corrective actions to prevent recurrence.
Vse pritožbe in druge informacije, vključno z informacijami o hudih neželenih reakcijah in pojavih, ki bi kazali na to, da je bila izdana neustrezna komponenta krvi, je treba zabeležiti in skrbno raziskati vzroke napak, čemur po potrebi sledi odpoklic krvi in uvedba korektivnih ukrepov, ki naj preprečijo ponovitev napak.
Procedures shall be in place to ensure that the competent authorities are notified as appropriate of serious adverse reactions or serious adverse events in accordance with regulatory requirements.
Vzpostavijo se postopki, s katerimi se zagotovi, da so pristojni organi ustrezno obveščeni o hudih neželenih reakcijah ali pojavih, v skladu s predpisanimi zahtevami.
Recall
Odpoklic
There shall be personnel authorised within the blood establishment to assess the need for blood and blood component recall and to initiate and coordinate the necessary actions.
V transfuzijski ustanovi mora biti osebje, ki je pooblaščeno za sprejetje ocene o potrebi po odpoklicu krvi in komponent krvi in ki lahko sproži ter koordinira potrebne ukrepe.
An effective recall procedure shall 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 shall include notification to the competent authority.
Ta mora vključevati tudi obveščanje pristojnih organov.
Actions shall be taken within pre-defined periods of time and shall include tracing all relevant blood components and, where applicable, shall include trace-back.
Ukrepi morajo biti izpeljani v predhodno določenih časovnih rokih in vključevati sledenje vseh vpletenih komponent krvi in po potrebi tudi sledenje do dajalca.
The purpose of the investigation is to identify any donor who might have contributed to causing the transfusion reaction and to retrieve available blood components from that donor, as well as to notify consignees and recipients of components collected from the same donor in the event that they might have been put at risk.
Namen preiskovanja je identifikacija dajalcev, ki so morda sopovzročili reakcijo pri transfuziji, pridobitev vseh komponent krvi tega dajalca in obveščanje prejemnikov komponent krvi tega dajalca o njihovi morebitni izpostavljenosti tveganju.
Corrective and preventive actions
Korektivni in preventivni ukrepi
A system to ensure corrective and preventive actions on blood component non-conformity and quality problems shall be in place.
Vzpostavi se sistem zagotavljanja korektivnih in preventivnih ukrepov v primeru neskladnosti in problemov s kakovostjo komponent krvi.
Data shall be routinely analysed to identify quality problems that may require corrective action or to identify unfavourable trends that may require preventive action.
Rutinsko se izvaja analiza podatkov za ugotavljanje problemov s kakovostjo, zaradi katerih bi bil potreben korektivni ukrep, ali neugodnih trendov, zaradi katerih bi bil potreben preventivni ukrep.
All errors and accidents shall be documented and investigated in order to identify system problems for correction.
Vse napake in nezgode se dokumentirajo in raziščejo zaradi ugotavljanja problemov v sistemu in načina njihove odprave.
SELF-INSPECTION, AUDITS AND IMPROVEMENTS
NOTRANJI NADZOR, PREVERJANJE IN IZBOLJŠAVE
Self-inspection or audit systems shall be in place for all parts of the operations to verify compliance with the standards set out in this Annex.
Na vseh ravneh izvajanja dejavnosti se vzpostavijo sistemi notranjega nadzora ali preverjanj zaradi presoje skladnosti s standardi, določenimi v tej Prilogi.
They shall be carried out regularly by trained and competent persons in an independent way according to approved procedures.
Redno jih izvajajo usposobljene in zanje pristojne osebe, ki delujejo neodvisno in v skladu z odobrenimi postopki.
All results shall be documented and appropriate corrective and preventive actions shall be taken in a timely and effective manner.
Vsi rezultati se dokumentirajo ter nato pravočasno in učinkovito izvedejo ustrezni korektivni in preventivni ukrepi.
OJ L 262, 17.10.2000, p. 21.
UL 262, 17.10.2000, str. 21.
OJ L 331, 7.12.1998, p. 1.
UL L 331, 7.12.1998, str. 1.
Commission Directive 2005/63/EC
Direktiva Komisije 2005/63/ES
correcting Directive 2005/26/EC concerning the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council
o popravku Direktive 2005/26/ES glede seznama živilskih sestavin ali snovi, začasno izključenih iz Priloge IIIa Direktive 2000/13/ES
Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [1] and in particular Article 6 (11), thereof,
ob upoštevanju Direktive Evropskega parlamenta in Sveta 2000/13/ES z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [1], in zlasti člena 6(11) Direktive,
Commission Directive 2005/26/EC [2] established the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC, having heard the opinion of the European Food Safety Authority (EFSA).
Zaradi mnenja Evropske agencije za varno hrano (EFSA) je v Direktivi Komisije 2005/26/ES [2] določen seznam živilskih sestavin ali snovi, začasno izključenih iz Priloge IIIa Direktive 2000/13/ES.
In its opinion of 2 December 2004 on certain uses of fish gelatine, the EFSA concluded that this product, when used as a carrier for vitamin and carotenoid preparations, is not likely to cause severe allergic reactions.
V svojem mnenju z dne 2. decembra 2004 glede posameznih uporab ribje želatine je EFSA ugotovila, da ni verjetno, da bi pri uporabi tega proizvoda kot nosilne snovi za vitamine in karotenoide ta povzročil hude alergijske reakcije.
Carotenoids were wrongly omitted from the list in annex to Directive 2005/26/EC and must therefore be added to it,
Karotenoidi so bili po pomoti izpuščeni iz seznama v Prilogi k Direktivi 2005/26/ES, zato jih je treba vanj dodati –
In the second column of the Annex to Directive 2005/26/EC, the seventh row shall be replaced by the following:
V drugem stolpcu Priloge k Direktivi 2005/26/ES se sedma alinea zamenja z naslednjim:
Fish gelatine used as a carrier for vitamin or carotenoid preparations and flavours.’
Ribja želatina, ki se uporablja kot nosilna snov za vitamine ali karotenoide in arome.“
The Member States shall adopt and publish, by 3 December 2005 at the latest, the rules, regulations and administrative provisions necessary to comply with the present Directive.
Države članice najpozneje do 3. decembra 2005 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall immediately communicate the text of those provisions to the Commission together with a correlation table those provisions and this Directive.
Komisiji takoj posredujejo besedila navedenih predpisov in primerjalno tabelo med navedenimi predpisi in to direktivo.
They shall apply those provisions from 25 November 2005.
Države članice te predpise uporabljajo od 25. novembra 2005.
When the Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by a reference at the time of their official publication.
Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi.
The Member States shall determine how such reference is to be made.
Način sklicevanja določijo države članice.
The Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice predložijo Komisiji besedila temeljnih predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
Done at Brussels, 3 October 2005.
V Bruslju, 3. oktobra 2005
Directive 2005/64/EC of the European Parliament and of the Council
Direktiva Evropskega parlamenta in Sveta 2005/64/ES
on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC
o homologaciji motornih vozil glede na njihovo ponovno uporabnost, možnost recikliranja in predelave ter o spremembi Direktive Sveta 70/156/EGS
Acting in accordance with the procedure referred to in Article 251 of the Treaty,
v skladu s postopkom, določenim v členu 251 Pogodbe,
In accordance with Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles, appropriate provisions should be laid down to ensure that type-approved vehicles belonging to category M1, and those belonging to category N1, may be put on the market only if they are reusable and/or recyclable to a minimum of 85 % by mass and are reusable and/or recoverable to a minimum of 95 % by mass.
V skladu z Direktivo Evropskega parlamenta in Sveta 2000/53/ES z dne 18. septembra 2000 o izrabljenih vozilih bi bilo treba sprejeti ustrezne določbe, ki omogočajo prodajo homologiranih vozil kategorij M1 in N1, le v primeru, ko se lahko ponovno uporabi in/ali reciklira najmanj 85 % njihove mase ter ponovno uporabi in/ali predela najmanj 95 % njihove mase.
Reusability of component parts, recyclability and recoverability of materials constitute a substantial part of the Community strategy for waste management.
Ponovna uporabnost sestavnih delov, možnost recikliranja in predelave materialov predstavlja pomemben del strategije Skupnosti za ravnanje z odpadki.
Therefore vehicle manufacturers and their suppliers should be requested to include those aspects at the earliest stages of the development of new vehicles, in order to facilitate the treatment of vehicles at the time when they reach the end of their life.
Zato bi bilo treba od proizvajalcev vozil in njihovih dobaviteljev zahtevati, da v začetni fazi razvijanja novih vozil vključijo te vidike za lažje ravnanje z vozili ob koncu njihove življenjske dobe.
This Directive constitutes one of the separate directives within the framework of the Community whole vehicle type-approval system established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers.
Ta direktiva predstavlja posebno direktivo v okviru sistema homologacije celotnega vozila na ravni Skupnosti, ki jo določa Direktiva Sveta 70/156/EGS z dne 6. februarja 1970 o približevanju zakonodaje držav članic o homologaciji motornih in priklopnih vozil.
That whole vehicle type-approval system is currently compulsory for vehicles belonging to category M1 and will be extended, in the near future, to all categories of vehicle.
Sistem homologacije celotnega vozila je trenutno obvezen za vozila kategorije M1 in bo v bližnji prihodnosti razširjen na vozila vseh kategorij.
It is therefore necessary to include in the whole vehicle type-approval system those measures concerning the re-usability, recyclability and recoverability of vehicles.
Zato bi bilo treba v sistem homologacije celotnega vozila vključiti določbe v zvezi s ponovno uporabnostjo, možnostjo recikliranja in predelave vozil.
Accordingly, it is necessary to lay down provisions to take into account the fact that N1 vehicles are not yet covered by the whole vehicle type-approval system.
V skladu s tem je treba sprejeti določbe, v katerih se bo upoštevalo, da sistem homologacije celotnega vozila še ne krije vozil kategorije N1.
The manufacturer should make available to the approval authority all relevant technical information as regards constituent materials and their respective masses in order to permit verification of the manufacturer's calculations in accordance with the standard ISO 22628: 2002.
Proizvajalec bi moral nuditi homologacijskemu organu vse pomembne tehnične informacije o sestavnih materialih in njihovih masah, da bi jim omogočil preverjanje izračunov proizvajalca v skladu s standardom ISO 22628: 2002.
The manufacturer's calculations can be properly validated at the time of the vehicle type-approval only if the manufacturer has put in place satisfactory arrangements and procedures to manage all information he receives from his suppliers.
Izračuni proizvajalca se lahko ustrezno potrdijo v trenutku homologacije vozila le, če je proizvajalec uvedel zadovoljive ukrepe in postopke za upravljanje vseh informacij, ki jih prejema od svojih dobaviteljev.
Before any type-approval can be granted, the competent body should carry out a preliminary assessment of those arrangements and procedures and should issue a certificate indicating that they are satisfactory.
Pred izdajo katere koli homologacije bi moral pristojni organ predhodno oceniti te ureditve in postopke ter izdati potrdilo o njihovi pravilnosti.
The relevance of the different inputs in the calculations of the recyclability and recoverability rates has to be assessed in accordance with the processes for treatment of end-of-life vehicles.
Pomembnost in ustreznost različnih spremenljivk v izračunih stopenj možnosti recikliranja in predelave vozil se oceni v skladu s postopki za ravnanje z izrabljenimi vozili.
The manufacturer should therefore recommend a strategy for the treatment of end-of-life vehicles and should provide details thereof to the competent body.
Proizvajalec bi moral zato priporočiti strategijo za ravnanje z izrabljenimi vozili in jo natančno opisati pristojnemu organu.
This strategy should be based on proven technologies, which are available or in development at the time of applying for the vehicle approval.
Ta strategija bi morala temeljiti na preizkušenih tehnologijah, ki so v razvoju ali na razpolago v trenutku, ko se vloži zahteva za homologacijo vozila.