natgillin/translations-raw huggingface dataset:
It is necessary to specify that a quality system is to be applied for any blood and blood components circulating in the Community and that Member States therefore should ensure that for blood and blood components coming from third countries there is a quality system in place for blood establishments in the stages preceding importation equivalent to the quality system provided under this Directive.
Treba je poudariti, da se mora sistem kakovosti uporabljati za vso kri in komponente krvi, ki so v prometu v Skupnosti, in da morajo države članice zagotoviti, da je v transfuzijskih ustanovah vzpostavljen sistem kakovosti za kri in komponente krvi, ki prihajajo iz tretjih držav, ki je v fazah pred uvozom enak sistemu kakovosti iz te direktive.
It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.
Treba je določiti enotno opredelitev tehnične terminologije, da se zagotovi dosledno izvajanje Direktive 2002/98/ES.
‘standard’ means the requirements that serve as the basis for comparison;
„standard“ so zahteve, ki služijo kot podlaga za primerjavo;
‘specification’ means a description of the criteria that must be fulfilled in order to achieve the required quality standard;
„specifikacija“ je opis meril, ki morajo biti izpolnjena, da bi bil dosežen standard kakovosti;
‘quality system’ means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management;
„sistem kakovosti“ vključuje organizacijsko strukturo, odgovornosti, postopke, procese in vire za izvajanje vodenja kakovosti;
‘quality management’ means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment;
„vodenje kakovosti“ so usklajene dejavnosti za usmerjanje in kontrolo organizacije, ki zadevajo kakovost na vseh ravneh transfuzijske ustanove;
‘quality control’ means part of a quality system focussed on fulfilling quality requirements;
„nadzor kakovosti“ je del sistema kakovosti, ki je usmerjen k izpolnjevanju zahtev kakovosti;
‘quality assurance’ means all the activities from blood collection to distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use;
„zagotavljanje kakovosti“ pomeni skupek vseh dejavnosti, od zbiranja do razdeljevanja krvi, sprejetih z namenom zagotavljanja, da so kri in komponente krvi takšne kakovosti, kot je to zahtevano za njihovo predvideno uporabo;
‘trace-back’ means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor;
„sledenje do dajalca“ je postopek preiskave suma s transfuzijo povezanega javljenega primera neželene reakcije pri prejemniku krvi, ki naj pripelje do morebiti vpletenega dajalca;
‘written procedures’ means controlled documents that describe how specified operations are to be carried out;
„pisni postopki“ so preverjeni dokumenti, ki opisujejo način izvajanja določenih postopkov;
‘mobile site’ means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment;
„mobilna transfuzijska ekipa“ je začasni ali premični oddelek, kjer se opravlja odvzem krvi in komponent krvi, ki deluje zunaj transfuzijske ustanove, vendar je pod njenim nadzorom;
‘processing’ means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component;
„predelava“ je kateri koli korak pri pripravi komponente krvi, ki se izvrši v času od zbiranja krvi do izdaje komponente krvi;
‘good practice’ means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations;
„dobra praksa“ so vsi elementi vzpostavljene prakse, ki naj skupaj pripeljejo do tega, da bodo kri in komponente krvi dosledno izpolnjevale vnaprej določene specifikacije in bile skladne z opredeljenimi pravili;
‘quarantine’ means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents;
„karantena“ je fizična izolacija komponent krvi ali pridobljenih materialov/reagentov v variabilnem časovnem obdobju, ki je potrebno, da se pridobljeni material/reagent ali komponente krvi sprejmejo, izdajo ali zavrnejo;
‘validation’ means the establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled;
„validacija“ je dokumentirani in objektivni dokaz, da je mogoče dosledno izpolniti vnaprej določene zahteve glede posebnega postopka ali procesa;
‘qualification’, as part of validation, means the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results;
„kvalifikacija“, kot del validacije, je ukrep preverjanja osebja, prostorov, opreme ali materialov, ki naj potrdi, ali ti ustrezno opravljajo svoje naloge in prinašajo pričakovane rezultate;
‘computerised system’ means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation.
„računalniški sistem“ je sistem, ki vključuje vnašanje podatkov, njihovo elektronsko obdelavo in izhodne informacije ter se uporablja za poročanje, avtomatsko kontrolo ali vodenje dokumentacije.
Quality system standards and specifications
Standardi in specifikacije sistema kakovosti
Member States shall ensure that the quality system in place in all blood establishments complies with the Community standards and specifications set out in the Annex to this Directive.
Države članice zagotovijo, da je sistem kakovosti v vseh transfuzijskih ustanovah skladen s standardi Skupnosti in specifikacijami, določenimi v Prilogi k tej direktivi.
Good practice guidelines shall be developed by the Commission, in accordance with Article 28 of Directive 2002/98/EC, for the interpretation of the Community standards and specifications referred to in paragraph 1.
Za razlago standardov in specifikacij Skupnosti iz odstavka 1 mora Komisija, v skladu s členom 28 Direktive 2002/98/ES, izdelati Smernice dobre prakse.
When developing these guidelines, the Commission shall take fully into account the detailed principles and guidelines of good manufacturing practice, as referred to in Article 47 of Directive 2001/83/EC.
Komisija pri izdelavi smernic v celoti upošteva podrobna načela in smernice dobre proizvodne prakse iz člena 47 Direktive 2001/83/ES.
Member States shall ensure that for blood and blood components imported from third countries and intended for use or distribution in the Community, there is a quality system for blood establishments in the stages preceding importation equivalent to the quality system provided for in Article 2.
Države članice zagotovijo, da je v transfuzijskih ustanovah vzpostavljen sistem kakovosti za kri in komponente krvi, uvožene iz tretjih držav in namenjene za razdeljevanje v Skupnosti, ki je v fazah pred uvozom enak sistemu kakovosti iz člena 2.
Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2006 at the latest.
Brez poseganja v člen 7 Direktive 2002/98/ES države članice sprejmejo zakone in druge predpise za uskladitev s to direktivo najpozneje do 31. avgusta 2006.
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Ta direktiva začne veljati 20. dan po objavi v Uradnem listu Evropske unije.
INTRODUCTION AND GENERAL PRINCIPLES
UVOD IN SPLOŠNA NAČELA
Quality system
Sistem kakovosti
Quality shall be recognised as being the responsibility of all persons involved in the processes of the blood establishment with management ensuring a systematic approach towards quality and the implementation and maintenance of a quality system.
Kakovosti mora biti zavezano celotno osebje, ki je vključeno v delo na transfuzijski ustanovi, vodstvo pa si mora prizadevati za sistematično usmerjanje h kakovosti ter k izvajanju in vzdrževanju sistema kakovosti.
The quality system encompasses quality management, quality assurance, continuous quality improvement, personnel, premises and equipment, documentation, collection, testing and processing, storage, distribution, quality control, blood component recall, and external and internal auditing, contract management, non-conformance and self-inspection.
Sistem kakovosti vključuje vodenje, zagotavljanje in nenehno izboljševanje kakovosti, osebje, prostore in opremo, dokumentacijo, zbiranje, preskušanje in predelavo, shranjevanje, razdeljevanje, nadzor kakovosti, odpoklic komponent krvi ter zunanje in notranje preverjanje, pogodbeno delo, nadzor nad neskladnostmi in notranji nadzor.
The quality system shall ensure that all critical processes are specified in appropriate instructions and are carried out in accordance with the standards and specifications set out in this Annex.
S sistemom kakovosti mora biti zagotovljeno, da so vsi kritični postopki v ustreznih navodilih podrobno opredeljeni in izvedeni v skladu s standardi in specifikacijami, določenimi v tej prilogi.
Management shall review the system at regular intervals to verify its effectiveness and introduce corrective measures if deemed necessary.
Vodstvo redno pregleduje sistem, preverja njegovo učinkovitost in po potrebi uvede korektivne ukrepe.
Quality assurance
Zagotavljanje kakovosti
All blood establishments and hospital blood banks shall be supported by a quality assurance function, whether internal or related, in fulfilling quality assurance.
Vsem transfuzijskim ustanovam in transfuzijskim bankam v bolnišnicah je pri izpolnjevanju zahtev zagotavljanja kakovosti v podporo služba zagotavljanja kakovosti.
That function shall be involved in all quality-related matters and review and approve all appropriate quality related documents.
Ta služba je vključena v vse zadeve povezane s kakovostjo in pregleduje ter potrjuje vse ustrezne dokumente, povezane s kakovostjo.
All procedures, premises, and equipment that have an influence on the quality and safety of blood and blood components shall be validated prior to introduction and be re-validated at regular intervals determined as a result of these activities.
Vsi postopki, prostori in oprema, ki lahko vplivajo na kakovost in varnost krvi in komponent krvi, se pred uvedbo validirajo, v rednih časovnih intervalih, določenih na podlagi rezultatov teh dejavnosti, pa morajo biti ponovno validirani.
PERSONNEL AND ORGANISATION
OSEBJE IN ORGANIZACIJA
Personnel in blood establishments shall be available in sufficient numbers to carry out the activities related to the collection, testing, processing, storage and distribution of blood and blood components and be trained and assessed to be competent to perform their tasks.
Osebje v transfuzijskih ustanovah mora biti dovolj številčno, da lahko izpelje dejavnosti, povezane z zbiranjem, testiranjem, predelavo, hranjenjem ter razdeljevanjem krvi in komponent krvi, biti mora usposobljeno za opravljanje svojih nalog in uspešno prestati ocenjevanje usposobljenosti.
All personnel in blood establishments shall have up to date job descriptions which clearly set out their tasks and responsibilities.
Vse osebje v transfuzijskih ustanovah mora imeti redno dopolnjevan opis del in nalog, ki jasno določa njihove naloge in odgovornosti.
Blood establishments shall assign the responsibility for processing management and quality assurance to different individuals and who function independently.
Transfuzijske ustanove za vodenje predelave in zagotavljanje kakovosti pooblastijo različne posameznike, ki delujejo neodvisno drug od drugega.
All personnel in blood establishments shall receive initial and continued training appropriate to their specific tasks.
Za vse osebje v transfuzijskih ustanovah mora biti zagotovljeno začetno in nadaljnje usposabljanje, ki ustreza njihovim posebnim nalogam.
Training records shall be maintained.
O usposabljanju se vodi evidenca.
Training programmes shall be in place and shall include good practice.
Izdela se program usposabljanja, ki vključuje dobro prakso.
The contents of training programmes shall be periodically assessed and the competence of personnel evaluated regularly.
Periodično se preverja vsebina programa usposabljanja in redno se ocenjuje usposobljenost osebja.
There shall be written safety and hygiene instructions in place adapted to the activities to be carried out and are in compliance with Council Directive 89/391/EEC [1] and Directive 2000/54/EC of the European Parliament and of the Council [2].
Glede na dejavnosti, ki se opravljajo na instituciji, se predpišejo pisna navodila glede varnosti in higiene, v skladu z Direktivo Sveta 89/391/EGS [1] in Direktivo Evropskega parlamenta in Sveta 2000/54/ES [2].
PREMISES
PROSTORI
Premises including mobile sites shall be adapted and maintained to suit the activities to be carried out.
Prostori, vključno z mobilnimi transfuzijskimi ekipami, morajo biti prilagojeni dejavnostim, ki se v njih izvajajo, in ustrezno vzdrževani.
They shall enable the work to proceed in a logical sequence so as to minimise the risk of errors, and shall allow for effective cleaning and maintenance in order to minimise the risk of contamination.
Omogočiti morajo logični potek dela, da se zmanjša nevarnost napak, ter učinkovito čiščenje in vzdrževanje, da se zmanjša nevarnost okužbe.
Blood donor area
Prostor za krvodajalce
There shall be an area for confidential personal interviews with and assessment of individuals to assess their eligibility to donate.
Na voljo mora biti prostor za zaupne pogovore s potencialnimi dajalci zaradi ocene njihove primernosti za dajanje krvi.
This area shall be separated from all processing areas.
Ta prostor mora biti ločen od prostorov, namenjenih predelavi.
Blood collection area
Prostor za zbiranje krvi
Blood collection shall be carried out in an area intended for the safe withdrawal of blood from donors, appropriately equipped for the initial treatment of donors experiencing adverse reactions or injuries from events associated with blood donation, and organised in such a way as to ensure the safety of both donors and personnel as well as to avoid errors in the collection procedure.
Zbiranje krvi se opravlja v prostorih, ki so namenjeni varnemu odvzemu krvi dajalcev, ki so ustrezno opremljeni, da je mogoče dajalcem nuditi začetno zdravljenje v primeru neželenih reakcij ali poškodb, nastalih v povezavi z odvzemom krvi, ki so urejeni tako, da je zagotovljena varnost dajalcev in osebja, ter da je omogočeno izogibanje napakam pri postopku zbiranja krvi.
Blood testing and processing areas
Prostori za testiranje in predelavo krvi
There shall be a dedicated laboratory area for testing that is separate from the blood donor and blood component processing area with access restricted to authorised personnel.
Vzpostavi se namenski laboratorij za testiranje, ki je ločen od prostorov za odvzem krvi in predelave komponent krvi, vanj pa ima dostop samo pooblaščeno osebje.
Storage area
Skladiščni prostor
Storage areas shall provide for properly secure and segregated storage of different categories of blood and blood components and materials including quarantine and released materials and units of blood or blood components collected under special criteria (e.g. autologous donation).
Skladiščni prostori so namenjeni ustrezno varnemu in ločenemu shranjevanju različnih vrst krvi in komponent krvi ter materialov, vključno z materiali v karanteni in sproščenimi materiali ter enotami krvi ali komponentami krvi, zbranimi na podlagi posebnih meril (npr. pri avtolognem odvzemu).
Provisions shall be in place in the event of equipment or power failure in the main storage facility.
Predvidijo se ukrepi za primer napake v opremi ali prekinitve napajanja v glavnem skladiščnem prostoru.
Waste disposal area
Prostor za odstranjevanje odpadkov
An area shall be designated for the safe disposal of waste, disposable items used during the collection, testing, and processing and for rejected blood or blood components.
Določi se mesto za varno odstranjevanje odpadkov, predmetov za enkratno uporabo, uporabljenih pri zbiranju, testiranju in predelavi pridobljene krvi, in za zavrnjeno kri ali komponente krvi.
EQUIPMENT AND MATERIALS
OPREMA IN MATERIALI
All equipment shall be validated, calibrated and maintained to suit its intended purpose.
Vsa oprema mora biti validirana, umerjena in vzdrževana ustrezno njenemu predvidenemu namenu.
Operating instructions shall be available and appropriate records kept.
Na voljo morajo biti navodila za uporabo in vodijo se ustrezni zapisi.
Equipment shall be selected to minimise any hazard to donors, personnel, or blood components.
Izbrati je treba takšno opremo, pri kateri bo ogroženost dajalcev, osebja ali komponent krvi čim manjša.
Only reagents and materials from approved suppliers that meet the documented requirements and specifications shall be used.
Uporabljajo se lahko zgolj reagenti in materiali pooblaščenih dobaviteljev, ki izpolnjujejo zapisane zahteve in specifikacije.
Critical materials shall be released by a person qualified to perform this task.
Kritične materiale lahko sprosti samo oseba, ki je usposobljena za opravljanje teh nalog.
Where relevant, materials, reagents and equipment shall meet the requirements of Council Directive 93/42/EEC [3] for medical devices and Directive 98/79/EC of the European Parliament and of the Council [4] for in vitro diagnostic medical devices or comply with equivalent standards in the case of collection in third countries.
Kadar je to ustrezno, morajo materiali, reagenti in oprema izpolnjevati zahteve iz Direktive Sveta 93/42/EGS [3] o medicinskih pripomočkih in Direktive 98/79/ES Evropskega parlamenta in Sveta [4] o in vitro diagnostičnih medicinskih pripomočkih ali izpolnjevati enake standarde v primeru zbiranja v tretjih državah.
Inventory records shall be retained for a period acceptable to and agreed with the competent authority.
O zalogah se hranijo zapisi, in sicer za obdobje, katerega dolžina je dogovorjena s pristojnim organom in mora biti zanj sprejemljiva.
When computerised systems are used, software, hardware and back-up procedures must be checked regularly to ensure reliability, be validated before use, and be maintained in a validated state.
V primeru uporabe računalniškega sistema je treba redno izvajati kontrolo programske in strojne opreme ter postopkov varnostnega kopiranja in zagotoviti njihovo zanesljivost, jih pred uporabo validirati in vzdrževati v validiranem stanju.
Hardware and software shall be protected against unauthorised use or unauthorised changes.
Strojna in programska oprema morata biti zaščiteni pred nepooblaščeno uporabo ali nepooblaščenimi posegi.
The back-up procedure shall prevent loss of or damage to data at expected and unexpected down times or function failures.
Uporabi se postopek varnostnega kopiranja, da se prepreči izguba ali poškodba podatkov ob predvidenih ali nepredvidenih izpadih sistema ali motnjah pri delovanju.
DOCUMENTATION
Dokumentacija
Documents setting out specifications, procedures and records covering each activity performed by the blood establishment shall be in place and kept up to date.
Vzpostavi se dokumentacija o specifikacijah, postopkih in zapisih o vseh dejavnostih transfuzijske ustanove, ki se sproti dopolnjuje.
Records shall be legible and may be handwritten, transferred to another medium such as microfilm or documented in a computerised system.
Zapisi morajo biti čitljivi, lahko so zapisani ročno, preneseni na drug podatkovni nosilec, npr. na mikrofilm, ali shranjeni v računalniški sistem.
All significant changes to documents shall be acted upon promptly and shall be reviewed, dated and signed by a person authorised to perform this task.
Vsaka pomembna sprememba dokumentov mora biti nemudoma upoštevana, za to pooblaščena oseba pa jo mora pregledati, datirati in podpisati.
BLOOD COLLECTION, TESTING AND PROCESSING
ZBIRANJE KRVI, TESTIRANJE IN PREDELAVA
Donor eligibility
Primernost dajalcev
Procedures for safe donor identification, suitability interview and eligibility assessment shall be implemented and maintained.
Izvajajo in vzdržujejo se postopki varne identifikacije dajalcev, pogovori glede njihove primernosti in ocenjevanje njihove primernosti.
They shall take place before each donation and comply with the requirements set out in Annex II and Annex III to Directive 2004/33/EC.
Opravljeni morajo biti pred vsakim odvzemom krvi in morajo biti v skladu z zahtevami iz Priloge II in Priloge III k Direktivi 2004/33/ES.
The donor interview shall be conducted in such a way as to ensure confidentiality.
Pogovor z dajalcem mora biti izpeljan na način, ki zagotavlja zaupnost.
The donor suitability records and final assessment shall be signed by a qualified health professional.
Zapis o primernosti dajalca in zaključno oceno podpiše usposobljeni zdravstveni delavec.
Collection of blood and blood components
Zbiranje krvi in komponent krvi
The blood collection procedure shall be designed to ensure that the identity of the donor is verified and securely recorded and that the link between the donor and the blood, blood components and blood samples is clearly established.
Postopek zbiranja krvi mora biti takšen, da je zagotovljeno preverjanje identitete dajalca in se identiteta varno zabeleži, tako da je nedvoumno mogoče povezati dajalca in kri, komponente krvi ter vzorce krvi.
The sterile blood bag systems used for the collection of blood and blood components and their processing shall be CE-marked or comply with equivalent standards if the blood and blood components are collected in third countries.
Sistem sterilnih vrečk za kri, ki se uporabljajo za zbiranje krvi in komponent krvi ter njeno predelavo, morajo imeti oznako CE ali ustrezati enakim standardom, če se kri in komponente krvi zbirajo v tretjih državah.
The batch number of the blood bag shall be traceable for each blood component.
Na podlagi serijske številke vrečke za kri mora biti zagotovljena sledljivost za vsako komponento krvi.
Blood collection procedures shall minimise the risk of microbial contamination.
Postopki zbiranja krvi morajo čim bolj zmanjšati tveganje okužbe z mikrobi.
Laboratory samples shall be taken at the time of donation and appropriately stored prior to testing.
Laboratorijski vzorci se vzamejo ob odvzemu krvi in se pred testiranjem ustrezno shranijo.
The procedure used for the labelling of records, blood bags and laboratory samples with donation numbers shall be designed to avoid any risk of identification error and mix-up.
Postopek označevanja dokumentacije, vrečk za zbiranje krvi in laboratorijskih vzorcev s številkami odvzemov mora biti načrtovan tako, da se bo mogoče izogniti vsaki nevarnosti napake pri identifikaciji in zamenjavi.
After blood collection, the blood bags shall be handled in a way that maintains the quality of the blood and at a storage and transport temperature appropriate to further processing requirements.
Po opravljenem zbiranju krvi se z vrečkami za kri ravna na način, ki ohranja kakovost krvi in pri temperaturi shranjevanja in prevoza, ki ustreza zahtevam za nadaljnjo predelavo.
There shall be a system in place to ensure that each donation can be linked to the collection and processing system into which it was collected and/or processed.
Vzpostavi se sistem, ki bo zagotavljal, da je vsak odvzem mogoče povezati s sistemom zbiranja in predelave, v katerem je bila kri zbrana in/ali predelana.
Laboratory testing
Laboratorijsko testiranje
All laboratory testing procedures shall be validated before use.
Vsi postopki laboratorijskega testiranja morajo biti pred uporabo validirani.
Each donation shall be tested in conformity with the requirements laid down in Annex IV to Directive 2002/98/EC.
Vsaka odvzeta enota krvi se testira v skladu z zahtevami iz Priloge IV k Direktivi 2002/98/ES.