natgillin/translations-raw huggingface dataset:
warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device or to any other person.
informacije o katerih koli znanih omejitvah za kombinacije pripomočkov in opreme;
This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;
navedbo o morebitnih posebnih pogojih skladiščenja (npr. temperatura, svetloba, vlaga itd.) in/ali ravnanja, ki se uporabljajo;
if the device is intended for single use, an indication of that fact.
Te informacije zajemajo, kadar je to ustrezno:
A manufacturer's indication of single use shall be consistent across the Union;
vsa opozorila in/ali previdnostne ukrepe v zvezi s potencialno kužnim materialom, ki je vključen v pripomoček;
As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging; (u) the label for devices for self-testing shall bear the following particulars:
kjer je relevantno, značilnosti klinične učinkovitosti, kot so mejna vrednost, diagnostična občutljivost in diagnostična specifičnost ter pozitivna in negativna napovedna vrednost;
the type of specimen(s) required to perform the test (e.g. blood, urine or saliva); (ii) the need for additional materials for the test to function properly;
(aa) kjer je relevantno, referenčne intervale pri normalni in prizadeti populaciji;
Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’): The following particulars shall appear on the sterile packaging:
Te informacije zajemajo, kadar je to ustrezno:
an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
(ad) ime, registrirano trgovsko ime ali registrirano blagovno znamko proizvajalca in naslov njegovega registriranega kraja poslovanja, na katerem je dosegljiv in ki je naslov njegove dejanske lokacije, skupaj s telefonsko številko in/ali številko telefaksa in/ali naslovom spletnega mesta za tehnično pomoč;
20.4.
(ae) datum izdaje navodil za uporabo, ali, če so bila popravljena, datum izdaje in identifikator zadnjega popravka navodil za uporabo z jasno navedbo uvedenih sprememb;
Information in the instructions for use
(af) obvestilo za uporabnika, da se o vsakem resnem zapletu, do katerega je prišlo v zvezi s pripomočkom, obvesti proizvajalec in pristojni organ države članice, v kateri ima uporabnik in/ali pacient stalno prebivališče;
The instructions for use shall contain all of the following particulars:
(ag) kadar kompleti pripomočkov vključujejo posamezne reagente in izdelke, ki so lahko na voljo kot ločeni pripomočki, je vsak tak pripomoček skladen z zahtevami glede navodil za uporabo iz tega oddelka in zahtevami iz te uredbe.
the name or trade name of the device; (b) the details strictly necessary for the user to uniquely identify the device;
(ah) za pripomočke z vgrajenimi elektronskimi sistemi, ki jih je mogoče programirati, vključno s programsko opremo, ali programsko opremo, ki je sama pripomoček, minimalne zahteve glede strojne opreme, značilnosti omrežij IT in varnostnih ukrepov v zvezi z IT, vključno z zaščito pred nepooblaščenim dostopom, ki morajo biti izpolnjene, da bi programska oprema delovala tako, kot je predvideno.
the device's intended purpose: (i) what is detected and/or measured;
Navodila za uporabo za pripomočke, predvidene za samotestiranje, so skladna tudi z vsemi naslednjimi načeli:
its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic);
navedejo se podrobnosti o testnem postopku, vključno s pripravo reagenta, odvzemom in/ali pripravo vzorcev in informacijami o tem, kako izvesti test in razlagati rezultate;
the specific information that is intended to be provided in the context of:
določene podrobnosti se lahko izpustijo pod pogojem, da druge informacije, ki jih je priskrbel proizvajalec, zadoščajo, da lahko uporabnik pripomoček uporabi in razume rezultat(e) pripomočka;
a physiological or pathological state;
predvideni namen pripomočka zagotavlja zadostne informacije, na podlagi katerih lahko uporabnik razume medicinski kontekst, predvideni uporabnik pa lahko pravilno razlaga rezultate;
congenital physical or mental impairments;
rezultati se izrazijo in predstavijo tako, da jih lahko predvideni uporabnik brez težav razume;
the predisposition to a medical condition or a disease; the determination of the safety and compatibility with potential recipients;
informacije se zagotovijo z nasvetom uporabniku glede ukrepov, ki se sprejmejo (v primeru pozitivnega, negativnega ali nedoločenega rezultata), omejitev testa in možnosti lažno pozitivnega in lažno negativnega rezultata.
the prediction of treatment response or reactions; the definition or monitoring of therapeutic measures;
Navedejo se tudi informacije o vseh dejavnikih, ki lahko vplivajo na rezultat testa, npr. starost, spol, menstruacija, okužba, telovadba, teščost, dieta ali zdravila;
whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative;
zagotovljene informacije vključujejo izjavo, v kateri je jasno navedeno, da uporabnik ne bi smel sprejeti nobene pomembne zdravstvene odločitve, ne da bi se prej posvetoval z ustreznim zdravstvenim delavcem, informacije o učinkih in razširjenosti bolezni ter, kadar so na voljo, informacije, specifične za države članice, v katerih je pripomoček dan na trg, ali lahko uporabnik pridobi dodatne nasvete, npr. nacionalne telefonske številke za pomoč uporabnikom, spletna mesta;
the type of specimen(s) required; (vii) where applicable, the testing population; and
za pripomočke za samotestiranje, ki se uporabljajo za spremljanje predhodno diagnosticirane obstoječe bolezni ali stanja, se v informacijah navede, naj pacient prilagodi zdravljenje le, če je bil za to ustrezno usposobljen.
for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test.
Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi, o spremembi in razveljavitvi direktiv 67/548/EGS in 1999/45/ES ter spremembi Uredbe (ES) št. 1907/2006 (UL L 353, 31.12.2008, str.
an indication that the device is an in vitro diagnostic medical device, or, if the device is a ‘device for performance study’, an indication of that fact;
1).
the intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare professionals); (f) the test principle;
Uredba (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) (UL L 136, 29.5.2007, str.
a description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only); (h) a description of the reagents and any limitation upon their use (e.g. suitable for a dedicated instrument only) and the composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement;
3).
a list of materials provided and a list of special materials required but not provided; (j) for devices intended for use in combination with or installed with or connected to other devices and/or general purpose equipment:
Direktiva Sveta 80/181/EGS z dne 20. decembra 1979 o približevanju zakonodaje držav članic, ki se nanašajo na merske enote, in o razveljavitvi direktive 71/352/EGS (UL L 39, 15.2.1980, str.
information to identify such devices or equipment, in order to obtain a validated and safe combination, including key performance characteristics, and/or
40).
information on any known restrictions to combinations of devices and equipment.
PRILOGA II
an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions which apply;
TEHNIČNA DOKUMENTACIJA
in-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant; (m) if the device is supplied as sterile, an indication of its sterile state, the sterilisation method and instructions in the event of the sterile packaging being damaged before use;
Proizvajalec sestavi jasno, dobro strukturirano in nedvoumno dokumentacijo, po potrebi pa tudi njen povzetek, v obliki, ki omogoča enostavno iskanje, ter pri tem navede zlasti elemente, naštete v tej prilogi.
information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device.
OPIS IN SPECIFIKACIJA PRIPOMOČKA, VKLJUČNO Z RAZLIČICAMI IN DODATKI
That information shall cover, where appropriate:
Opis in specifikacija pripomočka
warnings, precautions and/or measures to be taken in the event of malfunction of the device or its degradation as suggested by changes in its appearance that may affect performance, (ii) warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature,
ime izdelka ali trgovsko ime in splošen opis pripomočka, vključno z njegovim predvidenim namenom in predvidenimi uporabniki;
warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment, (iv) precautions related to materials incorporated into the device that contain or consist of CMR substances, or endocrine disrupting substances or that could result in sensitisation or an allergic reaction by the patient or user,
osnovni UDI-DI iz dela C Priloge VI, ki ga zadevnemu pripomočku dodeli proizvajalec, takoj ko se za identifikacijo tega pripomočka začne uporabljati sistem UDI, ali druga jasna identifikacija s kodo izdelka, kataloško številko ali drugo nedvoumno referenco, ki omogoča sledljivost;
if the device is intended for single use, an indication of that fact.
predvideni namen pripomočka, ki lahko vključuje naslednje informacije:
A manufacturer's indication of single use shall be consistent across the Union,
kaj naj bi se odkrilo in/ali merilo;
if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterilisation.
funkcijo pripomočka, npr. presejanje, spremljanje, diagnosticiranje ali pomoč pri diagnosticiranju, prognozi, predvidevanju, dopolnilni diagnostiki;
Information shall be provided to identify when the device should no longer be reused, such as signs of material degradation or the maximum number of allowable reuses;
posebna obolenja, stanja ali bistvene dejavnike tveganja, katerih namen je odkrivanje, opredeljevanje ali razlikovanje;
any warnings and/or precautions related to potentially infectious material that is included in the device;
ali je samodejen ali ne;
where relevant, requirements for special facilities, such as a clean room environment, or special training, such as on radiation safety, or particular qualifications of the intended user;
ali je kvalitativen, semikvantitativen ali kvantitativen;
conditions for collection, handling, and preparation of the specimen; (r) details of any preparatory treatment or handling of the device before it is ready for use, such as sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer;
vrsto zahtevanih vzorcev;
the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant: details of the nature, and frequency, of preventive and regular maintenance, including cleaning and disinfection;
po potrebi testno populacijo;
identification of any consumable components and how to replace them;
predvidenega uporabnika;
information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime; methods for mitigating the risks encountered by persons involved in installing, calibrating or servicing devices.
poleg tega za dopolnilno diagnostiko, ustrezno ciljno populacijo in pripadajoča zdravila;
where applicable, recommendations for quality control procedures; (u) the metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure;
opis načela testne metode ali načel delovanja instrumenta;
assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure; (w) analytical performance characteristics, such as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and measurement range, (information needed for the control of known relevant interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use of available reference measurement procedures and materials by the user;
utemeljitev za opredelitev izdelka kot pripomočka;
clinical performance characteristics as defined in Section 9.1 of this Annex;
razred tveganja pripomočka in utemeljitev pravila ali pravil, ki se uporabljajo za razvrščanje v skladu s Prilogo VIII;
the mathematical approach upon which the calculation of the analytical result is made;
opis sestavnih delov in po potrebi opis reaktivnih sestavin ustreznih sestavnih delov, kot so protitelesa, antigeni, začetni oligonukleotidi nukleinske kisline,
where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value;
ter, kadar je to ustrezno:
(aa) where relevant, reference intervals in normal and affected populations;
opis odvzema vzorca in transportnega materiala, zagotovljenega s pripomočkom, ali opisi specifikacij, priporočenih za uporabo;
(ab) information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of the device;
za instrumente za samodejne teste: opis ustreznih značilnosti testov ali namenskih testov;
(ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and the consumables used with it, if any.
za samodejne teste: opis ustreznih značilnosti instrumentov ali namenskih instrumentov;
This information shall cover, where appropriate:
opis morebitne programske opreme, ki se bo uporabljala s pripomočkom;
infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin;
opis ali popolni seznam različnih konfiguracij/različic pripomočka, ki naj bi bili dostopni na trgu;
environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation);
opis dodatkov za pripomoček, drugih pripomočkov in drugih izdelkov, ki niso pripomočki in so namenjeni uporabi v kombinaciji s pripomočkom.
physical hazards such as explosion.
Sklicevanje na prejšnje in podobne generacije pripomočka
(ad) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business at which he can be contacted and its location be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance;
Pregled predhodne generacije ali generacij pripomočka, ki ga izdeluje proizvajalec, če takšni pripomočki obstajajo;
(ae) date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use, with a clear indication of the introduced modifications;
pregled opredeljenih podobnih pripomočkov, ki so dostopni na trgu Unije ali mednarodnih trgih, če takšni pripomočki obstajajo.
(af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and/or the patient is established;
INFORMACIJE, KI JIH MORA PREDLOŽITI PROIZVAJALEC
(ag) where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the instructions for use requirements contained in this Section and with the requirements of this Regulation;
Celoten sklop
(ah) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
oznake ali oznak na pripomočku in njegovi embalaži, na primer embalaži ene same enote, prodajni embalaži, transportni embalaži v primeru posebnih pogojev upravljanja, in sicer v jezikih, sprejetih v državah članicah, v katerih naj bi se pripomoček prodajal; in
In addition, the instructions for use for devices intended for self-testing shall comply with all of the following principles:
navodil za uporabo v jezikih, sprejetih v državah članicah, v katerih naj bi se pripomoček prodajal.
details of the test procedure shall be given, including any reagent preparation, specimen collection and/or preparation and information on how to run the test and interpret the results;
INFORMACIJE O ZASNOVI IN IZDELAVI
specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
Informacije o zasnovi
the device's intended purpose shall provide sufficient information to enable the user to understand the medical context and to allow the intended user to make a correct interpretation of the results;
Informacije za razumevanje faz zasnove, ki se uporabljajo za pripomoček, vsebujejo:
the results shall be expressed and presented in a way that is readily understood by the intended user;
opis ključnih sestavin pripomočka, kot so protitelesa, antigeni, encimi in začetni oligonukleotidi nukleinske kisline, ki so zagotovljeni ali priporočeni za uporabo s pripomočkom;
information shall be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result.
za instrumente: opis glavnih podsistemov, analitične tehnologije, npr. načela delovanja, kontrolni mehanizmi, namenske računalniške strojne in programske opreme;
Information shall also be provided as to any factors that can affect the test result such as age, gender, menstruation, infection, exercise, fasting, diet or medication;
za instrumente in programsko opremo: pregled celotnega sistema;
the information provided shall include a statement clearly directing that the user should not take any decision of medical relevance without first consulting the appropriate healthcare professional, information on disease effects and prevalence, and, where available, information specific to the Member State(s) where the device is placed on the market on where a user can obtain further advice such as national helplines, websites;
za programsko opremo opis metodologije za razlago podatkov, tj. algoritem;
for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so.
za pripomočke za samotestiranje ali testiranje ob pacientu opis vidikov zasnove, zaradi katerih so ustrezni za samotestiranje ali testiranje ob pacientu.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.
Informacije v zvezi z izdelavo
1).
Informacije za razumevanje proizvodnih postopkov, kot so proizvodnja, sestavljanje, testiranje končnega izdelka in pakiranje končnega pripomočka.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 136, 29.5.2007, p.
Podrobnejše informacije se zagotovijo za presojo sistema vodenja kakovosti ali drugih veljavnih postopkov ugotavljanja skladnosti;
3).
opredelitev vseh lokacij, vključno z dobavitelji in podizvajalci, kjer se izvajajo dejavnosti izdelave.
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p.
Dokumentacija vsebuje informacije s prikazom skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I, ki se uporabljajo za pripomoček, ob upoštevanju njegovega predvidenega namena, ter vključujejo utemeljitev, potrditev in preverjanje rešitev, sprejetih za izpolnitev teh zahtev.
40).
Prikaz skladnosti zajema tudi:
ANNEX II
splošne zahteve glede varnosti in učinkovitosti, ki se uporabljajo za pripomočke, in razlago, zakaj se druge ne uporabljajo;
TECHNICAL DOCUMENTATION
metodo oziroma metode, ki se uporabljajo za dokazovanje skladnosti z vsako ustrezno splošno zahtevo glede varnosti in učinkovitosti;
The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.
veljavne harmonizirane standarde, uporabljene skupne specifikacije ali druge rešitve; in
DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
natančno opredelitev preverjenih dokumentov z dokazili o skladnosti z vsakim harmoniziranim standardom, uporabljeno skupno specifikacijo ali drugo metodo za dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti.
Device description and specification
Informacije iz te točke vključujejo sklicevanje na mesto navajanja teh dokazov v celotni tehnični dokumentaciji in po potrebi povzetku tehnične dokumentacije.
product or trade name and a general description of the device including its intended purpose and intended users;
ANALIZA RAZMERJA MED KORISTMI IN TVEGANJI TER OBVLADOVANJE TVEGANJ
the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;
Dokumentacija vsebuje naslednje informacije:
the intended purpose of the device which may include information on:
analizo razmerja med koristmi in tveganji iz oddelkov 1 in 8 Priloge I ter
what is to be detected and/or measured;
sprejete rešitve in rezultate obvladovanja tveganj iz oddelka 3 Priloge I.