natgillin/translations-raw huggingface dataset:
for automatiske test en beskrivelse af de relevante instrumenteringskarakteristika eller særlig instrumentering
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;
en beskrivelse af eventuel software, der skal anvendes med udstyret
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:
en beskrivelse af eller fuldstændig liste over de forskellige konfigurationer/varianter af udstyret, som er bestemt til at blive gjort tilgængelige på markedet
information to identify such devices or equipment, in order to obtain a validated and safe combination, including key performance characteristics, and/or
en beskrivelse af tilbehør til udstyr, andet udstyr og andre produkter, som ikke er udstyr, som er bestemt til at skulle anvendes sammen med udstyret.
information on any known restrictions to combinations of devices and equipment.
Henvisning til tidligere og tilsvarende generationer af udstyret
an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions which apply;
en oversigt over den eller de tidligere generationer af udstyret fremstillet af fabrikanten, hvis der findes sådant udstyr
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;
en oversigt over identificeret tilsvarende udstyr, der er tilgængeligt på EU-markedet eller internationale markeder, hvis der findes sådant udstyr.
information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device.
OPLYSNINGER, SOM FABRIKANTEN SKAL FREMLÆGGE
That information shall cover, where appropriate:
Et komplet sæt af
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,
mærkningen på udstyret og på emballagen hertil, f.eks. emballagen for hver enhed, salgsemballagen og transportemballagen i tilfælde af særlige forvaltningsforhold, på de sprog, der accepteres i de medlemsstater, hvor det er hensigten at sælge udstyret
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,
brugsanvisningen på de sprog, der accepteres i de medlemsstater, hvor det er hensigten at sælge udstyret.
if the device is intended for single use, an indication of that fact.
DESIGN- OG FREMSTILLINGSOPLYSNINGER
A manufacturer's indication of single use shall be consistent across the Union,
Designoplysninger
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.
Oplysninger, der gør det muligt at forstå de designfaser, som udstyret har gennemgået, skal omfatte:
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;
en beskrivelse af udstyrets kritiske ingredienser som f.eks. antistoffer, antigener, enzymer og primere for nukleinsyre, der leveres sammen med eller anbefales til anvendelse med udstyret
any warnings and/or precautions related to potentially infectious material that is included in the device;
for instrumenter en beskrivelse af større undersystemer, analytisk teknologi, f.eks. betjeningsprincipper og kontrolmekanismer, samt særlig computerhardware og -software
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;
for instrumenter og software en oversigt over hele systemet
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;
for software en beskrivelse af datafortolkningsmetoden, navnlig algoritmen
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;
for udstyr til selvtestning eller patientnær testning en beskrivelse af de designaspekter, der gør udstyret egnet til selvtestning eller patientnær testning.
identification of any consumable components and how to replace them;
Fremstillingsoplysninger
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.
oplysninger, der gør det muligt at forstå fremstillingsprocesserne, f.eks. produktion, samling, prøvning af slutproduktet og emballering af det færdige udstyr.
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;
Mere detaljerede oplysninger skal forelægges i forbindelse med audit af kvalitetsstyringssystemet eller andre gældende overensstemmelsesvurderingsprocedurer
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;
identifikation af alle faciliteter, herunder leverandører og underentreprenører, hvor der udføres fremstillingsaktiviteter.
clinical performance characteristics as defined in Section 9.1 of this Annex;
Dokumentationen skal indeholde oplysninger til påvisning af overensstemmelse med de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, og som gælder for udstyret, under hensyntagen til dets erklærede formål og skal indeholde en begrundelse, validering og verifikation af de løsninger, der er valgt til at opfylde disse krav.
the mathematical approach upon which the calculation of the analytical result is made;
Påvisningen af overensstemmelse skal også indeholde:
where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value;
de generelle krav til sikkerhed og ydeevne, der gælder for udstyret, og en redegørelse for, hvorfor andre krav ikke gælder
(aa) where relevant, reference intervals in normal and affected populations;
den eller de metoder, der er anvendt for at påvise overensstemmelse med hvert af de gældende generelle krav til sikkerhed og ydeevne
(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;
de harmoniserede standarder, fælles specifikationer eller andre løsninger, der er anvendt
(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.
den nøjagtige identitet af de kontrollerede dokumenter, der dokumenterer overensstemmelse med de enkelte harmoniserede standarder eller fælles specifikationer eller en anden anvendt metode til påvisning af overensstemmelse med de generelle krav til sikkerhed og ydeevne.
This information shall cover, where appropriate:
De i dette litra nævnte oplysninger skal indeholde en krydshenvisning til placeringen af denne dokumentation i den fuldstændige tekniske dokumentation og, hvis det er relevant, en sammenfatning af den tekniske dokumentation.
infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin;
ANALYSE AF FORHOLDET MELLEM FORDELE OG RISICI SAMT RISIKOSTYRING
environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation);
Dokumentationen skal indeholde oplysninger om:
physical hazards such as explosion.
analysen af forholdet mellem fordele og risici, jf. bilag I, punkt 1 og 8, og
(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;
de valgte løsninger og resultaterne af risikostyringen, jf. bilag I, punkt 3.
(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;
PRODUKTVERIFIKATION OG -VALIDERING
(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;
Dokumentationen skal omfatte resultaterne og kritiske analyser af alle verifikationer og valideringstest og/eller undersøgelser, der er foretaget for at påvise, at udstyret er i overensstemmelse med denne forordnings krav og navnlig de gældende generelle krav til sikkerhed og ydeevne.
(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;
Dette omfatter:
(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.
Oplysninger om udstyrets analytiske ydeevne
In addition, the instructions for use for devices intended for self-testing shall comply with all of the following principles:
Prøvetype
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;
Dette punkt skal beskrive de forskellige prøvetyper, som kan analyseres, herunder deres stabilitet, f.eks. opbevaring, eventuelt vilkår for transport af prøver og med henblik på tidskritiske analysemetoder oplysninger om, hvor lang tid der må gå mellem prøvens udtagning og analyse heraf, og opbevaringsvilkår, f.eks. varighed, temperaturgrænser og cykler for frysning og optøning.
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;
Karakteristika for analytisk ydeevne
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;
Målenøjagtighed
the results shall be expressed and presented in a way that is readily understood by the intended user;
Målekorrekthed
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.
Dette punkt skal indeholde oplysninger om korrektheden af måleproceduren og sammenfatte dataene tilstrækkelig detaljeret til, at der kan foretages en vurdering af de valgte midlers egnethed til at fastlægge korrektheden.
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;
Korrekthedsforanstaltninger finder kun anvendelse på kvantitative og kvalitative test, når der findes et certificeret referencemateriale eller en certificeret referencemetode.
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;
Målepræcision
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.
Repeterbarheds- og reproducerbarhedsundersøgelserne skal beskrives i dette punkt.
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.
Analytisk sensitivitet
1).
Dette punkt skal omfatte oplysninger om undersøgelsens design og resultater.
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.
Det skal indeholde en beskrivelse af prøvetypen og forberedelsen, herunder matrix, analytniveauer, og hvorledes niveauerne blev fastsat.
3).
Antallet af replikater, der er blevet testet ved hver enkelt koncentration skal også oplyses sammen med en beskrivelse af den beregning, der er anvendt til fastlæggelse af testfølsomhed.
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.
Analytisk specificitet
40).
I dette punkt beskrives de interferens- og krydsreaktionsundersøgelser, der foretages for at fastlægge den analytiske specificitet, når der optræder andre stoffer/agenser i prøven.
ANNEX II
Der skal forelægges oplysninger om evaluering af stoffer eller agenser, der potentielt medfører interferens og krydsreaktioner i testen, om den undersøgte stoftype eller agenstype og dens koncentration, prøvetype, analyttestkoncentration og resultater.
TECHNICAL DOCUMENTATION
Påvirkninger og stoffer eller agenser med krydsreaktioner, som varierer kraftigt alt afhængigt af testtype og -design, kan skyldes eksogene eller endogene kilder som f.eks.:
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.
stoffer, der anvendes til patientbehandling, f.eks. lægemidler
DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
stoffer indtaget af patienten, f.eks. alkohol og fødevarer
Device description and specification
stoffer, der er tilsat under prøveforberedelsen, f.eks. konserveringsmidler og stabilisatorer
product or trade name and a general description of the device including its intended purpose and intended users;
stoffer, der findes i specifikke prøvetyper, f.eks. hæmoglobin, fedtstoffer, bilirubin og proteiner
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;
analytter med tilsvarende struktur, f.eks. prækursorer og metabolitter, eller sygdomstilstande, der ikke er forbundet med den sygdom, der testes for, herunder prøver, der viser et negativt testresultat, men et positivt testresultat for en sygdom, der kan minde om den sygdom, der testes for.
the intended purpose of the device which may include information on:
Metrologisk sporbarhed af kalibratorer og kontrolmaterialeværdier
what is to be detected and/or measured;
Testens måleskala
its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic;
Dette punkt skal omfatte oplysninger om måleskalaen, uanset om målesystemerne er lineære eller ikkelineære, herunder detektionsgrænserne, og om, hvordan måleskalaen og detektionsgrænserne er fastlagt.
the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;
Disse oplysninger skal omfatte en beskrivelse af prøvetypen, antallet af prøver, antallet af replikater og prøveforberedelse, herunder oplysninger om matrixen, analytniveauer, og hvorledes niveauerne er fastsat.
whether it is automated or not;
Der skal, hvis det er relevant, tilføjes en beskrivelse af eventuelle hook-effekter ved høje doser og data vedrørende afbødende foranstaltninger, f.eks. fortynding.
whether it is qualitative, semi-quantitative or quantitative;
Definition af testafgrænsning
the type of specimen(s) required;
Dette punkt skal indeholde et resumé af de analytiske data med en beskrivelse af undersøgelsens design, herunder metoder til fastlæggelse af testafgrænsningen, f.eks.:
where applicable, the testing population;
undersøgt population: demografi, udvælgelse, inklusions- og eksklusionskriterier, antal omfattede personer
the intended user;
metode til karakterisering af prøver, og
in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s).
statistiske metoder, f.eks. ROC-kurve, til frembringelse af resultater og i givet fald definition af gråzone/tvetydighed.
the description of the principle of the assay method or the principles of operation of the instrument;
Rapporten om analytisk ydeevne, jf. bilag XIII
the rationale for the qualification of the product as a device;
Oplysninger om klinisk ydeevne og klinisk dokumentation.
the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;
Rapport om ydeevneevaluering
the description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers;
Dokumentationen skal omfatte rapporten om ydeevneevaluering, der omfatter rapporterne om den videnskabelige validitet og den analytiske og kliniske ydeevne, jf. bilag XIII, samt en vurdering af disse rapporter.
and where applicable:
Dokumenterne om undersøgelse af klinisk ydeevne, jf. bilag XIII, del A, punkt 2, skal vedlægges og/eller gengives i sin fulde ordlyd i den tekniske dokumentation.
the description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use;
Stabilitet (eksklusive prøvestabilitet)
for instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays;
Den angivne holdbarhed, stabilitet i brug og undersøgelser vedrørende stabilitet under forsendelse skal beskrives i dette punkt.
for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation;
Angivet holdbarhed
a description of any software to be used with the device;
I dette punkt skal der gives oplysninger om undersøgelser af stabilitetstestning til støtte for den holdbarhed, der er angivet for udstyret.
a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
Testningen skal udføres på mindst tre forskellige partier, der er fremstillet under betingelser, som i al væsentlighed svarer til de normale produktionsbetingelser.
a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device.
Der behøver ikke at være tale om tre partier fremstillet i fortløbende rækkefølge.
Reference to previous and similar generations of the device
Fremskyndede undersøgelser eller ekstrapolerede data fra realtidsdata accepteres for de første angivelser af holdbarhed, men skal følges op med stabilitetsundersøgelser i realtid.
an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;
Disse detaljerede oplysninger skal omfatte:
an overview of identified similar devices available on the Union or international markets, where such devices exist.
undersøgelsesrapporten, herunder plan, antal partier, acceptkriterier og testintervaller
INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
hvis der er foretaget fremskyndede undersøgelser forud for undersøgelser i realtid, skal den metode, der er anvendt ved de fremskyndede undersøgelser, være beskrevet
A complete set of
konklusioner og angivet holdbarhed.
the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in the case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold;
Stabilitet i brug
the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.
Dette punkt skal indeholde oplysninger om undersøgelser af stabiliteten i brug for et parti, der afspejler den almindelige brug af udstyret, uanset om den er virkelig eller simuleret.
DESIGN AND MANUFACTURING INFORMATION
Dette kan omfatte stabilitet i åben beholder og/eller »on board stability« for automatiske instrumenter.
Design information
I tilfælde af automatisk instrumentering, hvor der er påstand om kalibreringsstabilitet, skal der forelægges baggrundsdata.
Information to allow the design stages applied to the device to be understood shall include: