natgillin/translations-raw huggingface dataset:
Beskyttelse mod risici i forbindelse med medicinsk udstyr, der af fabrikanten er bestemt til at kunne anvendes af lægmand
Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.
Udstyr bestemt til at kunne anvendes af lægmand skal designes og fremstilles på en sådan måde, at det har en passende ydeevne i forhold til sit erklærede formål og under hensyntagen til de færdigheder og midler, en lægmand har, og til de påvirkninger, der skyldes den variation, som med rimelighed kan forventes i en lægmands teknik og omgivelser.
Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose whilst minimising radiation exposure of the patient and user.
Fabrikantens oplysninger og instruktioner skal være lette at forstå og anvende for en lægmand.
Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and, where appropriate, the quality of radiation.
Udstyr bestemt til at kunne anvendes af lægmand skal designes og fremstilles på en sådan måde, at
Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
det om nødvendigt efter passende uddannelse og/eller oplysninger kan anvendes sikkert og korrekt i alle håndteringsfaser af den tilsigtede bruger
Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use.
risikoen for utilsigtede snit og prik, såsom kanylestikskader, begrænses så meget som muligt og i det omfang, det er relevant, og
In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance.
risikoen for, at den tilsigtede bruger begår fejl i forbindelse med håndtering af udstyret og eventuel fortolkning af resultatet, mindskes mest muligt.
For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.
Udstyr bestemt til at kunne anvendes af lægmand skal, hvor det er hensigtsmæssigt, omfatte en metode, hvorved den pågældende lægmand
Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).
kan verificere, at udstyret på det tidspunkt, hvor det bruges, har den tilsigtede ydeevne, og
Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
hvis det er relevant, advares, hvis der ikke er opnået et gyldigt resultat med udstyret.
Active devices and devices connected to them
KRAV TIL DE OPLYSNINGER, DER GIVES SAMMEN MED UDSTYRET
For non-implantable active devices, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
Mærkning og brugsanvisning
Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical.
Generelle krav til fabrikantens oplysninger
If necessary, such warning or indication shall be given prior to the power supply becoming critical.
Hvert udstyr skal ledsages af de oplysninger, der er nødvendige for at identificere udstyret og dets fabrikant, og af alle oplysninger vedrørende sikkerhed og ydeevne, der er relevante for brugere eller eventuelt andre personer.
Devices where the safety of the patient depends on an external power supply shall include an alarm system to signal any power failure.
Disse oplysninger kan fremgå af selve udstyret, af emballagen eller af brugsanvisningen og skal, hvis fabrikanten har et websted, gøres tilgængelige og opdateres på webstedet, idet der tages hensyn til følgende:
Devices intended to monitor one or more clinical parameters of a patient shall be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.
Mediet, formatet, indholdet, læsbarheden og placeringen af mærkningen og brugsanvisningen skal være afpasset efter det pågældende udstyr, dets erklærede formål og den eller de tilsigtede brugeres teknologiske viden, erfaring og uddannelse.
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.
Navnlig brugsanvisningen skal affattes på en måde, som let forstås af den tilsigtede bruger, og den skal eventuelt suppleres med tegninger og diagrammer.
Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended.
De oplysninger, som mærkningen skal indeholde, skal findes på selve udstyret.
Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.
Hvis dette ikke er praktisk muligt eller hensigtsmæssigt, kan nogle eller alle oplysningerne anføres på emballagen til hver enhed og/eller på emballagen til flere udstyr.
Devices shall be designed and manufactured in such a way as to protect, as far as possible, against unauthorised access that could hamper the device from functioning as intended.
Mærkningen skal være i et menneskeligt læsbart format og kan suppleres med maskinlæsbare oplysninger såsom radiofrekvensidentifikation (RFID) eller stregkoder.
Particular requirements for active implantable devices
Udstyr skal leveres med en brugsanvisning.
Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:
Undtagelsesvis kræves der ingen brugsanvisning for udstyr i klasse I og klasse IIa, hvis sådant udstyr kan bruges sikkert uden en brugsanvisning, og medmindre andet er fastsat i andetsteds under dette punkt.
risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
Hvor flere udstyr leveres til en enkelt bruger og/eller et enkelt sted, kan der udleveres et eksemplar af brugsanvisningen, hvis dette er aftalt med køber, der under alle omstændigheder kan anmode om at få udleveret yderligere eksemplarer uden vederlag.
risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and
Brugsanvisningen kan udleveres til brugeren i ikkepapirformat (f.eks. elektronisk) i det omfang og kun på de betingelser, der er fastsat i forordning (EU) nr. 207/2012 eller i alle efterfølgende gennemførelsesbestemmelser, som er vedtaget i henhold til nærværende forordning.
risks which may arise where maintenance and calibration are impossible, including:
Oplysninger om tilbageværende risici, som skal meddeles brugeren og/eller anden person, medtages som begrænsninger, kontraindikationer, forholdsregler eller advarsler i fabrikantens oplysninger.
excessive increase of leakage currents,
Hvis det er hensigtsmæssigt, skal fabrikantens oplysninger anføres ved hjælp af internationalt anerkendte symboler.
ageing of the materials used,
Alle symboler eller identifikationsfarver skal være i overensstemmelse med de harmoniserede standarder eller fælles specifikationer.
excess heat generated by the device,
Hvis der ikke findes nogen harmoniserede standarder eller fælles specifikationer på det pågældende område, skal symboler og farver være beskrevet i den dokumentation, som ledsager udstyret.
decreased accuracy of any measuring or control mechanism.
Oplysninger på mærkningen
Active implantable devices shall be designed and manufactured in such a way as to ensure
Mærkningen skal indeholde alle de følgende oplysninger:
if applicable, the compatibility of the devices with the substances they are intended to administer, and
udstyrets navn eller handelsnavn
the reliability of the source of energy.
de angivelser, som er absolut nødvendige for, at brugeren kan identificere udstyret og emballagens indhold, og, hvor det ikke er indlysende for brugeren, udstyrets erklærede formål
Active implantable devices and, if appropriate, their component parts shall be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.
fabrikantens navn, registrerede firmanavn eller registrerede varemærke og adressen på det registrerede forretningssted
Active implantable devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.
den autoriserede repræsentants navn og adresse på den autoriserede repræsentants registrerede forretningssted, hvis fabrikanten har sit registrerede forretningssted uden for Unionen
Protection against mechanical and thermal risks
hvis det er relevant, en angivelse af, at udstyret indeholder eller inkorporerer
Devices shall be designed and manufactured in such a way as to protect patients and users against mechanical risks connected with, for example, resistance to movement, instability and moving parts.
et lægemiddel, herunder et humant blod- eller plasmaderivat, eller
Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.
væv eller celler af human oprindelse eller derivater heraf, eller
Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
væv eller celler af animalsk oprindelse eller derivater heraf, som omhandlet i forordning (EU) nr. 722/2012
Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks.
hvis det er relevant, oplysninger mærket i overensstemmelse med punkt 10.4.5.
Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.
ordene »LOTNUMMER« eller »SERIENUMMER« eller et tilsvarende symbol efterfulgt af udstyrets lotnummer eller serienummer
The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.
UDI-bæreren, jf. artikel 27, stk. 4, og bilag VII, del C
Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.
en entydig angivelse af fristen for sikker anvendelse eller implantation af udstyret, angivet med mindst år og måned, hvor det er relevant
Protection against the risks posed to the patient or user by devices supplying energy or substances
fremstillingsdatoen, hvis der ikke er nogen angivelse af den dato, frem til hvilken det er sikkert at anvende udstyret.
Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user.
Denne fremstillingsdato kan indgå i lotnummeret eller serienummeret, hvis datoen et let at identificere
Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of energy delivered or substances delivered which could pose a danger.
angivelse af særlige betingelser vedrørende opbevaring og/eller håndtering
Devices shall incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source.
hvis udstyret leveres i steril tilstand, en angivelse af dets sterile tilstand og steriliseringsmetoden
The function of the controls and indicators shall be clearly specified on the devices.
advarsler eller forholdsregler, som det er nødvendigt omgående at meddele brugeren af udstyret og andre personer.
Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.
Disse oplysninger kan under hensyntagen til de tilsigtede brugere holdes på et minimum, og i så fald anføres mere detaljerede oplysninger i brugsanvisningen
Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
hvis udstyret er beregnet til engangsbrug, en angivelse af dette.
Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person's technique and environment.
En fabrikants angivelse af engangsbrug skal være konsekvent i hele Unionen
The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.
hvis udstyret er engangsudstyr, der er blevet oparbejdet, en angivelse af dette, samt af hvor mange oparbejdningscyklusser der allerede er udført, og eventuelle begrænsninger med hensyn til antallet af oparbejdningscyklusser
Devices for use by lay persons shall be designed and manufactured in such a way as to:
hvis udstyret er efter mål, påtegningen »udstyr efter mål«
ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information,
angivelse af, at udstyret er medicinsk udstyr.
reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and
Hvis udstyret udelukkende er bestemt til klinisk afprøvning, påtegningen »udelukkende til klinisk afprøvning«
reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.
for så vidt angår udstyr, der består af stoffer eller af en kombination af stoffer, der er bestemt til at blive indgivet i det menneskelige legeme via en legemsåbning eller påført huden, og som absorberes af eller fordeles lokalt i det menneskelige legeme, den overordnede kvalitative sammensætning af udstyret og kvantitative oplysninger om den eller de vigtigste bestanddele, der skal sikre opnåelsen af den tilsigtede hovedvirkning
Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
for aktivt, implantabelt udstyr, serienummeret og, for andet implantabelt udstyr, serienummeret eller lotnummeret.
can verify that, at the time of use, the device will perform as intended by the manufacturer, and
Oplysninger på den emballage, der opretholder udstyrets sterile tilstand (»steril emballage«)
if applicable, is warned if the device has failed to provide a valid result.
Følgende oplysninger skal anføres på den sterile emballage:
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
oplysninger, der gør det muligt at genkende den sterile emballage som sådan
Label and instructions for use
en erklæring om, at udstyret er i steril tilstand
General requirements regarding the information supplied by the manufacturer
steriliseringsmetoden
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate.
fabrikantens navn og adresse
Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:
en beskrivelse af udstyret
The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s).
hvis udstyret er bestemt til klinisk afprøvning, påtegningen: »udelukkende til klinisk afprøvning«
In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
hvis udstyret er efter mål, påtegningen »udstyr efter mål«
The information required on the label shall be provided on the device itself.
fremstillingsmåned og -år
If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
en entydig angivelse af fristen for sikker anvendelse eller implantation af udstyret, angivet med mindst år og måned, og
Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.
en anvisning om at se i brugsanvisningen, hvad man skal gøre, hvis den sterile emballage er beskadiget eller utilsigtet er blevet åbnet inden brug.
Instructions for use shall be provided together with devices.
Oplysninger i brugsanvisningen
By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.
Brugsanvisningen skal indeholde alle de følgende oplysninger:
Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
de angivelser, der er omhandlet i punkt 23.2, litra a), c), e), f), k), l), n) og r)
Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
udstyrets erklærede formål med en klar specifikation af indikationer, kontraindikationer, patientmålgruppe eller -grupper og tilsigtede brugere, alt efter omstændighederne
Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
hvis det er relevant, en specifikation af de kliniske fordele, der kan forventes
Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols.
hvis det er relevant, links til sammenfatningen af sikkerhed og klinisk ydeevne, jf. artikel 32
Any symbol or identification colour used shall conform to the harmonised standards or CS.
udstyrets ydeevnekarakteristika
In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
hvis det er relevant, oplysninger, der gør det muligt for sundhedspersoner at verificere, om udstyret er egnet, og vælge det tilhørende software og tilbehør
Information on the label
eventuelle tilbageværende risici, kontraindikationer og alle uønskede bivirkninger, herunder oplysninger til patienterne herom
The label shall bear all of the following particulars:
de specifikationer, der er nødvendige for, at brugeren kan anvende udstyret korrekt, f.eks. hvis udstyret har en målefunktion, den opgivne grad af nøjagtighed
the name or trade name of the device;
oplysninger om eventuel forberedende behandling eller håndtering af udstyret, inden udstyret er klar til anvendelse eller under dets brug, f.eks. sterilisering, endelig samling, kalibrering mv., herunder de desinficeringsniveauer, der kræves for at sikre patientsikkerheden, og alle de tilgængelige metoder til opfyldelse af disse desinficeringsniveauer
the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
eventuelle krav om særlige faciliteter eller særlig uddannelse eller særlige kvalifikationer til brugeren af udstyret og/eller andre personer
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
de oplysninger, der er nødvendige for at verificere, om udstyret er installeret korrekt og er klar til at fungere sikkert og som tiltænkt af fabrikanten, samt, hvis det er relevant:
if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;
oplysninger om arten og hyppigheden af forebyggende og regelmæssig vedligeholdelse, og eventuel forberedende rengøring eller desinficering
where applicable, an indication that the device contains or incorporates:
identifikation af alle forbrugskomponenter, og oplysninger om, hvordan de udskiftes
a medicinal substance, including a human blood or plasma derivative, or
oplysninger om nødvendig kalibrering for at sikre, at udstyret fungerer korrekt og sikkert i hele sin forventede levetid, og
tissues or cells, or their derivatives, of human origin, or
metoder til eliminering af de risici, som personer, der beskæftiger sig med installering, kalibrering eller vedligeholdelse af udstyr, er udsat for
tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
hvis udstyret leveres i steril tilstand, anvisninger, i tilfælde af brud på eller utilsigtet åbning af den sterile emballage inden brug
where applicable, information labelled in accordance with Section 10.4.5.;
hvis udstyret leveres i ikkesteril tilstand i den hensigt, at det skal steriliseres inden brugen, passende instruktioner vedrørende sterilisering
the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;