natgillin/translations-raw huggingface dataset:
the risk of incorrect identification of specimens and the risk of erroneous results due to, for example, confusing colour and/or numeric and/or character codings on specimen receptacles, removable parts and/or accessories used with devices in order to perform the test or assay as intended;
Pripomočki so zasnovani, izdelani in pakirani tako, da se, kolikor je to mogoče, zmanjša izpostavljenost uporabnikov ali drugih oseb sevanju (namernemu, nenamernemu, neželenemu ali razpršenemu), in na način, ki se sklada s predvidenim namenom, ne da bi bila s tem omejena uporaba ustreznih določenih ravni za diagnostične namene.
the risks of any foreseeable interference with other devices.
Kadar so pripomočki namenjeni oddajanju nevarnega ali potencialno ionizirajočega/ali neionizirajočega sevanja, so v čim večji možni meri:
Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition.
zasnovani in izdelani tako, da zagotavljajo nadzor in/ali prilagoditev značilnosti in količine oddanega sevanja, in
Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.
opremljeni s prikazovalniki in/ali zvočnimi opozorili ob takem oddajanju.
Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
Operativna navodila za pripomočke, ki oddajajo nevarno ali potencialno nevarno sevanje, vsebujejo podrobne informacije o naravi oddanega sevanja, sredstvih za zaščito uporabnika ter načinih preprečevanja nepravilne uporabe in zmanjševanja tveganj pri montaži, kolikor je to mogoče in ustrezno.
Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
Prav tako se navedejo informacije v zvezi s testiranjem sprejemljivosti in učinkovitosti, merili sprejemljivosti, pa tudi postopkom vzdrževanja.
Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by users, or other person.
Elektronski sistemi, ki jih je mogoče programirati – pripomočki z vgrajenimi elektronskimi sistemi, ki jih je mogoče programirati, in programska oprema, ki je sama pripomoček
To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use.
Pripomočki z vgrajenimi elektronskimi sistemi, ki jih je mogoče programirati, vključno s programsko opremo, ali programska oprema, ki je sama pripomoček, so zasnovani tako, da se zagotovijo ponovljivost, zanesljivost in učinkovitost v skladu s predvideno uporabo.
Such procedures shall be described in the instructions for use.
V primeru ene same napake se sprejmejo ustrezni ukrepi, s katerimi se v čim večji meri odpravijo ali zmanjšajo posledična tveganja ali poslabšanje učinkovitosti.
The measuring, monitoring or display scale (including colour change and other visual indicators) shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.
Za pripomočke z vgrajeno programsko opremo ali za programsko opremo, ki je sama pripomoček, se programska oprema razvije in izdeluje v skladu z najnovejšim tehničnim razvojem, ob upoštevanju načel razvojnega cikla, obvladovanja tveganj, vključno z varnostjo informacij, ter preverjanja in potrjevanja.
Devices with a measuring function
Programska oprema iz tega oddelka, ki je namenjena uporabi v kombinaciji z mobilnimi računalniškimi platformami, je zasnovana in izdelana ob upoštevanju posebnih lastnosti mobilnih platform (npr. velikosti in kontrasta zaslona) in zunanjih dejavnikov, povezanih z njihovo uporabo (različno okolje glede na raven svetlobe ali hrupa).
Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I, taking into account the intended purpose of the device.
Proizvajalci določijo 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 measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC [3].15.
Pripomočki, priključeni na vir energije ali opremljeni z njim
Protection against radiation
V primeru ene same napake se pri pripomočkih, priključenih na vir energije ali opremljenih z njim, sprejmejo ustrezni ukrepi za odpravo ali čim večje zmanjšanje posledičnih tveganj.
Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for diagnostic purposes.
Pripomočki, pri katerih je varnost pacienta odvisna od notranjega električnega napajanja, so opremljeni s sistemi za ugotavljanje stanja električnega napajanja in ustreznim opozarjanjem ali javljanjem, če zmogljivost električnega napajanja postane kritična.
When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall as far as possible be:
Po potrebi pride do opozorila ali javljanja, še preden električno napajanje postane kritično.
designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted; and
Pripomočki so zasnovani in izdelani tako, da se v čim večji meri zmanjšajo tveganja za elektromagnetne interference, ki bi lahko vplivale na delovanje zadevnega ali drugih pripomočkov ali opreme v predvidenem okolju.
fitted with visual displays and/or audible warnings of such emissions.
Pripomočki so zasnovani in izdelani tako, da zagotavljajo ustrezno raven intrinzične imunosti na elektromagnetne interference, da lahko delujejo, kot je predvideno.
The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate.
Pripomočki so zasnovani in izdelani tako, da se v čim večji meri prepreči tveganje za uporabnika ali drugo osebo za naključni elektrošok pri običajni uporabi pripomočka in v primeru ene same napake pri pripomočku, če je pripomoček montiran in vzdrževan v skladu z navodili proizvajalca.
Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.
Zaščita pred mehanskimi in toplotnimi tveganji
Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
Pripomočki so zasnovani in izdelani tako, da so uporabniki in druge osebe zaščiteni pred mehanskimi tveganji.
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.
Pripomočki so dovolj stabilni pri predvidenih pogojih delovanja.
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.
So ustrezni, da prenesejo obremenitve, značilne za predvideno delovno okolje, in da se ta odpornost ohrani med pričakovano življenjsko dobo pripomočkov, za katere veljajo morebitne zahteve glede inšpekcijskih pregledov in vzdrževanja, kot jih navede proizvajalec.
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.
Kadar obstajajo tveganja zaradi prisotnosti gibljivih delov, tveganja zaradi razpada ali odcepitve gibljivega dela ali uhajanja snovi, se vgradijo ustrezna zaščitna sredstva.
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).
Vsa varovala ali druga sredstva, vgrajena v pripomoček za zagotavljanje zaščite, zlasti pred gibljivimi deli, so varna in ne motijo dostopa za običajno delovanje pripomočka oziroma ne omejujejo rutinskega vzdrževanja pripomočka, kot ga je predvidel proizvajalec.
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.
Pripomočki so zasnovani in izdelani tako, da se čim bolj zmanjšajo ravni tveganj zaradi tresenja, ki ga ustvarjajo pripomočki, ob upoštevanju tehničnega napredka in razpoložljivih sredstev za omejevanje tresenja, zlasti pri izvoru, razen če je tresenje del navedenega delovanja.
Devices connected to or equipped with an energy source
Pripomočki so zasnovani in izdelani tako, da se čim bolj zmanjšajo ravni tveganj zaradi hrupa, ki ga ustvarjajo pripomočki, ob upoštevanju tehničnega napredka in razpoložljivih sredstev za zmanjševanje hrupa, zlasti pri izvoru, razen če je hrup del navedenega delovanja.
For devices connected to or equipped with an energy source, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
Terminali in priključki na vire elektrike, plina ali hidravlične in pnevmatične energije, s katerimi mora ravnati uporabnik ali druga oseba, so zasnovani in zgrajeni tako, da se čim bolj zmanjša raven vseh mogočih tveganj.
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.
Napake, ki bi se lahko pojavile pri montaži ali ponovni montaži nekaterih delov in bi lahko bile vir tveganj, se preprečijo med zasnovo in zgradbo takih delov, če to ni izvedljivo, pa z navedbo informacij na samih delih in/ali njihovih ohišjih.
If necessary, such warning or indication shall be given prior to the power supply becoming critical.
Enake informacije se navedejo na gibljivih delih in/ali njihovih ohišjih, kadar mora biti znana smer gibanja, da bi se izognili tveganju.
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.
Dostopni deli pripomočkov (razen delov ali področij, ki so namenjeni oddajanju toplote ali doseganju določenih temperatur) in njihova okolica pri običajnih pogojih uporabe ne dosegajo potencialno nevarnih temperatur.
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.
Zaščita pred tveganji, ki jih predstavljajo pripomočki, predvideni za samotestiranje ali testiranje ob pacientu
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 user, or 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.
Pripomočki, predvideni za samotestiranje ali testiranje ob pacientu, so zasnovani in izdelani tako, da delujejo v skladu z njihovim predvidenim namenom, ob upoštevanju spretnosti in sredstev, ki so na voljo predvidenemu uporabniku, ter vpliva, ki izhaja iz spremembe, ki jo je mogoče upravičeno pričakovati glede na tehniko in okolje predvidenega uporabnika.
Protection against mechanical and thermal risks
Informacije in navodila, ki jih zagotovi proizvajalec, so takšna, da jih predvideni uporabnik zlahka razume in uporablja, da bi se rezultat uporabe pripomočka pravilno razlagal in bi se preprečile zavajajoče informacije.
Devices shall be designed and manufactured in such a way as to protect users and other persons against mechanical risks.
V primeru testiranja ob pacientu so z informacijami in navodili proizvajalca jasno določene stopnja usposabljanja, kvalifikacije in/ali izkušnje, ki se zahtevajo od uporabnika.
Devices shall be sufficiently stable under the foreseen operating conditions.
Pripomočki, predvideni za samotestiranje ali testiranje ob pacientu, so zasnovani in izdelani tako, da:
They shall be suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer.
lahko predvideni uporabnik, po potrebi z ustreznim usposabljanjem in/ali informacijami, varno in pravilno uporablja pripomoček v vseh fazah postopka in
Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated.
se v čim večji meri zmanjša tveganje za napako predvidenega uporabnika pri ravnanju s pripomočkom in po potrebi vzorcem ter pri razlagi rezultatov.
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.
lahko preveri, ali bo pripomoček med uporabo deloval, kot je predvidel proizvajalec, in
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.
po potrebi prejme opozorilo, če pripomoček ne zagotovi veljavnega rezultata.
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.
ZAHTEVE GLEDE INFORMACIJ, PRILOŽENIH PRIPOMOČKU
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.
Oznaka in navodila za uporabo
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.
Splošne zahteve glede informacij, ki jih zagotovi proizvajalec
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.
Vsakemu pripomočku so priložene informacije, potrebne za identifikacijo pripomočka in njegovega proizvajalca, ter informacije v zvezi z varnostjo in učinkovitostjo za uporabnika ali drugo osebo, kakor je ustrezno.
Protection against the risks posed by devices intended for self-testing or near-patient testing
Take informacije so lahko navedene na samem pripomočku, embalaži ali v navodilih za uporabo, če ima proizvajalec svoje spletno mesto, pa te informacije objavi tudi tam in jih nato redno posodablja, pri čemer se upošteva naslednje:
Devices intended for self-testing or near-patient testing 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 the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user's technique and environment.
nosilec, oblika, vsebina, čitljivost in lokacija oznake in navodil za uporabo ustrezajo posameznemu pripomočku, njegovemu predvidenemu namenu ter tehničnemu znanju, izkušnjam, izobrazbi ali usposobljenosti predvidenih uporabnikov.
The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information.
Zlasti navodila za uporabo so napisana tako, da jih predvideni uporabnik brez težav razume, po potrebi pa so dopolnjena z risbami in diagrami;
In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user.
zahtevane informacije na oznaki so navedene na samem pripomočku.
Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as to:
Če to ni izvedljivo ali ustrezno, se nekatere ali vse informacije navedejo na embalaži vsake enote.
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; and
Če celotno označevanje posamičnih enot ni izvedljivo, je treba informacije navesti na embalaži več pripomočkov.
reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, the specimen, and also in the interpretation of the results.
oznake so v čitljivi obliki in se lahko dopolnijo s strojno čitljivimi informacijami, kot so radiofrekvenčna identifikacija (RFID) ali črtne kode;
Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by which the intended user:
navodila za uporabo se predložijo skupaj s pripomočki.
can verify that, at the time of use, the device will perform as intended by the manufacturer; and
Vendar pa v ustrezno utemeljenih in izjemnih primerih navodila za uporabo niso potrebna ali so lahko skrajšana, če se pripomoček brez takih navodil za uporabo lahko uporablja varno in kot je predvidel proizvajalec;
be warned if the device has failed to provide a valid result.
Kadar se več pripomočkov, z izjemo pripomočkov, predvidenih za samotestiranje ali testiranje ob pacientu, dobavi enemu uporabniku in/ali na eno lokacijo, je dovolj en brezplačen izvod navodil za uporabo, če se s tem strinja kupec, ki pa lahko v vsakem primeru zahteva nadaljnje brezplačne izvode;
REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
če je pripomoček namenjen samo za strokovno uporabo, se navodila za uporabo lahko zagotovijo uporabniku v nepapirni obliki (npr. elektronski obliki), razen če je pripomoček predviden za testiranje ob pacientu;
Label and instructions for use
preostala tveganja, ki jih je treba sporočiti uporabniku in/ali drugi osebi, so kot omejitve, kontraindikacije, previdnostni ukrepi ali opozorila vključena v informacije, ki jih zagotovi proizvajalec;
General requirements regarding the information supplied by the manufacturer
Na področjih, na katerih takšni harmonizirani standardi ali skupne specifikacije ne obstajajo, so simboli in barve opisani v dokumentaciji, priloženi pripomočku;
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.
v primeru pripomočkov, ki vsebujejo snov ali zmes, ki se lahko šteje za nevarno, ob upoštevanju narave ter količine njenih sestavin in oblike, v kateri so prisotne, se uporabljajo ustrezni piktogrami za nevarnosti in zahteve glede označevanja iz Uredbe (ES) št. 1272/2008.
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:
Kadar ni dovolj prostora za vse informacije na samem pripomočku ali njegovi oznaki, se ustrezni piktogrami za nevarnosti navedejo na oznaki, druge informacije, ki se zahtevajo po Uredbi (ES) št. 1272/2008, pa se vključijo v navodila za uporabo;
In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
Informacije na oznaki
The information required on the label shall be provided on the device itself.
Na oznaki so navedeni vsi naslednji podatki:
If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit.
ime ali trgovsko ime pripomočka;
If individual full labelling of each unit is not practicable, the information shall be set out on the packaging of multiple devices.
podatki, ki so nujno potrebni, da lahko uporabnik prepozna pripomoček in, kadar to ni očitno za uporabnika, predvideni namen pripomočka;
Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification or bar codes.
ime, registrirano trgovsko ime ali registrirana blagovna znamka proizvajalca ter naslov njegovega registriranega kraja poslovanja;
Instructions for use shall be provided together with devices.
kadar ima proizvajalec svoj registrirani kraj poslovanja zunaj Unije, ime njegovega pooblaščenega predstavnika in naslov registriranega kraja poslovanja pooblaščenega predstavnika;
Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use.
kadar je to ustrezno, navedba sterilnega stanja pripomočka in metode sterilizacije ali izjava, v kateri je naveden vsak poseben mikrobni status ali status čistosti;
The label shall bear all of the following particulars:
navedbo, ali je pripomoček predviden za enkratno uporabo.
the name or trade name of the device;
Navedba proizvajalca o enkratni uporabi je enotna po vsej Uniji;
the details strictly necessary for a user to identify the device and, where it is not obvious for the user, the intended purpose of the device;
treba je navesti, ali je pripomoček namenjen za samotestiranje ali testiranje ob pacientu;
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
če hitri testi niso namenjeni za samotestiranje ali testiranje ob pacientu, navedba o njihovi izključitvi;
an unambiguous indication of the time limit for using the device safely, without degradation of performance, expressed at least in terms of year and month and, where relevant, the day, in that order;
posebne informacije, ki se zagotovijo v zvezi s:
where there is no indication of the date until when it may be used safely, the date of manufacture.
fiziološkim ali patološkim stanjem;
where appropriate, an indication of the sterile state of the device and the sterilisation method, or a statement indicating any special microbial state or state of cleanliness;
informacije za prepoznavanje takih pripomočkov ali opreme, da se doseže potrjena in varna kombinacija, vključno z bistvenimi značilnostmi učinkovitosti, in/ali