natgillin/translations-raw huggingface dataset:
The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.
Pri označevanju pripomočka se razlikuje med enakimi ali podobnimi pripomočki, ki se dajejo na trg v sterilnem in nesterilnem stanju, poleg simbola, ki označuje, da so pripomočki sterilni.
Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
Pripomočki, ki vsebujejo snov, ki se šteje za zdravilo, in pripomočki, sestavljeni iz snovi ali kombinacij snovi, ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu
In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable conformity assessment procedure under this Regulation.
V primeru pripomočkov iz prvega pododstavka člena 1(8) se kakovost, varnost in uporabnost snovi, ki bi se ob ločeni uporabi štela za zdravilo v smislu točke (2) člena 1 Direktive 2001/83/ES, preveri po analogiji z metodami iz Priloge I k Direktivi 2001/83/ES, kot se zahteva v veljavnem postopku ugotavljanja skladnosti iz te uredbe.
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation.
Pripomočki, sestavljeni iz snovi ali kombinacij snovi, ki so namenjene vnosu v človeško telo in ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu, izpolnjujejo, kadar je to ustrezno in omejeno na vidike, ki niso zajeti v tej uredbi, ustrezne zahteve iz Priloge I k Direktivi 2001/83/ES glede vrednotenja absorpcije, porazdelitve, metabolizma, izločanja, lokalne tolerance, toksičnosti, interakcije z drugimi pripomočki, zdravili ali drugimi snovmi ter možnosti neželenih reakcij, kot se zahteva v veljavnem postopku ugotavljanja skladnosti iz te uredbe.
Devices incorporating materials of biological origin
Pripomočki, ki vsebujejo materiale biološkega izvora
For devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable covered by this Regulation in accordance with point (g) of Article 1(6), the following shall apply:
Za pripomočke, izdelane z uporabo derivatov človeških tkiv ali celic, ki so neviabilni ali so postali neviabilni, ki jih zajema ta uredba v skladu s točko (g) člena 1(6), velja naslednje:
donation, procurement and testing of the tissues and cells shall be done in accordance with Directive 2004/23/EC;
darovanje, pridobivanje ter testiranje tkiv in celic se izvaja v skladu z Direktivo 2004/23/ES;
processing, preservation and any other handling of those tissues and cells or their derivatives shall be carried out so as to provide safety for patients, users and, where applicable, other persons.
pri obdelavi, konzerviranju in kakršnem koli drugem ravnanju z navedenimi tkivi in celicami ali njihovimi derivati je poskrbljeno za varnost pacientov, uporabnikov in, kjer je to ustrezno, drugih oseb.
In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process;
Zlasti se poskrbi za varnost pred virusi in drugimi prenosljivimi povzročitelji z ustreznimi metodami pridobivanja in izvajanjem potrjenih metod uničevanja ali inaktivacije med postopkom izdelave;
the traceability system for those devices shall be complementary and compatible with the traceability and data protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC.
sistem sledljivosti za te pripomočke se dopolnjuje in je združljiv z zahtevami glede sledljivosti in varstva podatkov iz Direktive 2004/23/ES in Direktive 2002/98/ES.
For devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable the following shall apply:
Za pripomočke, izdelane z uporabo živalskih tkiv ali celic ali njihovih derivatov, ki so neviabilni ali so postali neviabilni, velja naslednje:
where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, shall originate from animals that have been subjected to veterinary controls that are adapted to the intended use of the tissues.
kadar je to izvedljivo, ob upoštevanju vrste živali, živalska tkiva in celice ali njihovi derivate izvirajo iz živali, ki so bile predmet veterinarskih pregledov, prilagojenih predvideni uporabi tkiv.
Information on the geographical origin of the animals shall be retained by manufacturers;
Proizvajalci shranijo informacije o geografskem poreklu živali;
sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other persons.
pri pridobivanju, obdelavi, konzerviranju in preskušanju živalskih tkiv, celic in snovi ali njihovih derivatov ter ravnanju z njimi se zagotovi varnost pacientov, uporabnikov in po potrebi drugih oseb.
In particular safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the device;
Zlasti se poskrbi za varnost pred virusi in drugimi prenosljivimi povzročitelji z izvajanjem potrjenih metod uničevanja ali inaktivacije virusov med postopkom izdelave, razen kadar bi zaradi uporabe takšnih metod prišlo do nesprejemljivega poslabšanja, ki bi ogrozilo klinične koristi pripomočka;
in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.
pri pripomočkih, izdelanih z uporabo živalskih tkiv ali celic ali njihovih derivatov iz Uredbe (EU) št. 722/2012, se uporabljajo posebne zahteve iz navedene uredbe.
For devices manufactured utilising non-viable biological substances other than those referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain.
Za pripomočke, izdelane z uporabo neviabilnih bioloških snovi, razen tistih iz oddelkov 13.1. in 13.2 pri obdelavi, konzerviranju in testiranju navedenih snovi ter ravnanju z njimi se zagotovi varnost pacientov, uporabnikov in, kjer je to ustrezno, drugih oseb, tudi pri odstranjevanju odpadkov.
In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.
Zlasti se poskrbi za varnost pred virusi in drugimi prenosljivimi povzročitelji z ustreznimi metodami pridobivanja in izvajanjem potrjenih metod uničevanja ali inaktivacije virusov med postopkom izdelave.
Construction of devices and interaction with their environment
Zgradba pripomočkov in interakcija z njihovim okoljem
If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices.
Če je pripomoček namenjen uporabi v kombinaciji z drugimi pripomočki ali opremo, je celotna kombinacija, vključno s priključnim sistemom, varna in ne vpliva na navedeno učinkovitost pripomočkov.
Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use.
Morebitne omejitve uporabe, ki veljajo za take kombinacije, so navedene na oznaki in/ali v navodilih za uporabo.
Connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling, shall be designed and constructed in such a way as to minimise all possible risks, such as misconnection.
Priključki, s katerimi mora uporabnik ravnati, kot so tekoče, plinske, električne ali mehanske naprave za spajanje, so zasnovani in zgrajeni tako, da se v kar največji možni meri preprečijo vsa mogoča tveganja, na primer nepravilna priključitev.
Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
Pripomočki so zasnovani in izdelani tako, da se preprečijo ali zmanjšajo, kolikor je to mogoče:
the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;
tveganje za poškodbe zaradi fizikalnih lastnosti, vključno z razmerjem prostornina/pritisk, dimenzionalnih in, kadar je to ustrezno, ergonomskih lastnosti pripomočkov;
risks connected with 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, temperature, variations in pressure and acceleration or radio signal interferences;
tveganja, povezana z razumno predvidljivimi zunanjimi vplivi ali okoljskimi razmerami, kot so magnetna polja, zunanji električni in elektromagnetni učinki, elektrostatična razelektritev, sevanje, povezano z diagnostičnimi ali terapevtskimi postopki, pritisk, vlažnost, temperatura, nihanje tlaka in pospeška ali motnje radijskih signalov;
the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;
tveganja, povezana z uporabo pripomočka pri stiku z materiali, tekočinami in snovmi, vključno s plini, ki jim je izpostavljen pri običajnih pogojih uporabe;
the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;
tveganja, povezana z morebitno negativno interakcijo med programsko opremo in okoljem IT, v katerem deluje in se povezuje;
the risks of accidental ingress of substances into the device;
tveganja za naključno prodiranje snovi v pripomoček;
the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given; and
tveganja za vzajemne interference z drugimi pripomočki, ki se običajno uporabljajo pri raziskavah ali zdravljenju, in
risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.
tveganja, ki se pojavijo, kadar vzdrževanje ali kalibracija nista mogoča (npr. pri vsadkih) zaradi staranja uporabljenih materialov ali izgube natančnosti katerih koli merilnih ali kontrolnih mehanizmov.
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.
Pripomočki so zasnovani in izdelani tako, da se čim bolj zmanjšajo tveganja za požar ali eksplozijo pri običajni uporabi in v primeru ene same napake.
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.
Posebna pozornost se nameni pripomočkom, katerih predvidena uporaba vključuje izpostavljenost ali uporabo v povezavi z vnetljivimi ali eksplozivnimi snovmi ali snovmi, ki bi lahko povzročile gorenje.
Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
Pripomočki so zasnovani in izdelani tako, da se lahko varno in učinkovito prilagajajo, kalibrirajo in vzdržujejo.
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.
Pripomočki, ki so namenjeni za uporabo skupaj z drugimi pripomočki ali izdelki, so zasnovani in izdelani tako, da sta interoperabilnost in kompatibilnost zanesljivi in varni.
Any measurement, monitoring or display scale 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.
Meritve, nadzor ali prikaz podatkov so zasnovani in izdelani v skladu z ergonomskimi načeli, ob upoštevanju predvidenih namenov, uporabnikov in okoljskih razmer, v katerih naj bi se pripomočki uporabljali.
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 the user, patient or other person.
Pripomočki so zasnovani in izdelani tako, da se uporabniku, pacientu ali drugi osebi olajša varno odstranjevanje pripomočka in/ali pripadajočih odpadnih snovi.
To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use.
V ta namen proizvajalci preučijo in preskušajo postopke in ukrepe, s katerimi se lahko njihovi pripomočki po uporabi varno odstranijo.
Such procedures shall be described in the instructions for use.
Ti postopki se opišejo v navodilih za uporabo.
Devices with a diagnostic or measuring function
Pripomočki z diagnostično ali merilno funkcijo
Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods.
Diagnostični pripomočki in pripomočki z merilno funkcijo so zasnovani in izdelani tako, da zagotavljajo zadostno točnost, natančnost in stabilnost za njihov predvideni namen na podlagi ustreznih znanstvenih in tehničnih metod.
The limits of accuracy shall be indicated by the manufacturer.
Proizvajalec navede omejitve točnosti pripomočka.
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 [4].16.
Merjenja, ki se opravljajo s pripomočki z merilno funkcijo, so izražena v zakonitih enotah, v skladu z določbami Direktive Sveta 80/181/EGS [4].16.
Protection against radiation
Zaščita pred sevanjem
Devices shall be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation 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 therapeutic and diagnostic purposes.
Pripomočki so zasnovani, izdelani in pakirani tako, da se v skladu s predvidenim namenom in v kar največji možni meri zmanjša izpostavljenost pacientov, uporabnikov in drugih oseb sevanju, ne da bi bila s tem omejena uporaba ustreznih določenih ravni za terapevtske in diagnostične namene.
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 patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate.
Operativna navodila za pripomočke, ki oddajajo nevarno ali potencialno nevarno sevanje, vsebujejo podrobne informacije o naravi sevanja, sredstvih za zaščito pacienta in uporabnika ter načinih preprečevanja nepravilne uporabe in zmanjševanja tveganj, povezanih z montažo, kolikor je to mogoče in ustrezno.
Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.
Prav tako so navedene informacije v zvezi s preskusi sprejemljivosti, testiranjem učinkovitosti, merili sprejemljivosti in postopki vzdrževanja.
Intended radiation
Namensko sevanje
Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or non-ionizing radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent to the emission, it shall be possible for the user to control the emissions.
Kadar so pripomočki namenjeni oddajanju nevarnih ali potencialno nevarnih ravni ionizirajočega in/ali neionizirajočega sevanja, potrebnega za specifične medicinske namene, katerega korist naj bi odtehtala tveganja zaradi emisij, se uporabniku omogoči nadzor emisij.
Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.
Taki pripomočki so zasnovani in izdelani tako, da je mogoče reproducirati relevantno spremenljive parametre znotraj sprejemljivega odstopanja.
Where devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions.
Kadar so pripomočki namenjeni oddajanju nevarnega ali potencialno nevarnega ionizirajočega in/ali neionizirajočega sevanja, so po možnosti opremljeni s prikazovalniki in/ali zvočnimi opozorili o takih emisijah.
Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible.
Pripomočki so zasnovani in izdelani tako, da so pacienti, uporabniki in druge osebe čim manj izpostavljeni emisijam nenamenskega, slučajnega ali razpršenega sevanja.
Where possible and appropriate, methods shall be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.
Če je to mogoče in ustrezno, se izberejo metode, ki zmanjšujejo izpostavljenost pacientov, uporabnikov in drugih morebitnih prizadetih oseb sevanju.
Devices intended to emit ionizing radiation shall be designed and manufactured taking into account the requirements of the Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation.
Pripomočki, namenjeni oddajanju ionizirajočega sevanja, so zasnovani in izdelani ob upoštevanju zahtev iz Direktive 2013/59/Euratom o določitvi temeljnih varnostnih standardov za varstvo pred nevarnostmi zaradi ionizirajočega sevanja.
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.
Pripomočki, namenjeni oddajanju ionizirajočega sevanja, so zasnovani in izdelani tako, da, kadar je to mogoče in ob upoštevanju predvidene uporabe, omogočajo spreminjanje in nadzorovanje količine, geometrije in kakovosti oddanega sevanja ter po možnosti njihovo spremljanje med zdravljenjem.
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.
Pripomočki, ki oddajajo ionizirajoče sevanje za diagnostično radiologijo, so zasnovani in izdelani tako, da se doseže takšna kakovost slike in/ali rezultatov, ki ustreza predvidenemu medicinskemu namenu ob čim manjši izpostavljenosti pacienta in uporabnika sevanju.
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.
Pripomočki, ki oddajajo ionizirajoče sevanje in so namenjeni za terapevtsko radiologijo, so zasnovani in izdelani tako, da je mogoče zanesljivo spremljanje in nadzorovanje prejetega odmerka, tipa žarka, energije in, kjer je to ustrezno, kakovosti sevanja.
Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
Elektronski sistemi, ki jih je mogoče programirati – pripomočki z vgrajenimi elektronskimi sistemi, ki jih je mogoče programirati, in programska oprema, ki je sama pripomoček
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 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 z njihovo predvideno uporabo.
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.
V primeru ene same napake se sprejmejo ustrezni ukrepi za odpravo ali zmanjšanje posledičnih tveganj ali poslabšanja učinkovitosti, kolikor je to mogoče.
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.
Za pripomočke s programsko opremo ali za programsko opremo, ki je sama pripomoček, se programska oprema razvija in izdeluje v skladu z najnovejšim tehničnim razvojem, ob upoštevanju načel razvojnega cikla, obvladovanja tveganj, vključno z varnostjo informacij, preverjanja in potrjevanja.
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).
Programska oprema iz tega oddelka, ki je namenjena uporabi v kombinaciji z mobilnimi računalniškimi platformami, je zasnovana in izdelana ob upoštevanju posebnih lastnosti mobilne platforme (npr. velikosti in kontrasta zaslona) in zunanjih dejavnikov, povezanih z njihovo uporabo (različno okolje glede na raven svetlobe ali hrupa).
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.
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.
Active devices and devices connected to them
Aktivni pripomočki in z njimi povezani pripomočki