natgillin/translations-raw huggingface dataset:
if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
navesti je treba, ali gre za pripomoček za enkratno uporabo, ki je bil ponovno obdelan, število že izvedenih ciklusov ponovne obdelave in morebitne omejitve glede števila ciklusov ponovne obdelave;
if the device is custom-made, the words ‘custom-made device’;
če je pripomoček izdelan za posameznega uporabnika, se navede besedilo „pripomoček, izdelan za posameznega uporabnika“;
an indication that the device is a medical device.
oznaka, da je pripomoček medicinski pripomoček.
If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;
Če je pripomoček namenjen samo kliničnim raziskavam, se navede besedilo „izključno za klinične raziskave“;
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;
v primeru pripomočkov, sestavljenih iz snovi ali kombinacij snovi, ki so namenjene vnosu v človeško telo skozi telesno odprtino ali ki se nanesejo na kožo in ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu, navedba splošne kakovostne sestave naprave in kvantitativnih informacij o glavni sestavini oziroma sestavinah, odgovornih za doseganje glavnega predvidenega učinka;
for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
pri aktivnih pripomočkih za vsaditev se navede serijska številka, pri drugih pripomočkih za vsaditev pa serijska številka ali številka partije.
Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)
Informacije na embalaži, ki ohranja sterilno stanje pripomočka („sterilna embalaža“):
The following particulars shall appear on the sterile packaging:
Na sterilni embalaži se navedejo naslednji podatki:
an indication permitting the sterile packaging to be recognised as such,
navedba, na podlagi katere je mogoče embalažo prepoznati kot sterilno;
a declaration that the device is in a sterile condition,
izjava, da je pripomoček v sterilnem stanju;
a description of the device,
opis pripomočka;
if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
če je pripomoček namenjen samo kliničnim raziskavam, se navede besedilo „izključno za klinične raziskave“;
if the device is custom-made, the words ‘custom-made device’,
če je pripomoček izdelan za posameznega uporabnika, se navede besedilo „pripomoček, izdelan za posameznega uporabnika“;
the month and year of manufacture,
mesec in leto izdelave;
an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and
nedvoumna navedba roka, do katerega je pripomoček varen za uporabo ali vsaditev in ki je izražen vsaj kot leto in mesec, in
an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
navodilo, naj se navodila za uporabo preverijo v primeru, če je sterilna embalaža poškodovana ali nenamerno odprta pred uporabo.
Information in the instructions for use
Informacije v navodilih za uporabo
The instructions for use shall contain all of the following particulars:
Navodila za uporabo vključujejo vse naslednje podatke:
the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;
podatke iz točk (a), (c), (e), (f), (k), (l), (n) in (r) oddelka 23.2.;
the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;
predvideni namen pripomočka z jasno opredelitvijo indikacij, kontraindikacij, ciljne skupine oziroma skupin pacientov in predvidenih uporabnikov, kot je ustrezno;
where applicable, a specification of the clinical benefits to be expected.
po potrebi specifikacijo pričakovanih kliničnih koristi;
where applicable, links to the summary of safety and clinical performance referred to in Article 32;
po potrebi povezavo do povzetka o varnosti in klinični učinkovitosti iz člena 32;
the performance characteristics of the device;
učinkovitost pripomočka;
where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;
po potrebi podatke, ki zdravstvenemu delavcu omogočajo, da preveri, ali je pripomoček ustrezen, in da izbere ustrezno programsko opremo in dodatke;
any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;
morebitna preostala tveganja, kontraindikacije ter katere koli neželene stranske učinke, vključno z informacijami za pacienta v zvezi s tem;
specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it;
specifikacije, ki jih uporabnik potrebuje za ustrezno uporabo pripomočka, npr. če ima pripomoček merilno funkcijo, stopnjo natančnosti, ki se zagotavlja zanjo;
details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;
podrobnosti o morebitnih pripravljalnih postopkih ali obdelavah pripomočka, preden je pripravljen za uporabo ali med uporabo (npr. o sterilizaciji, končnem sestavljanju, kalibraciji itd.), pa tudi o stopnjah razkuževanja, ki morajo biti dosežene, da se zagotovi varnost pacientov, in o vseh razpoložljivih metodah, s katerimi je mogoče doseči takšne stopnje razkuževanja;
any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons;
morebitne zahteve za posebno opremo ali posebno usposabljanje ali posebne kvalifikacije uporabnika pripomočka in/ali drugih oseb;
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:
informacije za preverjanje, ali je pripomoček pravilno nameščen ter pripravljen na varno in takšno delovanje, kot ga je predvidel proizvajalec, kadar je ustrezno, pa tudi:
details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection,
podrobnosti o naravi in pogostosti preventivnega in rednega vzdrževanja ter morebitne pripravljalne postopke čiščenja ali razkuževanja;
identification of any consumable components and how to replace them,
identifikacijo katerih koli potrošnih sestavnih delov in informacije o načinu njihove zamenjave;
information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime, and
informacije o katerih koli potrebnih kalibracijah za zagotovitev, da pripomoček deluje pravilno in varno v času svoje predvidene življenjske dobe, in
methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices;
metode za odpravo tveganj, katerim so izpostavljene osebe, ki nameščajo, umerjajo ali vzdržujejo pripomočke;
if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
če je pripomoček ob dobavi sterilen, navodila v primeru poškodbe ali nenamernega odprtja sterilne embalaže pred uporabo;
if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;
če pripomoček ob dobavi ni sterilen, vendar ga je treba pred uporabo sterilizirati, ustrezna navodila za sterilizacijo;
if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market.
če se pripomoček lahko ponovno uporabi, informacije o ustreznih postopkih, ki omogočajo ponovno uporabo, vključno s čiščenjem, razkuževanjem, pakiranjem in po potrebi potrjeno metodo ponovne sterilizacije, ustrezno v državi članici oziroma državah članicah, v katerih je pripomoček dan na trg.
Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;
Navedejo se informacije o tem, kdaj se pripomoček ne sme več ponovno uporabiti, npr. znaki razgradnje materiala ali največje število dovoljenih ponovnih uporab;
an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements;
po potrebi navedbo, da se lahko pripomoček znova uporabi samo, če se spet usposobi, pri čemer je proizvajalec odgovoren za skladnost s splošnimi zahtevami glede varnosti in učinkovitosti;
if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used.
če je na pripomočku oznaka o enkratni uporabi, informacije o znanih značilnostih in tehničnih dejavnikih, ki so znani proizvajalcu in bi lahko predstavljali tveganje v primeru ponovne uporabe pripomočka.
This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail.
Te informacije temeljijo na specifičnem delu dokumentacije proizvajalca o obvladovanju tveganj, v katerem se te značilnosti in tehnični dejavniki podrobno obravnavajo.
If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request;
Če se v skladu s točko (d) oddelka 23.1. navodila za uporabo ne zahtevajo, se uporabniku na njegovo zahtevo omogoči dostop do teh informacij;
for devices intended for use together with other devices and/or general purpose equipment:
za pripomočke, predvidene za uporabo skupaj z drugimi pripomočki in/ali opremo za splošno uporabo:
information to identify such devices or equipment, in order to obtain a safe combination, and/or
informacije za prepoznavanje takih pripomočkov ali opreme, da se doseže varna kombinacija, in/ali
information on any known restrictions to combinations of devices and equipment;
informacije o katerih koli znanih omejitvah za kombinacije pripomočkov in opreme;
if the device emits radiation for medical purposes:
če pripomoček oddaja sevanje za medicinske namene:
detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation,
podrobne informacije o naravi, vrsti in po potrebi intenzivnosti in distribuciji sevanja;
the means of protecting the patient, user, or other person from unintended radiation during use of the device;
ukrepi za zaščito pacienta, uporabnika ali druge osebe pred nenamernim sevanjem med uporabo pripomočka;
information that allows the user and/or patient to be informed of any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device.
informacije, ki uporabniku in/ali pacientu omogočajo, da je seznanjen z morebitnimi opozorili, previdnostnimi ukrepi, kontraindikacijami ter ukrepi, ki jih je treba sprejeti, in omejitvami pri uporabi pripomočka.
That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device.
Te informacije, kjer je to ustrezno, uporabniku omogočajo, da pacienta na kratko seznani z morebitnimi opozorili, previdnostnimi ukrepi, kontraindikacijami, ukrepi, ki jih je treba sprejeti, in omejitvami pri uporabi pripomočka.
The information shall cover, where appropriate:
Informacije zajemajo, kadar je to ustrezno:
warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety,
opozorila, previdnostne ukrepe in/ali ukrepe, ki jih je treba sprejeti v primeru okvare pripomočka ali spremembe njegove učinkovitosti, ki bi lahko vplivala na varnost;
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,
opozorila, previdnostne ukrepe in/ali ukrepe, ki jih je treba sprejeti v zvezi z izpostavljenostjo razumno predvidljivim zunanjim vplivom ali okoljskim razmeram, kot so magnetna polja, zunanji električni in elektromagnetni učinki, elektrostatična razelektritev, sevanje, povezano z diagnostičnimi ali terapevtskimi postopki, tlak, vlažnost ali temperatura;
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, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment,
opozorila, previdnostne ukrepe in/ali ukrepe, ki jih je treba sprejeti v zvezi s tveganji za interference – npr. elektromagnetne interference, ki jih oddaja pripomoček in vplivajo na drugo opremo –, ki jih predstavlja razumno predvidljiva navzočnost pripomočka med posebnimi diagnostičnimi preiskavami, ocenjevanji ali terapevtskim zdravljenjem ali drugimi postopki;
if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered,
če je pripomoček namenjen dajanju zdravil, človeških ali živalskih tkiv ali celic ali njihovih derivatov ali bioloških snovi, morebitne omejitve ali nekompatibilnosti pri izbiri snovi;
warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and
opozorila, previdnostne ukrepe in/ali omejitve, povezane z zdravilnimi učinkovinami ali biološkimi materiali, ki so zajeti v pripomoček kot sestavni del pripomočka, in
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;
previdnostne ukrepe v zvezi z materiali v pripomočku, ki vsebujejo ali so sestavljeni iz rakotvornih, mutagenih ali strupenih snovi ali endokrinih motilcev ali ki bi lahko povzročili preobčutljivost ali alergijske reakcije pacienta ali uporabnika;
in the case of 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, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra-indications, undesirable side-effects and risks relating to overdose;
v primeru pripomočkov, sestavljenih 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, opozorila in previdnostne ukrepe, kadar je to ustrezno, v zvezi s splošnim profilom interakcije pripomočka in njegovih produktov presnove z drugimi pripomočki, zdravili in drugimi snovmi ter kontraindikacije in neželene stranske učinke in tveganja, povezane s prevelikim odmerjanjem;
in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
v primeru pripomočkov za vsaditev splošne kvalitativne in kvantitativne informacije o materialih in snoveh, ki bi jim lahko bili pacienti izpostavljeni;
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.
opozorila ali previdnostni ukrepi, ki jih je treba sprejeti, da se omogoči varna odstranitev pripomočka, njegovih dodatkov in potrošnega materiala, ki se z njim uporablja, če obstaja.
This information shall cover, where appropriate:
Te informacije zajemajo, kadar je to ustrezno:
infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and
nevarnosti okužbe ali mikrobiološke nevarnosti, npr. eksplanti, igle ali kirurška oprema, kontaminirana s potencialno infekcioznimi snovmi človeškega izvora, in
physical hazards such as from sharps.
fizikalne nevarnosti, npr. zaradi ostrih predmetov.
If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request;
Če se v skladu s točko (d) oddelka 23.1. navodila za uporabo ne zahtevajo, se uporabniku na njegovo zahtevo omogoči dostop do teh informacij;
for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;
za pripomočke, ki naj bi jih uporabljali nestrokovnjaki, okoliščine, v katerih naj bi se uporabnik posvetoval z zdravstvenim delavcem;
for the devices covered by this Regulation pursuant to Article 1(2), information regarding the absence of a clinical benefit and the risks related to use of the device;
za pripomočke, ki jih zajema ta uredba v skladu z členom 1(2), informacije glede neobstoja kliničnih koristi in tveganj, povezanih z uporabo pripomočka;
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;
datum izdaje navodil za uporabo, ali, če so bila popravljena, datum izdaje in identifikator zadnjega popravka navodil za uporabo;
a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;
obvestilo za uporabnika in/ali pacienta, da je treba o vsakem resnem zapletu, do katerega je prišlo v zvezi s pripomočkom, obvestiti proizvajalca in pristojni organ države članice, v kateri ima uporabnik in/ali pacient stalno prebivališče;
(aa) information to be supplied to the patient with an implanted device in accordance with Article 18;
(aa) informacije za pacienta, ki ima vsajen pripomoček v skladu s členom 18;
(ab) 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.
(ab) za pripomočke z vgrajenimi elektronskimi sistemi, ki jih je mogoče programirati, vključno s programsko opremo, ali programsko opremo, ki je sama pripomoček, minimalne zahteve glede strojne opreme, značilnosti omrežij IT in varnostnih ukrepov v zvezi z IT, vključno z zaščito pred nepooblaščenim dostopom, ki morajo biti izpolnjene, da bi programska oprema delovala tako, kot je predvideno.
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. 1).
Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi, o spremembi in razveljavitvi direktiv 67/548/EGS in 1999/45/ES ter spremembi Uredbe (ES) št. 1907/2006 (UL L 353, 31.12.2008, str.
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 396, 30.12.2006, p. 1).
1).
Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
Uredba (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) (UL L 396, 30.12.2006, str.
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. 40).
1).
ANNEX II
Uredba (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov (UL L 167, 27.6.2012, str.
TECHNICAL DOCUMENTATION
1).
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.
Direktiva Sveta 80/181/EGS z dne 20. decembra 1979 o približevanju zakonodaje držav članic, ki se nanašajo na merske enote, in o razveljavitvi direktive 71/354/EGS (UL L 39, 15.2.1980, str.
DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
40).
Device description and specification
PRILOGA II
product or trade name and a general description of the device including its intended purpose and intended users;
TEHNIČNA DOKUMENTACIJA
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;
Proizvajalec pripravi jasno, dobro strukturirano in nedvoumno dokumentacijo, po potrebi pa tudi njen povzetek, v obliki, ki omogoča enostavno iskanje, ter pri tem navede zlasti elemente, opisane v tej prilogi.
the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;
OPIS IN SPECIFIKACIJA PRIPOMOČKA, VKLJUČNO Z RAZLIČICAMI IN DODATKI
principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
Opis in specifikacija pripomočka
the rationale for the qualification of the product as a device;
Ime izdelka ali trgovsko ime in splošen opis pripomočka, vključno z njegovim predvidenim namenom in predvidenimi uporabniki;
the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;
osnovni UDI-DI iz dela C Priloge VI, ki ga zadevnemu pripomočku dodeli proizvajalec, takoj ko se za identifikacijo tega pripomočka začne uporabljati sistem UDI, ali druga jasna identifikacija s kodo izdelka, kataloško številko ali drugo nedvoumno referenco, ki omogoča sledljivost;
an explanation of any novel features;
predvidena populacija pacientov in zdravstvena stanja, ki jih je treba diagnosticirati, zdraviti in/ali spremljati ter drugi vidiki, kot so merila za izbiro pacienta, indikacije, kontraindikacije, opozorila;