natgillin/translations-raw huggingface dataset:
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.
V primeru ene same napake pri aktivnih pripomočkih, ki niso namenjeni vsaditvi, se sprejmejo ustrezni ukrepi za odpravo ali zmanjšanje posledičnih tveganj v kar največji možni meri.
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.
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.
If necessary, such warning or indication shall be given prior to the power supply becoming critical.
Po potrebi pride do opozorila ali javljanja, še preden električno napajanje postane kritično.
Devices where the safety of the patient depends on an external power supply shall include an alarm system to signal any power failure.
Pripomočki, pri katerih je varnost pacienta odvisna od zunanjega električnega napajanja, vključujejo alarmni sistem za obveščanje o morebitni napaki pri napajanju.
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.
Pripomočki za spremljanje enega ali več kliničnih parametrov pacienta so opremljeni z ustreznimi alarmnimi sistemi za opozarjanje uporabnika na situacije, ki bi lahko privedle do smrti ali resnega poslabšanja zdravstvenega stanja pacienta.
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.
Pripomočki so zasnovani in izdelani tako, da se zmanjšajo, kolikor je to mogoče, tveganja za elektromagnetne interference, ki bi lahko vplivala na delovanje zadevnega ali drugih pripomočkov ali opreme v predvidenem okolju.
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.
Pripomočki so zasnovani in izdelani tako, da zagotavljajo ustrezno raven intrinzične imunosti na elektromagnetne interference, da lahko delujejo, kot je predvideno.
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.
Pripomočki so zasnovani in izdelani tako, da se čim bolj prepreči nevarnost naključnega elektrošoka za pacienta, uporabnika ali katere koli druge osebe pri običajni uporabi pripomočka in v primeru ene same napake pri pripomočku, če je pripomoček montiran in vzdrževan v skladu z navodili proizvajalca.
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.
Pripomočki so zasnovani in izdelani tako, da se v kar največji možni meri prepreči nepooblaščeni dostop, ki bi lahko oviral pripomoček pri predvidenem delovanju.
Particular requirements for active implantable devices
Posebne zahteve za aktivne pripomočke za vsaditev
Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:
Aktivni pripomočki za vsaditev so zasnovani in izdelani tako, da se odpravijo ali čim bolj zmanjšajo:
risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
nevarnosti, povezane z uporabo virov energije, zlasti kar zadeva izolacijo, uhajajoče tokove in pregrevanje pripomočkov pri uporabi električne energije,
risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and
nevarnosti, povezane z medicinskim zdravljenjem, zlasti tiste, ki se pojavijo zaradi uporabe defibrilatorjev ali visokofrekvenčne kirurške opreme, in
risks which may arise where maintenance and calibration are impossible, including:
nevarnosti, ki se lahko pojavijo, kadar nista mogoča vzdrževanje in kalibracija, vključno s:
excessive increase of leakage currents,
čezmernim povečanjem uhajajočih tokov,
ageing of the materials used,
staranjem uporabljenih materialov,
excess heat generated by the device,
čezmerno toploto, ki jo ustvarja pripomoček,
decreased accuracy of any measuring or control mechanism.
manjšo natančnostjo katerega koli merilnega ali kontrolnega mehanizma.
Active implantable devices shall be designed and manufactured in such a way as to ensure
Aktivni pripomočki za vsaditev so zasnovani in izdelani tako, da zagotavljajo:
if applicable, the compatibility of the devices with the substances they are intended to administer, and
po potrebi kompatibilnost pripomočkov s snovmi, ki naj bi jih dajali, in
the reliability of the source of energy.
zanesljivost vira energije.
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.
Aktivne pripomočke za vsaditev in po potrebi njihove sestavne dele je mogoče identificirati, da bi bilo mogoče izvesti potrebne ukrepe ob odkritju morebitnih nevarnosti v zvezi s pripomočki ali njihovimi sestavnimi deli.
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.
Aktivni pripomočki za vsaditev so opremljeni s kodo, po kateri lahko nedvoumno prepoznamo njih in njihovega proizvajalca (zlasti kar zadeva tip pripomočka in njegovo leto izdelave); to kodo je po potrebi mogoče prebrati, ne da bi bilo treba opraviti kirurški poseg.
Protection against mechanical and thermal risks
Zaščita pred mehanskimi in toplotnimi tveganji
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.
Pripomočki so zasnovani in izdelani tako, da so pacienti in uporabniki zaščiteni pred mehanskimi tveganji, povezanimi na primer z zaščito pred gibanjem, nestabilnostjo in gibljivimi deli.
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.
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 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.
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.
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.
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.
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.
Napake, ki bi se lahko pojavile pri montaži ali ponovni montaži nekaterih delov in bi lahko bile vir tveganja, se preprečijo med zasnovo in zgradbo takih delov, če to ni izvedljivo, pa z navedbo informacij na samih delih in/ali njihovih ohišjih.
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.
Enake informacije se navedejo na gibljivih delih in/ali njihovih ohišjih, kadar mora biti znana smer gibanja, da bi se izognili tveganju.
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.
Dostopni deli pripomočkov (razen delov ali področij, ki so namenjeni oddajanju toplote ali doseganju danih temperatur) in njihova okolica pri običajnih pogojih uporabe ne dosegajo potencialno nevarnih temperatur.
Protection against the risks posed to the patient or user by devices supplying energy or substances
Zaščita pred tveganji za pacienta ali uporabnika pri pripomočkih za preskrbo z energijo ali snovmi
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.
Pripomočki za preskrbo pacienta z energijo ali snovmi so zasnovani in zgrajeni tako, da je mogoče količino oddanega nastaviti in vzdrževati dovolj natančno, da je zagotovljena varnost pacienta in uporabnika.
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.
Pripomočki so opremljeni s sredstvi za preprečevanje in/ali prikazovanje morebitnih nepravilnosti v količini oddane energije ali oddanih snovi, ki bi lahko bile nevarne.
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.
Pripomočki vključujejo ustrezna sredstva za preprečevanje, v kolikor je to mogoče, naključnih sprostitev nevarnih ravni energije ali snovi iz vira energije in/ali snovi.
The function of the controls and indicators shall be clearly specified on the devices.
Delovanje nadzornih mehanizmov in kazalnikov je jasno navedeno na pripomočkih.
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.
Kadar so na pripomočku navedena navodila, potrebna za njegovo delovanje, ali kadar pripomoček z vizualnim sistemom prikazuje obratovalne ali uravnalne parametre, morajo biti te informacije uporabniku in po potrebi pacientu razumljive.
Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
Zaščita pred tveganji zaradi medicinskih pripomočkov, za katere je proizvajalec predvidel, da jih bodo uporabljali nestrokovnjaki
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.
Pripomočki, ki naj bi jih uporabljali nestrokovnjaki, so zasnovani in izdelani tako, da delujejo v skladu z njihovim predvidenim namenom, ob upoštevanju spretnosti in sredstev, ki so na voljo nestrokovnjakom, in vpliva zaradi razlik, ki se lahko razumno pričakujejo pri metodah in okolju nestrokovnjaka.
The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.
Informacije in navodila, ki jih zagotovi proizvajalec, so takšna, da jih nestrokovnjak zlahka razume in uporablja.
Devices for use by lay persons shall be designed and manufactured in such a way as to:
Pripomočki, ki naj bi jih uporabljali nestrokovnjaki, so zasnovani in izdelani tako, da:
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,
lahko predvideni uporabnik, po potrebi z ustreznim usposabljanjem in/ali informacijami, varno in pravilno uporablja pripomoček v vseh fazah postopka,
reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and
je, kadar je to ustrezno, nevarnost nenamernih ureznin in vbodov, npr. poškodb z injekcijsko iglo, čim manjša in
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.
je čim manj možnosti, da bi predvideni uporabnik napačno ravnal s pripomočkom, če je to ustrezno, pa tudi čim manj možnosti za napačno razlaganje rezultatov.
Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
Pripomočki, ki naj bi jih uporabljali nestrokovnjaki, kadar je to ustrezno, vključujejo postopek, s katerim:
can verify that, at the time of use, the device will perform as intended by the manufacturer, and
nestrokovnjak lahko preveri, ali bo pripomoček med uporabo deloval, kot je predvidel proizvajalec, in
if applicable, is warned if the device has failed to provide a valid result.
se nestrokovnjaka po potrebi opozori, če pripomoček ne zagotovi veljavnega rezultata.
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
ZAHTEVE GLEDE INFORMACIJ, PRILOŽENIH PRIPOMOČKU
Label and instructions for use
Oznaka in navodila za uporabo
General requirements regarding the information supplied by the manufacturer
Splošne zahteve glede informacij, ki jih zagotovi proizvajalec
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.
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.
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:
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:
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).
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.
In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
Zlasti navodila za uporabo so napisana tako, da jih predvideni uporabnik brez težav razume, po potrebi pa so dopolnjena z risbami in diagrami;
The information required on the label shall be provided on the device itself.
zahtevane informacije na oznaki so navedene na samem pripomočku.
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.
Če to ni izvedljivo ali ustrezno, se nekatere ali vse informacije navedejo na embalaži vsake enote in/ali embalaži več pripomočkov;
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.
oznake so v čitljivi obliki in se lahko dopolnijo s strojno čitljivimi informacijami, kot so radiofrekvenčna identifikacija (RFID) ali črtne kode;
Instructions for use shall be provided together with devices.
navodila za uporabo se predložijo skupaj s pripomočki.
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.
Izjemoma navodila za uporabo niso potrebna za pripomočke razredov I in IIa, če se takšni pripomočki lahko varno uporabljajo brez takšnih navodil in razen če ni drugače določeno v tem oddelku;
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.
kadar se enemu uporabniku in/ali na eno lokacijo dobavi več pripomočkov, je dovolj en izvod navodil za uporabo, če se s tem strinja kupec, ki pa lahko v vsakem primeru zahteva nadaljnje brezplačne izvode;
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.
navodila za uporabo se uporabniku zagotovijo v nepapirni obliki (npr. elektronski obliki), in sicer v obsegu in samo pod pogoji, določenimi v Uredbi (EU) št. 207/2012 ali v kakršnih koli naknadnih izvedbenih pravilih, sprejetih na podlagi te uredbe;
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.
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;
Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols.
če je to ustrezno, so informacije, ki jih navede proizvajalec, v obliki mednarodno priznanih simbolov.
Any symbol or identification colour used shall conform to the harmonised standards or CS.
Vsak uporabljen simbol ali identifikacijska barva je v skladu s harmoniziranimi standardi ali skupnimi specifikacijami.
In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
Na področjih, na katerih harmonizirani standardi ali skupne specifikacije ne obstajajo, so simboli in barve opisani v dokumentaciji, priloženi pripomočku.
Information on the label
Informacije na oznaki
The label shall bear all of the following particulars:
Na oznaki so navedeni vsi naslednji podatki:
the name or trade name of the device;
ime ali trgovsko ime pripomočka;
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;
podatki, ki so nujno potrebni, da lahko uporabnik prepozna pripomoček, vsebino embalaže in, kadar to ni očitno za uporabnika, predvideni namen pripomočka;
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
ime, registrirano trgovsko ime ali registrirana blagovna znamka proizvajalca ter naslov njegovega registriranega kraja poslovanja;
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;
kadar ima proizvajalec svoj registrirani kraj poslovanja zunaj Unije, ime pooblaščenega predstavnika in naslov registriranega kraja poslovanja pooblaščenega predstavnika;
where applicable, an indication that the device contains or incorporates:
po potrebi navedba, da pripomoček vključuje ali zajema:
a medicinal substance, including a human blood or plasma derivative, or
zdravilno učinkovino, vključno z derivati človeške krvi ali plazme, ali
tissues or cells, or their derivatives, of human origin, or
človeška tkiva ali celice ali njihove derivate ali
tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
živalska tkiva ali celice ali njihove derivate iz Uredbe (EU) št. 722/2012;
where applicable, information labelled in accordance with Section 10.4.5.;
po potrebi informacije, označene v skladu z oddelkom 10.4.5.;
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;
številka partije ali serijska številka pripomočka, ki sledi besedi ŠTEVILKA PARTIJE ali SERIJSKA ŠTEVILKA ali enakovrednemu simbolu, kot je ustrezno;
the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
zapis UDI iz člena 27(4) in dela C Priloge VII;
an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
nedvoumna navedba roka, do katerega je pripomoček varen za uporabo ali vsaditev in izraženega vsaj kot leto in mesec, kjer je to ustrezno;
where there is no indication of the date until when it may be used safely, the date of manufacture.
kadar ni navedbe datuma, do katerega se lahko varno uporablja, datum izdelave.
This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;
Ta datum izdelave je lahko vključen kot del številke partije ali serijske številke, če je datum jasno prepoznaven;
an indication of any special storage and/or handling condition that applies;
navedba morebitnih posebnih veljavnih pogojev skladiščenja in/ali ravnanja;
if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
če je pripomoček ob dobavi sterilen, navedba njegovega sterilnega stanja in metode sterilizacije;
warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person.
opozorila ali previdnostni ukrepi, ki jih je treba sprejeti, na katere je treba takoj opozoriti uporabnika pripomočka in katero koli drugo osebo.
This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;
Količina teh informacij je lahko minimalna, vendar se v tem primeru in ob upoštevanju predvidenih uporabnikov v navodila za uporabo vključijo podrobnejše informacije;
if the device is intended for single use, an indication of that fact.
treba je navesti, ali je pripomoček predviden za enkratno uporabo.
A manufacturer's indication of single use shall be consistent across the Union;
Navedba proizvajalca o enkratni uporabi je enotna v vsej Uniji;