natgillin/translations-raw huggingface dataset:
are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;
razred I, če so namenjeni prehodni uporabi;
are reusable surgical instruments, in which case they are classified as class I;
razred IIa, če so namenjeni kratkoročni uporabi, razen če se uporabljajo v ustni votlini do žrela, v ušesnem kanalu do bobniča ali v nosni votlini; v tem primeru se razvrstijo v razred I; in
are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;
razred IIb, če so namenjeni dolgoročni uporabi, razen če se uporabljajo v ustni votlini do žrela, v ušesnem kanalu do bobniča ali v nosni votlini in če jih sluznica ne vsrka; v tem primeru se razvrstijo v razred IIa.
are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
Vsi invazivni pripomočki, ki se uporabljajo prek telesnih odprtin ter ki niso kirurško invazivni pripomočki in so namenjeni priključitvi na aktivne pripomočke razreda IIa, razreda IIb ali razreda III, se razvrstijo v razred IIa.
have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or
Pravilo 6
are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.
Vsi kirurško invazivni pripomočki, namenjeni prehodni uporabi, se razvrstijo v razred IIa, razen če:
Rule 7
so posebej namenjeni nadziranju, diagnosticiranju, spremljanju ali odpravljanju okvar srca ali centralnega krvožilnega sistema prek neposrednega stika s temi deli telesa; v tem primeru se razvrstijo v razred III;
All surgically invasive devices intended for short-term use are classified as class IIa unless they:
so kirurški instrumenti za ponovno uporabo; v tem primeru se razvrstijo v razred I;
are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;
so posebej namenjeni uporabi v neposrednem stiku s srcem, centralnim krvožilnim sistemom ali centralnim živčnim sistemom; v tem primeru se razvrstijo v razred III;
have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;
so namenjeni dovajanju energije v obliki ionizirajočega sevanja; v tem primeru se razvrstijo v razred IIb;
are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or
imajo biološki učinek ali se v celoti ali v glavnem absorbirajo; v tem primeru se razvrstijo v razred IIb; ali
are intended to administer medicines, in which case they are classified as class IIb.
so namenjeni dajanju zdravil s pomočjo sistema za doziranje, če se takšno dajanje zdravila izvaja na način, ki je potencialno nevaren ob upoštevanju načina uporabe; v tem primeru se razvrstijo v razred IIb.
Rule 8
Pravilo 7
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
Vsi kirurško invazivni pripomočki, namenjeni kratkoročni uporabi, se razvrstijo v razred IIa, razen če:
are intended to be placed in the teeth, in which case they are classified as class IIa;
so namenjeni dovajanju energije v obliki ionizirajočega sevanja; v tem primeru se razvrstijo v razred IIb;
are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;
imajo biološki učinek ali se v celoti ali v glavnem absorbirajo; v tem primeru se razvrstijo v razred III;
have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;
so namenjeni kemični spremembi v telesu; v tem primeru se razvrstijo v razred IIb, razen če se pripomočki vstavljajo v zobe, ali
are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;
so namenjeni dajanju zdravil; v tem primeru se razvrstijo v razred IIb.
are intended to administer medicinal products, in which case they are classified as class III;
Pravilo 8
are active implantable devices or their accessories, in which cases they are classified as class III;
Vsi pripomočki za vsaditev ali dolgoročno kirurško invazivni pripomočki se razvrstijo v razred IIb, razen če:
are breast implants or surgical meshes, in which cases they are classified as class III;
so namenjeni vstavljanju v zobe; v tem primeru se razvrstijo v razred IIa;
are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or
so namenjeni uporabi v neposrednem stiku s srcem, centralnim krvožilnim sistemom ali centralnim živčnim sistemom; v tem primeru se razvrstijo v razred III;
are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.
imajo biološki učinek ali se v celoti ali v glavnem absorbirajo; v tem primeru se razvrstijo v razred III;
ACTIVE DEVICES
so namenjeni kemični spremembi v telesu; v tem primeru se razvrstijo v razred III, razen če se pripomočki vstavljajo v zobe; ali
Rule 9
so namenjeni dajanju zdravil; v tem primeru se razvrstijo v razred III.
All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.
so aktivni pripomočki za vsaditev ali njihovi dodatki; v tem primeru se razvrstijo v razred III,
All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.
so prsni vsadki ali kirurške mrežice; v tem primeru se razvrstijo v razred III;
All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
so celotne ali delne proteze; v tem primeru se razvrstijo v razred III, z izjemo pomožnih sestavnih delov, kot so vijaki, zagozde, ploščice in instrumenti; ali
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.
so vsadki za nadomeščanje medvretenčne ploščice ali pripomočki za vsaditev, ki pridejo v stik s hrbtenico; v tem primeru se razvrstijo v razred III, z izjemo sestavnih delov, kot so vijaki, zagozde, ploščice in instrumenti.
Rule 10
AKTIVNI PRIPOMOČKI
Active devices intended for diagnosis and monitoring are classified as class IIa:
Pravilo 9
if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;
Vsi aktivni terapevtski pripomočki, namenjeni dajanju ali izmenjavi energije, se razvrstijo v razred IIa, razen če so njihove lastnosti take, da se lahko z njimi vnaša energija v človeško telo ali izmenjuje energija s človeškim telesom na potencialno nevaren način, ob upoštevanju narave, gostote in mesta dovajanja energije; v tem primeru se razvrstijo v razred IIb.
if they are intended to image in vivo distribution of radiopharmaceuticals; or
Vsi aktivni pripomočki, namenjeni nadzoru ali spremljanju učinkovitosti aktivnih terapevtskih pripomočkov razreda IIb ali namenjeni neposrednemu vplivu na učinkovitost takih pripomočkov, se razvrstijo v razred IIb.
if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.
Vsi aktivni pripomočki, namenjeni oddajanju ionizirajočega sevanja za terapevtske namene, vključno s pripomočki, ki nadzorujejo ali spremljajo takšne pripomočke ali ki neposredno vplivajo na njihovo delovanje, se razvrstijo v razred IIb.
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
Vsi aktivni pripomočki, namenjeni nadzoru, spremljanju ali neposrednemu vplivu na učinkovitost aktivnih pripomočkov za vsaditev, se razvrstijo v razred III.
Rule 11
Pravilo 10
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
Aktivni pripomočki, namenjeni diagnozi in spremljanju, se razvrstijo v razred IIa:
death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
če so namenjeni dovajanju energije, ki jo bo absorbiralo človeško telo, razen pripomočkov, ki so namenjeni osvetljevanju človeškega telesa v vidnem spektru; v tem primeru se razvrstijo v razred I;
a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
če so namenjeni slikanju in vivo distribucije radiofarmakov ali
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
če so namenjeni neposrednemu diagnosticiranju ali spremljanju vitalnih fizioloških procesov, razen če so izrecno namenjeni spremljanju vitalnih fizioloških parametrov, narava sprememb teh parametrov pa je taka, da bi lahko to pomenilo neposredno nevarnost za pacienta, na primer sprememb delovanja srca, dihanja in delovanja centralnega živčnega sistema, ali če so namenjeni diagnosticiranju v kliničnih stanjih, ko je pacient v neposredni nevarnosti; v tem primeru se razvrstijo v razred IIb.
All other software is classified as class I.
Aktivni pripomočki, namenjeni oddajanju ionizirajočega sevanja in namenjeni diagnostični ali terapevtski radiologiji, vključno s pripomočki za intervencijsko radiologijo in pripomočki, ki nadzorujejo ali spremljajo takšne pripomočke ali ki neposredno vplivajo na njihovo delovanje, se razvrstijo v razred IIb.
Rule 12
Pravilo 11
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.
Programska oprema, namenjena pridobivanju informacij, potrebnih za sprejemanje odločitev glede diagnoze ali terapije, se razvrsti v razred IIa, razen če lahko te odločitve povzročijo:
Rule 13
smrt ali nepopravljivo poslabšanje zdravstvenega stanja osebe; v tem primeru se razvrsti v razred III; ali
All other active devices are classified as class I.
resno poslabšanje zdravstvenega stanja osebe ali kirurški poseg; v tem primeru se razvrsti v razred IIb.
SPECIAL RULES
Programska oprema, namenjena spremljanju fizioloških procesov, se razvrsti v razred IIa, razen če je namenjena spremljanju vitalnih fizioloških parametrov, pri čemer je narava sprememb teh parametrov taka, da bi lahko pomenila neposredno nevarnost za pacienta; v tem primeru se razvrsti v razred IIb.
Rule 14
Vsa druga programska oprema se razvrsti v razred I.
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.
Pravilo 12
Rule 15
Vsi aktivni pripomočki, namenjeni dajanju in/ali odstranjevanju zdravil, telesnih tekočin ali drugih snovi v telo ali iz njega, se razvrstijo v razred IIa, razen če se to izvaja na potencialno nevaren način, ob upoštevanju narave zadevnih snovi, zadevnega dela telesa in načina uporabe; v tem primeru se razvrstijo v razred IIb.
All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.
Pravilo 13
Rule 16
Vsi drugi aktivni pripomočki se razvrstijo v razred I.
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.
POSEBNA PRAVILA
All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.
Pravilo 14
This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.
Vsi pripomočki, ki kot sestavni del vsebujejo snov, ki se ob ločeni uporabi lahko šteje za zdravilo, kot je opredeljeno v točki 2 člena 1 Direktive 2001/83/ES, vključno z zdravilom, pridobljenim iz človeške krvi ali človeške plazme, kot je opredeljeno v točki 10 člena 1 navedene direktive, in ki dopolnjuje učinek pripomočkov, se razvrstijo v razred III.
Rule 17
Pravilo 15
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.
Vsi pripomočki, ki se uporabljajo za kontracepcijo ali preprečevanje prenosa spolno prenosljivih bolezni, se razvrstijo v razred IIb, razen če so pripomočki za vsaditev ali dolgoročno invazivni pripomočki; v tem primeru se razvrstijo v razred III.
Rule 18
Pravilo 16
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.
Vsi pripomočki, izrecno namenjeni dezinfekciji, čiščenju, izpiranju ali po potrebi vlaženju kontaktnih leč, se razvrstijo v razred IIb.
Rule 19
Vsi pripomočki, izrecno namenjeni dezinfekciji ali sterilizaciji medicinskih pripomočkov, se razvrstijo v razred IIa, razen če so to dezinfekcijske raztopine ali čistilno-dezinfekcijski pripomočki, izrecno namenjeni dezinfekciji invazivnih pripomočkov, kot končna faza obdelave; v tem primeru se razvrstijo v razred IIb.
All devices incorporating or consisting of nanomaterial are classified as:
To pravilo se ne uporablja za pripomočke, ki so namenjeni čiščenju pripomočkov, razen kontaktnih leč, samo z mehanskim delovanjem.
class III if they present a high or medium potential for internal exposure;
Pravilo 17
class IIb if they present a low potential for internal exposure; and
Pripomočki, izrecno namenjeni snemanju diagnostičnih slik z rentgenskimi žarki, se razvrstijo v razred IIa.
class IIa if they present a negligible potential for internal exposure.
Pravilo 18
Rule 20
Vsi pripomočki, izdelani z uporabo človeških ali živalskih tkiv, celic ali njihovih derivatov, ki so neviabilni ali so postali neviabilni, se razvrstijo v razred III, razen če so takšni pripomočki izdelani z uporabo živalskih tkiv, celic ali njihovih derivatov, ki so neviabilni ali so postali neviabilni, in so pripomočki namenjeni samo stiku z nepoškodovano kožo.
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.
Pravilo 19
Rule 21
Vsi pripomočki, ki vsebujejo nanomateriale ali so sestavljeni iz njih, se razvrstijo v:
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 are classified as:
razred III, če pri njih obstaja velika ali srednje velika nevarnost za notranjo izpostavljenost;
class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;
razred IIb, če pri njih obstaja majhna nevarnost za notranjo izpostavljenost, in
class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;
razred IIa, če pri njih obstaja zanemarljiva nevarnost za notranjo izpostavljenost.
class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and
Pravilo 20
class IIb in all other cases.
Vsi invazivni pripomočki, ki se uporabljajo prek telesnih odprtin ter niso kirurško invazivni pripomočki, in pri katerih se zdravila vnašajo z vdihavanjem, se razvrstijo v razred IIa, razen če njihov način delovanja bistveno vpliva na učinkovitost in varnost vnesenih zdravil ali so namenjeni zdravljenju stanj, v katerih je ogroženo življenje; v tem primeru se razvrstijo v razred IIb.
Rule 22
Pravilo 21
Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.
Pripomočki, sestavljeni iz snovi ali kombinacij snovi, ki so namenjene vnosu v človeško telo skozi telesno odprtino ali nanosu na kožo in ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu se razvrstijo v:
ANNEX IX
razred III, če njih ali njihove produkte presnove človeško telo sistematično absorbira, da bi dosegli predvideni namen;
CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
razred III, če svoj predvideni namen dosežejo v želodcu ali spodnjem prebavnem traktu in če njih ali njihove produkte presnove človeško telo sistematično absorbira;
QUALITY MANAGEMENT SYSTEM
razred IIa, če se nanašajo na kožo ali če se uporabljajo v nosni ali ustni votlini do žrela in svoj predvideni namen dosežejo v teh votlinah, in
The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned.
razred IIb v vseh drugih primerih.
The manufacturer shall ensure the application of the quality management system as specified in Section 2 and shall be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as specified in Section 3.
Pravilo 22
Quality management system assessment
Aktivni terapevtski pripomočki, ki so namenjeni tudi diagnosticiranju ali pa je vanje ta funkcija vključena in se s tem bistveno posega v način obravnavanja pacientov s pripomočkom, na primer sistemi z zaprto zanko ali avtomatski zunanji defibrilatorji, se razvrstijo v razred III.
The manufacturer shall lodge an application for assessment of its quality management system with a notified body.
PRILOGA IX
The application shall include:
UGOTAVLJANJE SKLADNOSTI NA PODLAGI SISTEMA VODENJA KAKOVOSTI IN OCENJEVANJA TEHNIČNE DOKUMENTACIJE
the name of the manufacturer and address of its registered place of business and any additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative, the name of the authorised representative and the address of the authorised representative's registered place of business,
SISTEM VODENJA KAKOVOSTI
all relevant information on the device or group of devices covered by the quality management system,
Proizvajalec vzpostavi, dokumentira in izvaja sistem vodenja kakovosti, kot je opisano v členu 10(9), in ohranja njegovo učinkovitost v celotni življenjski dobi zadevnih pripomočkov.
a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system,
Proizvajalec zagotovi uporabo sistema vodenja kakovosti, kot je navedeno v oddelku 2; pri proizvajalcu se opravi presoja, kot je določeno v oddelkih 2.3 in 2.4, in nadzor, kot je določeno v oddelku 3.
a draft of an EU declaration of conformity in accordance with Article 19 and Annex IV for the device model covered by the conformity assessment procedure,
Ocena sistema vodenja kakovosti
the documentation on the manufacturer's quality management system,
Proizvajalec pri priglašenem organu vloži vlogo za oceno svojega sistema vodenja kakovosti.
a documented description of the procedures in place to fulfil the obligations arising from the quality management system and required under this Regulation and the undertaking by the manufacturer in question to apply those procedures,
Vloga vključuje:
a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures,
ime proizvajalca in naslov njegovega registriranega kraja poslovanja in vseh dodatnih proizvodnih obratov, vključenih v sistem vodenja kakovosti, in, če vlogo proizvajalca vloži njegov pooblaščeni predstavnik, ime pooblaščenega predstavnika in naslov njegovega registriranega kraja poslovanja;
the documentation on the manufacturer's post-market surveillance system and, where applicable, on the PMCF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92,
vse relevantne informacije o pripomočku ali skupini pripomočkov, vključenih v sistem vodenja kakovosti;
a description of the procedures in place to keep up to date the post-market surveillance system, and, where applicable, the PMCF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92, as well as the undertaking by the manufacturer to apply those procedures,
pisno izjavo, da vloga ni bila vložena pri nobenem drugem priglašenem organu za isti sistem vodenja kakovosti za navedeni pripomoček, ali informacije o vsaki predhodni vlogi za isti sistem vodenja kakovosti za navedeni pripomoček;
documentation on the clinical evaluation plan, and
osnutek izjave EU o skladnosti v skladu s členom 19 in Prilogo IV za model pripomočka, zajetega v postopek ugotavljanja skladnosti;