natgillin/translations-raw huggingface dataset:
Directive 70/156/EEC is repealed with effect from 29 April 2009, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the directives set out in Part B of Annex XX.
Direktiva 70/156/EGS, se razveljavi z učinkom od 29. aprila 2009, kar pa ne vpliva na obveznosti držav članic v zvezi z roki za prenos v državno zakonodajo ter uporabo direktiv iz dela B Priloge XX.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex XXI.
Sklicevanje na razveljavljeno direktivo se razume kot sklicevanje na to direktivo in se bere skladno s tabelo ujemanja v Prilogi XXI.
OJ C 108, 30.4.2004, p. 29.
UL C 108, 30.4.2004, str. 29.
Opinion of the European Parliament of 11 February 2004 (OJ C 97 E, 22.4.2004, p. 370), Council Common Position of 11 December 2006 (OJ C 64 E, 20.3.2007, p. 1), Position of the European Parliament of 10 May 2007 (not yet published in the Official Journal) and Council Decision of 23 July 2007.
Mnenje Evropskega parlamenta z dne 11. februarja 2004 (UL C 97 E, 22.4.2004, str. 370), skupno stališče Sveta z dne 11. decembra 2006 (UL C 64 E, 20.3.2007, str. 1), Stališče Evropskega parlamenta z dne 10. maja 2007 (še ni objavljeno v UL) in Sklep Sveta z dne 23. julija 2007.
Directive as last amended by Regulation (EC) No 715/2007 of the European Parliament and of the Council (OJ L 171, 29.6.2007, p. 1).
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 715/2007 Evropskega parlamenta in Sveta (UL L 171, 29.6.2007, str. 1).
Directive as last amended by Council Directive 2006/96/EC.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Sveta 2006/96/ES.
Directive as last amended by Directive 2006/103/EC (OJ L 363, 20.12.2006, p. 344).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Sveta 2006/103/ES (UL L 363, 20.12.2006, str. 344).
Annex I Complete list of information for the purpose of EC type-approval of vehicles
Priloga I Popoln seznam podatkov za ES-homologacijo vozila
Annex II Definition of vehicle categories and vehicle types
Priloga II Opredelitev kategorij in tipov vozil
Annex III Information document for the purpose of EC type-approval of vehicles
Priloga III Opisni list za ES-homologacijo vozila
Annex IV List of requirements for the purpose of EC type-approval of vehicles
Priloga IV Seznam zahtev za ES-homologacijo vozil
Appendix: List of requirements for EC type-approval of vehicles belonging to category M1, produced in small series
Dodatek: Seznam zahtev za ES-homologacijo vozil kategorije M1, izdelanih v majhnih serijah
Annex V Procedures to be followed during EC type-approval of vehicles
Priloga V Postopki za ES-homologacijo vozil
Appendix 1: Standards with which the entities referred to in Article 41 have to comply
Dodatek 1: Standardi, katerih zahteve morajo izpolnjevati organi iz člena 41
Appendix 2: Procedure for the assessment of the technical services
Dodatek 2: Postopek presoje tehničnih služb
Annex VI EC type-approval certificate
Priloga VI Certifikat o ES-homologaciji
Appendix: List of the regulatory acts to which the type of vehicle complies
Dodatek: Seznam regulativnih aktov, s katerimi je skladen tip vozila
Annex VII EC type-approval certificate numbering system
Priloga VII Sistem številčnega označevanja certifikatov o ES-homologaciji
Appendix: EC component and separate technical unit type-approval mark
Dodatek: Oznaka ES-homologacije za sestavne dele in samostojne tehnične enote
Annex VIII Test results
Priloga VIII Rezultati preskusov
Annex IX EC Certificate of conformity
Priloga IX ES-certifikat o skladnosti
Annex X Conformity of production procedures
Priloga X Skladnost proizvodnje
Annex XI Nature of and provisions for special purpose vehicles
Priloga XI Lastnosti vozil za posebne namene in določbe zanje
Appendix 1: Motor-caravans, ambulances and hearses
Dodatek 1: Bivalna vozila, reševalna vozila in pogrebna vozila
Appendix 2: Armoured vehicles
Dodatek 2: Neprebojna vozila
Appendix 3: Wheel-chair accessible vehicles
Dodatek 3: Vozila, dostopna z invalidskim vozičkom
Appendix 4: Other special purpose vehicles (including trailer caravans)
Dodatek 4: Druga vozila za posebne namene (vključno z bivalnimi prikolicami)
Appendix 5: Mobile cranes
Dodatek 5: Avto-dvigala
Annex XII Small series and end-of-series limits
Priloga XII Omejitve števila vozil za majhne serije in za zaključek serije
Annex XIII List of parts or equipment which are capable of posing a significant risk to the correct functioning of systems that are essential for the safety of the vehicle or its environmental performance, their performance requirements, appropriate test procedures, marking and packaging provisions
Priloga XIII Seznam delov ali opreme, ki lahko predstavljajo veliko tveganje za pravilno delovanje sistemov, ki so bistveni za varnost vozila ali njegovo okoljsko učinkovitost, njihove zahteve glede učinkovitosti, ustrezni preskusni postopki ter določbe o označevanju in pakiranju
Annex XIV List of EC type-approvals issued pursuant to regulatory acts
Priloga XIV Seznam ES-homologacij, izdanih na podlagi regulativnih aktov
Annex XV List of the regulatory acts for which a manufacturer may be designated as technical service
Priloga XV Seznam regulativnih aktov, za katere je proizvajalec lahko imenovan kot tehnična služba
Annex XVI List of the regulatory acts for which virtual testing methods may be used by a manufacturer or a technical service
Priloga XVI Seznam regulativnih aktov, za katere lahko proizvajalec oziroma tehnična služba uporabi virtualne preskusne metode
Appendix 1: General conditions required from virtual testing methods
Dodatek 1: Splošni pogoji za virtualne preskusne metode
Appendix 2: Specific conditions concerning virtual testing methods
Dodatek 2: Posebni pogoji v zvezi z virtualnimi preskusnimi metodami
Annex XVII Procedures to be followed during multi-stage EC type-approval
Priloga XVII Postopki za večstopenjsko ES-homologacijo
Appendix: Model of the manufacturer’s additional plate
Dodatek: Vzorec dodatne tablice proizvajalca
Annex XVIII Certificate of origin of the vehicle — Manufacturer’s declaration of base/incomplete vehicle which is not provided with a Certificate of Conformity
Priloga XVIII Potrdilo o poreklu vozila – Izjava proizvajalca osnovnega/nedodelanega vozila, ki nima certifikata o skladnosti
Annex XIX Timetable for the enforcement of this Directive in respect of type-approval
Priloga XIX Časovni razpored izvrševanja te direktive za homologacijo
Annex XX Time-limits for the transposition of repealed directives into national law
Priloga XX Časovne omejitve za prenos razveljavljenih direktiv v nacionalno zakonodajo
Annex XXI Correlation table
Priloga XXI Korelacijska tabela
Council Directive 92/53/EEC of 18 June 1992 amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers [4] limited application of the Community whole vehicle type-approval procedure to the vehicle category M1. However, in order to complete the internal market and to ensure that it functions properly, the scope of the present Directive should cover all categories of vehicles, enabling manufacturers to benefit from the advantages of the internal market by means of the Community type-approval.
Direktiva Sveta 92/53/EGS z dne 18. junija 1992 o spremembah Direktive 70/156/EGS o približevanju zakonodaje držav članic v zvezi s homologacijo motornih in priklopnih vozil [4] je omejila uporabo postopka ES-homologacije za celotno vozilo na vozila kategorije M1, vendar bi moralo zaradi vzpostavitve notranjega trga in zagotovitve njegovega pravilnega delovanja področje uporabe te direktive zajeti vse kategorije vozil, s čimer bi proizvajalcem omogočili izkoristiti prednosti notranjega trga z uporabo ES-homologacije.
Directive 2007/47/EC of the European Parliament and of the Council
Direktiva 2007/47/ES Evropskega parlamenta in Sveta
amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
o spremembah Direktive Sveta 90/385/EGS o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev, Direktive Sveta 93/42/EGS o medicinskih pripomočkih in Direktive 98/8/ES o dajanju biocidnih pripravkov v promet
Council Directive 93/42/EEC requires the Commission to submit a report to the Council, no later than five years from the date of implementation of that Directive, concerning: (i) information on incidents occurring following the placing of devices on the market, (ii) clinical investigation carried out in accordance with the procedure set out in Annex VIII to Directive 93/42/EEC, and (iii) design examination and EC type examination of medical devices that incorporate, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and which is liable to act upon the body with action ancillary to that of the device.
Direktiva Sveta 93/42/EGS zahteva, da Komisija, najpozneje pet let po datumu začetka izvajanja te direktive, Svetu predloži poročilo o: (i) podatkih o zapletih, do katerih pride po dajanju pripomočkov na trg, (ii) kliničnih preiskavah, izvedenih v skladu s postopkom iz Priloge VIII k Direktivi 93/42/EGS, in (iii) pregledih načrtovanja in tipskih preskusih medicinskih pripomočkov s strani ES, ki kot sestavni del vsebujejo snov, ki lahko velja, če se uporablja ločeno, za zdravilo, kakor je določeno v Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, in ki ima lahko ob tem medicinskem pripomočku na telo dopolnilni učinek.
The Commission brought forward the conclusions of that report in its Communication to the Council and the European Parliament on medical devices which, at the request of the Member States, was expanded to cover all aspects of the Community regulatory framework for medical devices.
Komisija je sklepe navedenega poročila predstavila v Sporočilu Svetu in Evropskemu parlamentu o medicinskih pripomočkih, ki je bilo na zahtevo držav članic razširjeno, da je zajelo vse vidike regulatornega okvira Skupnosti, ki velja za medicinske pripomočke.
This Communication was welcomed by the Council in its Conclusions on medical devices of 2 December 2003.
To sporočilo je Svet povzel v Sklepih o medicinskih pripomočkih z dne 2. decembra 2003.
It was also discussed by the European Parliament which on 3 June 2003 adopted a resolution on the health implications of Directive 93/42/EEC.
O njem je razpravljal tudi Evropski parlament, ki je 3. junija 2003 sprejel resolucijo o posledicah Direktive 93/42/EGS za zdravje.
Following from the conclusions drawn in that Communication it is necessary and appropriate to amend Council Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/8/EC of the European Parliament and of the Council.
Glede na sklepe tega sporočila je potrebno in primerno spremeniti Direktivo Sveta 90/385/EGS, Direktivo 93/42/EGS in Direktivo 98/8/ES Evropskega parlamenta in Sveta.
To ensure consistency of interpretation and implementation between Directives 93/42/EEC and 90/385/EEC the legal framework related to issues such as authorised representative, the European databank, health protection measures, and the application of Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma, as introduced by Directive 2000/70/EC, should be extended to Directive 90/385/EEC.
Da bi zagotovili doslednost pri razlaganju in izvajanju direktiv 93/42/EGS in 90/385/EGS, bi se moral pravni okvirov zvezi z zadevami, kot so pooblaščeni zastopnik, Evropska banka podatkov, ukrepi za varovanje zdravja in uporaba Direktive 93/42/EGS v zvezi z medicinskimi pripomočki, ki vsebujejo stabilne derivate človeške krvi ali človeške plazme, kakor jih določa Direktiva 2000/70/ES, razširiti na Direktivo 90/385/EGS.
The application of the provisions on medical devices incorporating stable derivates of human blood or human plasma includes application of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.
Uporaba določb o medicinskih pripomočkih, ki vsebujejo stabilne derivate človeške krvi ali človeške plazme, vključuje uporabo Direktive 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES.
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device.
Treba je pojasniti, da je programska oprema sama po sebi, kadar jo proizvajalec posebej nameni za uporabo za enega ali več medicinskih namenov, določenih v opredelitvi medicinskega pripomočka, medicinski pripomoček.
Software for general purposes when used in a healthcare setting is not a medical device.
Programska oprema za splošne namene, ki se uporablja v zdravstvenem okolju, ni medicinski pripomoček.
Particular care should be taken to ensure that the reprocessing of medical devices does not endanger patients’ safety or health.
Zlasti bi bilo treba zagotoviti, da ponovna predelava medicinskih pripomočkov ne ogroža varnosti ali zdravja bolnikov.
It is therefore necessary to provide clarification on the definition of the term ‘single use’, as well as to make provision for uniform labelling and instructions for use.
Zato je treba pojasniti opredelitev izraza „enkratna uporaba“, kakor tudi uvesti določbe za enotne oznake in navodila za uporabo.
Moreover, the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.
Poleg tega bi morala Komisija nadalje analizirati, ali so dodatni ukrepi ustrezni za zagotovitev visoke ravni varnosti bolnikov.
In the light of technical innovation and the development of initiatives at the international level it is necessary to enhance the provisions on clinical evaluation, including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.
Glede na tehnične inovacije in razvoj pobud na mednarodni ravni je treba okrepiti določbe o kliničnem vrednotenju, vključno s pojasnilom, da se klinični podatki običajno zahtevajo za vse pripomočke, ne glede na razvrstitev, in možnosti centralizacije podatkov o kliničnih preiskavah v Evropski banki podatkov.
In order to provide clearer evidence of the compliance of custom-made device manufacturers, an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced, as is already in place for other devices, and to enhance patient information, a requirement should be introduced that the ‘Statement’ under Annex VIII to Directive 93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.
Da se zagotovijo bolj jasni dokazi o skladnosti proizvajalcev uporabniku prilagojenih pripomočkov, bi bilo treba vpeljati izrecno zahtevo po poprodajnem sistemu pregledov proizvodnje, ki bi vključevalo poročanje o neželenih dogodkih, za poročanje organom, ki že obstaja za druge pripomočke; da se okrepi informiranje bolnikov, bi bilo treba oblikovati zahtevo, da bi morala biti tudi bolniku na voljo „izjava“ iz Priloge VIII k Direktivi 93/42/EGS, ki bi morala vključevati ime proizvajalca.
In the light of technical progress in information technology and medical devices, a process should be provided to allow information supplied by the manufacturer to be available by other means.
Glede na tehnični napredek na področjih informacijske tehnologije in medicinskih pripomočkov bi bilo treba zagotoviti postopek, ki bo omogočil razpoložljivost podatkov, ki jih predloži proizvajalec, z drugimi sredstvi.
Manufacturers of Class I sterile and/or measuring medical devices should be given the option of using the full quality assurance conformity assessment module in order to provide them with more flexibility in the choice of compliance modules.
Proizvajalci sterilnih pripomočkov in/ali merilnih medicinskih pripomočkov iz razreda I bi morali imeti možnost uporabe modula za popolno zagotavljanje kakovosti pri ocenjevanju skladnosti, da se jim zagotovi večja prožnost pri izbiri modulov skladnosti.
In order to support market surveillance activities by Member States it is necessary and appropriate, in the case of implantable devices, to increase the time period for the retention of documents for administrative purposes to at least 15 years.
Da se podpre nadzor trga s strani držav članic, je potrebno in primerno v primeru pripomočkov za vsaditev povečati obdobje hranjenja dokumentov za upravne namene na najmanj 15 let.
For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.
Za ustrezno in učinkovito izvajanje Direktive 93/42/EGS v zvezi z regulatornimi nasveti glede vprašanj razvrščanja na nacionalni ravni, zlasti vprašanja, ali je izdelek opredeljen kot medicinski pripomoček ali ne, je v interesu nacionalnega nadzora trga ter zdravja in varstva ljudi, da se vzpostavi postopek odločanja, ali je izdelek opredeljen kot medicinski pripomoček ali ne.
To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device.
Da se v primeru, ko proizvajalec nima registrirane poslovne enote v Skupnosti, zagotovi, da imajo pristojni organi eno osebo, ki jo je pooblastil proizvajalec, na katero se lahko obrnejo pri zadevah, ki se nanašajo na skladnost pripomočkov z Direktivo, je treba za takšne proizvajalce uvesti obveznost imenovanja pooblaščenega zastopnika za pripomoček.
This designation should be effective at least for all devices of the same model.
To imenovanje bi moralo veljati vsaj za vse pripomočke istega modela.
To further ensure public health and safety it is necessary to provide for a more consistent application of the provisions on health protection measures.
Da se še naprej varujeta javno zdravje in javna varnost, je treba zagotoviti bolj enotno uporabo določb o ukrepih za varovanje zdravja.
Particular care should be taken to ensure that, when in use, the products do not endanger patients’ health or safety.
Zlasti bi bilo treba zagotoviti, da ob uporabi pripomočkov nista ogrožena varnost ali zdravje bolnikov.
In support of transparency in Community legislation, certain information related to medical devices and their conformity with Directive 93/42/EEC, in particular information on registration, on vigilance reports and on certificates, should be available to any interested party and the general public.
V podporo preglednosti zakonodaje Skupnosti bi bilo treba vsaki zainteresirani stranki in širši javnosti zagotoviti dostop do nekaterih informacij v zvezi z medicinskimi pripomočki in njihovo skladnostjo z Direktivo 93/42/EGS, zlasti informacij o registraciji, vigilančnih poročilih in potrdilih.
To better coordinate the application and efficiency of national resources when applied to issues related to Directive 93/42/EEC, the Member States should cooperate with each other and at international level.
Za boljše usklajevanje uporabe in učinkovitosti nacionalnih virov, kadar se uporabljajo za vprašanja v zvezi z Direktivo 93/42/EGS, bi morale države članice sodelovati med seboj in na mednarodni ravni.
As design for patient safety initiatives play an increasing role in public health policy, it is necessary to expressly set out the need to consider ergonomic design in the essential requirements.
Ker imajo pobude za načrtovanje varnosti bolnikov vedno večjo vlogo v politiki javnega zdravja, je treba izrecno določiti potrebo po upoštevanju ergonomskega načrtovanja v bistvenih zahtevah.
In addition the level of training and knowledge of the user, such as in the case of a lay user, should be further emphasised within the essential requirements.
Poleg tega bi morala biti v bistvenih zahtevah nadalje poudarjena stopnja usposobljenosti in znanje uporabnika, kot v primeru laičnega uporabnika.
The manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.
Proizvajalec izdelka bi moral posebno pozornost posvetiti posledicam zlorabe izdelka in njegovim škodljivim učinkom na človeško telo.
In the light of experience gained regarding activities of both the notified bodies and the authorities in the assessment of devices which require intervention of the appropriate authorities for medicines and human blood derivatives their duties and tasks should be clarified.
Glede na izkušnje, pridobljene v zvezi z dejavnostmi priglašenih organov in pristojnih organov, bi bilo treba pri oceni pripomočkov, ki zahtevajo posredovanje ustreznih organov, pristojnih za zdravila in derivate človeške krvi, pojasniti njihove dolžnosti in naloge.
Taking account of the growing importance of software in the field of medical devices, be it as stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement.
Ob upoštevanju naraščajočega pomena programske opreme na področju medicinskih pripomočkov, ne glede na to, ali gre za samostojno programsko opremo ali programsko opremo, vgrajeno v pripomoček, bi morala validacija ustreznosti programske opreme v skladu s stanjem tehničnega razvoja postati bistvena zahteva.
In the light of the increased use of third Parties to carry out the design and manufacture of devices on behalf of the manufacturer, it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.
Glede na naraščajoče izvajanje načrtovanja in izdelave pripomočkov s strani tretjih oseb v imenu proizvajalca, je pomembno, da proizvajalec dokaže, da izvaja ustrezni nadzor tretjih oseb za nadaljnje zagotavljanje učinkovitega delovanja sistema kakovosti.
The classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices.
Klasifikacijska pravila temeljijo na spoznanjih o ranljivosti človeškega telesa ob upoštevanju morebitnih nevarnosti v zvezi s tehničnim načrtovanjem in izdelavo pripomočkov.
Explicit prior authorisation with regard to conformity, including an assessment of the design documentation, is required for Class III devices to be placed on the market.
Za dajanje pripomočkov iz razreda III na trg je potrebna izrecna predhodna odobritev z vidika skladnosti, vključno z oceno projektne dokumentacije.