natgillin/translations-raw huggingface dataset:
Conformity based on full quality management system plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the interoperability constituents concerned satisfy the requirements of the technical specification for interoperability (TSI) that apply to them.
Skladnost na podlagi celovitega sistema vodenja kakovosti in pregleda projektiranja je postopek ocenjevanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2 in 6 ter zagotovi in na lastno odgovornost izjavi, da zadevne komponente interoperabilnosti izpolnjujejo zahteve tehničnih specifikacij za interoperabilnost (TSI), ki se zanje uporabljajo.
The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.
Proizvajalec izvaja odobren sistem vodenja kakovosti za projektiranje, proizvodnjo ter končni pregled in preskušanje zadevnih komponent interoperabilnosti iz točke 3 ter je nadzorovan v skladu s točko 5.
The adequacy of the technical design of the interoperability constituents shall have been examined in accordance with point 4.
Ustreznost tehničnega projektiranja komponent interoperabilnosti se pregleda v skladu z določbami iz točke 4.
The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1.
Zahtevek za pregled projektiranja vloži proizvajalec pri priglašenem organu iz točke 3.1.
The application shall make it possible to understand the design, manufacture, maintenance and operation of the interoperability constituent, and to assess the conformity with the requirements of the TSI that apply to it.
Zahtevek omogoča razumevanje projektiranja, proizvodnje, vzdrževanja in delovanja komponente interoperabilnosti ter oceno njene skladnosti z zahtevami TSI, ki se zanjo uporabljajo.
It shall include:
Zahtevek vključuje:
The technical documentation shall make it possible to assess the interoperability constituent’s conformity with the requirements of the relevant TSI.
Tehnična dokumentacija omogoča ocenjevanje skladnosti komponente interoperabilnosti z zahtevami ustrezne TSI.
The technical documentation shall specify the requirements and cover, as far as relevant for the assessment, the design and operation of the interoperability constituent.
Tehnična dokumentacija opredeljuje zahteve in v obsegu, ki je pomemben za ocenjevanje, zajema projektiranje in delovanje komponente interoperabilnosti.
the supporting evidence for the adequacy of the technical design.
dodatna dokazila o ustreznosti tehničnega projektiranja.
The notified body shall examine the application, and where the design meets the requirements of the TSI that apply to the interoperability constituent it shall issue an EC design examination certificate to the manufacturer.
Priglašeni organ pregleda zahtevek in če projektiranje izpolnjuje zahteve TSI, ki se uporabljajo za komponento interoperabilnosti, proizvajalcu izda certifikat o ES-pregledu projektiranja.
The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design and if relevant, a description of the product’s functioning.
Certifikat vsebuje ime in naslov proizvajalca, ugotovitve pregleda, pogoje (če ti obstajajo) njegove veljavnosti, potrebne podatke za identifikacijo odobrenega projektiranja in, če je ustrezno, opis delovanja proizvoda.
The certificate and its annexes shall contain all relevant information to allow the conformity of interoperability constituent s with the examined design to be evaluated.
Certifikati in priloge vsebujejo vse ustrezne informacije, da se lahko oceni skladnost komponent interoperabilnosti s pregledanim projektom.
Where the design does not satisfy the requirements of the TSI, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če projekt ne izpolnjuje zahtev TSI, priglašeni organ zavrne izdajo certifikata o pregledu projektiranja in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the requirements of the TSI or the conditions for validity of the certificate until the expiry of the validity of the certificate.
Proizvajalec obvesti priglašeni organ, ki je izdal certifikat o ES-pregledu projektiranja, o kakršnih koli spremembah odobrenega projekta, ki bi lahko vplivale na skladnost z zahtevami TSI in s pogoji veljavnosti certifikata do izteka veljavnosti certifikata.
Such modifications shall require additional approval — from the notified body that issued the EC design examination certificate — in the form of an addition to the original EC design examination certificate.
Priglašeni organ, ki je izdal certifikat o ES-pregledu projektiranja, mora te spremembe dodatno odobriti v obliki dodatka k izvirnemu certifikatu o ES-pregledu projektiranja.
Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti priglasitvene organe o izdanih ali preklicanih certifikatih o ES-pregledu projektiranja in/ali dodatkih k certifikatom ter redno ali na zahtevo da na voljo priglasitvenim organom seznam zavrnjenih, začasno opuščenih ali drugače omejenih certifikatov in/ali dodatkov.
Each notified body shall inform the other notified bodies of the EC design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o certifikatih o ES-pregledu projektiranja, ki jih je zavrnil, začasno opustil ali drugače omejil, ter jih na zahtevo obvesti o certifikatih in/ali dodatkih, ki jih je izdal.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC design examination certificates and/or additions thereto.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvode certifikatov o ES-pregledu projektiranja in/ali njihovih dodatkov.
The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.
Priglašeni organ hrani izvod certifikata o ES-pregledu projektiranja, njegovih prilog in dodatkov ter tehnični dosje, vključno z dokumentacijo, ki jo predloži proizvajalec do izteka veljavnosti certifikata.
The manufacturer shall keep a copy of the EC design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
Proizvajalec hrani izvod certifikata o ES-pregledu projektiranja, njegove priloge in dodatke skupaj s tehnično dokumentacijo, ki je nacionalnim organom na voljo v obdobju, določenem v ustrezni TSI oziroma, kadar TSI tega obdobja ne določa, 10 let po tem, ko je bila proizvedena zadnja komponenta interoperabilnosti.
the quality records as provided for by the design part of the quality management system, such as results of analyses, calculations, tests, etc.,
zapise o kakovosti, predvidene v projektnem delu sistema vodenja kakovosti, kot so rezultati analiz, izračunov, preskusov itd.,
The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up and shall mention the number of the design examination certificate.
Izjava o skladnosti opredeljuje komponento interoperabilnosti, za katero je bila sestavljena, in navaja številko certifikata o pregledu projektiranja.
the quality management system approval indicated in point 3.3 and audit reports indicated in point 5.3, if any,
odobritev sistema vodenja kakovosti iz točke 3.3 in revizijska poročila iz točke 5.3, če ta obstajajo,
the EC design examination certificate indicated in point 4.3 and its additions.
ES-certifikat o pregledu projektiranja iz točke 4.3 in njegovi dodatki.
The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.
Pooblaščeni zastopnik lahko v imenu proizvajalca in na njegovo odgovornost vloži zahtevek iz točk 4.1 in 4.2 ter izpolni obveznosti iz točk 3.1, 3.5, 4.4., 4.6, 6 in 7, pod pogojem, da je naveden v pooblastilu.
MODULES FOR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS
MODULI V ZVEZI S PRIMERNOSTJO ZA UPORABO KOMPONENT INTEROPERABILNOSTI
Type validation by in-service experience is the part of assessment procedure in which a notified body ascertains and attests that a specimen, representative of the production envisaged meets the requirements for suitability for use of the technical specification for interoperability (TSI) that apply to it.
Validacija tipa na podlagi izkušenj pri obratovanju je del postopka, v okviru katerega priglašeni organ preveri in potrdi, da reprezentativni vzorec predvidene proizvodnje glede primernosti za uporabo izpolnjuje zahteve tehnične specifikacije za interoperabilnost (TSI), ki se zanjo uporabljajo.
The manufacturer shall lodge an application for type validation by in-service experience with a notified body of his choice.
Proizvajalec vloži zahtevek za validacijo tipa na podlagi izkušenj pri obratovanju pri priglašenem organu, ki ga izbere sam.
the technical documentation referred to in point 3,
tehnično dokumentacijo iz točke 3,
the programme for validation by in-service experience, as described in point 4,
program validacije na podlagi izkušenj pri obratovanju, kot je opisan v točki 4,
the name and address of the company(ies) (infrastructure managers and/or railway undertaking), with which the applicant has obtained an agreement to contribute to a suitability for use assessment by in-service experience:
ime in naslov podjetja ali podjetij (upraviteljev infrastrukture in/ali železniških podjetij), s katerim je vložnik sklenil dogovor o prispevanju k oceni primernosti za uporabo na podlagi izkušenj pri obratovanju:
by operating the interoperability constituent in service,
z upravljanjem obratujoče komponente interoperabilnosti,
by monitoring the in-service behaviour, and
z nadzorovanjem vedenja med obratovanjem in
by issuing a report about in-service experience,
z izdajo poročila o izkušnjah,
the name and the address of the company undertaking the maintenance of the interoperability constituent during the time period or running distance required for in-service experience, and
ime in naslov podjetja, ki vzdržuje komponento interoperabilnosti v časovnem obdobju ali na razdalji, ki se zahteva za obratovalne izkušnje, in
the EC type examination certificate when module CB was used for design phase, or EC design examination certificate when module CH1 was used for design phase.
certifikat o ES-pregledu tipa, če je bil za fazo projektiranja uporabljen modul CB, ali certifikat o ES-pregledu projektiranja, če je bil za fazo projektiranja uporabljen modul CH1.
The manufacturer shall place at the disposal of the company(ies), undertaking the operation of the interoperability constituent in service, a specimen or a sufficient number of specimens, representative of the production envisaged and hereinafter called ‘type’.
Proizvajalec podjetju ali podjetjem, ki prevzamejo upravljanje obratujoče komponente interoperabilnosti, da na voljo vzorec ali zadostno število vzorcev, ki predstavljajo predvideno proizvodnjo in se v nadaljevanju navajajo kot „tip“.
A type may cover several versions of the interoperability constituent provided that the differences between the versions are all covered by EC certificates as mentioned above.
Tip lahko zajema več verzij komponente interoperabilnosti, pod pogojem, da so vse razlike med verzijami zajete v izjavah ES o skladnosti in zgoraj navedenih certifikatih.
The notified body may request further specimens if needed for carrying out the validation by in-service experience.
Priglašeni organ lahko zahteva dodatne vzorce, če so ti potrebni za izvajanje validacije na podlagi izkušenj pri obratovanju.
The technical documentation shall make it possible to assess the interoperability constituent’s conformity with the requirements of the TSI.
Tehnična dokumentacija omogoča ocenjevanje skladnosti komponente interoperabilnosti z zahtevami TSI.
The technical documentation shall cover the design, manufacturing, maintenance and operation of the interoperability constituent.
Tehnična dokumentacija zajema projektiranje, proizvodnjo, vzdrževanje in delovanje komponente interoperabilnosti.
The technical documentation shall contain the following elements:
Tehnična dokumentacija vsebuje naslednje podatke:
the technical documentation specified in point 9 of Module CB or in point 4.6 of Module CH1,
tehnični dosje iz točke 9 modula CB in točke 4.6 modula CH1,
conditions for use and maintenance of the interoperability constituent (e.g. restrictions of running time or distance, wear limits, etc.).
pogoje za uporabo in vzdrževanje komponente interoperabilnosti (npr. omejitve časa vožnje ali razdalje, meje obrabe itd.).
If the TSI requires further information for the technical documentation, this shall be included.
Če TSI zahteva za tehnično dokumentacijo še druge informacije, se te vključijo.
The programme for the validation by in-service experience shall include:
Program za validacijo na podlagi izkušenj pri obratovanju vsebuje:
the required performance or behaviour in service of the interoperability constituent under trial,
zahtevano zmogljivost ali obnašanje komponente interoperabilnosti med preskušanjem,
the installation arrangements,
priprave za namestitev,
the duration of the programme — either time or distance,
trajanje programa, izraženo bodisi v času ali razdalji,
the operating conditions and the service programme expected,
pričakovane pogoje obratovanja in obratovalni program,
the maintenance programme,
vzdrževalni program,
the special in-service tests, if any, to be performed,
posebne preskuse med obratovanjem, če naj se ti izvedejo,
the batch size of the specimens — if more than one,
velikost serij vzorcev – če jih je več kot ena,
the inspection programme (nature, number and frequency of inspections, documentation),
program inšpekcij (vrsto, število in pogostost inšpekcij, dokumentacija),
criteria for tolerable defects and their impact on the programme,
merila za dopustne okvare in njihov vpliv na program,
the information to be included in the report of the company(ies) operating the interoperability constituent in service (see point 2, fifth indent).
informacije, ki se vključijo v poročilo podjetja, ki upravlja z obratujočo komponento interoperabilnosti (peto alineo točke 2).
Type validation by in-service experience
Validacija tipa na podlagi izkušenj pri obratovanju
examine the technical documentation and the programme for validation by in-service experience;
pregleda tehnično dokumentacijo in program za validacijo na podlagi izkušenj pri obratovanju;
verify that the type is representative and has been manufactured in conformity with the technical documentation;
preveri, ali je tip reprezentativen in proizveden v skladu s tehnično dokumentacijo;
verify that the programme for validation by in-service experience is well adapted to assess the required performance and in-service behaviour of the interoperability constituents;
preveri, ali je program validacije na podlagi izkušenj pri obratovanju dobro prilagojen za oceno zahtevane zmogljivosti in obnašanja komponent interoperabilnosti med obratovanjem;
agree with the applicant and the company(ies) undertaking the operation of the interoperability constituent referred to in point 2 the programme and the location where the inspections will be carried out and if necessary, the test(s) and the body performing the test(s);
se z vložnikom in podjetji, ki prevzamejo upravljanje komponente interoperabilnosti iz točke 2, dogovori o programu in kraju izvajanja pregledov ter po potrebi preskusov in o organizaciji, ki bo preskuse opravljala;
monitor and inspect the progress of in-service running, operation and maintenance of the interoperability constituent;
spremlja in pregleduje napredek obratovanja, delovanja in vzdrževanja komponente interoperabilnosti;
assess the report, to be issued by the company(ies) undertaking the operation the interoperability constituent referred to in point 2, and all other documentation and information, collected during the procedure (test reports, maintenance experience etc.);
oceni poročilo, ki ga morajo izdati podjetja, ki prevzamejo upravljanje komponente interoperabilnosti iz točke 2, in vso drugo dokumentacijo in informacije, pridobljene med postopkom (poročila o preskusih, izkušnje pri vzdrževanju itd.);
evaluate whether the in-service behaviour results meet the requirements of the TSI.
oceni, ali obnašanje med obratovanjem izpolnjuje zahteve TSI.
Where the type meets the requirements of the TSI that apply to the interoperability constituent concerned, the notified body shall issue an EC certificate of suitability for use to the manufacturer.
Če tip izpolnjuje zahteve TSI, ki se uporabljajo za zadevno komponento interoperabilnosti, priglašeni organ proizvajalcu izda certifikat ES o primernosti za uporabo.
The certificate shall contain the name and address of the manufacturer, the conclusions of the validation, the conditions (if any) for its validity and the necessary data for identification of the approved type.
Certifikat vsebuje ime in naslov proizvajalca, ugotovitve v okviru validacije, pogoje (če ti obstajajo) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega tipa.
A list of the relevant parts of the technical documentation shall be annexed to the EC certificate of suitability for use and a copy kept by the notified body.
Priglašeni organ k certifikatu ES o primernosti za uporabo priloži seznam pomembnih delov tehnične dokumentacije in obdrži en izvod.
Where the type does not satisfy the requirements of the TSI, the notified body shall refuse to issue an EC certificate of suitability for use and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če tip ne izpolnjuje veljavnih zahtev TSI, priglašeni organ zavrne izdajo certifikata ES o primernosti za uporabo in ustrezno seznani vložnika s podrobno utemeljitvijo zavrnitve.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EC certificate of suitability for use of all modifications to the approved type that may affect the suitability for use of the interoperability constituent or the conditions for validity of the certificate.
Proizvajalec obvesti priglašeni organ, ki hrani tehnično dokumentacijo v zvezi s certifikatom ES o primernosti za uporabo, o kakršnih koli spremembah odobrenega tipa, ki bi lahko vplivale na primernost komponente interoperabilnosti za uporabo ali pogoje veljavnosti certifikata.
Such modifications shall require additional approval in the form of an addition to the original EC certificate of suitability for use.
Take spremembe zahtevajo dodatno odobritev v obliki dodatka k izvirnemu certifikatu ES o primernosti za uporabo.
Each notified body shall inform its notifying authorities concerning the EC certificate of suitability for uses and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti svoje priglasitvene organe o certifikatih ES o primernosti za uporabo in/ali dodatkih k certifikatom, ki jih je izdal ali preklical, ter redno ali na zahtevo da na voljo priglasitvenim organom seznam certifikatov in/ali dodatkov, ki jih je zavrnil, začasno opustil ali drugače omejil.
Each notified body shall inform the other notified bodies concerning the EC certificate of suitability for uses and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o certifikatih ES o primernosti za uporabo in/ali dodatkih k certifikatom, ki jih je zavrnil, začasno opustil ali drugače omejil, ter jih na zahtevo obvesti o certifikatih in/ali dodatkih, ki jih je izdal.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC certificate of suitability for uses and/or additions thereto.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvode certifikatov ES primernosti za uporabo in/ali njihovih dodatkov.
The notified body shall keep a copy of the EC certificate of suitability for use, its annexes and additions, until the expiry of the validity of the certificate.
Priglašeni organ do izteka veljavnosti certifikata hrani izvod certifikata ES o primernosti za uporabo ter njegovih prilog in dodatkov.
EC declaration of suitability for use
ES-izjava o primernosti za uporabo
The manufacturer shall draw up a written EC declaration of suitability for use for an interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
Proizvajalec za komponento interoperabilnosti sestavi pisno ES-izjavo o primernosti za uporabo in jo hrani, da je nacionalnim organom na voljo v obdobju, določenem v ustrezni TSI oziroma, kadar TSI tega obdobja ne določa, 10 let po tem, ko je bila proizvedena zadnja komponenta interoperabilnosti.
The EC declaration of suitability for use shall identify the interoperability constituent for which it has been drawn up.
ES-izjava o primernosti za uporabo opredeljuje komponento interoperabilnosti, za katero je bila sestavljena.
A copy of the EC declaration of suitability for use shall be made available to the relevant authorities upon request.
Pristojnim organom se na zahtevo zagotovi izvod ES-izjave o primernosti za uporabo.
The EC declaration of suitability for use shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC.
ES-izjava o primernosti za uporabo izpolnjuje zahteve iz člena 13(3) in točke 3 Priloge IV k Direktivi 2008/57/ES.
EC certificate of suitability for use.
certifikat ES o primernosti za uporabo.
The interoperability constituent may be placed on the market only after the following EC declarations have been drawn up:
Komponenta interoperabilnosti se lahko da na trg le, če se prej pripravita naslednji izjavi:
EC declaration of suitability for use referred to in point 11.1, and
ES-izjava o primernosti za uporabo iz točke 11.1 in
EC declaration of conformity.
ES-izjava o skladnosti.
The manufacturer’s obligations set out in points 2, 7 and 11.1 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Obveznosti proizvajalca iz točk 2, 7 in 11.1 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
MODULES FOR EC VERIFICATION OF SUBSYSTEMS
MODULI ZA ES-VERIFIKACIJO PODSISTEMOV