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101–150/376
type-examination certificate
101 Končna redakcija
DRUGO
The adjudicating entity or its authorised representative established within the Community must keep with the technical documentation copies of type-examination certificates and their additions throughout the service life of the subsystem, it must be sent to any other Member State who so requests.
Naročnik ali njegov pooblaščeni zastopnik s sedežem v Skupnosti mora skupaj s tehnično dokumentacijo shranjevati kopije ES-certifikatov o pregledu tipa in njihove dodatke do konca dobe obratovanja podsistema in jih poslati kateri koli drugi državi članici, če ta tako zahteva.
102 Končna redakcija
DRUGO
The manufacturer or his authorised representative established within the Community must keep with the technical documentation copies of the EC type-examination certificates and their additions for a period of 10 years after the last product has been manufactured Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti mora poleg tehnične dokumentacije hraniti tudi izvode ES-certifikatov o pregledu tipa in njihove dodatke za obdobje 10 let po izdelavi zadnjega proizvoda. Kadar nima niti proizvajalec niti njegov pooblaščeni zastopnik sedeža v Skupnosti, mora obveznost do shranjevanja razpoložljive tehnične dokumentacije, prevzeti oseba, ki daje komponento interoperabilnosti na trg Skupnosti.
103 Končna redakcija
DRUGO
Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then, based on the type-examination and the approval and surveillance of the quality system(s), draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.
Če podsistem izpolnjuje zahteve Direktive 96/48/ES in TSI, mora priglašeni organ na podlagi pregleda tipa ter odobritve in nadzora sistema(-ov) kakovosti sestaviti ES-certifikat o verifikaciji, namenjen za naročnika ali njegovega pooblaščenega zastopnika s sedežem v Skupnosti, ki sestavi ES-izjavo o verifikaciji, namenjeno za nadzorni organ v državi članici, kjer se podsistem nahaja in/ali obratuje.
104 Pravna redakcija
finance
CELEX: 31990L0396
documentation relating to the approved type and a copy of the EC type-examination certificate.
dokumentacijo, ki se nanaša na odobreni tip, in izvod certifikata ES-pregleda tipa.
105 Pravna redakcija
DRUGO
the documentation relating to the approved type and a copy of the EC type-examination certificate.
dokumentacijo, ki se nanaša na odobreni tip, in izvod certifikata ES-pregleda tipa.
106 Pravna redakcija
DRUGO
where appropriate, the type-examination certificate referred to in Annex III.
kjer to pride v poštev, potrdilo o tipskem preskusu, kot je omenjeno v Prilogi III.
107 Pravna redakcija
DRUGO
the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.
tehnično dokumentacijo odobrenega tipa in kopijo certifikata tipskega preskusa ES.
108 Pravna redakcija
DRUGO
the technical documentation of the approved type and a copy of the type-examination certificate, issued after the completion of the type-examination procedure of module SB.
tehnično dokumentacijo o odobrenem tipu in izvod certifikata o pregledu tipa, izdanega ob zaključku postopka o pregledu tipa modula SB.
109 Pravna redakcija
DRUGO
where appropriate, reference to the EC type-examination certificate issued by a notified body,
če je ustrezno, napotitev k ES-certifikatu o skladnosti tipa, ki ga izda priglašeni organ,
110 Pravna redakcija
DRUGO
Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.
Uveljavljanje sistema kakovosti mora zagotavljati skladnost izdelkov s tipom, ki je opisan v potrdilu o ES tipskem preskusu.
111 Pravna redakcija
DRUGO
It is necessary to provide for an adequate transitional period for medical devices already covered by an EC design-examination certificate or by an EC type examination certificate.
Treba je zagotoviti ustrezno prehodno obdobje za medicinske pripomočke, ki so že predmet ES-certifikata o pregledu načrtovanja ali ES-certifikata o tipskem pregledu.
112 Pravna redakcija
DRUGO
where appropriate, the technical documentation of the approved type (see Annex XIII) and a copy of the EC type-examination certificate.
kadar je ustrezno, tehnično dokumentacijo odobrenega tipa (glej Prilogo XIII) in kopijo ES-certifikata o skladnosti tipa.
113 Pravna redakcija
DRUGO
Where the type meets the provisions of the Directive, the notified body shall issue an EC type-examination certificate to the applicant.
Kadar tip izpolnjuje določbe direktive, izda priglašeni organ vlagatelju ES-certifikat o skladnosti tipa.
114 Pravna redakcija
DRUGO
If the type conforms to the provisions of this Directive, the notified body issues the applicant with an EC type-examination certificate.
Če tip izpolnjuje določbe te direktive, priglašeni organ vlagatelju prošnje izda potrdilo o ES tipskem preskusu.
115 Pravna redakcija
DRUGO
This additional approval is given in the form of an addition to the original EC type-examination certificate.
Dodatna odobritev je v obliki dodatka izvirnemu certifikatu tipskega preskusa ES.
116 Pravna redakcija
DRUGO
Where the type satisfies the provisions of this Directive, the notified body must issue an EC type-examination certificate to the applicant.
Če tip zadošča določbam te direktive, mora priglašeni organ vlagatelju izdati certifikat ES-pregleda tipa.
117 Pravna redakcija
DRUGO
Where the type meets the relevant provisions of this Directive, the notified body issues an EC type-examination certificate to the applicant.
Kadar tip izpolnjuje ustrezne določbe te direktive, organ za ugotavljanje skladnosti izda prosilcu certifikat tipskega preskusa ES.
118 Pravna redakcija
DRUGO
This additional approval is to be given in the form of an addition to the original EC type-examination certificate.
Ta dodatna odobritev mora biti izdana v obliki dodatka k originalnemu certifikatu ES-pregleda tipa.
119 Pravna redakcija
DRUGO
Where the type meets the provisions of Directive 96/48/EC and of the TSI, the notified body must issue a type-examination certificate to the applicant.
Kadar tip ustreza določbam Direktive 96/48/ES in TSI, mora priglašeni organ vlagatelju izdati certifikat o pregledu tipa.
120 Pravna redakcija
DRUGO
This new approval must, where appropriate, take the form of a supplement to the initial EC type-examination certificate.
Ta nova odobritev mora imeti, kjer je to primerno, obliko dodatka k prvotnemu potrdilu o ES tipskem preskusu.
121 Pravna redakcija
DRUGO
Holders of EC design-examination certificates or EC type-examination certificates issued before 1 April 2004 for medical devices referred to in Article 1(1) shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in the Annex to this Directive.
Imetniki ES-certifikatov o pregledu načrtovanja ali ES-certifikatov o tipskem pregledu, izdanih za medicinske pripomočke iz člena 1(1) pred 1. aprilom 2004, zaprosijo za dodatni ES-certifikat o pregledu načrtovanja ali ES-certifikat o tipskem pregledu, ki dokazuje skladnost s tehničnimi zahtevami iz Priloge k tej direktivi.
122 Pravna redakcija
DRUGO
the appliances or the fittings do not conform to the appliance or fitting as referred to in the EG type-examination certificate,
naprave ali oprema ne ustrezajo napravi ali opremi, kakor je navedena v certifikatu ES-pregleda tipa,
123 Pravna redakcija
DRUGO
An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect.
Nadzorni organ, ki umakne certifikat ES-tipskega preskusa, o tem obvesti državo članico, ki ga je odobrila.
124 Pravna redakcija
DRUGO
Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact.
Nadzorni organ, ki zavrne izdajo certifikata ES-tipskega preskusa, o tem obvesti druge odobrene nadzorne organe.
125 Pravna redakcija
DRUGO
The notified body must inform the other notified bodies forthwith of the issuing of the EC type-examination certificate and any additions to the said type as referred to in point 1.7.
Priglašeni organ mora takoj obvestiti druge priglašene organe o izdaji certifikata ES-pregleda tipa in o kakršnih koli dodatkih k omenjenemu tipu, kakor je navedeno v točki 1.7.
126 Pravna redakcija
DRUGO
The quality system must ensure conformity of explosives with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them.
Sistem kakovosti mora zagotoviti skladnost eksplozivov s tipom, ki je opisan v certifikatu tipskega preskusa ES, in z zahtevami te direktive, ki veljajo zanje.
127 Pravna redakcija
DRUGO
The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.
Sistem kakovosti mora zagotoviti tipsko skladnost izdelkov, skladno z ES-certifikatom o skladnosti tipa, in njihovo izpolnjevanje zahtev direktive, ki zanje veljajo.
128 Pravna redakcija
DRUGO
The applicant must inform the notified body which issued the EC type-examination certificate of any significant change made to the approved product.
Prosilec mora obvestiti priglašeni organ, ki je izdal potrdilo o ES tipskem preskusu, o vseh pomembnih spremembah odobrenega izdelka.
129 Pravna redakcija
DRUGO
Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within 12 weeks from the date on which the opinion of the national competent authorities was sought.
Preden izdajo ES-certifikat o pregledu načrtovanja ali ES-certifikat o tipskem pregledu, priglašeni organi ustrezno upoštevajo kakršne koli pripombe, prejete v 12 tednih od datuma, ko so bili nacionalni pristojni organi oblasti zaprošeni za mnenje.
130 Pravna redakcija
DRUGO
Until 30 September 2004, Member States shall accept the placing on the market and the putting into service of medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1 April 2004.
Do 30. septembra 2004 države članice dovolijo dajanje v promet in v uporabo medicinskih pripomočkov iz člena 1(1), ki imajo ES-certifikat o pregledu načrtovanja ali ES-certifikat o tipskem pregledu, izdan pred 1. aprilom 2004.
131 Pravna redakcija
DRUGO
The applicant must keep the notified body that has issued the EC type-examination certificate informed of all modifications to the approved type which might affect conformity with the essential requirements.
Vlagatelj mora priglašeni organ, ki je izdal certifikat ES-pregleda tipa, stalno obveščati o vseh spremembah odobrenega tipa, ki bi lahko vplivale na usklajenost z osnovnimi zahtevami.
132 Pravna redakcija
DRUGO
If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect.
Če model izpolnjuje ustrezne določbe, nadzorni organ sestavi certifikat ES-tipskega pregleda in o tem obvesti vlagatelja vloge.
133 Pravna redakcija
DRUGO
the technical documentation regarding the approved type, including the type-examination certificate, as issued after completion of the procedure defined in module SB, and, if not included in this documentation,
tehnično dokumentacijo v zvezi z odobrenim tipom, vključno s certifikatom o pregledu tipa, kot je bil izdan po zaključku postopka iz modula SB in, če niso vključene v tej dokumentaciji,
134 Pravna redakcija
DRUGO
They may obtain a copy of the EC type-examination certificate and/ or its additions and on a reasoned request may obtain a copy of the Annexes to the certificate and the reports on the examinations and tests carried out.
Dobijo lahko izvod certifikata ES-pregleda tipa in/ali njegove dodatke ter na utemeljeno zahtevo tudi izvod prilog k certifikatu ter poročila o pregledih in opravljenih preskusih.
135 Pravna redakcija
DRUGO
The manufacturer shall apply a quality system that ensures conformity of the appliances with the type as described in the EC type-examination certificate and with the essential requirements of this Directive which apply to them.
Proizvajalec mora uporabiti sistem kakovosti, ki zagotavlja usklajenost naprav s tipom, kakor je opisano v certifikatu ES-pregleda tipa, in z osnovnimi zahtevami v direktivi, ki jih zadevajo.
136 Pravna redakcija
DRUGO
This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives are in conformity with the type as described in the EC type-examination certificate.
V tem modulu je opisan postopek, s katerim proizvajalec, ki izpolnjuje zahteve 2. razdelka, zagotovi in izjavi, da so eksplozivi skladni s tipom, ki je opisan v certifikatu tipskega preskusa ES.
137 Pravna redakcija
DRUGO
the appliances or the fittings conform to the appliance or fitting as referred to in the EC type-examination certificate but do not meet the essential requirements applicable to them,
naprave ali oprema ustrezajo napravi ali opremi, kakor je navedena v certifikatu ES-pregleda tipa, vendar ne izpolnjujejo zanje veljavnih osnovnih zahtev,
138 Pravna redakcija
DRUGO
In accordance with Article 10(5) of Directive 88/378/EEC, the Swiss bodies shall inform the Swiss Federal Office of Public Health when refusing to issue an EC type-examination certificate.
Švicarski organi v skladu s členom 10(5) Direktive 88/378/EGS obvestijošvicarski zvezni urad za javno zdravje, če zavrnejo izdajo ES-certifikata o odobritvi tipa.
139 Pravna redakcija
DRUGO
The EC declaration of conformity to type is that part of the procedure whereby the manufacturer declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the essential requirements of this Directive which apply to them.
ES-izjava o skladnosti s tipom je tisti del postopka, v katerem proizvajalec izjavi, da so zadevne naprave usklajene s tipom, kakor je opisano v certifikatu ES-pregleda tipa, in zadoščajo osnovnim zahtevam te direktive, ki jih zadevajo.
140 Pravna redakcija
DRUGO
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and to the requirements of the Directive which apply to them.
Proizvajalec ukrene vse potrebno za zagotovitev, da iz proizvodnega postopka izhajajo izdelki, ki so v skladu s tipom, kot je opisan v potrdilu o ES tipskem preskusu, in z vsemi zahtevami te direktive, ki veljajo zanje.
141 Pravna redakcija
DRUGO
The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.
Proizvajalec uvede vse potrebne ukrepe, da postopek izdelave zagotovi tipsko skladnost izdelanih izdelkov z ES-certifikatom o skladnosti tipa ter njihovo izpolnjevanje zahtev direktive, ki zanje veljajo.
142 Pravna redakcija
DRUGO
The manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them.
Proizvajalec, ki izpolnjuje obveznosti iz točke 2, zagotovi in izjavi, da so zadevni izdelki tipsko skladni z ES-certifikatom o skladnosti tipa in da izpolnjujejo zahteve direktive, ki zanje veljajo.
143 Pravna redakcija
DRUGO
The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the explosives with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da s proizvodnim procesom zagotovi skladnost eksplozivov s tipom, ki je opisan v certifikatu tipskega preskusa ES, in z zahtevami direktive, ki veljajo zanje.
144 Pravna redakcija
DRUGO
Modifications to the approved type must receive additional approval from the notified body that issued the EC type-examination certificate where such changes affect conformity with the essential requirements or. the prescribed conditions for use of the appliance.
Spremembe odobrenega tipa mora dodatno odobriti priglašeni organ, ki je izdal certifikat ES-pregleda tipa, kadar te spremembe vplivajo na usklajenost z osnovnimi zahtevami ali predpisanimi pogoji uporabe naprave.
145 Pravna redakcija
DRUGO
The manufacturer must take all measures necessary to ensure that the manufacturing process assures the conformity of the manufactured product with the type as described in the EC type-examination certificate with the essential safety requirements of the Directive.
Proizvajalec mora sprejeti vse potrebne ukrepe za zagotovitev, da proizvodni proces zagotavlja skladnost izdelanega izdelka s tipom, ki je opisan v certifikatu tipskega preskusa ES, in z bistvenimi varnostnimi zahtevami direktive.
146 Pravna redakcija
DRUGO
If the conformity of the subsystem with the type as described in the EC type-examination certificate and the compliance of the subsystem with the requirements of Directive 96/48/EC and the TSI is based on more than one quality system, it has to examine in particular,
Če skladnost podsistema s tipom, opisanim v ES-certifikatu o pregledu tipa, in skladnost podsistema z zahtevami Direktive 96/48/ES in TSI, temeljita na več kakor enem sistemu kakovosti, mora priglašeni organ pregledati zlasti,
147 Pravna redakcija
DRUGO
The manufacturer shall take all measures necessary to ensure that the manufacturing process assures compliance of the manufactured products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.
Proizvajalec uvede vse potrebne ukrepe, s katerimi zagotovi, da je izdelek v postopku izdelave tipsko skladen z ES-certifikatom o skladnosti tipa, ter njihovo izpolnjevanje zahtev direktive, ki zanje veljajo.
148 Pravna redakcija
DRUGO
The notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type as described in the EC type-examination certificate and with the requirements of Directive 96/48/EC and the TSI by examination and testing of every subsystem, manufactured as a serial product, as specified under Point 4.
Priglašeni organ mora opraviti ustrezne preglede in preskuse, da preveri skladnost podsistema s tipom, opisanim v ES-certifikatu o pregledu tipa, in zahtevami Direktive 96/48/ES in TSI s pregledi in preskušanjem vsakega podsistema, proizvedenega kot serijski proizvod, kot je določeno pod točko 4.
149 Pravna redakcija
DRUGO
A notified body which refuses to issue or withdraws an EC type-examination certificate must inform the Member State which notified it and the other notified bodies accordingly, giving the reasons for its decision.
Priglašeni organ, ki zavrne izdajo certifikata ES-pregleda tipa ali ga odvzame, mora o tem obvestiti državo članico, ki ga je priglasila, in tudi druge priglašene organe ter navesti razloge za svojo odločitev.
150 Pravna redakcija
DRUGO
The manufacturer shall take all necessary measures in order that the manufacturing process ensures conformity of the instruments, where applicable, with the type as described in the EC type-examination certificate and with the requirements of this Directive which apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces zagotovi skladnost instrumentov, kadar je primerno, s tipom opisanim v potrdilu o tipskem pregledu ES, in z zahtevami te direktive, ki veljajo zanje.
Prevodi: en > sl
101–150/376
type-examination certificate