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101–150/246
examination of conformity
101 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.
102 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.
103 Pravna redakcija
DRUGO
In accordance with Annex I, point 7f of Directive 98/13/EC, the conformity assessment bodies listed in section II of this Annex shall make available to the other bodies the relevant information concerning type-examination certificates issued and withdrawn.
V skladu s Prilogo I, točka 7f Direktive 98/13/ES organi za ugotavljanje skladnosti s seznama v Oddelku II te priloge dajo na razpolago drugim organom vse ustrezne informacije v zvezi s certifikati o pregledih tipa, ki so bili izdani in preklicani.
104 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.
105 Pravna redakcija
DRUGO
if a design review is requested in the TSI, perform an examination of the design methods, the design tools and the design results to evaluate their capability to fulfil the requirements for conformity for the subsystem at the completion of the design process;
4.2 če TSI zahteva pregled načrtovanja, izvesti pregled metod načrtovanja, orodja za načrtovanje in rezultate načrtovanja, da ovrednoti njihovo sposobnost za izpolnitev zahtev po skladnosti za podsistem ob zaključku postopka načrtovanja;
106 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,
107 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.
108 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.
109 Pravna redakcija
DRUGO
Changes to the approved product must receive further approval from the notified body which issued the EC type-examination certificate wherever the changes may affect conformity with the essential requirements or with the conditions prescribed for use of the product.
Spremembe odobrenega izdelka mora dodatno odobriti priglašeni organ, ki je izdal potrdilo o ES tipskem preskusu, če bi te spremembe lahko vplivale na skladnost z bistvenimi zahtevami ali s pogoji, predpisanimi za uporabo izdelka.
110 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.
111 Pravna redakcija
promet
CELEX: 32000R2603
Without prejudice to the question of whether the scheme constitutes a drawback system in conformity with the provisions of the basic Regulation, the Commission, following further examination, accepts that there is in fact no excess remission of duty in the case of either company concerned.
Ne glede na vprašanje, ali shema pomeni sistem povračil v skladu z določbami osnovne uredbe, Komisija po dodatni preučitvi priznava, da dejansko pri nobenem od zadevnih podjetij ni prišlo do presežnega odpusta dajatev.
112 Pravna redakcija
DRUGO
Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product.
Spremembe odobrenega načrta morajo biti dodatno odobrene s strani priglašenega organa, ki je izdal ES potrdilo o pregledu načrta, če bi te spremembe lahko vplivale na skladnost z bistvenimi zahtevami v tej direktivi in s pogoji, predpisanimi za uporabo izdelka.
113 Pravna redakcija
DRUGO
This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive.
V tem modulu je opisan postopek, s katerim proizvajalec, ki izpolnjuje zahteve iz 2. razdelka, zagotovi in izjavi, da so zadevna eksplozivi skladni s tipom, ki je opisan v certifikatu tipskega preskusa ES, in izpolnjujejo zahteve te direktive.
114 Pravna redakcija
DRUGO
The manufacturer or his authorized representative established within the Community 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 applies to them.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotovi in izjavi, da so zadevni izdelki tipsko skladni z ES-certifikatom o skladnosti tipa in da izpolnjujejo zahteve direktive, ki zanje veljajo.
115 Pravna redakcija
DRUGO
During the examination of a legislative proposal, Parliament shall pay particular attention to respect for fundamental rights and in particular that the legislative act is in conformity with the European Union Charter of Fundamental Rights, the principles of subsidiarity and proportionality and the rule of law.
Med obravnavo zakonodajnega predloga Parlament posebno pozornost posveča spoštovanju temeljnih pravic in zlasti skladnosti zakonodajnega akta z Listino Evropske unije o temeljnih pravicah ter z načeli subsidiarnosti, sorazmernosti in pravne države.
116 Pravna redakcija
DRUGO
The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.
Izjava o skladnosti je del postopka, s katerim proizvajalec, ki izpolnjuje obveznosti, ki jih predpisuje oddelek 1, zagotavlja in izjavlja, da so zadevni izdelki v skladu s tipom, opisanim v potrdilu o ES tipskem preskusu, in izpolnjujejo določbe te direktive, ki veljajo zanje.
117 Pravna redakcija
DRUGO
The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meets the provisions of this Directive which apply to them.
Izjava o skladnosti je del postopka, s katero proizvajalec, ki izpolnjuje obveznosti, ki jih predpisuje oddelek 1, zagotavlja in izjavlja, da so zadevni izdelki v skladu s tipom, opisanim v potrdilu o ES tipskem preskusu, in izpolnjujejo določbe te direktive, ki veljajo zanje.
118 Pravna redakcija
DRUGO
The manufacturer or his authorized representative established within the Community shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti sprejme vse potrebne ukrepe, da proizvodni proces zagotovi skladnost izdelkov s tipom, opisanim v potrdilu o tipskem pregledu ES, in z zahtevami te direktive, ki veljajo zanje.
119 Pravna redakcija
DRUGO
The manufacturer or his authorized representative established within the Community must take all measures necessary in order that the manufacturing process ensures conformity of the appliances to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti mora sprejeti vse potrebne ukrepe, da proizvodni proces zagotavlja skladnost naprav s tipom, opisanim v potrdilu o tipskem pregledu ES, in z zahtevami te direktive, ki veljajo zanje.
120 Pravna redakcija
DRUGO
The adjudicating entity must take all measures necessary in order that the manufacturing process (including assembling and integration of interoperability constituents) ensures conformity of the subsystem with the type as described in the EC type-examination certificate and with the requirements of the TSI that apply to them.
Naročnik je dolžan izvesti vse potrebne ukrepe, da lahko proizvodni postopek (vključno z montažo in integracijo komponent interoperabilnosti) zagotovi skladnost podsistema s tipom, opisanim v ES-certifikatu o pregledu tipa, in zahtevami TSI, ki veljajo zanju.
121 Pravna redakcija
DRUGO
After examination of the programmes they were found to comply with the Community criteria relating to the eradication of these diseases, in conformity with Council Decision 90/638/EEC of 27 November 1990 laying down Community criteria for the eradication and monitoring of certain animal diseases (3) as last amended by Directive 92/65/EEC (4).
Po pregledu programov je bilo ugotovljeno, da so merila Skupnosti, povezana z izkoreninjenjem teh bolezni, v skladu z Odločbo Sveta 90/638/EGS z dne 27. novembra 1990 o določitvi meril Skupnosti za izkoreninjenje in spremljanje nekaterih živalskih bolezni fn, kakor je bila nazadnje spremenjena z Direktivo 92/65/EGS fn, izpolnjena.
122 Pravna redakcija
DRUGO
The manufacturer must take all necessary measures to ensure that the manufacturing process, including final product inspection and testing, results in homogeneity of production and conformity of the appliances with the type as described in the EC type-examination certificate and with the requirements of this Directive which apply to them.
Proizvajalec mora sprejeti vse potrebne ukrepe za zagotovitev, da proizvodni proces, vključno z nadzorom in preskušanjem končnega izdelka, dosega homogeno proizvodnjo in usklajenost naprav s tipom, kakor je opisano v certifikatu ES-pregleda tipa, in z zahtevami te direktive, ki jih zadevajo.
123 Pravna redakcija
DRUGO
This module describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the explosives subject to the provisions of 3 are in conformity with the type as described in the EC type-examination certificate and satisfy the relevant requirements of the Directive.
V tem modulu je opisan postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti preveri in potrdi, da so eksplozivi, za katera veljajo določbe iz 3, skladni s tipom, ki je opisan v certifikatu tipskega preskusa ES, in izpolnjujejo ustrezne zahteve direktive.
124 Pravna redakcija
DRUGO
All products shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to verify their conformity with the type as described in the EC type-examination certificate and the requirements of the Directive that apply to them.
Vsi izdelki se posamično pregledajo in na njih se opravijo primerni preskusi, določeni v ustreznem (-ih) standardu (-ih) iz člena 5, ali drugi enako ustrezni preskusi, da se preveri, ali so tipsko skladni z ES-certifikatom o skladnosti tipa in ali izpolnjujejo zahteve direktive, ki zanje veljajo.
125 Pravna redakcija
DRUGO
The applicant informs the notified body that holds the technical documents concerning the EC type-examination certificate of all modidfications to the approved appliance which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the product.
Prosilec obvesti organ za ugotavljanje skladnosti, ki ima tehnično dokumentacijo o certifikatu tipskega preskusa ES, o vseh spremembah odobrene vloge, za katere je potrebna dodatna odobritev, kadar bi takšne spremembe lahko vplivale na skladnost z bistvenimi zahtevami ali predpisanimi pogoji uporabe izdelka.
126 Pravna redakcija
DRUGO
This module describes that part of the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the explosives concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive that apply to them.
V tem modulu je opisan tisti del postopka, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotovi in izjavi, da so zadevni eksplozivi skladni s tipom, ki je opisan v certifikatu tipskega preskusa ES, in izpolnjujejo zahteve te direktive, ki veljajo zanje.
127 Pravna redakcija
DRUGO
All appliances must be individually examined and appropriate tests, as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, must be carried out in order to verify their conformity with the type as described in the EC type-examination certificate and the requirements of this Directive that apply to them.
Vse naprave morajo biti pregledane posamič in opravljeni morajo biti ustrezni preskusi, kot je predpisano v ustreznem(ih) standardu(ih) iz člena 5, ali enakovredni preskusi, da bi se preverila njihova skladnost s tipom, opisanim v potrdilu o tipskem pregledu, in z zahtevami te direktive, ki veljajo zanje.
128 Pravna redakcija
DRUGO
in addition to the testing standards specifically mentioned, a number of provisions, which must be checked during type-examination (type approval) as referred to in the modules for conformity assessment in Annex B, are to be found in the applicable requirements of the international conventions and the relevant resolutions and circulars of the IMO.
Poleg posebej navedenih standardov preskušanja obstajajo v veljavnih zahtevah mednarodnih konvencij in ustreznih resolucij ter okrožnic IMO številne določbe, ki se morajo preveriti med tipskim pregledom (homologacijo), kakor je navedeno v modulih ugotavljanja skladnosti v Prilogi B.
129 Pravna redakcija
DRUGO
Within that part of the procedure the adjudicating entity or his authorised representative established within the Community checks and attests that the subsystem concerned is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of the Directive 96/48/EC and the TSI that apply to them.
Znotraj tega dela postopka naročnik ali njegov pooblaščeni zastopnik s sedežem v Skupnosti, preveri in potrdi, da je zadevni podsistem v skladu s tipom, kot je opisan v ES-certifikatu o pregledu tipa, in zahtevami Direktive 96/48/ES in TSI, ki veljajo zanju.
130 Pravna redakcija
DRUGO
The applicant shall inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved product which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the product.
Vlagatelj mora priglašeni organ, ki hrani tehnično dokumentacijo v zvezi s certifikatom o opravljenem ES-tipskem ocenjevanju, obvestiti o kakršnih koli spremembah odobrenega izdelka, ki jih je treba dodatno odobriti, kadar lahko take spremembe vplivajo na izpolnjevanje bistvenih zahtev ali predpisane pogoje uporabe izdelka.
131 Pravna redakcija
DRUGO
The notified body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Directive either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides.
Priglašeni organ mora opravljati ustrezne preglede in preizkuse, da preveri skladnost izdelkov z relevantnimi zahtevami te direktive, bodisi s proučitvijo in preizkusom vsakega izdelka, kot je navedeno v oddelku 5, bodisi s proučevanjem in preizkušanjem izdelkov na statistični osnovi, kot je navedeno v oddelku 6, kot se odloči proizvajalec.
132 Pravna redakcija
DRUGO
This module describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the products subject to the provisions of point 3 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.
Ta modul opisuje postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti preveri in potrdi, da so izdelki, za katere veljajo določbe točke 3, tipsko skladni z ES-certifikatom o skladnosti tipa in da izpolnjujejo zahteve direktive, ki zanje veljajo.
133 Pravna redakcija
DRUGO
EC verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the appliances subject to the provisions of point 3 are in conformity to the type as described in the EC type-examination certification and satisfy the requirements of this Directive that apply to them.
Overjanje je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotavlja in izjavi, da so naprave po določbah točke 3 skladne s tipom, opisanim v potrdilu o tipskem pregledu ES, in ustrezajo zahtevam te direktive, ki veljajo zanje.
134 Pravna redakcija
DRUGO
EC verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the products subject to the provisions of section 3 are in conformity with the type as described in the EC type-examination certification and satisfy the requirements of this Directive that apply to them.
Overjanje ES je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti, zagotovi in izjavi, da so izdelki, ki jih urejajo določbe oddelka 3, usklajeni s tipom, opisanim v potrdilu o tipskem pregledu ES, in ustrezajo zahtevam te direktive, ki veljajo zanje.
135 Pravna redakcija
DRUGO
copies of the "EC" declarations of conformity or suitability for use with which the abovementioned constituents must be provided in accordance with Article 13 of the Directive accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications;
izvodi ES-izjave o skladnosti ali primernosti za uporabo, ki jih morajo imeti zgoraj navedene komponente v skladu s členom 13 te direktive, po potrebi skupaj z ustreznimi izračuni in zvodom zapisnikov o preskusih in pregledih, ki jih opravljajo priglašeni organi na podlagi splošnih tehničnih specifikacij;
136 Pravna redakcija
DRUGO
All instruments shall be individually examined and appropriate tests, as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, shall be carried out in order to verify their conformity, where applicable, to the type as described in the EC type-examination certificate and the requirements of this Directive that apply to them.
Vse tehtnice so posamič pregledane in opravljeni so ustrezni pregledi, kot določa(jo) ustrezen(ni) standard(i) iz člena 5, ali enakovredni pregledi za preverjanje njihove skladnosti, kadar je primerno, s tipom, opisanim v potrdilu o tipskem pregledu ES, in z zahtevami te direktive, ki veljajo zanje.
137 Pravna redakcija
DRUGO
Every product is examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out in order to verify, where appropriate, the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them.
Vse izdelke se posamič prouči in opravi ustrezne preizkuse, kot je določeno v relevantnih standardih iz člena 5, ali pa je treba opraviti enakovredne preizkuse, da se, kjer to pride v poštev, potrdi skladnost izdelkov s tipom ES, opisanim v potrdilu otipskem preskusu, in z zahtevami te direktive, ki veljajo zanje.
138 Pravna redakcija
DRUGO
'inspections' shall mean any operation whereby the customs authorities or any other inspection authority carries out the physical examination or visual inspection of the means of transport or of the goods themselves in order to ascertain that their nature, origin, condition, quantity and value are in conformity with the particulars contained in the documents produced;
“pregledi” pomenijo postopke, s katerimi carinski organi ali kateri koli drugi organi pregleda opravljajo fizično preverjanje ali vizualni pregled prevoznih sredstev ali samega blaga, da bi ugotovili, ali so njegova narava, poreklo, stanje, količina in vrednost v skladu s podatki v predloženih dokumentih;
139 Pravna redakcija
DRUGO
This module describes that part of the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the interoperability constituent concerned is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of Directive 96/48/EC and of the TSI that apply to it.
Ta modul opisuje tisti del postopka, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotavlja in izjavlja, da je zadevna komponenta interoperabilnosti skladna s tipom, kot je določeno v ES-certifikatu o pregledu tipa, in izpolnjuje zahteve Direktive 96/48/ES in TSI, ki veljajo zanje.
140 Pravna redakcija
DRUGO
All subsystems (as serial products) must be individually examined and appropriate tests and verifications as set out in the TSI and in the relevant European Specifications (or equivalent tests) shall be carried out in order to verify their conformity with the type as described in the type-examination certificate and the requirements of the TSI that apply to them.
Vsi podsistemi (kot serijski proizvodi) se morajo posamezno preveriti in izvedejo se ustrezni preskusi in preverjanja, kot je določeno v TSI in v ustreznih evropskih specifikacijah (ali primerljivi preskusi), z namenom preveriti njihovo skladnost s tipom, opisanim v certifikatu o pregledu tipa, in zahtevam TSI, ki zanje veljajo.
141 Pravna redakcija
DRUGO
"inspections" shall mean the carrying out by customs or any other supervisory department of an operation which consists of the physical examination, including visual inspection, of the means of transport and/or the goods themselves with the aim of checking that their nature, origin, state, quantity or value are in conformity with the particulars given in the documents which have been presented;
"pregledi" pomenijo postopek, sestavljen iz fizičnega pregleda, vključno z vizualnim pregledom, prevoznega sredstva in/ali samega blaga, ki ga opravlja carina ali kateri koli drug nadzorni oddelek, da preveri, ali je narava, poreklo, količina ali vrednost blaga skladna s podatki, navedenimi v predloženih dokumentih;
142 Pravna redakcija
DRUGO
The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of products on a statistical basis, as specified in section 6. The manufacturer must authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate.
Priglašeni organ preveri skladnost izdelka z zahtevami te direktive s pregledovanjem in preskušanjem izdelkov na statistični podlagi, kakor je določeno v oddelku 6. Proizvajalec mora pooblastiti priglašeni organ, da z revizijo, kadar je primerno, ovrednoti uspešnost sprejetih ukrepov, določenih v oddelku 3.
143 Pravna redakcija
DRUGO
EC verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the instruments which have been checked in accordance with paragraph 3. 3 are, where applicable, in conformity to the type described in the EC type-examination certificate and satisfy the requirements of the Directive which apply to them.
Overjanje ES je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotovi in izjavi, da so tehtnice, ki so bile preverjene v skladu z odstavkom 3.3, kadar je primerno, skladne s tipom, opisanim v potrdilu o tipskem pregledu ES in ustrezajo zahtevam direktive, ki veljajo zanje.
144 Pravna redakcija
DRUGO
Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the body of which notification has been given shall conduct the necessary examinations and tests to establish the conformity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to these basic requirements.
Kjer proizvajalec ni uporabil usklajenih standardov, ali jih je uporabil le delno, ali kjer takšnih standardov ni, mora priglašeni organ opraviti potrebne preglede in preskuse, da bi ugotovil skladnost vzorca s tehničnimi specifikacijami, ki jih je uporabil proizvajalec, glede na njihovo ustreznost tem osnovnim zahtevam.
145 Pravna redakcija
DRUGO
The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements of this Directive.
Proizvajalec mora pred začetkom izdelave pripraviti dokumente, ki določajo proizvodne procese, zlasti kar zadeva sterilizacijo, skupaj z vsemi utečenimi deli, predhodnimi določbami, ki se izvajajo za zagotovitev enotne proizvodnje in skladnosti izdelkov s tipom, kakor je opisan v potrdilu o tipskem pregledu ES, in tudi z ustreznimi zahtevami te direktive.
146 Pravna redakcija
DRUGO
EC verification is the procedure whereby a manufacturer or his authorized representative established within the Community ensures and declares that the vessels which have been checked in accordance with paragraph 3 are in conformity to the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in Annex II section 3 having received a certificate of adequacy.
Preverjanje ES je postopek, s katerim proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti zagotavlja in izjavi, da so posode, ki so bile pregledane v skladu z odstavkom 3, usklajene s tipom, opisanim v potrdilu o tipskem pregledu ES, ali s projektnim in delovnim načrtom iz oddelka 3 Priloge II, ki je prejel potrdilo o ustreznosti.
147 Pravna redakcija
DRUGO
The manufacturer shall take all the necessary measures for the manufacturing process to ensure that the vessels conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to in Annex II section 3- The manufacturer or his authorized representative established within the Community shall affix the CE marking to each vessel and draw up a declaration of conformity.
Proizvajalec sprejme vse potrebne ukrepe glede proizvodnega procesa za zagotovitev, da so posode skladne s tipom, ki je opisan v potrdilu o tipskem pregledu ES ali s projektnim in delovnim načrtom iz oddelka 3 Priloge II. Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti pritrdi znak CE na vsako posodo in sestavi izjavo ES o skladnosti.
148 Pravna redakcija
DRUGO
The products which make up the sample are examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to them in order to determine whether to accept or reject the batch.
Izdelki, ki tvorijo vzorec, se posamič proučijo, opravijo pa se tudi ustrezni preizkusi, definirani v relevantnih standardih, omenjenih v členu 5, ali enakovredni preizkusi, da se, kjer to pride v poštev, ugotovi skladnost izdelkov s tipom, opisanim v potrdilu o ES tipskem preskusu, in z zahtevami te direktive, ki veljajo zanje, in na tej podlagi ugotovi, ali naj se serija sprejme ali zavrne.
149 Pravna redakcija
DRUGO
Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilization where necessary, together with all the routine, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, conformity of the products with the type described in the EC type-examination certificate and with the requirements of this Directive which apply to them.
Pred začetkom proizvodnje mora proizvajalec pripraviti dokumente z razlago proizvodnega procesa, zlasti kar zadeva sterilizacijo, kjer je ta potrebna, skupaj z vsemi rutinskimi, vnaprej določenimi določbami, ki se morajo uveljavljati za zagotovitev homogene proizvodnje in, kjer je to primerno, skladnosti izdelkov s tipom, opisanim v potrdilu o ES tipskem preskusu, in z vsemi zahtevami te direktive, ki veljajo zanje.
150 Pravna redakcija
DRUGO
Member States shall presume that the PPE referred to in Article 8(2) satisfies the basic requirements referred to in Article 3 if it bears the EC mark with respect to which the manufacturer is able to produce, on demand, not only the declaration referred to in Article 12 but also the certificate issued by the body of which notification has been given in accordance with Article 9 attesting to their conformity to the relevant national standards, transposing the harmonized standards, assessed at the EC type examination level in accordance with the first indent of Article 10 (4) (a) and (b).
Države članice domnevajo, da v členu 8(2) navedena OZO izpolnjuje osnovne zahteve iz člena 3, če ima ES-oznako, v zvezi s katero lahko proizvajalec na zahtevo predloži ne le izjavo iz člena 12, temveč tudi certifikat, ki ga izda organ, priglašen v skladu s členom 9, in potrjuje skladnost z ustreznimi nacionalnimi standardi, ki prevzemajo usklajene standarde, ocenjeno na ravni ES-tipskega preskusa v skladu s prvo alineo člena 10(4)(a) in (b).
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101–150/246
examination of conformity