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preskušanje skladnosti
1 Objavljeno
finance
Ur. l. RS, št. MP 2004-1
(c) »tehnična specifikacija«: specifikacija, vsebovana v dokumentu, ki določa zahtevane značilnosti izdelka, kot je raven kakovosti, učinkovitosti, varnosti ali mer, vključno z zahtevami za izdelek glede imena, pod katerim se prodaja, izrazja, simbolov, preskušanja in preskusnih metod, embalaže, oznak ali označevanja ter postopkov ugotavljanja skladnosti.
(c) "technical specification": a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures.
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DRUGO
POSTOPEK ZA PRESKUŠANJE SKLADNOSTI PROIZVODNJE NA ZAHTEVO PROIZVAJALCA
PROCEDURE FOR PRODUCTION CONFORMITY TESTING AT MANUFACTURER'S REQUEST
3 Končna redakcija
finance
CELEX: 31999L0096
POSTOPEK ZA PRESKUŠANJE SKLADNOSTI PROIZVODNJE, ČE JE STANDARDNO ODSTOPANJE ZADOVOLJIVO
PROCEDURE FOR PRODUCTION CONFORMITY TESTING WHEN STANDARD DEVIATION IS SATISFACTORY
4 Končna redakcija
finance
CELEX: 31999L0096
POSTOPEK ZA PRESKUŠANJE SKLADNOSTI PROIZVODNJE, ČE STANDARDNO ODSTOPANJE NI ZADOVOLJIVO ALI ČE PODATKI NISO NA VOLJO
PROCEDURE FOR PRODUCTION CONFORMITY TESTING WHEN STANDARD DEVIATION IS UNSATISFACTORY OR UNAVAILABLE
5 Končna redakcija
finance
CELEX: 31999L0096
ker bo treba od leta 2005 naprej uvesti posebne zahteve glede vzdržljivosti novih težkih vozil in za preskušanje skladnosti težkih vozil v uporabi,
whereas specific requirements for the durability of new heavy duty engines and for the conformity testing of in-service heavy duty vehicles should be introduced from 2005;
6 Končna redakcija
CELEX: 32004R0726
koordiniranje nadzora kakovosti zdravil, danih v promet, z zahtevo za preskušanje skladnosti z odobrenimi specifikacijami, ki ga opravi uradni kontrolni laboratorij za analizno preskušanje zdravil ali pa laboratorij, ki ga je država članica imenovala v ta namen;
coordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose;
7 Končna redakcija
finance
CELEX: 31999L0096
Shematski prikaz preskušanja skladnosti proizvodnje
Schematic of production conformity testing
8 Končna redakcija
CELEX: 32004L0043
Rezultat analitskega preskušanja, pri katerem je upoštevan izkoristek, se uporabi pri preverjanju skladnosti (glej točko 5 Priloge 5).
The analytical result corrected for recovery shall be used for checking compliance (see Annex I, point 5)
9 Končna redakcija
pravo
CELEX: 31999L0036
Priglašeni organ mora opraviti ustrezne preglede in preskuse, da bi preveril skladnost premične tlačne opreme z ustreznimi zahtevami direktive s pregledovanjem in preskušanjem vsakega proizvoda v skladu s točko 4.
The notified body must perform the appropriate examinations and tests in order to check the conformity of the transportable pressure equipment with the relevant requirements of the Directive by examining and testing every product in accordance with point 4.
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DRUGO
Priglašeni organ mora izvesti ustrezne preglede ali preskuse, da preveri skladnost komponente interoperabilnosti s tipom, kakor je opisan v certifikatu o pregledu tipa, in zahtevami TSI, bodisi s pregledi in preskušanjem vsake komponente interoperabilnosti, kakor je določeno v točki 4, bodisi s pregledi in preskušanjem komponent interoperabilnosti na statistični podlagi, kakor je določeno v točki 5, na izbiro proizvajalca.
The notified body must carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the type-examination certificate and with the requirements of the TSI either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of interoperability constituents on a statistical basis, as specified in point 5, at the choice of the manufacturer.
11 Končna redakcija
finance
CELEX: 31976L0757
ker usklajen postopek homologacije odsevnikov omogoča vsaki državi članici, da preveri skladnost s skupnimi zahtevami za izdelavo in preskušanje in da obvesti druge države članice o svojih ugotovitvah tako, da jim pošlje kopijo certifikata o homologaciji sestavnega dela za vsak tip odsevnika;
Whereas a harmonized type-approval procedure for reflectors makes it possible for each Member State to check compliance with the common construction and testing requirements and to inform the other Member States of its findings by sending a copy of the component type-approval certificate completed for each type of reflex reflector;
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Priglašeni organ mora opraviti ustrezne preglede in preskuse, da preveri skladnost podsistema s tipom, kakor je opisan v ES-certifikatu o pregledu tipa, in zahtevami Direktive 96/48/ES ter TSI s pregledi in preskušanjem vsakega podsistema, ki se proizvaja kakor serijski proizvod, kakor je določeno pod točko 4.
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.
13 Končna redakcija
CELEX: 32004L0018
Ti tehnični predpisi vključujejo stopnje okoljske uspešnosti, zahteve v zvezi s konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, kakovosti, varnosti ali dimenzij, vključno s postopki v zvezi z zagotavljanjem kakovosti, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem ali uporabo nalepk.
These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling and production processes and methods.
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CELEX: 32004L0017
"tehnična specifikacija" v primeru javnih naročil storitev ali blaga pomeni specifikacijo v dokumentu, ki opredeljuje zahtevane lastnosti proizvoda ali storitve, kot so kakovost, varstvo okolja, zahteve za konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, izvedbe, varnosti ali dimenzij, vključno z zahtevami v zvezi s proizvodom glede imena, pod katerim se bo prodajal, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem, uporabo nalepk, navodili za uporabnike, proizvodnimi postopki in metodami ter postopki ocenjevanja skladnosti;
"Technical specification", in the case of service or supply contracts, means a specification in a document defining the required characteristics of a product or a service, such as quality levels, environmental performance levels, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, use of the product, safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production processes and methods and conformity assessment procedures;
15 Končna redakcija
CELEX: 32004L0017
Te tehnične zahteve vključujejo stopnje varnosti za okolje, zahteve v zvezi s konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, izvedbo, varnost ali dimenzije, vključno s postopki v zvezi z zagotavljanjem kakovosti, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem in uporabo nalepk, navodili za uporabnike, proizvodnimi postopki in metodami.
These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, and production processes and methods.
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CELEX: 32004L0018
"tehnična specifikacija" v primeru javnih naročil blaga ali storitev pomeni specifikacijo v dokumentu, ki opredeljuje zahtevane značilnosti proizvoda ali storitve, kot so stopnje kakovosti, stopnje okoljske uspešnosti, zahteve za konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, kakovosti, varnosti ali dimenzij, vključno z zahtevami v zvezi s proizvodom glede imena, pod katerim se bo prodajal, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem, uporabo nalepk, navodili za uporabnike, proizvodnimi postopki in metodami ter postopki ocenjevanja skladnosti;
"technical specification", in the case of public supply or service contracts, means a specification in a document defining the required characteristics of a product or a service, such as quality levels, environmental performance levels, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, use of the product, safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production processes and methods and conformity assessment procedures;
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Statistični postopek za preskušanje skladnosti v prometu
Statistical procedure for in-service conformity testing
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STATISTIČNI POSTOPEK ZA PRESKUŠANJE SKLADNOSTI VOZIL V PROMETU
STATISTICAL PROCEDURE FOR IN-SERVICE CONFORMITY TESTING
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promet
SMERNICE ZA PRESKUŠANJE SKLADNOSTI PISARNIŠKE OPREME Z ZAHTEVAMI ENERGY STAR
TEST GUIDELINES FOR ENERGY STAR OFFICE EQUIPMENT
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(b) standardizacijo, preskušanje skladnosti in certificiranje za informacijsko tehnologijo in telekomunikacije;
(b) standardisation, conformity testing and certification for information technology and telecommunications;
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standardizaciji, preskušanju skladnosti in certificiranju za informacijsko tehnologijo in telekomunikacije,
standardization, testing and certification relating to information technology and telecommunications,
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V prihodnje bodo lahko v programe preskušanja skladnosti predložena tudi vozila, ki uporabljajo posebne tehnologije za majhno porabo goriva.
In the future, vehicles with special fuel efficient technologies may be offered which could be submitted to complementary testing programmes.
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Ta dodatek določa merila, navedena v točki 7.1.7 te priloge, v zvezi z izbiro vozil za preskušanje in postopke za pregled skladnosti vozil v prometu.
This Appendix sets out the criteria referred to in section 7.1.7 of this Annex regarding the selection of vehicles for testing and the procedures for the in-service conformity control.
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Odobreni organ opravi ustrezne preglede in preskuse, da preveri skladnost posod z zahtevami te direktive s pregledovanjem in preskušanjem posod v skladu z naslednjimi odstavki:
The approved body shall carry out the appropriate examinations and tests in order to check the conformity of the vessels with the requirements of this Directive by examination and testing of vessels in accordance with the following paragraphs:
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Priglašeni organ opravi ustrezne preglede in preskuse, da preveri skladnost izdelka z zahtevami te direktive s pregledovanjem in preskušanjem vsake tehtnice, kot je določeno v odstavku 3.5
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 every instrument, as specified in paragraph 3. 5.
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Obseg spremljanja skladnosti bi moral biti določen tako glede na kategorije kemikalij kot tudi glede na tipe preskušanja, na primer, fizikalna, kemijska, toksikološka in/ali ekotoksikološka,
The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, for example, physical, chemical, toxicological and/or ecotoxicological,
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ker je Komisija v svojem sporočilu z dne 15. junija 1989 o globalnem pristopu v zvezi s certifikacijo in preskušanjem fn gala, da se sestavijo skupna pravila v zvezi z znak skladnosti CE enotne oblike
Whereas, in its communication of 15 June 1989 on a global approach to certification and testing (5), the Commission proposed that common rules be drawn up concerning a 'CE' conformity marking with a single design;
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ker je Komisija v svojem sporočilu z dne 15. junija 1989 o globalnem pristopu v zvezi s certifikacijo in preskušanjem fn gala, da se sestavijo skupna pravila v zvezi z znak skladnosti CE enotne oblike;
whereas it is therefore necessary to harmonize these provisions, particularly with regard to products which may fall within the scope of several of these Directives;
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ker bi bilo za pospešitev postopka prikazovanja skladnosti z bistvenimi zahtevami zelo koristno uvesti na evropski ravni usklajene standarde, ki se med drugim nanašajo na metode preskušanja eksplozivov;
whereas, in order to facilitate the process of demonstrating compliance with the essential requirements, it would be very useful to process standards harmonized at European level concerning, inter alia, methods for testing explosives;
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Priglašeni organ mora s pregledovanjem in preskušanjem vsake naprave, kot to določa točka 5.4, opraviti ustrezne preglede in preskuse, da preveri skladnost naprave z zahtevami te direktive, ali s pregledovanjem in preskušanjem naprav na statistični podlagi, kot je določeno v točki 5.5, po izbiri proizvajalca.
The notified body must carry out the appropriate examinations and tests in order to check the conformity of the appliance to the requirements of this Directive by examination and testing of every appliance, as specified in point 5. 4, or by examination and testing of appliances on a statistical basis, as specified in point 5. 5, at the choice of the manufacturer.
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Proizvajalec mora organu za ugotavljanje skladnosti omogočiti dostop do krajev pregledovanja, preskušanja in skladiščenja zaradi inšpekcijskih namenov ter mu zagotoviti vse potrebne informacije, še zlasti:
The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage premises and provide it with all necessary information, in particular:
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promet
sodelovati v shemi Mednarodne elektrotehnične komisije (IEC) IECEE priznavanja rezultatov preskušanja varnosti električne opreme na standarde (shema certifikacijskih organov (CB)) v IEC sistemu preskušanja skladnosti varnosti električne opreme s standardi IEC (IECEE), kakor je opredeljeno v dokumentu IECEE 02/1992-05, ali
be a participant in the International Electrotechnical Commission (IEC) scheme of the IECEE for recognition of results of testing to standards for safety of electrical equipment (certification bodies (CB) scheme) under the IEC system for conformity testing to standards for safety of electrical equipment (IECEE) as defined in IECEE Document 02/1992-05; or
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Skladnost ali neskladnost proizvodnje se ugotavlja s preskušanjem vozil, vključno s preskusnim vzorcem, dokler ni sprejeta odločitev o odobritvi za vse mejne vrednosti ali odločitev o zavrnitvi za eno mejno vrednost.
The production of the series is deemed to conform or not to conform by testing vehicles comprising a test sample until a pass decision is reached for all limit values or a fail decision is reached for one limit value.
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Proizvajalec mora organ za ugotavljanje skladnosti dovoliti dostop do krajev proizvodnje, pregledovanja, preskušanja in skladiščenja zaradi inšpekcijskih namenov ter mu zagotoviti vse potrebne informacije, še zlasti:
2 The manufacturer must allow the notified body access for inspection purposes to the manufacturing, inspection, testing and storage premises and provide it with all necessary information, in particular:
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Ne glede na zahteve iz točke 2.1.1 Priloge III lahko organ za preskušanje, odgovoren za preverjanje skladnosti proizvodnje, s pristankom proizvajalca izvaja preskuse tipov I, II in III na vozilih z manj kot 3000 prevoženimi kilometri."
Notwithstanding the requirements of item 2.1.1 of Annex III, the technical department responsible for checking conformity of production may, with the consent of the manufacturer, carry out tests of Types I, II and III on vehicles which have been driven less than 3000 km.'
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Ne glede na zahteve točke 3.1.1 Priloge III lahko organ za tehnično preskušanje, odgovoren za preverjanje skladnosti proizvodnje, s pristankom proizvajalca opravi preskuse tipov I, II in III na vozilih z manj kot 3000 prevoženimi kilometri.
Notwithstanding the requirements of 3.1.1 of Annex III, the technical service responsible for verifying the conformity of production may, with the consent of the manufacturer, carry out tests of types I, II and III on vehicles which have been driven less than 3 000 km.
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ker je treba skladnost proizvodov z usklajenimi standardi in z na ravni Skupnosti priznanimi tehničnimi specifikacijami, zagotoviti s postopki kontrole proizvodnje, ki jih izvajajo proizvajalci, in z nadzorom, preskušanjem, ocenjevanjem in certificiranjem, ki ga izvaja neodvisna, za to usposobljena tretja oseba, ali pa skladnost zagotavlja kar proizvajalec sam;
Whereas it is necessary to ensure the conformity of products with harmonized standards and with non-harmonized technical specifications recognized at European level by means of procedures of production control by manufacturers and of supervision, testing assessment and certification by independent qualified third parties, or by the manufacturer himself;
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promet
potrditev skladnosti preskusnih laboratorijev z načeli DLP za preskušanje kemikalij, bodisi snovi ali pripravkov, kakor je določeno v zakonih, predpisih in upravnih določbeh vsake pogodbenice, navedenih v oddelku I dela B te sektorske priloge; in
the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex; and,
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promet
Organi za imenovanje, so tisti oblastni organi in organizacije, odgovorni za imenovanje in zagotavljanje usposobljenosti organov za ugotavljanje skladnosti za preskušanje in certificiranje opreme, ki jo ureja ta priloga, po zahtevah druge pogodbenice.
Designating authorities are those authorities and organisations responsible for designating and assuring the competence of conformity assessment bodies to test and certify equipment covered by this Annex to the requirements of the other Party.
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Za proizvode, ki so predmet potrjevanja skladnosti, velja domneva, da so skladni s tehničnimi specifikacijami iz člena 4. Skladnost se ugotavlja s preskušanjem ali z drugimi načini dokazovanja na podlagi tehničnih specifikacij, skladno s Prilogo III.
Products that are the subject of an attestation of conformity shall benefit from the presumption of conformity with technical specifications within the meaning of Article 4. Conformity shall be established by means of testing or other evidence on the basis of the technical specifications in accordance with Annex III.
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Države članice bodo sprejele načela DLP in določile postopke nadzora skladnosti, v skladu z nacionalno pravno in upravno prakso in v skladu s prednostjo, ki jo namenjajo, na primer, obsegu začetne in nadaljnje vključitve kategorij kemikalij in tipov preskušanja.
It is recognised that Member States will adopt GLP principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, for example the scope of initial and subsequent coverage concerning categories of chemicals and types of testing.
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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.
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.
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Za homologacijo in potrditev skladnosti proizvodnje za vozila kategorije M 1 z motorjem s prostornino, večjo ali enako 1400 cm 3, lahko organ za tehnično preskušanje na zahtevo proizvajalca namesto preskusa iz točke 5.2.1.1 opravi enakovreden preskus, naveden v Prilogi IIIA (cikel EPA).
For the type-approval and verification of production of vehicles of category M1 equipped with an engine whose capacity > 1 400 cm3, the technical service may, at the request of a manufacturer, carry out the equivalent test described in Annex IIIA (EPA cycle) instead of that described in 5.2.1.1.
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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.
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.
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glede zahteve za terminalske priključke in radijske oddajnike - preskušanje, izdajanje in sprejem poročil o preskusih, izvajanje potrebnih tehničnih vrednotenj in certificiranje skladnosti z zahtevami zakonov in predpisov, ki veljajo na območjih pogodbenic za proizvode, na katere se nanaša ta priloga,
for terminal attachment and radio transmission requirements - testing, issuing and acceptance of test reports, performance of required technical evaluation and certification of compliance with the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Annex,
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finance
CELEX: 32003L0063
Ti preskusi so pomembni za preverjanje skladnosti zdravila s sestavo, če vlagatelj izjemoma predlaga analizno metodo za preskušanje končnega izdelka, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi ob upoštevanju enakih zahtev kot za zdravilne učinkovine).
These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient constituents subject to the same requirements as the active substances).
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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.
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.
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Priglašeni organ opravi primerne preglede in preskuse, da preveri skladnost izdelka z zahtevami direktive, bodisi s pregledom in preskusom vsakega izdelka, skladno z določbami točke 4, bodisi s pregledovanjem in preskušanjem izdelkov na statistični podlagi, skladno z določbami točke 5, po izbiri proizvajalca.
The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product with the requirements of the Directive either by examination and testing of every product as specified in point 4 or by examination and testing of products on a statistical basis, as specified in point 5, at the choice of the manufacturer.
49 Pravna redakcija
DRUGO
Ti preskusi so ključnega pomena za preverjanje skladnosti zdravila s sestavo, če izjemoma predlagatelj predlaga analitsko metodo za preskušanje končnega proizvoda, ki ne vključuje določanja vsebnosti vseh zdravilnih učinkovin (ali vseh sestavin pomožnih snovi, za katere veljajo iste zahteve kot za zdravilne učinkovine).
These tests are essential for checking the conformity of the medicinal product with the formula when, exceptionally, an applicant proposes an analytical method for testing the finished product which does not include the assay of all the active substances (or of all the excipient components subject to the same requirements as the active substances).
50 Pravna redakcija
DRUGO
ker je, da bi olajšali dokazovanje skladnosti s temi osnovnimi zahtevami, bistveno, da so na voljo evropski usklajeni standardi, zlasti glede zasnove in izdelave osebne zaščitne opreme, prav tako pa tudi veljavne specifikacije in metode preskušanja, saj se zaradi skladnosti z njimi domneva skladnost teh izdelkov z zgoraj navedenimi osnovnimi zahtevami;
whereas, in order to facilitate proof of conformity with those basic requirements, it is essential that harmonized European standards be available relating, in particular, to the design and manufacture of, and the specifications and test methods applicable to, personal protective equipment, since compliance therewith confers on these products a presumption of conformity with the abovementioned basic requirements;
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