FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: (notified under document number C(2004) 1275)
French: [notifiée sous le numéro C(2004) 1275]
Portuguese: [notificada com o número C(2004) 1275]
Slovak: (oznámené pod číslom dokumentu C(2004) 1275)
Polish: (notyfikowana jako dokument nr C(2004) 1275)
Hungarian: (az értesítés a C(2004) 1275. dokumentummal történt)
Slovenian: (notificirana pod dokumentarno številko K(2004) 1275)
Romanian: [notificată cu numărul C(2004) 1275]
Bulgarian: (нотифицирано с № С(2004) 1275)
Estonian: (teatavaks tehtud numbri K(2004) 1275 all)
Latvian: (izziņots ar dokumenta numuru C(2004) 1275)
Lithuanian: (pranešta dokumentu Nr. C(2000) 1275)
Maltese: (notifikat taħt id-dokument numru K(2004) 1275)
English: It is considered that there is a need to improve the relationship between EN 12180:2000 and certain essential requirements of Directive 93/42/EEC, to facilitate compliance with clauses 7.1 and 7.5 of the essential requirements which support General Requirements 1, 2 and 4.
French: Il est nécessaire d'améliorer le rapport entre la norme EN 12180:2000 et certaines exigences essentielles de la directive 93/42/CEE afin que les clauses 7.1 et 7.5 des exigences essentielles, qui étayent les exigences générales 1, 2 et 4, puissent être mieux respectées.
Portuguese: Afigura-se necessário melhorar a relação entre a norma EN 12180:2000 e certos requisitos essenciais da Directiva 93/42/CEE, com vista a facilitar o cumprimento das cláusulas 7.1 e 7.5 dos requisitos essenciais que sustentam os requisitos gerais 1, 2 e 4.
Slovak: Je treba zlepšiť vzťah medzi EN 12180:2000a niektorými základnými požiadavkami smernice 93/42/EHS, aby sa umožnil súlad s klauzulami 7.1 a 7.5 základných požiadaviek, ktoré podporujú všeobecné požiadavky 1, 2 a 4;
Polish: Uważa się, że należy wzmocnić związek między EN 12180:2000 a niektórymi wymogami zasadniczymi dyrektywy 93/42/EWG w celu ułatwienia zgodności z klauzulami 7.1 i 7.5 wymogów zasadniczych, wspierających wymogi ogólne 1,2 i 4.
Hungarian: Szükségesnek tartott az EN 12180:2000 és a 93/42/EGK irányelv egyes alapvető követelményei közötti kapcsolat javítása, az 1., 2. és 4. általános követelményt alátámasztó alapvető követelmények 7.1. és 7.5. előírásának való megfelelés elősegítésére.
Slovenian: Ocenjuje se, da obstaja potreba po izboljšanju povezave med EN 12180:2000 in nekaterimi bistvenimi zahtevami Direktive 93/42/EGS, da se omogoči skladnost z določbami točke 7.1 in 7.5 bistvenih zahtev, ki spremljajo točko 1, 2 in 4 splošnih zahtev.
Bulgarian: Счита се, че е необходимо да се подобри връзката между EN 12180:2000 с някои съществени изисквания на Директива 93/42/ЕИО, за да се улесни съответствието с клаузите 7.1 и 7.5 от съществените изисквания, които поддържат общите изисквания 1, 2 и 4.
Estonian: Peetakse vajalikuks parandada vastavust standardi EN 12180:2000 ja mõnede direktiivi 93/42/EMÜ põhinõuete vahel, et hõlbustada põhinõuete punktide 7.1 ja 7.5 täitmist, mis toetavad üldnõudeid 1, 2 ja 4.
Latvian: Uzskata, ka jāuzlabo attiecība starp Eiropas standarta 12180:2000 un Direktīvā 93/42/EEK noteiktajām pamatprasībām, lai būtu vieglāk ievērot pamatprasības 7.1. un 7.5. noteikumu, ar ko pamato 1., 2. un 4. vispārīgo prasību.
Lithuanian: Manoma, kad reikia pagerinti EN 12180:2000 sąsajas su tam tikrais esminiais direktyvos 93/42/EEB reikalavimais tam, kad būtų labiau laikomasi esminių reikalavimų 7.1 ir 7.5 punktų, užtikrinančių bendrųjų reikalavimų 1, 2 ir 4 dalies charakteristikas ir veikimą.
Maltese: Huwa kunsidrat li hemm il-ħtieġa li tittejjeb ir-relazzjoni bejn EN 12180:2000 u ċerti ħtiġiet essenzali tad-Direttiva 93/42/KEE, biex tiġi faċilitata l-konformità mal-klawżoli 7.1 u 7.5 tal-ħtiġiet essenzali li jsostnu l-Ħtiġiet Ġenerali 1, 2 u 4.
English: HAS ADOPTED THIS DECISION
French: A ARRÊTÉ LA PRÉSENTE DÉCISION
Portuguese: ADOPTOU A PRESENTE DECISÃO:
Slovak: PRIJALA TOTO ROZHODNUTIE:
Polish: PRZYJMUJE NINIEJSZĄ DECYZJĘ:
Hungarian: ELFOGADTA EZT A HATÁROZATOT:
Slovenian: SPREJELA NASLEDNJO ODLOČBO:
Romanian: ADOPTĂ PREZENTA DECIZIE:
Bulgarian: ПРИЕ НАСТОЯЩОТО РЕШЕНИЕ:
Estonian: ON VASTU VÕTNUD KÄESOLEVA OTSUSE:
Latvian: IR PIEŅĒMUSI ŠĀDU LĒMUMU.
Lithuanian: PRIĖMĖ ŠĮ SPRENDIMĄ:
Maltese: ADOTTAT DIN ID-DEĊIŻJONI
English: Article 1
French: Article premier
Portuguese: Artigo 1.º
Slovak: Článok 1
Polish: Artykuł 1
Hungarian: 1. cikk
Slovenian: Člen 1
Romanian: Articolul 1
Bulgarian: Член 1
Estonian: Artikkel 1
Latvian: 1. pants
Lithuanian: 1 straipsnis
Maltese: Artikolu 1
English: The standard shall not therefore continue to confer the presumption of conformity to the relevant provisions of Directive 93/42/EEC.
French: La norme ne continuera donc pas à bénéficier de la présomption de conformité aux dispositions correspondantes de la directive 93/42/CEE.
Portuguese: Por conseguinte, a norma em causa deixará de beneficiar da presunção de conformidade com as disposições pertinentes da Directiva 93/42/CEE.
Slovak: Norma preto nemôže naďalej ťažiť z predpokladu zhody s príslušnými ustanoveniami smernice 93/42/EHS.
Polish: Norma ta dlatego nie zakłada już zgodności z odpowiednimi przepisami dyrektywy 93/42/EWG.
Hungarian: Ennél fogva a szabvány a továbbiakban nem keletkeztet vélelmet a 93/42/EGK irányelv megfelelő rendelkezéseinek való megfelelésre.
Slovenian: Zato ta standard ne izkazuje več domneve o skladnosti z ustreznimi določbami Direktive 93/42/EGS.
Romanian: Prin urmare, acest standard nu va mai continua să confere prezumția de conformitate cu dispozițiile relevante ale Directivei 93/42/CEE.
Bulgarian: Стандартът следователно няма да се счита за съответстващ със съответните разпоредби на Директива 93/42/ЕИО.
Estonian: Seega ei tähenda vastavus kõnealusele standardile enam vastavust direktiivi 93/42/EMÜ asjaomastele sätetele.
Latvian: Tādēļ uz šo standartu neturpina attiecināt Direktīvas 93/42/EEK attiecīgo noteikumu atbilstības prezumpciju.
Lithuanian: Todėl standartas nebegali būti pripažįstamas atitinkančiu atitinkamas Direktyvos 93/42/EEB nuostatas.
Maltese: Dan l-istandard ma għandux għalhekk ikompli jikkonferixxi l-preżunzjoni ta' konformità għad-disposizzjonijiet relevanti tad-Direttiva 93/42/KEE.
English: Article 2
French: Article 2
Portuguese: Artigo 2.º
Slovak: Článok 2
Polish: Artykuł 2
Hungarian: 2. cikk
Slovenian: Člen 2
Romanian: Articolul 2
Bulgarian: Член 2
Estonian: Artikkel 2
Latvian: 2. pants
Lithuanian: 2 straipsnis
Maltese: Artikolu 2
English: Done at Brussels, 20 April 2004.
French: Fait à Bruxelles, le 20 avril 2004.
Portuguese: Feito em Bruxelas, em 20 de Abril de 2004.
Slovak: V Bruseli 20. apríla 2004
Polish: Sporządzono w Brukseli, dnia 20 kwietnia 2004 r.
Hungarian: Kelt Brüsszelben, 2004. április 20-án.
Slovenian: V Bruslju, 20. aprila 2004
Romanian: Adoptată la Bruxelles, 20 aprilie 2004.
Bulgarian: Съставено в Брюксел на 20 април 2004 година.
Estonian: Brüssel, 20. aprill 2004
Latvian: Briselē, 2004. gada 20. aprīlī
Lithuanian: Priimta Briuselyje, 2004 m. balandžio 20 d.
Maltese: Magħmul fi Brussel, fl-20 ta' April 2004.
English: For the Commission
French: Par la Commission
Portuguese: Pela Comissão
Slovak: Za Komisiu
Polish: W imieniu Komisji
Hungarian: A Bizottság részéről
Slovenian: Za Komisijo
Romanian: Pentru Comisie
Bulgarian: За Комисията
Estonian: Komisjoni nimel
Latvian: Komisijas vārdā
Lithuanian: Komisijos vardu
Maltese: Għall-Kummissjoni
English: Erkki Liikanen
French: Erkki Liikanen
Portuguese: Erkki Liikanen
English: Member of the Commission
French: Membre de la Commission
Portuguese: Membro da Comissão
Slovak: člen Komisie
Polish: Członek Komisji
Hungarian: A Bizottság tagja
Slovenian: Član Komisije
Romanian: Membru al Comisiei
Bulgarian: Член на Kомисията
Estonian: komisjoni liige
Latvian: Komisijas loceklis
Lithuanian: Komisijos narys
Maltese: Membru tal-Kummissjoni
English: Article 2 of Directive 93/42/EEC stipulates that medical devices may be placed on the market and put into service only if, when normally used, they do not compromise the safety of persons.
French: L'article 2 de la directive 93/42/CEE prévoit que les dispositifs médicaux ne peuvent être mis sur le marché et en service que s'ils ne compromettent pas la sécurité des personnes dans des conditions normales d'utilisation.
Portuguese: O artigo 2.º da Directiva 93/42/CEE determina que os dispositivos médicos só podem ser colocados no mercado e entrar em serviço se, quando utilizados em conformidade com a respectiva finalidade, não comprometerem a segurança das pessoas.
Slovak: článok 2 smernice 93/42/EHS určuje, že zdravotnícke pomôcky sa môžu uviesť na trh a do služby iba ak neohrozujú bezpečnosť osôb pri podmienkach bežného používania;
Polish: Artykuł 2 dyrektywy 93/42/EWG stanowi, że wyroby medyczne mogą być wprowadzane do obrotu i używania tylko wtedy, gdy prawidłowo używane, nie zagrażają bezpieczeństwu użytkowników.
Hungarian: A 93/42/EGK irányelv 2. cikke előírja, hogy orvosi eszközöket csak akkor lehet forgalomba hozni és üzembe helyezni, ha azok rendeltetésszerű használatuk során nem veszélyeztetik a személyek biztonságát.
Slovenian: Člen 2 Direktive 93/42/EGS določa, da se medicinski pripomočki lahko dajo na trg ali v uporabo le, če pri normalni uporabi ne ogrožajo varnosti ljudi.
Romanian: Articolul 2 din Directiva 93/42/CEE prevede că dispozitivele medicale pot fi introduse pe piață și date în folosință doar în cazul în care, în condiții normale de utilizare, nu pun în pericol siguranța persoanelor.
Bulgarian: Член 2 от Директива 93/42/ЕИО постановява, че медицински продукти могат да се пускат на пазара и да се въвеждат в действие само ако при нормалната им употреба не вредят на здравето на хората.
Estonian: Direktiivi 93/42/EMÜ artiklis 2 nähakse ette, et meditsiiniseadmeid võib turule lasta ja kasutusele võtta üksnes sel juhul, kui need tavapärasel kasutamisel ei ohusta inimeste tervist.
Latvian: Direktīvas 93/42/EEK 2. pantā paredzēts, ka medicīnas ierīces var laist tirgū un nodot ekspluatācijā tikai tad, ja, pareizi lietojot, tās negatīvi neietekmē cilvēku drošību.
Lithuanian: Direktyvos 93/42/EEB 2 straipsniu nustatoma, kad medicinos prietaisai gali būti pateikiami rinkai arba pradedami naudoti tiktai tuomet, jei įprastai juos naudojant, jie nekenkia asmenų saugai,
Maltese: L-Artikolu 2 tad-Direttiva 93/42/KEE jistipula li mekkaniżmi mediċi jistgħu jitqegħdu fis-suq u jitqegħdu fis-servizz biss jekk, meta jintużaw b'mod normali, ma jikkompromettux is-sigurezza ta' persuna.
English: Member States are required to publish the reference numbers of national standards transposing harmonised standards, the reference numbers of which have been published in the Official Journal of the European Union.
French: Les États membres sont tenus de publier les références des normes nationales transposant les normes harmonisées dont les numéros de référence ont été publiés au Journal officiel de l'Union européenne.
Portuguese: Os Estados-Membros devem publicar as referências das normas nacionais que transpõem as normas harmonizadas, cujas referências tenham sido publicadas no Jornal Oficial da União Europeia.
Slovak: od členských štátov sa požaduje uverejnenie referenčných čísiel vnútroštátnych noriem pri transponovaní harmonizovaných noriem, ktorých referenčné čísla sú uverejnené v Úradnom vestníku Európskej únie;
Polish: Państwa Członkowskie są zobowiązane do publikacji odniesień do krajowych norm transponujących normy zharmonizowane, których odniesienia zostały opublikowane w Dzienniku Urzędowym Unii Europejskiej.
Hungarian: A tagállamoknak közzé kell tenniük az olyan harmonizált szabványok szerint bevezetett nemzeti szabványok hivatkozási számait, amelyek hivatkozási számait az Európai Unió Hivatalos Lapjában már közzétették
Slovenian: Države članice morajo objaviti sklicne številke nacionalnih standardov, ki prevzemajo harmonizirane standarde, katerih sklicne številke so bile objavljene v Uradnem listu Evropske unije.
Romanian: Statele membre trebuie să publice numerele de referință ale standardelor naționale care transpun standardele armonizate ale căror numere de referință au fost publicate în Jurnalul Oficial al Uniunii Europene.
Bulgarian: От държавите-членки се изисква да публикуват референтните номера на националните стандарти, транспониращи хармонизирани стандарти, чиито номера са били публикувани в Официален вестник на Европейския съюз.
Estonian: Liikmesriigid peavad avaldama Euroopa Liidu Teatajas avaldatud viidete kohaste ühtlustatud standardite ülevõtmiseks vastu võetud siseriiklike standardite viited.
Latvian: Dalībvalstīm jāpublicē atsauces numuri valsts standartiem, kuros transponēti saskaņotie standarti un kuru atsauces numuri ir publicēti Eiropas Savienības Oficiālajā Vēstnesī.
Lithuanian: Reikalaujama, kad valstybės narės skelbtų nuorodas į nacionalinius standartus, kurie buvo priimti pagal suderintus standartus, kurių nuorodos buvo paskelbtos Europos Sąjungos oficialiajame leidinyje.
Maltese: L-Istati Membri huma meħtieġa li jippublikaw in-numri ta' referenza ta' l-istandards nazzjonali li jittrasportaw l-istandards armonizzati, li n-numri ta' referenza tagħhom ġew pubblikati fil-Ġurnal Uffiċjali ta' l-Unjoni Ewropea.
English: On the basis of the information received in the framework of the consultation of the members of the CEN technical board, CEN has asked the European Commission to withdraw the citation of EN 12180:2000 from the Official Journal of the European Communities,
French: D'après les informations recueillies dans le cadre de la procédure de consultation des membres du bureau technique du CEN, le CEN a demandé à la Commission européenne de retirer la norme EN 12180:2000 du Journal officiel des Communautés européennes,
Portuguese: Com base na informação recolhida no âmbito da consulta aos membros do Conselho Técnico do CEN, este organismo solicitou à Comissão Europeia que a referência da norma EN 12180:2000 fosse retirada do Jornal Oficial das Comunidades Europeias,
Slovak: na základe informácií obdržaných v rámci konzultácie s členmi technickej rady CEN, CEN požiadal Európsku komisiu, aby stiahla znenie EN 12180:2000 z Úradného vestníka Európskych spoločenstiev,
Polish: Na podstawie informacji otrzymanych w ramach konsultacji członków Biura Technicznego CEN, CEN zwróciło się do Komisji Europejskiej o wycofanie odniesienia EN 12180:2000 z Dziennika Urzędowego Wspólnot Europejskich,
Hungarian: A CEN technikai tanácsának tagjai által lefolytatott konzultáció keretében kapott információk alapján a CEN felkérte az Európai Bizottságot, hogy vonja vissza az EN 12180:2000 szabványnak az Európai Közösségek Hivatalos Lapjában történt közzétételét,
Slovenian: Na podlagi podatkov, prejetih v okviru posvetovanja članov CEN tehničnega odbora, je CEN zahteval od Evropske komisije, da le-ta umakne navedbo EN 12180:2000 iz Uradnega lista Evropskih skupnosti –
Bulgarian: На базата на информацията, получена в рамките на консултацията с членовете на техническия борд на CEN, CEN е поискал Европейската комисия да оттегли стандарт EN 12180:2000 от Официален вестник на Европейския съюз.
Estonian: Tuginedes konsultatsioonide käigus Euroopa Standardikomitee tehnilise nõukogu liikmetelt saadud informatsioonile, on Euroopa Standardikomitee palunud Euroopa Komisjoni jätta Euroopa Liidu Teatajast välja viide standardile EN 12180:2000,
Latvian: Pamatojoties uz informāciju, kas saņemta, apspriežoties ar CEN Tehniskās padomes locekļiem, CEN ir prasījusi Eiropas Komisijai svītrot Eiropas standarta 12180:2000 norādi Eiropas Kopienu Oficiālajā Vēstnesī,
Lithuanian: Remdamasis informacija, gauta konsultacijų su CEN techninės tarybos nariais metu, CEN paprašė Europos Komisiją pašalinti iš Europos Bendrijų oficialiojo leidinio nuorodą į EN 12180:2000,
Maltese: Fuq il-bażi ta' l-informazzjoni riċevuta fil-qafas tal-konsultazzjoni tal-membri tal-bord tekniku CEN, is-CEN talbet lill-Kummissjoni Ewropea biex tirtira ċ-ċitazzjoni ta' l-EN 12180:2000 mill-Ġurnall Uffiċjali tal-Komunitajiet Ewropej,
English: The reference of standard EN 12180:2000
Latvian: Atsauci uz Eiropas standartu 12180:2000
English: "Non-active surgical implants
Latvian: "Neaktīvie ķirurģiskie implanti
English: Body contouring implants
Latvian: ķermeņa kontūrimplanti
English: Specific requirements for mammary implants", adopted by the European Committee For Standardisation (CEN) and published for the first time in the Official Journal of the European Communities of 31 July 2002, shall be withdrawn from the list of standards published in the Official Journal of the European Communities.
Latvian: īpašas prasības krūšu implantiem", ko Eiropas Standartizācijas komiteja (CEN) ir pieņēmusi un pirmo reizi publicējusi 2002. gada 31. jūlija Eiropas Kopienu Oficiālajā Vēstnesī, svītro no Eiropas Kopienu Oficiālajā Vēstnesī publicēto standartu saraksta.
English: Having regard to the opinion of the Standing Committee set up in accordance with Article 5 of Directive 98/34/EC of the European Parliament
Romanian: având în vedere avizul Comitetului permanent instituit în temeiul articolului 5 din Directiva 98/34/CE a Parlamentului European
English: and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(3),
Romanian: și a Consiliului din 22 iunie 1998 de stabilire a unei proceduri pentru furnizarea de informații în domeniul standardelor și reglementărilor tehnice și al normelor privind serviciile societății informaționale,
English: as amended by Directive 98/48/EC(4),
Romanian: astfel cum a fost modificată prin Directiva 98/48/CE, întrucât:
English: Pursuant to Article 5 of Directive 93/42/EEC,
Romanian: În temeiul articolului 5 din Directiva 93/42/CEE,
English: medical devices are presumed to comply with the essential requirements referred to in Article 3 of that Directive
Romanian: dispozitivele medicale sunt prezumate a fi în conformitate cu cerințele esențiale prevăzute la articolul 3 din directiva menționată
English: if they conform to the national standards applicable to them transposing the harmonised standards, the reference numbers of which have been published in the Official Journal of the European Union.
Romanian: în cazul în care sunt în conformitate cu standardele naționale care le sunt aplicabile și care transpun standardele armonizate ale căror numere de referință au fost publicate în Jurnalul Oficial al Uniunii Europene.
English: EN 12180:2000 should be considered in the light of the Commission communication "Communication from the Commission on Community and national measures in relation to breast implants (COM(2001) 666(01))",
Romanian: Standardul EN 12180:2000 ar trebui examinat în lumina comunicării Comisiei, „Comunicarea Comisiei privind măsurile comunitare și naționale aplicabile implanturilor mamare [COM(2001) 666(01)]”,
English: on the basis of which the European Commission gave CEN a new standardisation mandate, M/320 "Breast Implants", aimed at rectifying possible shortcomings of EN 12180:2000.
Romanian: în temeiul căreia Comisia Europeană a conferit CEN un nou mandat de standardizare, M/320 „Implanturi mamare”, cu scopul de a corecta eventualele neajunsuri ale standardului EN 12180:2000.
English: It is considered that there is a need to improve the relationship between EN 12180:2000 and certain essential requirements of Directive 93/42/EEC,
Romanian: Este necesar să se îmbunătățească relația dintre standardul EN 12180:2000 și anumite cerințe esențiale prevăzute de Directiva 93/42/CEE,
English: to facilitate compliance with clauses 7.1 and 7.5 of the essential requirements which support General Requirements 1, 2 and 4.
Romanian: pentru a facilita respectarea clauzelor 7.1 și 7.5 din cerințele esențiale care sprijină cerințele generale 1, 2 și 4.
English: On the basis of the information received in the framework of the consultation of the members of the CEN technical board,
Romanian: Pe baza informațiilor obținute în cadrul procedurii de consultare a membrilor comitetului tehnic al CEN,
English: CEN has asked the European Commission to withdraw the citation of EN 12180:
Romanian: CEN a solicitat Comisiei Europene să retragă referința la standardul EN 12180:
English: 2000 from the Official Journal of the European Communities,
Romanian: 2000 din Jurnalul Oficial al Comunităților Europene,
English: The reference of standard EN 12180:2000 "Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants",
Romanian: Referința la standardul EN 12180:2000, „Implanturi chirurgicale neactive. Implanturi pentru morfologia corpului. Cerințe specifice pentru implanturi mamare”,
English: adopted by the European Committee For Standardisation (CEN) and published for the first time in the Official Journal of the European Communities of 31 July 2002,
Romanian: adoptat de Comitetul European pentru Standardizare (CEN) și publicat pentru prima dată în Jurnalul Oficial al Comunităților Europene la 31 iulie 2002
English: shall be withdrawn from the list of standards published in the Official Journal of the European Communities.
Romanian: este retrasă din lista standardelor publicate în Jurnalul Oficial al Comunităților Europene.
English: EN 12180:2000 should be considered in the light of the Commission communication "Communication from the Commission on Community and national measures in relation to breast implants (COM(2001) 666(01)", on the basis of which the European Commission gave CEN a new standardisation mandate, M/320 "Breast Implants", aimed at rectifying possible shortcomings of EN 12180:2000.
Slovak: EN 12180:2000 by sa mala posudzovať na základe komuniké Komisie "Komuniké od Komisie o opatreniach spoločenstva a vnútroštátnych opatreniach vo vzťahu k prsným implantátom (COM(2001) 666 (01)", na základe ktorého Európska Komisia dala CEN nový normalizačný mandát, M/320 "Prsné implantáty", zameraný na opravu možných nedostatkov EN 12180:2000.