FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements;
Italian: considerando che, in conformità dei principi fissati nella risoluzione del Consiglio, del 7 maggio 1985, relativa ad una nuova strategia in materia di armonizzazione tecnica e normalizzazione, le norme che disciplinano l'elaborazione e la fabbricazione dei dispositivi medici si devono limitare alle disposizioni necessarie a soddisfare i requisiti essenziali;
English: Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices;
Italian: considerando che la direttiva 90/385/CEE del Consiglio, del 20 giugno 1990, per il ravvicinamento delle legislazioni degli Stati membri relative ai dispositivi medici impiantabili attivi rappresenta il primo caso di applicazione del nuovo approccio nel settore dei dispositivi medici;
English: whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility;
Italian: che la presente direttiva deve contenere disposizioni specifiche in materia rispetto alla direttiva 89/336/CEE del Consiglio, del 3 maggio 1989, per il ravvicinamento delle legislazioni degli Stati membri relative alla compatibilità elettromagnetica;
English: whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment;
Italian: che essa non osta all'autorizzazione richiesta dalla direttiva 80/836/Euratom del Consiglio, del 15 luglio 1980, che modifica le direttive che fissano le norme fondamentali relative alla protezione sanitaria della popolazione e dei lavoratori contro i rischi derivanti dalle radiazioni ionizzanti, né all'applicazione della direttiva 84/466/Euratom del Consiglio, del 3 settembre 1984, che stabilisce le misure fondamentali relative alla protezione radiologica delle persone sottoposte ad esami e trattamenti medici (10);
English: whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and the specific directives on the same subject should continue to apply;
Italian: che rimangono d'applicazione la direttiva 89/391/CEE del Consiglio, del 12 giugno 1989, concernente l'attuazione di misure volte a promuovere il miglioramento della sicurezza e della salute dei lavoratori durante il lavoro, nonché le relative direttive particolari;
English: Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations, and pursuant to the abovementioned general guidelines;
Italian: considerando che ai fini della presente direttiva una norma armonizzata è una specifica tecnica (norma europea o documento di armonizzazione) adottata, su mandato della Commissione, dall'uno o l'altro o da entrambi i due organismi, in conformità della direttiva 83/189/CEE del Consiglio, del 28 marzo 1983, che prevede una procedura d'informazione nel settore delle norme e delle regolamentazioni tecniche, nonché a norma degli orientamenti generali summenzionati;
English: whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC;
Italian: che per l'eventuale modifica delle norme armonizzate la Commissione deve farsi assistere dal comitato istituito con la direttiva 83/189/CEE e che le misure de adottare devono essere prese secondo la procedura I di cui alla decisione 87/373/CEE;
English: Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives, the Council has laid down harmonized conformity assessment procedures;
Italian: considerando che, con la decisione 90/683/CEE, del 13 dicembre 1990, concernente i moduli relativi alle diverse fasi delle procedure di valutazione della conformità, da utilizzare nelle direttive di armonizzazione tecnica, il Consiglio ha creato gli strumenti armonizzati nel campo della procedura di valutazione della conformità;
English: Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level, medical devices used for protection against the HIV virus must afford a high level of protection;
Italian: considerando che, nella lotta contro l'AIDS e tenuto conto delle conclusioni del Consiglio del 16 maggio 1989 riugardanti le future attività di prevenzione e di controllo dell'AIDS a livello comunitario, è necessario che i dispositivi medici utilizzati per la prevenzione contro il virus HIV presentino un elevato grado di protezione;
English: Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers;
Italian: considerando che la presente direttiva comprende i dispositivi medici disciplinati dalla direttiva 76/764/CEE del Consiglio, del 27 luglio 1976, per il ravvicinamento delle legislazioni degli Stati membri relative ai termometri clinici di vetro a mercurio del tipo a massima;
English: whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine must be amended,
Italian: che per gli stessi motivi occorre modificare la direttiva 84/539/CEE del Consiglio, del 17 settembre 1984, per il ravvicinamento delle legislazioni degli Stati membri relative agli apparecchi elettrici utilizzati in medicina umana e veterinaria,
English: cosmetic products covered by Directive 76/768/EEC;
Italian: ai prodotti cosmetici contemplati dalla direttiva 76/768/CEE;
English: These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC (*).
French: Ces mesures sont arrêtées selon la procédure définie à l'article 7 paragraphe 2 de la directive 93/42/CEE (*).
Spanish: Dichas medidas se adoptarán con arreglo al procedimiento definido en el apartado 2 del artículo 7 de la Directiva 93/42/CEE (*).
Italian: Tali misure sono adottate secondo la procedura prevista all'articolo 7, paragrafo 2 della direttiva 93/42/CEE (*).
Czech: Opatření se přijímají v souladu s postupem uvedeným v čl. 7 odst. 2 směrnice 93/42/EHS*.
Slovak: Tieto opatrenia sa prijmú podľa postupu uvedeného v článku 7 ods. 2 smernice 93/42/EHS*.
Polish: Środki te są przyjmowane zgodnie z procedurą określoną w art. 7 ust. 2 dyrektywy 93/42/EWG*.
Hungarian: Ezeket az intézkedéseket a 93/42/EGK irányelv** 7. cikke (2) bekezdésében említett eljárásnak megfelelően kell elfogadni.
Slovenian: Ti ukrepi se sprejmejo po postopku iz člena 7(2) Direktive 93/42/EGS *.
Romanian: Aceste măsuri sunt adoptate în conformitate cu procedura descrisă la articolul 7 alineatul (2) din Directiva 93/42/CEE (*).
Bulgarian: Тези мерки се приемат в съответствие с процедурите, предвидени в член 7, параграф 2 от Директива 93/42/ЕИО *.
Estonian: Need meetmed võetakse direktiivi 93/42/EMÜ* artikli 7 lõikes 2 sätestatud korras.
Latvian: Šos pasākumus paredz saskaņā ar Direktīvas 93/42/EEK * 7. panta 2. punktā minēto procedūru.
Lithuanian: Tos priemonės taikomos Direktyvos 93/42/EEB 7 straipsnio 2 dalyje nustatyta tvarka*.
Maltese: Dawn il-miżuri għandhom jiġu adottati b'mod konformi mal-proċedura msemmija fl-Artikolu 7(2) tad-Direttiva 93/42/KEE ([20]).
English: The Standing Committee referred to in Article 7 may assume its tasks from the date of notification of this Directive.
Italian: Il comitato permanente di cui all'articolo 7 può assumere le sue funzioni immediatamente dopo la notifica della presente direttiva.
English: REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
Italian: REQUISITI RELATIVI ALLA PROGETTAZIONE E ALLA COSTRUZIONE
Romanian: CERINȚE PRIVIND PROIECTAREA ȘI CONSTRUCȚIA
Bulgarian: ИЗИСКВАНИЯ ОТНОСНО ПРОЕКТИРАНЕТО И КОНСТРУКЦИЯТА
English: The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the 'General requirements'. Particular attention must be paid to:
Italian: I dispositivi devono essere progettati e fabbricati in modo tale da garantire le caratteristiche e le prestazioni previste alla parte I «Requisiti generali».
Lithuanian: Prietaisai turi būti suprojektuoti ir pagaminti taip, kad užtikrintų I skirsnyje "Bendrieji reikalavimai" nurodytas charakteristikas ir veikimą.Ypatingas dėmesys turi būti kreipiamas į tai, kad:
English: EC DECLARATION OF CONFORMITY (Full quality assurance system)
French: DÉCLARATION CE DE CONFORMITÉ (Système complet d'assurance de qualité) 1.
Italian: DICHIARAZIONE CE DI CONFORMITÀ (Sistema completo di garanzia di qualità)
Romanian: Declarația CE de conformitate
Bulgarian: ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ НА ЕО (ЦЯЛОСТНА СИСТЕМА ЗА ОСИГУРЯВАНЕ НА КАЧЕСТВОТО)
Lithuanian: EB ATITIKTIES DEKLARACIJA (Visiškas kokybės užtikrinimas)
English: The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.
Italian: Nell'adottare una decisione l'organismo notificato tiene nel debito conto le opinioni espresse in occasione di tale consultazione e trasmette la decisione finale all'autorità competente interessata.
English: EC TYPE-EXAMINATION
French: EXAMEN CE DE TYPE
Italian: CERTIFICAZIONE CE
Dutch: EG-TYPEONDERZOEK
Hungarian: K-TÍPUSVIZSGÁLAT
Romanian: Examinare CE de tip
Bulgarian: ТИПОВИ ИЗПИТВАНИЯ НА ЕО
Latvian: EK MODEĻA PĀRBAUDE
Lithuanian: EB TIPINIO PAVYZDŽIO PATIKRINIMAS
English: examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation; it must also record the items designed in conformity with the applicable provisions of the standards referred to in Article 5, as well as the items not designed on the basis of the relevant provisions of the abovementioned standards;
Italian: esamina e valuta la documentazione, verifica che il tipo sia stato fabbricato secondo detta documentazione, controlla anche gli elementi progettati secondo le disposizioni applicabili delle norme previste all'articolo 5, nonché gli elementi la cui progettazione non è basata sulle disposizioni pertinenti di dette norme;
Dutch: onderzoekt en beoordeelt de documentatie, gaat na of het type dienovereenkomstig is vervaardigd en beziet welke elementen zijn ontworpen in overeenstemming met de desbetreffende bepalingen van de in artikel 5 bedoelde normen en voor welke elementen het ontwerp niet gebaseerd is op de desbetreffende bepalingen van die normen;
Estonian: uurima ja hindama dokumente ning kindlaks tegema, kas tüüpeksemplar on valmistatud nende dokumentide kohaselt, samuti registreerima artiklis 5 osutatud standardite kohaldatavate sätete kohaselt kavandatud esemed ning esemed, mis ei ole kavandatud eespool nimetatud standardite vastavate sätete põhjal;
English: ANNEX IV
French: ANNEXE IV
Spanish: ANEXO IV
Italian: ALLEGATO IV
Dutch: BIJLAGE IV
Czech: PŘÍLOHA IV
Slovak: PRÍLOHA IV
Polish: ZAŁĄCZNIK IV
Hungarian: MELLÉKLET
Slovenian: PRILOGA IV
Romanian: Anexa IV
Bulgarian: ПРИЛОЖЕНИЕ ІV
Estonian: IV LISA
Latvian: IV PIELIKUMS
Lithuanian: IV PRIEDAS
Maltese: ANNESS IV
English: EC VERIFICATION
French: VÉRIFICATION CE
Italian: VERIFICA CE
Dutch: EG-KEURING
Hungarian: EK-ELLENŐRZÉS
Romanian: Verificarea CE
Bulgarian: ПРОВЕРКА НА ЕО
Latvian: EK VERIFIKĀCIJA
Lithuanian: EB PATIKRA
English: EC DECLARATION OF CONFORMITY (Production quality assurance)
Italian: DICHIARAZIONE DI CONFORMITÀ CE (Garanzia di qualità della produzione)
Bulgarian: ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ НА ЕО (ОСИГУРЯВАНЕ НА КАЧЕСТВОТО НА ПРОДУКЦИЯТА)
Estonian: EÜ VASTAVUSDEKLARATSIOON (Tootmise kvaliteedigarantii)
Lithuanian: EB ATITIKTIES DEKLARACIJA (Gaminio kokybės užtikrinimas)
English: EC DECLARATION OF CONFORMITY (Product quality assurance)
Italian: DICHIARAZIONE DI CONFORMITÀ CE (Garanzia di qualità del prodotto)
Dutch: EG-VERKLARING VAN OVEREENSTEMMING (Produktkwaliteitsborging)
Slovenian: ES IZJAVA O SKLADNOSTI (Sistem za zagotavljanje kakovosti izdelka)
Bulgarian: ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ НА ЕО (ОСИГУРЯВАНЕ КАЧЕСТВОТО НА ПРОДУКЦИЯТА)
Lithuanian: EB ATITIKTIES DEKLARACIJA (Gaminio kokybės užtikrinimas)
English: EC DECLARATION OF CONFORMITY
Italian: DICHIARAZIONE DI CONFORMITÀ CE
Dutch: EG-VERKLARING VAN OVEREENSTEMMING
Romanian: Declarația CE de conformitate
Bulgarian: ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ НА ЕО
Latvian: EK ATBILSTĪBAS DEKLARĀCIJA
Lithuanian: EB ATITIKTIES DEKLARAVIMAS
English: the results of the design calculations and of the inspections carried out, etc.;
French: les résultats des calculs de conception et des inspections effectuées, etc.;
Italian: i risultati dei calcoli di progettazione, dei controlli svolti, ecc.
Czech: výsledky konstrukčních výpočtů, provedených inspekcí atd.;
Slovak: výsledky výpočtov a vykonaných inšpekcií atď.;
Polish: wyniki obliczeń projektowych i przeprowadzanych kontroli itp.;
Hungarian: a tervezési számítások és az elvégzett ellenőrzések stb. eredményei;
Slovenian: rezultate opravljenih načrtovalnih izračunov in opravljenih inšpekcij itd.;
Romanian: rezultatele calculelor de proiect și ale inspecțiilor efectuate etc.;
Bulgarian: резултатите от конструкционните изчисления и проведените инспекции и др.;
Estonian: tehtud konstruktsiooniarvutuste ja kontrolli jne tulemused;
Latvian: konstrukcijas aprēķinu, veikto pārbaužu u.c. rezultāti;
Lithuanian: projekto skaičiavimų bei atliktų tikrinimų rezultatai;
Maltese: ir-riżultati tal-kalkolazzjonijiet tad-disinn u ta' l-ispezzjonijiet imwettqa, eċċ.;
English: STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
Italian: DICHIARAZIONE RELATIVA AI DISPOSITIVI PER DESTINAZIONI PARTICOLARI
Dutch: VERKLARING BETREFFENDE DE HULPMIDDELEN MET EEN BIJZONDERE BESTEMMING
Romanian: Declarație privind dispozitivele cu utilizare specială
Bulgarian: ДЕКЛАРАЦИЯ ОТНОСНО ПРОДУКТИ ЗА СПЕЦИАЛНИ ЦЕЛИ
Latvian: PAZIŅOJUMS PAR IERĪCĒM, KAS PAREDZĒTAS ĪPAŠIEM NOLŪKIEM
Lithuanian: PAREIŠKIMAS APIE SPECIALIOSIOS PASKIRTIES PRIETAISUS
English: CLASSIFICATION CRITERIA
Italian: CRITERI DI CLASSIFICAZIONE
Dutch: CLASSIFICATIECRITERIA
Czech: KLASIFIKAČNÍ KRITÉRIA
Slovak: KRITÉRIÁ POUŽÍVANÉ NA TRIEDENIE
Slovenian: KLASIFIKACIJSKA MERILA
Romanian: Criterii de clasificare
Bulgarian: КЛАСИФИКАЦИОННИ КРИТЕРИИ
Lithuanian: KLASIFIKAVIMO KRITERIJAI
English: DEFINITIONS
Italian: DEFINIZIONI
Dutch: DEFINITIES
Czech: DEFINICE
Slovak: DEFINÍCIE
Slovenian: OPREDELITVE
Lithuanian: APIBRĖŽIMAI
English: IMPLEMENTING RULES
French: RÈGLES D'APPLICATION
Italian: REGOLE DI APPLICAZIONE
Dutch: TOEPASSINGSREGELS
Romanian: NORME DE APLICARE
Bulgarian: ПРАВИЛА ЗА ПРИЛАГАНЕ
Latvian: IZPILDES NOTEIKUMI
Lithuanian: ĮGYVENDINIMO TAISYKLĖS
English: All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner:
French: Tous les dispositifs actifs destinés à administrer dans le corps et/ou à en soustraire des médicaments, des liquides biologiques ou d'autres substances font partie de la classe IIa,
Italian: Tutti i dispositivi attivi destinati a somministrare e/o a sottrarre medicinali, liquidi corporei o altre sostanze dal corpo rientrano nella classe IIa, a meno che ciò sia effettuato in una forma:
Dutch: Alle actieve hulpmiddelen die bestemd zijn om geneesmiddelen, lichaamsvochten of andere stoffen aan het lichaam toe te dienen of te onttrekken, behoren tot klasse IIa, tenzij dit gedaan wordt op een wijze:
Czech: Aktivní prostředky určené k podávání léčivých přípravků, tělních tekutin nebo jiných látek do těla a/nebo jejich odstraňování z těla spadají do třídy IIa, pokud se tak neděje způsobem,
Polish: Wszystkie aktywne wyroby medyczne przeznaczone do podawania i/lub usuwania lekarstw, płynów ustrojowych lub innych substancji do lub z ciała, znajdują się w klasie IIa, chyba że sporządzono je w sposób:
Hungarian: Valamennyi aktív eszköz, amelynek rendeltetése gyógyszerek, testfolyadékok vagy más anyagok bejuttatása a testbe és/vagy eltávolítása a testből, a IIa. osztályba tartozik, kivéve, ha ezt olyan módon végzi:
Slovenian: Vsi aktivni pripomočki, namenjeni dajanju in/ali odstranjevanju zdravil, telesnih tekočin ali drugih snovi v telo oziroma iz njega, spadajo v razred IIa, razen če to dosegajo na način:
Romanian: Toate dispozitivele active destinate administrării în organism și/sau eliminării medicamentelor, lichidelor organismului uman sau a altor substanțe din organism fac parte din clasa IIa, cu excepția cazului în care acest lucru se face de o manieră:
Bulgarian: Всички активни продукти, планирани да предписват и/или пренасят лекарства, телесни течности или други субстанции към или от тялото са в клас ІІ а, освен ако това е направено по начин, така че:
Latvian: Visas aktīvās ierīces, kas paredzētas tam, lai ievadītu un/vai izvadītu zāles, ķermeņa šķidrumus vai citas vielas uz cilvēka ķermeni vai no tā, ir IIa klasē, ja vien tas nav:
Lithuanian: Visi aktyvieji prietaisai, skirti įvesti į organizmą ir (ar) pašalinti iš organizmo vaistus, kūno skysčius ar kitas medžiagas, priklauso IIa klasei, išskyrus tuos atvejus, kai tai daroma tokiu būdu:
Maltese: Kull mezz attiv intenzjonat sabiex jamministra u/jew ineħħi mediċini, likwidi tal-ġisem jew sostanzi oħra lil jew mill-ġisem huwa fi Klassi IIa, sakemm dan ma jsirx b'mod:
English: that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.
French: sauf si cette opération est potentiellement dangereuse, compte tenu de la nature des substances administrées, de la partie du corps concernée et du mode d'administration, auquel cas ils font partie de la classe IIb.
Italian: potenzialmente pericolosa, tenuto conto della natura delle sostanze in questione, della parte del corpo interessata e del modo di applicazione, nel qual caso essi rientrano nella classe IIb.
Dutch: die potentieel gevaarlijk is gezien de aard van de betrokken stoffen, het betrokken lichaamsdeel en de wijze van toepassing. In dat geval vallen zij in klasse IIb.
Czech: který je potenciálně nebezpečný s přihlédnutím k povaze používaných látek, části těla, o kterou se jedná, a způsobu aplikace, kdy spadají do třídy IIb.
Polish: potencjalnie niebezpieczny, przy uwzględnieniu rodzaju substancji, części ciała oraz sposobu stosowania, w którym to przypadku zaliczają się do klasy IIb.
Hungarian: amely potenciálisan veszélyes, tekintettel az alkalmazott anyagokra, az érintett testrészre és az alkalmazási mód jellegére, amely esetben a IIb. osztályba tartozik.
Slovenian: ki je potencialno nevaren ob upoštevanju narave zadevnih snovi, zadevnega dela telesa ali načina aplikacije; v tem primeru spadajo v razred IIb.
Romanian: care este potențial periculoasă, luând în considerare natura substanțelor implicate, partea organismului uman vizată și modul de aplicare, situație în care fac parte din clasa IIb.
Bulgarian: това е потенциално опасно, вземайки предвид естеството на включената субстанция, засегнатата част на тялото и начина на прилагане, в който случай те са в клас ІІ б.
Latvian: potenciāli bīstami, ņemot vērā izmantoto vielu īpašības, konkrētas ķermeņa daļas un izmantošanas veidu, šajā gadījumā tās ir IIb klasē.
Lithuanian: kuris dėl naudojamų medžiagų, organizmo dalies arba taikymo specifikos gali būti pavojingas; tokie prietaisai priklauso IIb klasei.
Maltese: li jista' jkun perikoluż, wara li wieħed jikkonsidra n-natura tas-sostanzi konċernati, tal-parti tal-ġisem konċernata u l-metodu ta' applikazzjoni f'liema każ huwa fi Klassi IIb.
English: CLINICAL EVALUATION
French: ÉVALUATION CLINIQUE
Italian: VALUTAZIONE CLINICA
Dutch: KLINISCHE EVALUATIE
Romanian: Evaluarea clinică
Bulgarian: КЛИНИЧНА ОЦЕНКА
Latvian: KLĪNISKAIS IZVĒRTĒJUMS
Lithuanian: KLINIKINIS ĮVERTINIMAS
English: General provisions
French: Dispositions générales
Spanish: Disposiciones generales
Italian: Disposizioni generali
Dutch: Algemene bepalingen
Czech: Obecná ustanovení
Slovak: Všeobecné ustanovenia
Polish: Przepisy ogólne
Hungarian: Általános rendelkezések
Slovenian: Splošne določbe
Romanian: Dispoziții generale
Bulgarian: Общи положения
Estonian: Üldsätted
Latvian: Vispārīgi noteikumi
Lithuanian: Bendrosios nuostatos
Maltese: Dispożizzjonijiet ġenerali
English: ANNEX XI
French: ANNEXE XI
Spanish: ANEXO XI
Italian: ALLEGATO XI
Dutch: BIJLAGE XI
Czech: PŘÍLOHA XI
Slovak: PRÍLOHA XI
Polish: ZAŁĄCZNIK XI
Hungarian: MELLÉKLET
Slovenian: PRILOGA XI
Romanian: Anexa XI
Bulgarian: ПРИЛОЖЕНИЕ ХІ
Estonian: XI LISA
Latvian: XI PIELIKUMS
Lithuanian: XI PRIEDAS
Maltese: ANNESS XI
English: CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
Italian: CRITERI INDISPENSABILI PER LA DESIGNAZIONE DEGLI ORGANISMI NOTIFICATI
Dutch: MINIMUMCRITERIA VOOR DE AANWIJZING VAN DE AAN TE MELDEN INSTANTIE
Romanian: Criterii minime care trebuie respectate la desemnarea organismelor ce urmează a fi notificate
Bulgarian: НЕОБХОДИМИ КРИТЕРИИ ЗА НАЗНАЧАВАНЕТО НА НОТИФИЦИРАНИТЕ ОРГАНИ
Latvian: KRITĒRIJI PILNVAROTO IESTĀŽU NOZĪMĒŠANAI
Lithuanian: KRITERIJAI, KURIŲ PAGRINDU PASKIRIAMOS NOTIFIKUOTOSIOS ĮSTAIGOS
English: This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.
French: Ceci n'exclut pas la possibilité d'un échange d'informations techniques entre le constructeur et l'organisme.
Italian: Ciò non esclude la possibilità di uno scambio di informazioni tecniche tra il costruttore e l'organismo.
Dutch: Een eventuele uitwisseling van technische informatie tussen fabrikant en aangemelde instantie wordt door deze bepaling niet uitgesloten.
Czech: To však nevylučuje možnost výměny technických informací mezi výrobcem a subjektem.
Slovak: Toto nevylučuje možnosť výmeny technických informácií medzi výrobcom a notifikovaným orgánom.
Polish: Nie wyklucza to w żaden sposób możliwości wymiany informacji technicznych między wytwórcą i tą jednostką.
Hungarian: Ez semmiképpen nem zárja ki a műszaki információ cseréjének lehetőségét a gyártó és a szervezet között.
Slovenian: To pa ne izključuje možnosti izmenjave tehničnih informacij med proizvajalcem in tem organom.
Romanian: Aceasta nu exclude în nici un fel posibilitatea schimbului de informații tehnice între producător și organismul notificat.
Bulgarian: Това по никакъв начин не изключва възможността за обмяна на техническа информация между производителя и органа.
Estonian: See ei välista võimalust vahetada tehnilist informatsiooni tootja ja volitatud asutuse vahel.
Latvian: Tas neizslēdz iespēju ražotājam un iestādei apmainīties ar tehnisko informāciju.
Lithuanian: Tai jokiu būdu nedraudžia gamintojui ir tai įstaigai keistis technine informacija.
Maltese: Dan bl-ebda mod ma jimpedixxi l-possibbilità ta' xi skambji ta' informazzjoni teknika bejn il-fabbrikant u l-korp.