FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The application must include: - all documentation and undertakings referred to in Annex IV, section 3.1, and
Hungarian: A kérelemnek a következőket kell tartalmaznia: - a IV. melléklet 3.1. pontjában említett minden dokumentáció és kötelezettségvállalás, és
English: It must include in particular an adequate description of: (a) the manufacturer's quality objectives;
Hungarian: Megfelelő leírást kell tartalmaznia különösen a következőkről: a) a gyártó minőségre vonatkozó célkitűzései;
English: the organisation of the business and in particular: - the organisational structures, the responsibilities of the managerial staff and their organisational authority where quality of manufacture of the devices is concerned,
Hungarian: a vállalkozás szervezete és különösen: - a szervezeti felépítés, a vezetőség felelősségi köre és szervezeti hatásköre az érintett eszközök gyártási minősége tekintetében,
English: the inspection and quality assurance techniques at the manufacturing stage and in particular: - the processes and procedures which will be used, particularly as regards sterilisation,
Hungarian: ellenőrzési és minőségbiztosítási módszerek a gyártási szakaszban, különösen: - az alkalmazott módszerek és eljárások, különösen a sterilizálás tekintetében,
English: The statement shall contain the following information: - data allowing identification of the device in question,
Hungarian: A nyilatkozatnak a következő információkat kell tartalmaznia: - a kérdéses eszköz azonosításához szükséges adatok,
English: The inspection staff must have: - sound vocational training covering all the assessment and verification operations for which the body has been designated,
Hungarian: Az ellenőrzést végző alkalmazottaknak rendelkezniük kell a következőkkel: - alapos szakmai képzés, amely az összes olyan értékelési és igazolási műveletre kiterjed, amelyekre a szervezetet kijelölték,
English: "Specimen receptacles" are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;`
Polish: "Pojemniki na próbki" to wyroby typu próżniowego lub inne, przeznaczone przez wytwórcy do przechowywania i konserwacji próbek pochodzących z organizmu ludzkiego do celów badania diagnostycznego in vitro.Wyroby do ogólnego zastosowania laboratoryjnego nie są wyrobami medycznymi używanymi do diagnozy in vitro, chyba że produkty te, mając na uwadze ich właściwości, zostały wyraźnie przeznaczone przez wytwórcę do zastosowania w badaniach diagnostycznych in vitro;"
English: in Annex XI, section 3 the following sentence shall be inserted after the second sentence: 'This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I.`
Polish: w załączniku XI sekcja 3 po drugim zdaniu dodaje się następujące zdanie:"To zakłada dostępność wystarczającej liczby personelu naukowego w ramach danej organizacji, który to personel posiada doświadczenie i wiedzę wystarczającą do oceny medycznej funkcjonalności i działania wyrobów, do której został powołany, z uwzględnieniem wymogów niniejszej dyrektywy, w szczególności wymogów określonych w załączniku I."
English: Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 December 1999. They shall immediately inform the Commission thereof.
Portuguese: Os Estados-membros adoptarão e publicarão as disposições legislativas, regulamentares e administrativas necessárias para dar cumprimento à presente directiva o mais tardar até 7 de Dezembro de 1999.Desse facto informarão imediatamente a Comissão.
Polish: Państwa Członkowskie przyjmują i publikują przepisy ustawowe, wykonawcze i administracyjne niezbędne do wykonania niniejszej dyrektywy nie później niż do dnia 7 grudnia 1999 r. oraz niezwłocznie powiadomią o tym Komisję.
English: Opinion of the European Parliament of 12 March 1996
Polish: Opinia Parlamentu Europejskiego z dnia 12 marca 1996 r.
English: Council common position of 23 March 1998 and Decision of the European Parliament of 18 June 1998
Polish: wspólne stanowisko Rady z dnia 23 marca 1998 r. i decyzja Parlamentu Europejskiego z dnia 18 czerwca 1998 r.
English: GENERAL REQUIREMENTS
French: EXIGENCES GÉNÉRALES
Italian: REQUISITI GENERALI
Portuguese: REQUISITOS GERAIS
Czech: OBECNÉ POŽADAVKY
Slovak: VŠEOBECNÉ POŽIADAVKY
Polish: WYMOGI OGÓLNE
Hungarian: ÁLTALÁNOS KÖVETELMÉNYEK
Slovenian: SPLOŠNE ZAHTEVE
Bulgarian: ОБЩИ ИЗИСКВАНИЯ
Estonian: ÜLDNÕUDED
Latvian: VISPĀRĪGAS PRASĪBAS
Lithuanian: BENDRIEJI REIKALAVIMAI
Maltese: ĦTIĠIET ĠENERALI
English: Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, Directive as last amended by Commission Directive 97/69/EC
Polish: Dyrektywa Rady 67/548/EWG z dnia 27 czerwca 1967 r. w sprawie zbliżenia przepisów ustawowych, wykonawczych i administracyjnych odnoszących się do klasyfikacji, pakowania i etykietowania substancji niebezpiecznych ostatnio zmieniona dyrektywą Komisji 97/69/WE
English: Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ,Directive as last amended by Commission Directive 96/65/EC
Polish: Dyrektywa Rady 88/379/EWG z 7 czerwca 1988 r. w sprawie zbliżenia przepisów ustawowych, wykonawczych i administracyjnych Państw Członkowskich odnoszących się do klasyfikacji, pakowania i etykietowania preparatów niebezpiecznych ostatnio zmieniona dyrektywą Komisji 96/65/WE
English: phenylketonuria,
Polish: fenyloketonuria,
Slovenian: fenilketonurija,
Bulgarian: фенилкетонурия,
English: reagents and reagent products, including related calibrators and control materials, for determining the following human infections:
Polish: odczynniki oraz produkty odczynników, łącznie z odpowiednimi wzorcami i materiałami kontrolnymi, do wykrywania następujących infekcji u ludzi:
Slovenian: Reagenti in reagenčni izdelki, vključno z njimi povezani umerjevalci in kontrolni materiali za določanje naslednjih človeških infekcij:
Bulgarian: реактиви и продукти от реактиви, включително съответните калибратори и контролни материали за определяне на следните човешки инфекции:
English: reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker:
Polish: odczynniki oraz produkty odczynników, łącznie z odpowiednimi wzorcami i materiałami kontrolnymi, do wykrywania następującego markera nowotworowego:
Slovenian: Reagenti in reagenčni izdelki, vključno z njimi povezani umerjevalci in kontrolni materiali za določanje naslednjih tumorskih markerjev:
Bulgarian: реактиви и продукти от реактиви, включително съответните калибратори и контролни материали за определяне на следния туморен маркер:
English: PSA,
Polish: PSA,
English: Safeguard clause 1.
Bulgarian: Предпазна клауза
English: European databank 1.
Bulgarian: Европейска банка данни
English: DESIGN AND MANUFACTURING REQUIREMENTS 1.
Bulgarian: ИЗИСКВАНИЯ КЪМ ПРОЕКТИРАНЕТО И ПРОИЗВОДСТВОТО
English: In areas for which no standards exist, the symbols and colour used must be described in the documentation supplied with the device. 8.3.
Bulgarian: За областите, в които не съществуват стандарти, използваните символи и цвят трябва да бъдат описани в документацията, предоставена с изделието.
English: EC DECLARATION OF CONFORMITY 1.
Bulgarian: ЕО ДЕКЛАРАЦИЯ ЗА СЪОТВЕТСТВИЕ
English: The additional approval must take the form of a supplement to the EC design-examination certificate. 4.5.
Bulgarian: Това допълнително одобрение трябва да приеме формата на допълнение към ЕО сертификата за изследване на проекта.
English: In this connection, the manufacturer shall inform the notified body whether any such change is likely to affect the performance of the in vitro diagnostic medical device concerned. 5.
Bulgarian: В тази връзка, производителят информира нотифициращия орган дали подобна промяна има вероятност да повлияе на функционирането на съответното диагностично медицинско устройство in vitro.
English: It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. 6.
Bulgarian: Той трябва да предостави на производителя отчет от проверката и, ако е било проведено изпитване, отчет от изпитването.
English: agree with the applicant on the place where the necessary examinations and tests will be carried out. 5.
Bulgarian: съгласува със заявителя мястото, където необходимите изследвания и изпитвания ще бъдат проведени.
English: Whereas it is necessary to draw up as quickly as possible the legislation which is lacking on medical devices manufactured using substances of human origin, HAVE ADOPTED THIS DIRECTIVE:
Slovenian: ker je treba kakor hitro je mogoče sprejeti manjkajočo zakonodajo o medicinskih pripomočkih izdelanih z uporabo snovi človeškega izvora, SPREJELA NASLEDNJO DIREKTIVO:
English: there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter; (b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years.
Slovenian: na trgu Skupnosti v predhodnih treh letih ni bilo stalno takega pripomočka za ustrezni analit ali drug parameter; (b) postopek vključuje analitično tehnologijo, ki se na trgu Skupnosti v predhodnih treh letih ni stalno uporabljala v zvezi z danim analitom ali drugim parametrom.
English: The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the procedure referred to in Article 7. 6.
Slovenian: Postopki za izvajanje tega člena in zlasti tisti, ki se nanašajo na priglasitev in pojem bistvene spremembe, se sprejmejo v skladu s postopkom iz člena 7. 6.
English: The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the procedure referred to in Article 7(2).
Slovenian: Države članice na zahtevo obvestijo druge države članice o podrobnostih iz odstavkov 1 do 4. Postopki za izvajanje tega člena se sprejmejo v skladu s postopkom iz člena 7(2).