Gaois

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  1. SOCIAL QUESTIONS|health|medical science · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #648838

    IATE #3544151
    imscrúdú cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinische Untersuchung | klinische Prüfung
    de
    Definition systematische Untersuchung an einem oder mehreren menschlichen Probanden, die zwecks Bewertung der Sicherheit oder Leistung eines Produkts durchgeführt wird Reference "Vorschlag für eine Verordnung über Medizinprodukte, Art.2 Nr.33; COM(2012)0542 final CELEX:52012PC0542/DE"
    Comment "entspricht der klinischen Prüfung (EN clinical trial) bei Arzneimitteln IATE:1686971 ; NICHT dasselbe wie ""klinische Bewertung"" (EN ""clinical evaluation"") IATE:3545137"
    clinical investigation
    en
    Definition any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device Reference "Regulation (EU) 2017/745 on medical devices"
    Comment Please note that in general usage, clinical investigation is a broader concept which in addition to medical devices covers also, e.g. in the USA, investigational new drug and investigational device exemption studies.
    investigation clinique
    fr
    Definition toute investigation systématique impliquant un ou plusieurs participants humains destinée à évaluer la sécurité ou les performances d'un dispositif Reference "Règlement (UE) 2017/745 relatif aux dispositifs médicaux (art. 2, point 45)"