Gaois

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2 results

  1. AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health · SOCIAL QUESTIONS|health|medical science

    #565204

    IATE #1687525
    scrúdú cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ní eiseofar oideas tréidliachta le haghaidh beatha íocleasaithe ach amháin i ndiaidh scrúdú cliniciúil nó aon mheasúnú ceart eile a bheith déanta ag tréidlia ar stádas sláinte an ainmhí nó an ghrúpa ainmhithe agus ní eiseofar é ach amháin le haghaidh galar diagnóisithe.' Reference Rialachán (AE) 2019/452 lena gcuirtear ar bun creat maidir le hinfheistíochtaí díreacha coigríche isteach san Aontas a scagadh, CELEX:32019R0452/GA
    klinische Untersuchung | klinische Pruefung
    de
    Definition eine vom Arzt oder seinem Vertreter im Krankenhaus durchgefuehrte Untersuchung oder Messung Reference Reimen
    clinical examination
    en
    Definition examination of a patient including taking the history, physical examination by palpation, auscultation and percussion, clinicopathological examination and examination of the environment Reference Blood, Studdert, Gay, 'Saunders Comprehensive Veterinary Dictionary', Third edition (2007)
    examen clinique
    fr
    Definition examen que fait le médecin à l'hôpital ou à la clinique ; examen pratiqué par un médecin ou un vétérinaire, sur un patient ou un animal, aux fins de déceler et diagnostiquer une pathologie éventuelle. Reference Reimen ;
  2. PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research · SOCIAL QUESTIONS|health|medical science

    #582306

    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 investigations | 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 of the European Parliament and of the Council on medical devices [..], CELEX:32017R0745/EN
    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. Ref.: a) FDA. Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf [11.6.2012] b) FDA. Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER) http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/InvestigationalNewDrugINDorDeviceExemptionIDEProcess/default.htm [11.6.2012] c) FDA. Device Advice: Investigational Device Exemption (IDE) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm [11.6.2012]
    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)