Gaois

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  1. SOCIAL QUESTIONS|health|medical science

    #667240

    IATE #3627749
    eiseamal a táirgeadh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déanfar tástálacha roimh léirmhíniú an staidéir ar thorthaí agus úsáid á baint, nuair is féidir, as an gcineál eiseamail atá beartaithe ag an monaróir. Féadfar na tástálacha a dhéanamh ar eiseamail a táirgeadh d’aon ghnó bunaithe ar an maitrís nádúrtha den chineál eiseamail faoi seach.' Reference "Rialachán Cur Chun Feidhme (AE) 2022/1107 lena leagtar síos sonraíochtaí coiteanna le haghaidh feistí leighis diagnóiseacha in vitro áirithe d’aicme D i gcomhréir le Rialachán (AE) 2017/746 ó Pharlaimint na hEorpa agus ón gComhairle (Téacs atá ábhartha maidir le LEE),CELEX:32022R1107/GA"
    bréag-eiseamal Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    simulierte Probe
    de
    contrived sample | contrived specimen | mock sample | simulated specimen
    en
    Definition artificially produced sample to yield a target value after performing a test Reference "COM-Terminology Coordination, based on:- Technical Guidance Series for WHO Prequalification – Diagnostic Assessment: Principles of performance studies TGS–3 (16.6.2022). World Health Organization, 2017.- Qiagen. HC2 High-Risk HPV DNA Test (16.6.2022)"
    Comment These samples are prepared to give a range of different results: non-reactive, reactive, weak reactive and invalid. This can be achieved by mixing different specimens, or spiking in elements, or by other methods.
    échantillon artificiel
    fr
    Definition échantillon préparé en laboratoire à partir d’un échantillon clinique auquel sont ajoutées des quantités connues de l’agent pathogène concerné afin de fournir une valeur cible lors d'un test Reference "COM-FR, d'après:- OMS (mars 2017), Technical Guidance Series for WHO Prequalification – Diagnostic Assessment: Principles of performance studies TGS-3 (7.7.2022)- Site du gouvernement du Canada > Ministères et organismes > Santé Canada > Médicaments > Demandes et présentations - Médicaments > Lignes directrices – Demandes et présentations – Médicaments > International Council for Harmonisation (ICH) > Q2(R1): Validation des méthodes d'analyse: Texte et méthodologie (7.7.2022)"