Gaois

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  1. SOCIAL QUESTIONS|health|health policy|organisation of health care|medical device

    #664259

    IATE #3591553
    tástáil bhith-chomhoiriúnachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh sa doiciméadacht, i gcás nach ndearnadh aon tástáil nua, réasúnaíocht don chinneadh sin. Mar léiriú samplach ar an gcineál sin réasúnaíochta cuir i gcás go ndearnadh tástáil bhith-chomhoiriúnachta ar na hábhair chomhionanna nuair a ionchorpraíodh iadsan i leagan den fheiste a bhí ann roimhe sin agus a cuireadh ar an margadh nó i seirbhís go dleathach...' Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle, CELEX:32017R0745/GA"
    biocompatibility testing
    en
    Definition critical part of the regulatory approval process for medical devices ensuring that there are no unintended complications produced if the materials used cause a biological reaction in the patient Reference "COM-Terminology Coordination, based on: Eurofins > Medical Device Testing > 'Biocompatibility' (29.10.2020)"