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Validoinnin tulokset on raportoitu akkreditointia valvovalle organisaatiolle, FINASille. Lymfosyyttien alaluokkam\u00e4\u00e4rityksiss\u00e4 ja kantasolum\u00e4\u00e4rityksiss\u00e4 on k\u00e4yt\u00f6ss\u00e4 kokonaiset, CE\/IVD -merkityt protokollat. T\u00e4m\u00e4 tarkoittaa, ett\u00e4 reagenssi- ja laitevalmistaja takaa menetelm\u00e4n toimivuuden CE\/IVD-tasoisesti silloin, kun k\u00e4ytet\u00e4\u00e4n valmistajan reagensseja, tarvikkeita, laitteita ja analyysiohjelmistoja. Mik\u00e4li n\u00e4iden protokollien vasta-aineet muutetaan toisen valmistajan vasta-aineiksi, protokolla ei en\u00e4\u00e4 t\u00e4yt\u00e4 CE\/IVD-merkinn\u00e4n vaatimuksia. Vuonna 2020 voimaan tullut IVD-asetus m\u00e4\u00e4r\u00e4\u00e4 k\u00e4ytt\u00e4m\u00e4\u00e4n CE-\/IVD merkittyj\u00e4 tuotteita, laitteita ja protokollia silloin, kun siihen on mahdollisuus.", "", "Hankintalain 40 \u00a7 kohdan 2 mukaan, hankintayksikk\u00f6 voi valita suorahankinnan, jos teknisest\u00e4 tai yksinoikeuden suojaamiseen liittyv\u00e4st\u00e4 syyst\u00e4 vain tietty toimittaja voi toteuttaa hankinnan; lis\u00e4edellytyksen\u00e4 on, ett\u00e4 j\u00e4rkevi\u00e4 vaihtoehtoisia tai korvaavia ratkaisuja ei ole eik\u00e4 kilpailun puuttuminen johdu hankinnan ehtojen keinotekoisesta kaventamisesta.", "", "Hankintayksik\u00f6n on k\u00e4ytett\u00e4v\u00e4 CE-\/IVD-merkittyj\u00e4 tuotteita, josta syist\u00e4 vain tietyt toimittajat voivat toteuttaa hankinnan. Edell\u00e4 mainituista syist\u00e4 edell\u00e4 mainituissa akkreditoiduissa tutkimuksissa k\u00e4ytett\u00e4vi\u00e4 vasta-aineita tai reagensseja ei voi vaihtaa ja kilpailutus ei ole n\u00e4in ollen mahdollinen.", "", "", "", "" ] } }, "isPrivateSmallValueProcurement": false, "espdRequestReferences": [], "dateCreated": "2021-05-27T06:00:12.1795665", "dateModified": "2021-06-01T07:00:07.2789386" }