11:55 Apr 27, 2019 |
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English to Polish translations [PRO] Environment & Ecology / general | |||||||
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2 | parametry walidacyjne metody |
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parametry walidacyjne metody Explanation: Zgodnie z wymaganiami zawartymi w normie PN-EN ISO 17025 oraz w normie ISO 15189 metody badawcze wykorzystywane w diagnostyce medycznej muszą przejść proces walidacji, który potwierdza ich przydatność osiągnięcia zamierzonego celu diagnostycznego. Słowa kluczowe wyroby medyczne, klasyfikacja, certyfikacja, diagnostyka in vitro, walidacja, parametry walidacyjne, reakcje kontrolne In accordance with the requirements of PN-EN ISO 17025 and in the ISO 15189 test method used in medical diagnosis must undergo a validation process that confirms their suitability for achieving intended purpose tool. Key words medical devices, classification, certification, In vitro diagnostics, validation, performance validation, control reactions https://www.researchgate.net/publication/268978847_Walidacja... |
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