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    • In vitro diagnostic test systems
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    ISO 21474-1:2020

    In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

    International Organization for Standardization

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    ISO 21151:2020

    In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

    International Organization for Standardization

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    ISO 17511:2020

    In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

    International Organization for Standardization

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    ISO 20186-3:2019

    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3:Isolated circulating cell free DNA from plasma

    International Organization for Standardization

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    ISO 20916 : 2019

    In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

    International Organization for Standardization

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    ISO 20186-2:2019

    Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA

    International Organization for Standardization

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    ISO 20186-1:2019

    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA

    International Organization for Standardization

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    ISO 20166-3:2018

    Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 3: Isolated DNA

    International Organization for Standardization

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    ISO 20166-2 : 2018

    Molecular in vitro diagnostic examinations — Specifications for preexaminations processes for formalinfixed and paraffin-embedded (FFPE) tissue-Part 2: Isolated proteins

    International Organization for Standardization

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    ISO 20166-1:2018

    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue —Part 1: Isolated RNA

    International Organization for Standardization

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