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    • In vitro diagnostic test systems
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    ISO 4307:2021

    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

    International Organization for Standardization

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    ISO 16256:2021

    Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

    International Organization for Standardization

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    ISO 6717:2021

    In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

    International Organization for Standardization

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    ISO 20166-4:2021

    Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques

    International Organization for Standardization

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    ISO 23118:2021

    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

    International Organization for Standardization

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    ISO 20184-3:2021

    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA

    International Organization for Standardization

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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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