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ISO 20184-1:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNAISO 20184-2:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteinsISO 20186-1:2019PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNAISO 20186-2:2019PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNAISO 20186-3:2019PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasmaISO 20916:2019PublishedIn vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practiceISO 21151:2020PublishedIn vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samplesISO 21474-3:2024PublishedIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reportsISO 21474-2:2022PublishedIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verificationISO 21474-1:2020PublishedIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluationISO 23118:2021PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasmaISO 23640:2011PublishedIn vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagentsISO 24443:2021PublishedCosmetics — Determination of sunscreen UVA photoprotection in vitroISO 24884:2026PublishedElectronic instructions for use for in vitro diagnostic medical devices — Minimum required information and means of deliveryISO 29701:2010PublishedNanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) testISO/DTS 8219Under developmentRequirements and recommendations for the identification and characterisation of microbes using next generation sequencing directly from clinical specimens in the management of infectious diseaseISO/DIS 21474-4Under developmentIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 4: Detection of pathogensISO/DIS 23640Under developmentIn vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagentsISO/DTS 24883Under developmentIn vitro diagnostic medical devices — General guidance for manufacturers of lateral flow immunoassay (LFIA) for rapid diagnostic testing (RDT)ISO/DIS 25379-2Under developmentIn vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 2: Human RNA examinationISO/DIS 25379-1Under developmentIn vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 1: Human DNA examinationISO/DIS 25459Under developmentIn vitro diagnostic medical devices — Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controlsISO 15193:2009WithdrawnIn vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement proceduresISO 15193:2002WithdrawnIn vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement proceduresISO 15194:2009WithdrawnIn vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation