ISO/TC 212

Registration number (WIID)Project No.TitleStatus
70960ISO 21474-1:2020In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluationStandarts spēkā
77070ISO/TS 23824:2024Medical laboratories — Guidance on application of ISO 15189 in anatomic pathologyStandarts spēkā
85349ISO 18704:2026Molecular in vitro diagnostic examinations — Requirements and recommendations for pre-examination processes for urine and other body fluids — Isolated cell-free DNAStandarts spēkā
78024ISO 21474-2:2022In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verificationStandarts spēkā
83565ISO 21474-3:2024In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reportsStandarts spēkā
81712ISO/TS 5798:2022In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methodsStandarts spēkā
69799ISO 20186-2:2019Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNAStandarts spēkā
81506ISO 5649:2024Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed testsStandarts spēkā
75442ISO 20166-4:2021Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniquesStandarts spēkā
69803ISO 20166-3:2018Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNAStandarts spēkā
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