ISO/TC 212

Registration number (WIID)Project No.TitleStatus
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
81506ISO 5649:2024Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed testsStandarts spēkā
79379ISO 16256:2021Clinical 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 diseasesStandarts spēkā
79378ISO 17593:2022Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapyStandarts spēkā
79377ISO 20776-2:2021Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilutionStandarts spēkā
78110ISO 20184-3:2021Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNAStandarts spēkā
78024ISO 21474-2:2022In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verificationStandarts spēkā
77071ISO/PWI 20184-3Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissueIzstrādē
77070ISO/TS 23824:2024Medical laboratories — Guidance on application of ISO 15189 in anatomic pathologyStandarts spēkā
76677ISO 15189:2022Medical laboratories — Requirements for quality and competenceStandarts spēkā
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