CEN/TC 140

Registration number (WIID)Project No.TitleStatus
61693LVS EN ISO 20166-1:2019Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)Standarts spēkā
70933EN ISO 18113-5:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)Standarts spēkā
77643EN ISO 5649:2024Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)Standarts spēkā
74138CEN/TS 17981-1:2023In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examinationStandarts spēkā
70931EN ISO 18113-3:2024In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)Standarts spēkā
71064EN ISO 20916:2024In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)Standarts spēkā
60818EN ISO 15197:2015In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)Standarts spēkā
60817EN ISO 23640:2015In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)Standarts spēkā
67446LVS CEN/TS 17626:2021Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNAStandarts spēkā
60817LVS EN ISO 23640:2015In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)Standarts spēkā
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