CEN/TC 140
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
70929 | LVS EN ISO 18113-1:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022) | Standarts spēkā |
5109 | LVS EN 13532:2003 | General requirements for in vitro diagnostic medical devices for self-testing | Standarts spēkā |
75465 | CEN/TS 17981-2:2023 | In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination | Standarts spēkā |
65451 | LVS CEN/TS 17390-3:2020 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining | Standarts spēkā |
79016 | LVS EN ISO 15189:2022/A11:2023 | Medical laboratories - Requirements for quality and competence | Standarts spēkā |
76940 | CEN ISO/TS 7552-2:2024 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024) | Standarts spēkā |
62263 | LVS EN ISO 17511:2021 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020) | Standarts spēkā |
76941 | CEN ISO/TS 7552-1:2024 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024) | Standarts spēkā |
5106 | LVS EN 13975:2003 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects | Standarts spēkā |
5107 | LVS EN 13641:2003 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents | Standarts spēkā |
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