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Projects of CEN/TC 140/WG 3

DIN EN ISO 15194 2023-04-21 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023 More  Comment 
DIN EN ISO 18703 2023-02-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma More  Comment 
DIN CEN ISO/TS 18701 2023-02-06 Molecular in vitro diagnostic examinations - Specificationsfor pre-examination processes for human specimens - Isolated microbiome DNA More  Comment 
DIN CEN ISO/TS 18702 2023-02-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins More  Comment 
DIN EN ISO 18704 2023-02-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA (ISO/DIS 18704:2024); German and English version prEN ISO 18704:2024 More  Comment 
DIN CEN ISO/TS 7552-2 2022-12-14 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/DTS 7552-2:2024); German version FprCEN ISO/TS 7552-2:2024 More  Comment 
DIN CEN ISO/TS 7552-1 2022-12-14 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/DTS 7552-1:2024); German version FprCEN ISO/TS 7552-1:2024 More  Comment 
DIN CEN ISO/TS 7552-3 2022-12-14 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 (ISO/DTS 7552-3:2024); German version FprCEN ISO/TS 7552-3:2024 More  Comment 
DIN EN ISO 15193 2021-03-29 In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023 More  Comment 

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