CEN - CEN/TC 140

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CEN/TC 140

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In vitro diagnostic medical devices
 
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CEN/TC 140 Work programme

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EN ISO 15197:2015/prA11 (WI=00140164)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Under Drafting2024-02-212024-02-212024-06-212025-11-30
EN ISO 23640:2015/prA11 (WI=00140163)
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
Under Drafting2024-02-212024-02-212024-06-212025-11-30
prCEN ISO/TS 18701 (WI=00140157)
Molecular in vitro diagnostic examinations - Specificationsfor pre-examination processes for human specimens - Isolated microbiome DNA
Under Drafting2023-01-262023-01-262023-07-26 
prCEN ISO/TS 18702 (WI=00140158)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
Under Drafting2023-01-262023-01-262023-07-26 
prCEN ISO/TS 7552-1 (WI=00140155)
Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 1: Isolated RNA
Under Approval2022-11-022024-05-282024-09-03 
prCEN ISO/TS 7552-2 (WI=00140154)
Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 2: Isolated DNA
Under Approval2022-11-022024-05-282024-09-03 
prCEN ISO/TS 7552-3 (WI=00140156)
Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 3: Preparations for analytical CTC staining
Under Approval2022-11-022024-05-282024-09-03 
prEN ISO 15193 (WI=00140149)
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)
Under Approval2021-03-012024-03-192024-11-192024-11-19
prEN ISO 15194 (WI=00140150)
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)
Under Approval2021-03-012024-03-192024-11-192024-11-19
prEN ISO 18703 (WI=00140159)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
Under Drafting2023-01-302023-01-302023-07-312025-03-10
prEN ISO 18704 (WI=00140160)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
Under Drafting2023-01-302023-01-302023-07-312025-03-10
prEN ISO 22367 rev (WI=00140162)
Medical laboratories — Application of risk management to medical laboratories
Under Drafting2023-09-132023-09-132024-03-132025-10-21
prEN ISO 23640 rev (WI=00140166)
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
Under Drafting2024-03-022024-03-022024-09-022026-04-13
prEN ISO 5649 (WI=00140161)
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023)
Under Approval2023-02-222024-03-182024-11-182024-11-18
 

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