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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
60.60 Standard published
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
10.99 New project approved
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
60.60 Standard published
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
60.60 Standard published
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
60.55 Ratification completed (DOR)
Molecular in vitro diagnostic examinations - Specificationsfor pre-examination processes for human specimens - Isolated microbiome DNA
10.99 New project approved
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
10.99 New project approved
Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 1: Isolated RNA
10.99 New project approved
Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 2: Isolated DNA
10.99 New project approved
Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 3: Preparations for analytical CTC staining
10.99 New project approved
In-vitro diagnostic systems - Definitions of disciplines
40.20 DIS ballot initiated: 12 weeks
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)
40.60 Close of voting
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)
40.60 Close of voting