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In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
60.60 Standard published
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
60.60 Standard published
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
60.60 Standard published
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
60.60 Standard published
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
90.92 Standard to be revised
Nanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) test
90.93 Standard confirmed
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
60.60 Standard published
In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
60.60 Standard published
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for urine and other body fluids — Isolated cell free DNA
30.60 Close of voting/ comment period
Manufacturers’considerations for in vitro diagnostic medical devices in a public health crisis
30.60 Close of voting/ comment period
In vitro diagnostic medical devices — Requirements for reference measurement procedures
40.60 Close of voting
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
40.60 Close of voting
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports
40.99 Full report circulated: DIS approved for registration as FDIS
Medical laboratories — Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
40.60 Close of voting
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood — Part 1: Isolated RNA
50.00 Final text received or FDIS registered for formal approval
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood — Part 2: Isolated DNA
50.00 Final text received or FDIS registered for formal approval
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
50.00 Final text received or FDIS registered for formal approval
