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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
Cosmetics — Determination of sunscreen UVA photoprotection in vitro
60.60 Standard published
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
Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
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 circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNA
60.60 Standard published
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNA
60.60 Standard published
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC staining
60.60 Standard published
In vitro diagnostic medical devices — Requirements for reference measurement procedures
50.00 Final text received or FDIS registered for formal approval
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
50.00 Final text received or FDIS registered for formal approval
Molecular in vitro diagnostic examinations — Requirements and recommendations for pre-examination processes for urine and other body fluids — Isolated cell-free DNA
50.00 Final text received or FDIS registered for formal approval
Cosmetics — Determination of sunscreen UVA photoprotection in vitro — Amendment 1
50.00 Final text received or FDIS registered for formal approval
Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery
40.20 DIS ballot initiated: 12 weeks