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In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor 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 tumor 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 tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins
60.60 Standard published
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
60.60 Standard published
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination
60.60 Standard published
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination
60.60 Standard published
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
90.20 Standard under periodical review
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
60.60 Standard published
General requirements for in vitro diagnostic medical devices for self-testing
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
60.60 Standard published