11.100.10 In vitro diagnostic test systems

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

In vitro diagnostic medical devices Clinical performance studies using specimens from human subjects Good study practice

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

In vitro diagnostic medical devices -- Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

In vitro diagnostic medical devices -- Multiplex molecular testing for nucleic acids

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)