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ISO 4307:2021PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNAISO 5649:2024PublishedMedical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed testsISO 6717:2021PublishedIn vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than bloodISO/TS 7552-2:2024PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNAISO/TS 7552-3:2024PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC stainingISO/TS 7552-1:2024PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNAISO 13079:2011PublishedLaboratory glass and plastics ware — Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren methodISO 15193:2026PublishedIn vitro diagnostic medical devices — Requirements for reference measurement proceduresISO 15194:2026PublishedIn vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentationISO 15197:2013PublishedIn vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitusISO 16256:2021PublishedClinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseasesISO/TS 16766:2024PublishedManufacturers’ considerations for in vitro diagnostic medical devices in a public health emergencyISO 17511:2020PublishedIn vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samplesISO 18113-1:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirementsISO 18113-2:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional useISO 18113-3:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional useISO 18113-4:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testingISO 18113-5:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testingISO 18704:2026PublishedMolecular in vitro diagnostic examinations — Requirements and recommendations for pre-examination processes for urine and other body fluids — Isolated cell-free DNAISO 19001:2013PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biologyISO 20166-4:2021PublishedMolecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniquesISO 20166-1:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNAISO 20166-2:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteinsISO 20166-3:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNAISO 20184-3:2021PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA