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ISO 17511:2020PublishedIn vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samplesISO/TS 17518:2015PublishedMedical laboratories — Reagents for staining biological material — Guidance for usersISO 17593:2022PublishedClinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapyISO 17822:2020PublishedIn vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guideISO 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 DNAISO 20184-1:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNAISO 20184-2:2018PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteinsISO 20186-1:2019PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNAISO 20186-2:2019PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNAISO 20186-3:2019PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasmaISO 20658:2023PublishedRequirements for the collection and transport of samples for medical laboratory examinationsISO 20776-2:2021PublishedClinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilutionISO 20776-1:2019PublishedSusceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseasesISO/TS 20914:2019PublishedMedical laboratories — Practical guidance for the estimation of measurement uncertainty