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ISO 20916:2019PublishedIn vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practiceISO 21151:2020PublishedIn vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samplesISO 21474-3:2024PublishedIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reportsISO 21474-2:2022PublishedIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verificationISO 21474-1:2020PublishedIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluationISO/TR 21582:2021PublishedPyrogenicity — Principles and methods for pyrogen testing of medical devicesISO/TS 21726:2019PublishedBiological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituentsISO 22367:2026PublishedMedical laboratories — Application of risk management to medical laboratoriesISO 22442-1:2020PublishedMedical devices utilizing animal tissues and their derivatives — Part 1: Application of risk managementISO 22442-2:2020PublishedMedical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handlingISO/TR 22442-4:2010PublishedMedical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processesISO 22442-3:2007PublishedMedical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agentsISO 22544:2025PublishedLaboratory design — VocabularyISO/TS 22583:2024PublishedRequirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipmentISO 23118:2021PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasmaISO 23162:2021PublishedBasic semen examination — Specification and test methodsISO 23640:2011PublishedIn vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagentsISO/TS 23824:2024PublishedMedical laboratories — Guidance on application of ISO 15189 in anatomic pathologyISO 24443:2021PublishedCosmetics — Determination of sunscreen UVA photoprotection in vitroISO 24884:2026PublishedElectronic instructions for use for in vitro diagnostic medical devices — Minimum required information and means of deliveryISO 24998:2008PublishedPlastics laboratory ware — Single-use Petri dishes for microbiological proceduresISO 29701:2010PublishedNanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) testISO 35001:2019PublishedBiorisk management for laboratories and other related organisationsISO/DTS 8219Under developmentRequirements and recommendations for the identification and characterisation of microbes using next generation sequencing directly from clinical specimens in the management of infectious diseaseISO/DIS 10993-4Under developmentBiological evaluation of medical devices — Part 4: Selection of tests for interactions with blood