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ISO/DIS 10993-11.2Under developmentBiological evaluation of medical devices — Part 11: Tests for systemic toxicityInternational Standard · ISO/TC 194ISO/DIS 10993-2Under developmentBiological evaluation of medical devices — Part 2: Animal welfare requirementsInternational Standard · ISO/TC 194ISO/FDIS 10993-16Under developmentBiological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachablesInternational Standard · ISO/TC 194ISO/DTS 21385Under developmentRequirements and recommendations for the implementation of emerging technology in medical laboratoriesTechnical Specification · ISO/TC 212ISO/DIS 21474-4Under developmentIn vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 4: Detection of pathogensInternational Standard · ISO/TC 212ISO/DTS 21726Under developmentBiological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituentsTechnical Specification · ISO/TC 194ISO/DIS 23640Under developmentIn vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagentsInternational Standard · ISO/TC 212ISO/DIS 24051-1Under developmentMedical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratoriesInternational Standard · ISO/TC 212ISO/DIS 24051-2Under developmentMedical laboratories — Part 2: Digital pathology and artificial intelligence (AI)-based image analysisInternational Standard · ISO/TC 212ISO/DTS 24883Under developmentIn vitro diagnostic medical devices — General guidance for manufacturers of lateral flow immunoassay (LFIA) for rapid diagnostic testing (RDT)Technical Specification · ISO/TC 212ISO/TS 25364-1Under developmentChemical characterization of medical devices — Part 1: Identification of organic extractables in non-targeted analysis (NTA)Technical Specification · ISO/TC 194ISO/DIS 25379-2Under developmentIn vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 2: Human RNA examinationInternational Standard · ISO/TC 212ISO/DIS 25379-1Under developmentIn vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 1: Human DNA examinationInternational Standard · ISO/TC 212ISO/DIS 25459Under developmentIn vitro diagnostic medical devices — Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controlsInternational Standard · ISO/TC 212ISO 7405:2018WithdrawnDentistry — Evaluation of biocompatibility of medical devices used in dentistryInternational Standard · Published 15 Oct 2018 · ISO/TC 106ISO 7405:2008WithdrawnDentistry — Evaluation of biocompatibility of medical devices used in dentistryInternational Standard · Published 25 Nov 2008 · ISO/TC 106ISO 7405:1997WithdrawnDentistry — Preclinical evaluation of biocompatibility of medical devices used in dentistry — Test methods for dental materialsInternational Standard · Published 21 Aug 1997 · ISO/TC 106ISO/TR 7405:1984WithdrawnBiological evaluation of dental materialsTechnical Report · Published 1 Jan 1984 · ISO/TC 106ISO 10993-1:2018WithdrawnBiological evaluation of medical devices — Part 1: Evaluation and testing within a risk management processInternational Standard · Published 17 Aug 2018 · ISO/TC 194ISO 10993-6:2016WithdrawnBiological evaluation of medical devices — Part 6: Tests for local effects after implantationInternational Standard · Published 28 Nov 2016 · ISO/TC 194ISO/TR 10993-33:2015WithdrawnBiological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3Technical Report · Published 6 Mar 2015 · ISO/TC 194ISO 10993-3:2014WithdrawnBiological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityInternational Standard · Published 24 Sep 2014 · ISO/TC 194ISO 10993-12:2012WithdrawnBiological evaluation of medical devices — Part 12: Sample preparation and reference materialsInternational Standard · Published 29 Jun 2012 · ISO/TC 194ISO 10993-10:2010WithdrawnBiological evaluation of medical devices — Part 10: Tests for irritation and skin sensitizationInternational Standard · Published 27 Jul 2010 · ISO/TC 194ISO 10993-16:2010WithdrawnBiological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesInternational Standard · Published 9 Feb 2010 · ISO/TC 194