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ISO/TS 16782:2016PublishedClinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testingISO 17593:2022PublishedClinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapyISO 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/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 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/DIS 10993-11.2Under developmentBiological evaluation of medical devices — Part 11: Tests for systemic toxicityISO/DIS 10993-2Under developmentBiological evaluation of medical devices — Part 2: Animal welfare requirementsISO/FDIS 10993-16Under developmentBiological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachablesISO/DIS 10993-4Under developmentBiological evaluation of medical devices — Part 4: Selection of tests for interactions with bloodISO/DTS 21726Under developmentBiological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituentsISO/TS 25364-1Under developmentChemical characterization of medical devices — Part 1: Identification of organic extractables in non-targeted analysis (NTA)ISO 10993-1:2018WithdrawnBiological evaluation of medical devices — Part 1: Evaluation and testing within a risk management processISO 10993-6:2016WithdrawnBiological evaluation of medical devices — Part 6: Tests for local effects after implantationISO/TR 10993-33:2015WithdrawnBiological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3ISO 10993-3:2014WithdrawnBiological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityISO 10993-12:2012WithdrawnBiological evaluation of medical devices — Part 12: Sample preparation and reference materialsISO 10993-10:2010WithdrawnBiological evaluation of medical devices — Part 10: Tests for irritation and skin sensitizationISO 10993-16:2010WithdrawnBiological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesISO 10993-9:2009WithdrawnBiological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsISO 10993-1:2009WithdrawnBiological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process