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ISO 10993-6:2026PublishedBiological evaluation of medical devices — Part 6: Tests for local effects after implantationInternational Standard · Published 15 Apr 2026 · ISO/TC 194ISO 10993-7:2026PublishedBiological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsInternational Standard · Published 20 Apr 2026 · ISO/TC 194ISO 10993-3:2026PublishedBiological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicityInternational Standard · Published 6 Aug 2026 · ISO/TC 194ISO 10993-1:2025PublishedBiological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management processInternational Standard · Published 18 Nov 2025 · ISO/TC 194ISO/TR 10993-55:2023PublishedBiological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicityTechnical Report · Published 6 Feb 2023 · ISO/TC 194ISO 10993-17:2023PublishedBiological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituentsInternational Standard · Published 13 Sep 2023 · ISO/TC 194ISO 10993-2:2022PublishedBiological evaluation of medical devices — Part 2: Animal welfare requirementsInternational Standard · Published 3 Nov 2022 · ISO/TC 194ISO 10993-23:2021PublishedBiological evaluation of medical devices — Part 23: Tests for irritationInternational Standard · Published 20 Jan 2021 · ISO/TC 194ISO 10993-10:2021PublishedBiological evaluation of medical devices — Part 10: Tests for skin sensitizationInternational Standard · Published 16 Nov 2021 · ISO/TC 194ISO 10993-12:2021PublishedBiological evaluation of medical devices — Part 12: Sample preparation and reference materialsInternational Standard · Published 20 Jan 2021 · ISO/TC 194ISO 10993-18:2020PublishedBiological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processInternational Standard · Published 13 Jan 2020 · ISO/TC 194ISO/TS 10993-19:2020PublishedBiological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materialsTechnical Specification · Published 12 Mar 2020 · ISO/TC 194ISO 10993-15:2019PublishedBiological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloysInternational Standard · Published 26 Nov 2019 · ISO/TC 194ISO 10993-9:2019PublishedBiological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsInternational Standard · Published 26 Nov 2019 · ISO/TC 194ISO 10993-11:2017PublishedBiological evaluation of medical devices — Part 11: Tests for systemic toxicityInternational Standard · Published 14 Sep 2017 · ISO/TC 194ISO 10993-4:2017PublishedBiological evaluation of medical devices — Part 4: Selection of tests for interactions with bloodInternational Standard · Published 12 Apr 2017 · ISO/TC 194ISO 10993-16:2017PublishedBiological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesInternational Standard · Published 16 May 2017 · ISO/TC 194ISO/TR 10993-22:2017PublishedBiological evaluation of medical devices — Part 22: Guidance on nanomaterialsTechnical Report · Published 14 Jul 2017 · ISO/TC 194ISO 10993-13:2010PublishedBiological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devicesInternational Standard · Published 4 Jun 2010 · ISO/TC 194ISO 10993-5:2009PublishedBiological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicityInternational Standard · Published 20 May 2009 · ISO/TC 194ISO/TS 10993-20:2006PublishedBiological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devicesTechnical Specification · Published 3 Aug 2006 · ISO/TC 194ISO 10993-14:2001PublishedBiological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramicsInternational Standard · Published 22 Nov 2001 · ISO/TC 194ISO/TS 11796:2023PublishedBiological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devicesTechnical Specification · Published 27 Jul 2023 · ISO/TC 194ISO 13022:2012PublishedMedical products containing viable human cells — Application of risk management and requirements for processing practicesInternational Standard · Published 21 Mar 2012 · ISO/TC 194ISO 14155:2026PublishedClinical investigation of medical devices for human subjects — Good clinical practiceInternational Standard · Published 23 Mar 2026 · ISO/TC 194